What are the key components of informed consent in healthcare. How does informed consent protect patient autonomy. When can informed consent be waived in medical situations. What are the legal standards for adequate informed consent.

The Fundamental Principles of Informed Consent

Informed consent is a crucial ethical and legal obligation for healthcare providers in the United States. It stems from the patient’s fundamental right to make decisions about their own body and medical care. This process involves educating patients about the risks, benefits, and alternatives of proposed procedures or interventions, ensuring they can make voluntary and competent decisions about their healthcare.

The Joint Commission has established specific requirements for documenting informed consent discussions. These elements must be recorded in the patient’s medical record, whether in a dedicated form, progress notes, or elsewhere. The five essential components that must be documented are:

1. The nature of the procedure
2. The risks and benefits of the procedure
3. Reasonable alternatives
4. Risks and benefits of alternatives
5. Assessment of the patient’s understanding of elements 1 through 4

Healthcare providers must emphasize the patient’s active role in the decision-making process and avoid any perception of coercion. Additionally, the provider should offer a clear recommendation along with their reasoning for it.

Legal Approaches to Adequate Informed Consent

The standard for adequate informed consent varies by state, with three primary legal approaches recognized:

• Subjective standard: Focuses on the specific patient’s information needs
• Reasonable patient standard: Considers what an average patient would need to know
• Reasonable physician standard: Based on what a typical physician would disclose

Many states adopt the “reasonable patient standard” as it centers on the information a typical patient would require to make an informed decision. However, it remains the healthcare provider’s responsibility to determine the most appropriate approach for each unique situation.

Are there situations where informed consent can be bypassed?

Yes, there are specific circumstances where obtaining informed consent may not be required or possible. These exceptions include:

• Patient incapacitation
• Life-threatening emergencies with insufficient time to obtain consent
• Voluntary waiver of consent by the patient

In cases where a patient’s decision-making capacity is questionable, a psychiatric evaluation may be necessary to determine competency. If a patient is unable to make decisions independently and has not designated a decision-maker, healthcare providers must follow the state-specific hierarchy of surrogate decision-makers. In some instances, a court-appointed legal guardian may be required.

Informed Consent and Minors: Special Considerations

Children, typically those under 17 years of age, cannot provide informed consent. Instead, parents or legal guardians must give “informed permission” for treatments or interventions. However, there are exceptions to this rule, such as legally emancipated minors who can provide their own informed consent.

Examples of emancipated minors may include:

• Minors under 18 who are married
• Those serving in the military
• Individuals who can prove financial independence
• Mothers of children (regardless of marital status)

It’s important to note that legislation regarding minors and informed consent varies by state. Healthcare providers must be familiar with the specific laws in their jurisdiction to ensure compliance and protect patient rights.

The Importance of Informed Consent in Blood Transfusions

Informed consent plays a critical role in maintaining patient autonomy during blood transfusion procedures. This process requires healthcare providers to have a comprehensive understanding of transfusions and the ability to effectively communicate this information to patients in an understandable manner.

Research has shown that involving experts from transfusion units in the informed consent process can significantly improve patients’ comprehension of the risks and benefits associated with transfusions. However, this approach may not always be practical or efficient in all healthcare settings.

What are the common types of blood transfusions and their indications?

One of the most common types of blood transfusions involves red blood cells. This procedure is typically indicated in cases of acute blood loss exceeding 1,500 mL or 30% of the patient’s blood volume. Understanding these indications is crucial for healthcare providers when discussing the necessity and potential benefits of a transfusion with patients.

Challenges in Obtaining Informed Consent for Blood Transfusions

Despite the importance of informed consent in blood transfusion procedures, there are often deficiencies in the explanation provided to patients. Benefits may be overstated, while certain risks might be omitted. This highlights the need for improved education and training in transfusion medicine for healthcare providers, especially new graduates.

Studies have shown that physicians who have received specific education in transfusion medicine demonstrate a better understanding of the subject compared to those without such training. Given that most physicians will need to obtain informed consent for a transfusion at some point in their career, there is a strong argument for incorporating comprehensive transfusion medicine education into medical curricula.

Enhancing the Informed Consent Process

To improve the quality and effectiveness of informed consent discussions, healthcare providers should consider the following strategies:

1. Use plain language and avoid medical jargon when explaining procedures
2. Provide written materials to supplement verbal explanations
3. Encourage patients to ask questions and voice concerns
4. Utilize visual aids or diagrams to illustrate complex concepts
5. Allow sufficient time for patients to process information and make decisions
6. Regularly assess and document the patient’s understanding throughout the process

By implementing these strategies, healthcare providers can ensure that patients are truly informed and empowered to make decisions about their care.

Legal Implications of Informed Consent

Failure to obtain proper informed consent can have significant legal consequences for healthcare providers and institutions. It may lead to allegations of medical malpractice or battery, resulting in costly litigation and damage to professional reputations.

How can healthcare providers protect themselves legally while ensuring patient autonomy?

To minimize legal risks and uphold ethical standards, healthcare providers should:

• Thoroughly document all informed consent discussions
• Use standardized consent forms that cover all required elements
• Stay updated on state-specific laws and regulations regarding informed consent
• Regularly review and update informed consent protocols
• Provide ongoing training for staff on effective communication and consent procedures

By prioritizing comprehensive and patient-centered informed consent practices, healthcare providers can protect both their patients’ rights and their own professional interests.

Cultural Considerations in Informed Consent

In an increasingly diverse healthcare landscape, it’s essential to consider cultural factors that may influence the informed consent process. Different cultures may have varying attitudes towards medical decision-making, autonomy, and the role of family members in healthcare choices.

How can healthcare providers navigate cultural differences in informed consent?

To ensure culturally sensitive and effective informed consent, providers should:

• Be aware of cultural norms and beliefs that may impact decision-making
• Use professional interpreters when language barriers exist
• Respect family involvement in decision-making when appropriate
• Provide culturally tailored educational materials
• Allow for additional time and resources to address cultural concerns
• Seek guidance from cultural liaisons or ethics committees when necessary

By acknowledging and accommodating cultural differences, healthcare providers can ensure that the informed consent process is inclusive and respectful of all patients’ backgrounds and beliefs.

Technology and Informed Consent: New Frontiers

As healthcare continues to evolve, new technologies are emerging that may transform the informed consent process. Digital tools, multimedia presentations, and interactive platforms offer innovative ways to enhance patient understanding and engagement.

What are some promising technological advances in informed consent?

Several technological innovations are showing potential to improve the informed consent process:

• Interactive digital consent forms with embedded educational content
• Virtual reality simulations to illustrate procedures and outcomes
• Artificial intelligence-powered chatbots to answer patient questions
• Mobile apps for ongoing consent management and communication
• Blockchain technology for secure and transparent consent documentation

While these technologies offer exciting possibilities, it’s crucial to ensure that they complement rather than replace meaningful human interaction in the informed consent process. Healthcare providers must strike a balance between leveraging technology and maintaining the personal touch that is essential to building trust and understanding with patients.

Informed Consent in Clinical Research

The principles of informed consent are particularly critical in the context of clinical research. Participants in research studies must be fully aware of the potential risks, benefits, and alternatives before agreeing to participate. The informed consent process in research is typically more rigorous and closely regulated than in routine clinical care.

What additional considerations apply to informed consent in clinical trials?

When obtaining informed consent for clinical research, investigators must address several key points:

• The experimental nature of the study and its purpose
• The duration of participation and required procedures
• Potential risks and discomforts, including unknown risks
• Potential benefits to the participant and others
• Alternative treatments or procedures available
• Compensation and treatment available in case of injury
• The voluntary nature of participation and the right to withdraw
• Confidentiality measures and limits
• Contact information for questions or concerns

Research ethics committees or Institutional Review Boards (IRBs) play a crucial role in overseeing the informed consent process in clinical trials, ensuring that participants’ rights and welfare are protected throughout the study.

As the landscape of healthcare and medical research continues to evolve, the principles of informed consent remain fundamental to ethical practice. By prioritizing clear communication, patient understanding, and respect for autonomy, healthcare providers and researchers can uphold the highest standards of care and scientific integrity.

Informed Consent – StatPearls – NCBI Bookshelf

Introduction

Informed consent is the process in which a health care provider educates a patient about the risks, benefits, and alternatives of a given procedure or intervention. The patient must be competent to make a voluntary decision about whether to undergo the procedure or intervention.  Informed consent is both an ethical and legal obligation of medical practitioners in the US and originates from the patient’s right to direct what happens to their body. Implicit in providing informed consent is an assessment of the patient’s understanding, rendering an actual recommendation, and documentation of the process. The Joint Commission requires documentation of all the elements of informed consent “in a form, progress notes or elsewhere in the record.” The following are the required elements for documentation of the informed consent discussion: (1) the nature of the procedure, (2) the risks and benefits and the procedure, (3) reasonable alternatives, (4) risks and benefits of alternatives, and (5) assessment of the patient’s understanding of elements 1 through 4.

It is the obligation of the provider to make it clear that the patient is participating in the decision-making process and avoid making the patient feel forced to agree to with the provider. The provider must make a recommendation and provide their reasoning for said recommendation.[1][2][3]

Issues of Concern

Adequacy of Informed Consent

The required standard for informed consent is determined by the state. The three acceptable legal approaches to adequate informed consent are (1) Subjective standard: What would this patient need to know and understand to make an informed decision? (2) Reasonable patient standard: What would the average patient need to know to be an informed participant in the decision? (3) Reasonable physician standard: What would a typical physician say about this procedure?

Many states use the “reasonable patient standard” because it focuses on what a typical patient would need to know to understand the decision at hand. However, it is the sole obligation of the provider to determine which approach is appropriate for a given situation.[4][5][6][5]

Exceptions to Informed Consent

Several exceptions to the requirement for informed consent include (1) the patient is incapacitated, (2) life-threatening emergencies with inadequate time to obtain consent, and (3) voluntary waived consent.  If the patient’s ability to make decisions is questioned or unclear, an evaluation by a psychiatrist to determine competency may be requested. A situation may arise in which a patient cannot make decisions independently but has not designated a decision-maker. In this instance, the hierarchy of decision-makers, which is determined by each state’s laws, must be sought to determine the next legal surrogate decision-maker. If this is unsuccessful, a legal guardian may need to be appointed by the court.

Children and Informed Consent

Children (typically under 17) cannot provide informed consent.  As such, parents must permit treatments or interventions. In this case, it not termed “informed consent” but “informed permission.”  An exception to this rule is a legally emancipated child who may provide informed consent for himself. Some, but not all, examples of an emancipated minor include minors who are (1) under 18 and married, (2) serving in the military, (3) able to prove financial independence or (4) mothers of children (married or not). Legislation regarding minors and informed consent is state-based as well. It is important to understand the state laws.

Informed Consent for Blood Transfusion

Informed consent is essential to patient autonomy. Informed consent requires a thorough understanding of transfusions and the ability to convey this information to a patient in a way that they can understand it. However, obtaining consent often has deficiencies in the explanation where benefits may not be entirely true and risks related are omitted.[7]. It has been shown that involving experts from transfusion units in obtaining informed consent for transfusion results in patients having a better understanding of the risks and benefits.[8] However, always involving an expert may not be the most efficient way to obtain consent, although new graduate physicians have a knowledge deficit when it comes to transfusion medicine. However, physicians that had previous transfusion medicine education displayed more understanding than those who did not[9].  As most physicians will need to obtain informed consent for a transfusion at one point in their career, it could be argued that physicians should have enough education in regards to transfusion medicine.

The types of transfusions and their indications are:

1. Red blood cells

   • Acute blood loss of greater than 1,500 mL or 30% of blood volume or acute blood loss causing hemodynamic instability

   • Symptomatic anemia (myocardial ischemia, orthostatic hypotension, dyspnea at rest, tachycardia that is not responsive to fluid resuscitation) when hemoglobin is less than 10 g/dL

   • Hemoglobin of less than 7 g/dL in asymptomatic patients, hemodynamically stable patients in intensive care, and patients undergoing cardiovascular surgery[10][11][10]
   • Hemoglobin of less than 8 g/dL in patients with cardiovascular disease or postoperatively[12][13]
2. Fresh frozen plasma

   • Can be used for apheresis in thrombotic thrombocytopenic purpura or hemolytic uremic syndrome

   • Acute disseminated intravascular coagulopathy with active bleeding

   • Emergent reversal of warfarin in major or intracranial hemorrhage, prophylactically in an emergent surgical procedure

   • An International Normalized Ratio > 1.6 in hereditary clotting factor deficiencies, preventing active bleeding in a patient on anticoagulants prior to an invasive procedure, or with active bleeding

3. Platelets

   • Platelet count of < 10,000/mL in stable patients without active bleeding

   • < 20,000/mL stable patients without active bleeding with fever or are undergoing an invasive procedure

   • < 50,000/mL in surgery with active bleeding

   • ≤ 50,000/mL in major surgery or invasive procedure without active bleeding

   • ≤ 100,000/mL in ocular surgery or neurosurgery without active bleeding

5. Massive transfusion protocol

Adverse effects of transfusions[14]:

• Acute hemolytic reaction

  • The recipient’s antibodies attack transfused red blood cells whether caused by a reaction to the ABO blood group or antibodies produced from previous transfusions. Acute hemolytic transfusions occur within 24 hours of transfusion. Symptoms include fever, nausea, vomiting, dyspnea, hypotension, bleeding, pain at the infusion site, oliguria, anuria, dyspnea, or chest or back pain.

• Allergic reaction

  • It can present ranging from mild to life-threatening allergic reactions. Patients with mild symptoms may present with hives. More severe reactions will present with hypotension, angioedema, stridor, respiratory distress, or shock. These symptoms usually present within seconds to minutes of beginning a transfusion.

• Febrile nonhemolytic reaction
• Transfusion-associated circulatory overload

  • Transfusion-associated circulatory overload (TACO) is caused by the rapid infusion of blood products which overwhelms the recipient’s circulatory system. Patients may present with tachycardia, hypertension, dyspnea, and cough. Patients will have pulmonary edema on chest radiography as well as elevated brain natriuretic peptide levels.

• Transfusion-related acute lung injury

  • Transfusion-related acute lung injury (TRALI) is caused by an activation of the recipient’s immune system causing massive noncardiogenic pulmonary edema that causes hypoxemia. TRALI occurs within 6 hours of a transfusion. Patients will present with respiratory distress, usually within 1 to 2 hours of initiating a transfusion. Patients will have pulmonary infiltrates on chest radiography.

• Delayed hemolytic reaction

• Over and under transfusion

• Transfusion-associated graft-versus-host disease

  • Transfusion-associated graft-versus-host disease (GVHD) is caused by donor lymphocytes in blood products proliferating and mounting an attack against the recipient’s tissues and organs. It is most common in immunocompromised or in patients receiving a transfusion with shared HLA haplotypes. Symptoms of transfusion-associated graft-versus-host disease are fever, diarrhea, rash, liver dysfunction, and pancytopenia. Transfusion-associated GVHD has a mortality rate of 90%.

• Transfusion-related immunomodulation
  • Transfusion-related immunomodulation is the immunosuppressive effect of transfused blood products leading to postoperative infection, tumor recurrence, and nosocomial infection in critically ill patients. [15]

• Infection or contamination

Clinical Significance

Informed consent is required for many aspects of health care.[16][17][1] These include consent for:

1. Treatment, 

2. dissemination of patient information, 

3. discussion of HIPPA laws, 

4. specific procedures, 

5. surgery, 

6. blood transfusions, and 

7. anesthesia.  

Obtaining informed consent in medicine is process that should include: (1) describing the proposed intervention, (2) emphasizing the patient’s role in decision-making, (3) discussing alternatives to the proposed intervention, (4) discussing the risks of the proposed intervention and (5) eliciting the patient’s preference (usually by signature). Discussion of all risks is paramount to informed consent in this context. Most consent includes general risks, risks specific to the procedure, risks of no treatment and alternatives to treatment.  Additionally, many consent forms express that there are no guarantees that the proposed procedure will provide a cure to the problem being addressed.

Patient safety is a major focus in health care, and effective informed consent is considered a patient safety issue. The Joint Commission recently addressed the challenges to ensuring effective informed consent. The emphasis of a patient signature as an indication of understanding is being called into question. The process of informed consent is shifting to focus more on communication and less on signatures. Studies of informed consent have found that there are many barriers to obtaining effective informed consent. One major barrier is that some consent forms contain language that is at too high a reading level for many patients. Use of visual and digital communication tools is being encouraged to address some the inefficiencies in the process of obtaining consent. Patients should be actively engaged as a way to enhance communication and ensure patient safety and understanding. 

Informed consent may be waived in emergency situations if there is no time to obtain consent or if the patient is unable to communicate and no surrogate decision maker is available. Also, not every procedure requires explicit informed consent. For example taking a patient’s blood pressure is a part of many medical treatments. However, a discussion regarding the risks and benefits of using a sphygmomanometer usually is not required.

Clinical Significance in Human Clinical Studies

Informed consent is mandatory for all clinical trials involving human beings. The consent process must respect the patient’s ability to make decisions and adhere the individual hospital rules for clinical studies. Adherence to ethical standards in study design and execution is usually monitored by an Institutional Review Board (IRB). The IRB was established in the United States in 1974 by the National Research Act which called for regulation in human research that was prompted by questionable research tactics used in the Tuskegee syphillis experiments and others. Ethical and safe research standards have been an area of federal and presidential interest since then, with the development of many organizations and task forces since 1974 dedicated to this topic alone. Valid informed consent for research must include three major elements: (1) disclosure of information, (2) competency of the patient (or surrogate) to make a decision, and (3) voluntary nature of the decision. US federal regulations require a full, detailed explanation of the study and its potential risks. 

An IRB may waive informed consent if certain conditions are met.  Paramount to this is that there be ‘minimal risk’ to the research participants. One example of minimal risk research is the assessment of interventions that normally occur in emergency situations. Examples of this include studying medications used for intubations in the emergency room or conducting a retrospective chart review.

Shared Decision Making

Informed consent is a collaborative process allowing patients and healthcare providers to make decisions together when more than one reasonable alternative exists, accounting for the patient’s unique preferences and priorities and the best scientific evidence available.  

It is most appropriate in weighing the benefits and harms of invasive procedures, computed tomography (CT), and post-ED disposition including the use of thrombolytics for acute ischemic stroke, lumbar puncture to rule out subarachnoid hemorrhage, and CT for minor pediatric head injuries.

Shared decision-making (SDM) challenges in Emergency Medicine include patient, provider, system and evidence level limitations. Examples include: (1) if patients are capable of or willing to engage in decision making (2) if providers feel it provides more or less medico-legal protection, (3) if the Emergency Department is overwhelmed and time is of the essence to make decisions, and (4) if the facility lacks well-validated risk prediction tools to guide decision making.

Enhancing Healthcare Team Outcomes

As mentioned previously, there is a deficit in providing necessary information to patients when obtaining informed consent. Providers should be educated on common procedures and interventions from experts and should be able to relay this information to patients as well as other members of the healthcare team. Members of the healthcare team, such as nurses and patient care assistants, should also be educated about all potential adverse reactions so that they are able to identify them and notify a provider so that any immediate intervention that is needed can be performed in a timely manner. Members of the healthcare team involved with the care of a patient should also be informed about procedures and interventions as they may be used as witnesses in obtaining informed consent. They would be able to evaluate whether all necessary information was given to the patient and provide any information the provider obtaining informed consent may have forgotten.

References

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Slim K, Bazin JE. From informed consent to shared decision-making in surgery. J Visc Surg. 2019 Jun;156(3):181-184. [PubMed: 31101549]

2.

Edwards S. Review of a medical illustration department’s data processing system to confirm general data protection regulation (GDPR) compliance. J Vis Commun Med. 2019 Jul;42(3):140-143. [PubMed: 31088229]

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Williams CM, Nester C, Morrison SC. International approaches to paediatric podiatry curricula: It’s the same, but different. J Foot Ankle Res. 2019;12:28. [PMC free article: PMC6507174] [PubMed: 31086569]

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Boskey ER, Johnson JA, Harrison C, Marron JM, Abecassis L, Scobie-Carroll A, Willard J, Diamond DA, Taghinia AH, Ganor O. Ethical Issues Considered When Establishing a Pediatrics Gender Surgery Center. Pediatrics. 2019 Jun;143(6) [PubMed: 31085738]

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Xu J, Prince AER. Shared decision-making in vascular surgery. J Vasc Surg. 2019 Nov;70(5):1711-1715. [PubMed: 31068265]

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Krüger M. [On the judgment by the Federal Court of Justice on living organ donors]. Chirurg. 2019 Jun;90(6):496-500. [PubMed: 31069415]

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Friedman M, Arja W, Batra R, Daniel S, Hoehn D, Paniz AM, Selegean S, Slova D, Srivastava S, Vergara N. Informed consent for blood transfusion: what do medicine residents tell? What do patients understand? Am J Clin Pathol. 2012 Oct;138(4):559-65. [PubMed: 23010711]

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Furumaki H, Fujihara H, Yamada C, Watanabe H, Shibata H, Kaneko M, Nagai S, Ishizuka K, Tsuzuki M, Adachi M, Takeshita A. Involvement of transfusion unit staff in the informed consent process. Transfus Apher Sci. 2016 Feb;54(1):150-7. [PubMed: 26878975]

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O’Brien KL, Champeaux AL, Sundell ZE, Short MW, Roth BJ. Transfusion medicine knowledge in Postgraduate Year 1 residents. Transfusion. 2010 Aug;50(8):1649-53. [PubMed: 20345564]

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Hébert PC, Wells G, Blajchman MA, Marshall J, Martin C, Pagliarello G, Tweeddale M, Schweitzer I, Yetisir E. A multicenter, randomized, controlled clinical trial of transfusion requirements in critical care. Transfusion Requirements in Critical Care Investigators, Canadian Critical Care Trials Group. N Engl J Med. 1999 Feb 11;340(6):409-17. [PubMed: 9971864]

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Carson JL, Stanworth SJ, Alexander JH, Roubinian N, Fergusson DA, Triulzi DJ, Goodman SG, Rao SV, Doree C, Hebert PC. Clinical trials evaluating red blood cell transfusion thresholds: An updated systematic review and with additional focus on patients with cardiovascular disease. Am Heart J. 2018 Jun;200:96-101. [PubMed: 29898855]

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Docherty AB, O’Donnell R, Brunskill S, Trivella M, Doree C, Holst L, Parker M, Gregersen M, Pinheiro de Almeida J, Walsh TS, Stanworth SJ. Effect of restrictive versus liberal transfusion strategies on outcomes in patients with cardiovascular disease in a non-cardiac surgery setting: systematic review and meta-analysis. BMJ. 2016 Mar 29;352:i1351. [PMC free article: PMC4817242] [PubMed: 27026510]

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Carson JL, Terrin ML, Noveck H, Sanders DW, Chaitman BR, Rhoads GG, Nemo G, Dragert K, Beaupre L, Hildebrand K, Macaulay W, Lewis C, Cook DR, Dobbin G, Zakriya KJ, Apple FS, Horney RA, Magaziner J., FOCUS Investigators. Liberal or restrictive transfusion in high-risk patients after hip surgery. N Engl J Med. 2011 Dec 29;365(26):2453-62. [PMC free article: PMC3268062] [PubMed: 22168590]

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Informed Consent Checklist (1998) | HHS.gov

§46.116 Informed Consent Checklist – Basic and Additional Elements

• A statement that the study involves research
• An explanation of the purposes of the research
• The expected duration of the subject’s participation
• A description of the procedures to be followed
• Identification of any procedures which are experimental
• A description of any reasonably foreseeable risks or discomforts to the subject
• A description of any benefits to the subject or to others which may reasonably be expected from the research
• A disclosure of appropriate alternative procedures or courses of treatment, if any, that might be advantageous to the subject
• A statement describing the extent, if any, to which confidentiality of records identifying the subject will be maintained
• For research involving more than minimal risk, an explanation as to whether any compensation, and an explanation as to whether any medical treatments are available, if injury occurs and, if so, what they consist of, or where further information may be obtained
• Research, Rights or Injury: An explanation of whom to contact for answers to pertinent questions about the research and research subjects’ rights, and whom to contact in the event of a research-related injury to the subject
• A statement that participation is voluntary, refusal to participate will involve no penalty or loss of benefits to which the subject is otherwise entitled, and the subject may discontinue participation at any time without penalty or loss of benefits, to which the subject is otherwise entitled

Additional Elements as Appropriate

• A statement that the particular treatment or procedure may involve risks to the subject (or to the embryo or fetus, if the subject is or may become pregnant), which are currently unforeseeable
• Anticipated circumstances under which the subject’s participation may be terminated by the investigator without regard to the subject’s consent
• Any additional costs to the subject that may result from participation in the research
• The consequences of a subject’s decision to withdraw from the research and procedures for orderly termination of participation by the subject
• A statement that significant new findings developed during the course of the research, which may relate to the subject’s willingness to continue participation, will be provided to the subject
• The approximate number of subjects involved in the study

§46.117 Documentation of Informed Consent Checklist

1. Except as provided in paragraph “c” of this section, informed consent shall be documented by the use of a written consent form approved by the IRB, and signed by the subject or the subject’s legally authorized representative. A copy shall be given to the person signing the form.

Written
The consent form may be either of the following:

1. A written consent document that embodies the elements of informed consent required by §46.116. This form may be read to the subject or the subject’s legally authorized representative, but in any event, the investigator should give either the subject or the representative adequate opportunity to read it before it is signed.

Done Orally

2. A short form written consent document, stating that the elements of informed consent required by §46.116 have been presented orally to the subject or the subject’s legally authorized representative. When this method is used, there shall be a witness to the oral presentation. Also, the IRB shall approve a written summary of what is to be said to the subject or the representative. Only the short form itself is to be signed by the subject or the representative. However, the witness shall sign both the short form and a copy of the summary, and the person actually obtaining consent shall sign a copy of the summary. A copy of the summary shall be given to the subject or the representative, in addition to a copy of the short form.

Waiver of Requirement for Signed Form

c. An IRB may waive the requirement for the investigator to obtain a signed consent form for some or all subjects, if it finds either:

1. That the only record linking the subject and the research would be the consent document, and the principal risk would be potential harm resulting from a breach of confidentiality. Each subject will be asked whether the subject wants documentation linking the subject with the research, and the subject’s wishes will govern; or

2. That the research presents no more than minimal risk of harm to subjects, and involves no procedures, for which written consent is normally required outside of the research context.

In cases in which the documentation requirement is waived, the IRB may require the investigator to provide subjects with a written statement regarding the research.

IRB Latitude to Approve a Consent Procedure that Alters or Waives some or all of the Elements of Consent

§ 46.116 – An IRB may approve a consent procedure, which does not include, or which alters, some or all of the elements of informed consent set forth in this section, or waive the requirements to obtain informed consent, provided the IRB finds and documents that:

• C: 1.The research or demonstration project is to be conducted by, or subject to the approval of, state or local government officials, and is designed to study, evaluate, or otherwise examine: (i) public benefit or service programs; (ii) procedures for obtaining benefits or services under those programs; (iii) possible changes in or alternatives to those programs or procedures; or (iv) possible changes in methods or levels of payment for benefits or services under those programs; and
• C: 2.The research could not practicably be carried out without the waiver or alteration.
• D: 1. The research involves no more than minimal risk to the subjects;
• D: 2.The waiver or alteration will not adversely affect the rights and welfare of the subjects;
• D: 3.The research could not practicably be carried out without the waiver or alteration; and
• D: 4.Whenever appropriate, the subjects will be provided with additional pertinent information after participation.

Special Requirements – 45 CFR 46 Subpart D – Additional DHHS Protections for Children Involved as Subjects in Research

Assent/Waiver

The IRB shall determine that adequate provisions are made for soliciting the assent of the children, when in the judgment of the IRB the children are capable of providing assent. If the IRB determines that the capability of some or all of the children is so limited that they cannot reasonably be consulted, or that the intervention or procedure involved in the research holds out a prospect of direct benefit that is important to the health or well-being of the children, and is available only in the context of the research, the assent of the children is not a necessary condition for proceeding with the research. Even where the IRB determines that the subjects are capable of assenting, the IRB may still waive the assent requirement under circumstances, in which consent may be waived in accord with §46.116 of Subpart A.

Parents

• The IRB may find that the permission of one parent is sufficient for research to be conducted under §46.404 or §46.405.
• Where research is covered by §46.406 and §46.407, and permission is to be obtained from parents, both parents must give their permission, unless one parent is deceased, unknown, incompetent, or not reasonably available, or when only one parent has legal responsibility for the care and custody of the child.
• If the IRB determines that a research protocol is designed for conditions or for a subject population, for which parental or guardian permission is not a reasonable requirement to protect the subjects (for example, neglected or abused children), it may waive the consent requirements in Subpart A of this part and paragraph (b) of this section, provided an appropriate mechanism for protecting the children who will participate as subjects in the research is substituted, and provided further that the waiver is not inconsistent with Federal, state or local law.

Chapter 13 – Informed Consent and Documentation | Human Research Protection Office (HRPO)

General Overview of Informed Consent

Informed consent is one of the primary ethical requirements underpinning research involving humans; it reflects the basic principle of respect for persons. It should always be remembered that informed consent is an ongoing process, not a single event, designed to provide potential research subjects with all of the relevant information they need to make a fully informed, autonomous decision as to whether they wish to participate in a research study. In general, informed consent is to be documented by the use of a written consent document, approved by the IRB, and signed (including in an electronic format) by the subject or the subject’s legally authorized representative. A copy of the consent form should be given to the person signing the informed consent document.

To assist investigators and coordinators who are conducting research, information regarding the informed consent process is provided on the HRP website A-Z Guidance. Examples and instructions are available, including guidelines for the informed consent process and sample language for the informed consent document. 

IRB Review of Informed Consent Process

During its review of the informed consent process described in the protocol, the IRB requires that:

• Adequate opportunity is provided to the subject or the subject’s legally authorized representative to read the consent document and ask questions regarding the study before the informed consent document is signed.
• The consent process minimizes the possibility of coercion or undue influence.  
• The consent discussion is in language understandable to the subject or the subject’s legally authorized representative.
• The prospective subject or the legally authorized representative must be provided with the information that a reasonable person would want to have in order to make an informed decision about whether to participate, and an opportunity to discuss that information.

General Requirements of Informed Consent

Informed consent as a whole must present information in sufficient detail relating to the research, and must be organized and presented in a way that does not merely provide lists of isolated facts, but rather facilitates the prospective participant’s or legally authorized representative’s understanding of the reasons why one might or might not want to participate.

No informed consent may include any exculpatory language through which the participant or the legally authorized representative is made to waive or appear to waive any of the participant’s rights, or releases, or appears to release, the investigator, the sponsor, the institution, or its agents from liability.  

Key Information

The concept of Key Information was introduced in the Revised Common Rule, and while it is only required for federally funded studies, there may be times when the IRB may request a Key Information section be included regardless of funding.  

Informed consent must begin with a concise and focused presentation of the key information that is most likely to assist a prospective participant or legally authorized representative in understanding the reasons why one might or might not want to participate in the research. This part of the informed consent must be organized and presented in a way that facilitates comprehension. For additional information about what should be included in the Key Information section, see the guidance on the HRP website entitled “Consent Guidance” 

Basic Elements of Informed Consent

• A statement that the study involves research, an explanation of the purposes of the research and the expected duration of the subject’s participation, a description of the procedures to be followed, and identification of any procedures that are experimental.
• A description of any reasonably foreseeable risks or discomforts to the subject.
• A description of benefits to the subject or others that may be reasonably expected from the research.
• The disclosure of appropriate alternative procedures or course of treatment, if any, that might be advantageous to the subject. Where applicable, informed consent must disclose to subjects when treatments identical to those offered by the research may be obtained outside of the research.
• A statement describing the extent to which confidentiality of records identifying the subject will be maintained.
• For research involving more than minimal risk, an explanation as to whether or not any compensation or any medical treatments are available if injury occurs during study participation and, if so, what they consist of, or where further information may be obtained;
• The identification of an individual who can be contacted by the subject for answers to questions related to the research, research-related injury, or their rights as a research subject;
• A statement that participation is voluntary, refusal to participate will involve no penalty or loss of benefits to which the subject is otherwise entitled, and the subject may discontinue participation at any time without penalty or loss of benefits to which s/he is otherwise entitled.
• One of the following statements about any research that involves the collection of identifiable private information or identifiable biospecimens:
  • A statement that identifiers might be removed from the identifiable private information or identifiable biospecimens, and that, after such removal, the information or biospecimens could be used for future research studies or distributed to another investigator for future research studies without additional informed consent from the subject or the legally authorized representative, if this might be a possibility; or
  • A statement that the subject’s information or biospecimens collected as part of the research, even if identifiers are removed, will not be used or distributed for future research studies.

Additional Elements of Informed Consent

• A statement that the particular treatment or procedure may involve risks to the subject (or to the embryo or fetus, if the subject is or may become pregnant) which are currently unforeseeable;
• Anticipated circumstances under which the subject’s participation may be terminated by the investigator without regard to the subject’s consent;
• Any additional costs to the subject that may result from participation in the research;
• The consequences of a subject’s decision to withdraw from the research and procedures for orderly termination of participation by the subject;
• A statement that significant new findings developed during the course of the research which may relate to the subject’s willingness to continue participation will be provided to the subject;
• The approximate number of subjects involved in the study.
• A statement that the subject’s biospecimens (even if identifiers are removed) may be used for commercial profit and whether the subject will or will not share in this commercial profit.
• A statement regarding whether clinically relevant research results will be disclosed to subjects, and if so, under what condition.
• For research involving biospecimens, whether the research will (if known) or might include whole genome sequencing (ie., sequencing of a human germline or somatic specimen with the intent to generate the genome or exome sequence of that specimen).

Broad Consent

UPitt will not approve research utilizing Broad Consent and research reviewed on or after January 21, 2019 will not be reviewed by the UPitt IRB as Exempt under categories 7 and 8

Consent Form Addendum

When subjects need to be informed of specific changes in the risk or benefit of study participation, an addendum consent, which focuses on the new information, may be more appropriate than a modified consent document.  A consent form addendum may also be used to inform enrolled subjects about significant new findings that may have a bearing on their willingness to continue participation in the study.

Informed Consent | American Medical Association

Code of Medical Ethics Opinion 2.1.1

Code of Medical Ethics Opinion 2.1.1

Informed consent to medical treatment is fundamental in both ethics and law. Patients have the right to receive information and ask questions about recommended treatments so that they can make well-considered decisions about care. Successful communication in the patient-physician relationship fosters trust and supports shared decision making.

The process of informed consent occurs when communication between a patient and physician results in the patient’s authorization or agreement to undergo a specific medical intervention. In seeking a patient’s informed consent (or the consent of the patient’s surrogate if the patient lacks decision-making capacity or declines to participate in making decisions), physicians should:

1. Assess the patient’s ability to understand relevant medical information and the implications of treatment alternatives and to make an independent, voluntary decision.
2. Present relevant information accurately and sensitively, in keeping with the patient’s preferences for receiving medical information. The physician should include information about:
   1. The diagnosis (when known)
   2. The nature and purpose of recommended interventions
   3. The burdens, risks, and expected benefits of all options, including forgoing treatment
3. Document the informed consent conversation and the patient’s (or surrogate’s) decision in the medical record in some manner. When the patient/surrogate has provided specific written consent, the consent form should be included in the record.

In emergencies, when a decision must be made urgently, the patient is not able to participate in decision making, and the patient’s surrogate is not available, physicians may initiate treatment without prior informed consent. In such situations, the physician should inform the patient/surrogate at the earliest opportunity and obtain consent for ongoing treatment in keeping with these guidelines.

AMA Principles of Medical Ethics: I, II, V, VIII

Read more opinions about this topic

Read more opinions about this topic

Code of Medical Ethics: Informed Consent & Shared Decision Making

Visit the Ethics main page to access additional Opinions, the Principles of Medical Ethics and more information about the Code of Medical Ethics.

What Is Informed Consent?

Informed consent is a process of communication between you and your health care provider that often leads to agreement or permission for care, treatment, or services. Evey patient has the right to get information and ask questions before procedures and treatments. If adult patients are mentally able to make their own decisions, medical care cannot begin unless they give informed consent. 

The informed consent process makes sure that your health care provider has given you information about your condition along with testing and treatment options before you decide what to do.

This information can include:

• The name of your condition
• The name of the procedure or treatment that the health care provider recommends
• Risks and benefits of the treatment or procedure
• Risks and benefits of other options, including not getting the treatment or procedure

Signing informed consent means

• You have received all the information about your treatment options from your health care provider.
• You understand the information and you have had a chance to ask questions.
• You use this information to decide if you want to receive the recommended treatment option(s) that have been explained to you. Sometimes, you may choose to receive only part of the recommended care. Talk to your health care provider about your options.
• If you agree to receive all or some of the treatment options, you give your consent (agree) by signing a consent form. The completed and signed form is a legal document that lets your doctor go ahead with the treatment plan.

Why do I have to sign a consent form?

The main purpose of the informed consent process is to protect the patient. A consent form is a legal document that ensures an ongoing communication process between you and your health care provider. It implies that your health care provider has given you information about your condition and treatment options and that you have used this information to choose the option that you feel is right for you.

The way in which your treatment options must be given to you (for example, verbally or in writing) may be listed in your state’s laws. Your health care provider works with you to figure out the best way to give you the information you need. The provider may choose to use methods other than a verbal discussion or a written document, such as videos, interactive computer modules, audio files or other methods to help you understand the information better. Be sure you understand all the information given, even if it means going over it many times or asking your provider to explain it in different ways.

Can I change my mind after I’ve signed the consent?

Yes, you can change your mind at any time, even if you have already started treatment. Let your health care provider know of your wishes.

What if I don’t want the treatment being offered?

You have the right to refuse any and all treatment options. You may also choose other treatment options that have been presented to you by your health care provider, even if they are not as well proven as the one your health care provider recommends. You may also refuse part of the treatment options, without refusing all care.

For example, you may choose to refuse surgery, but still wish to be treated for pain. In this case, it may be up to you to find another health care provider or facility to treat you with such an approach if your health care provider is not comfortable with it.

If you have decided to refuse treatment or diagnostic tests, your health care provider may tell you about the risks or likely outcomes of this choice, so you can make an informed refusal (meaning, you understand what could happen to your health by refusing the recommended treatment but you still don’t want the treatment). In this case, you might be asked to sign a form to state that you received this information and that you still chose not to be treated.

What is shared decision-making?

Shared decision-making is actually part of the informed consent process and allows patients to play an active role in making decisions that affect their health. In shared decision-making, the health care provider and patient work together to choose tests, procedures, and treatments, and then to develop a plan of care. As described by the informed consent process, the provider gives the patient information about their condition and the pros and cons of all the treatment options. The patient then has a chance to ask questions and read more about the options. The patient also tells the health care provider what their preferences, personal values, opinions and such are about their condition and treatment options. The health care provider should always respect the patient’s preferences and goals, and use them to help guide the patient’s treatment recommendations. This type of decision-making is especially helpful when there is no single “best” treatment option.

What if I want the doctor to make the decisions about my care?

Treatment cannot be given without your consent, Unless care and treatment are needed in an emergency and you are unable to give consent. However, you have the right to refuse information and treatment. Or, in advance, you can assign a person to make decisions for you through an advance directive or other legal document. You can also ask for minimal information and trust your health care provider to make decisions for you. At the same time, informed consent laws do not allow a health care provider to keep a diagnosis from the patient, even at the family’s request.

Obtaining and Documenting Informed Consent

Consent Discussion (ongoing) ⇒ Give Experimental Subjects Bill of Rights (if applicable) ⇒ Sign Consent Form ⇒ Sign HIPAA Authorization (if applicable) ⇒ Consent Documentation (ongoing)

Informed Consent Overview

Consent for participation in research requires an informed consent process. This process involves an information exchange and on-going communication that takes place between the investigator (researcher) and the potential research participant (subject).

The consent process starts with the initial presentation of a research activity to a prospective subjective (including advertisements and notices), continues with a discussion and information exchange between the researcher and the prospective subject, and requires documenting that consent was obtained. The process may also be ongoing through the research activity until the participant decides to end his or her participation or until the study closes.

An effective informed consent process involves these elements:

Key Considerations

Several key considerations for obtaining informed consent are described below:

Informed consent from the subject and/or his legally authorized representative must be obtained prior to initiating any research activities, including screening procedures unless the IRB grants a waiver to do otherwise.

While the initial verbal explanation and dialogue with the subject are critical so that subjects know what they are agreeing to before they consent , ideally the consent process should be an ongoing conversation throughout the course of the study. Throughout the study, make yourself available to answer questions and encourage subjects to ask questions or voice concerns, tell subjects about changes in the study procedures or risks or alternatives, and allow subjects to withdraw from the study for any reason at any time.

With prior IRB approval, other methods of communicating information about a study may be used to supplement the consent process, or in rarer cases, substitute for a consent document. These approaches include the use of audio-visual materials, brochures, drawings and information posted on a specific website.

Principal investigators are responsible for assuring that all investigators obtaining consent are qualified and appropriately trained to explain the research and assess participant comprehension as described below. Any person who may obtain consent in a study should be listed in the IRB application as key personnel, though the person need not be listed as an investigator in the consent document itself.

• Decision-making capacity: Subjects should be able to understand the nature and consequences of the study. If they cannot, surrogate consent may be required. See general discussion of subject comprehension assessment below.
• Voluntariness: Subjects should be free from coercion when deciding to participate. This requires that researchers carefully evaluate, plan and implement the recruitment, consent documents, and the consent process as described below.

Obtaining Written or Verbal Informed Consent

Obtaining consent involves explaining the research and assessing participant comprehension using a consent document, usually a written consent form or information sheet, as a guide for the verbal explanation of the study. Informed consent from the participant and/or his or her legally-authorized representative (surrogate) must be obtained prior to initiating any research activities, including screening procedures.

Step One: Explaining the Research

Explain the study to the potential subject verbally, providing all pertinent information (purpose, procedures, risks, benefits, alternatives to participation), and allow the potential participant ample opportunity to ask questions or voice concerns. Do not read the consent document verbatim but, rather, paraphrase the information checking for comprehension and allowing for questions throughout the process. For some studies, it would be appropriate to include family members or close friends in the process.

After a verbal explanation, provide the potential subject the written consent form or information sheet (as required by the IRB), and afford sufficient time to absorb and appreciate the information to consider whether or not to participate in the research.

The time needed will vary depending on the complexity and/or nature of the research. Potential subjects, particularly those in higher risk studies, may need a waiting period and should be encouraged to discuss their possible participating with family members, close friends or trusted advisers.

After allowing the potential participant time to read the consent form/information sheet, meet with the potential participant and address any additional questions or concerns he or she might have.

Step 2: Assessing Subject Comprehension

The responsibility of ensuring that a potential subject understands the research and the risks and benefits involved falls primarily upon the investigator, not the potential subject.

Answer questions, but also ask questions to further the discussion and elicit questions from the potential participant. This will prompt the potential subject to think more carefully about the study.

Open-ended questions are those that begin with “who,” “what,” “when,” “where,” “why,” “how often,” or “please describe….”

Examples of open-ended questions:

• “Describe in your own words the purpose of this study.”
• “Would you explain to me what you will have to do if you are in the study?”
• “Can you tell me some other options for your care you would have if you decide not to participate in this study?”
• “What else would you like to know about this study?”
• “What is a possible benefit to you if you participate in this study?”
• “What are the possible risks to you if you participate in this study?”
• “How long does participation in this study last?”
• “Why are you eligible to participate in this study?”
• “Where will the study take place?”
• “Will you receive the investigational drug if you are in this study?”
• “Whom should you contact if you have questions or experience side effects once the study begins?”

Avoid or limit close-ended questions that ask for “yes” or “no” answers. Examples of closed-ended questions:

• “Do you understand what we are asking you to do?”
• “Do you have any questions?”
• “Do you understand there are risks to taking the study drug?”

Based upon the above, assess whether the potential participant adequately understands the study.

Consider using this decision-making capacity tool if needed to assess subject comprehension. Other tools and information about this topic may be available in your department and are also available on other UC IRB websites and elsewhere.

Documenting Informed Consent

Consent Discussion (ongoing) ⇒ Give Experimental Subjects Bill of Rights (if applicable) ⇒ Sign Consent Form ⇒ Sign HIPAA Authorization (if applicable) ⇒ Consent Documentation (ongoing)

Documenting informed consent occurs after explaining the research and assessing participant comprehension. At minimum, it involves obtaining the signature of the participant (or the legally-authorized representative or parent(s), when approved) as well as the person obtaining consent. The person obtaining consent indicates he/she has explained the research to the participant, ensured that the participant understand the research and that the subject freely consents to participate.

In most cases, the federal regulations require that informed consent be documented, but they also provide some important exceptions. See Verbal, Electronic or Implied Consent for more information.

Consent Documentation

Ensure subjects sign the currently approved consent form by printing the stamped copy from iRIS (not required, but strongly encouraged).

• Once participant agrees (or legally authorized representative [LAR] or parent(s) agrees on participant behalf) to participate in study, participant (or LAR or parent(s)) should sign and date the consent form.
• The person who has oriented and obtained consent must also sign and date the consent form, after the participant signs.
• A witness signature is not required except in limited circumstances. 

Give subjects a signed copy and keep the original signed copy in your research file.

Note in the research file when and with whom the consent discussion took place and if there were any issues.

Include a copy of the consent form in the medical record when study may affect subject’s health/treatment, and it would be helpful to share research-related treatment information with UCSF providers who may not be aware of the subject’s study participation. Also document when the consent process took place in the medical record.

Important Note: No changes may be made to the consent form (including crossing out or striking through the consent form text or making any changes in the wording) with out prior approval from the IRB.

Witness signatures are required by federal regulations in very limited circumstances and can be required by the IRB to assure an adequate informed consent process for some research studies.

Examples:

When required the witness must be impartial, such as an adult who is not a member of the study team and preferably who is not a family member of the participant (unless the person is a health professional or otherwise knowledgeable about research). The witness must sign and date the consent form at the time the consenting process occurs.A signature of the witness means:

• The requirements for informed consent have been satisfied.
• Consent is voluntary and freely given by the participant, guardian or legally-authorized representative.

Important Note: The California Medical Experiment Act requires attestation that the consent form is signed and dated by a person other than the participant or the participant’s guardian or legally-authorized representative who can attest that the requirements for informed consent has been met. At UCSF, the Investigator’s signature serves this purpose, unless an impartial witness is required as described above.

Additional Forms Required for Clinical Research

Experimental Participants Bill of Rights (BoR)

California state law (Health & Safety Code, Section 24172) requires that an “experimental subject’s bill of rights” be provided to all participants in a medical experiment. The IRB has interpreted “medical experiments” to include almost studies involving biomedical procedures, placebo controls, innovative therapy and/or normal volunteer subjects in studies involving more than minimal risks.

This list of rights must be written in a language in which the participant is fluent. Several translations are available.

If subjects should receive the Bill of Rights …

Include template language about the Bill of Rights in the “Consent” section of the consent form.

This form does not need to be signed, unless the study is being done under the auspices of the UCSF Helen Diller Family Comprehensive Cancer Center.

You do not need to submit this form to the IRB.

Give each subject a copy of the Bill of Rights. Then document that you gave the BoR to each individual subject by one of the following methods:

• Keep a copy of the BoR in the subject’s study file with the signed consent form (and HIPAA authorization if applicable), OR
• Write a note that the subject received the BoR on the consent form (study file copy) OR
• Write a note in the subject’s research record OR
• Add a subject signature line to the BoR and keep a copy in research file.

Important Note: The Cancer Center requires that subjects sign the BoR and that a signed copy is given to the subjects and kept in the file.

HIPAA Authorization Form

HIPAA allows researchers/UCSF personnel to access, use, create or disclose the individual’s protected health information (PHI) for research purposes. Check your approval letter (initial or continuing review) to see if subjects need to sign a HIPAA authorization form!

If subjects need to sign a HIPAA authorization…

Include HIPAA-specific template language in the “Consent” section of the consent form.

Submit this form to the IRB as an Other Study Document.

Review the information in the HIPAA research authorization form and ask subject to sign the document. Give a signed copy to the subject and keep the original signed form in the research file. A signed copy also should be kept with the consent form in the medical record, if applicable.

When and How

to “Reconsent” and Significant New Findings

Obtaining a signature on a consent form does not complete the consent process. Maintaining informed consent requires that you provide subjects with any new information that arises during the course of the study that may have an impact on the details of their participation or their decision about whether or not to continue participation in the study.

Important Note:

1. Except in the rare emergency situation, it is important to consult with or seek IRB approval before instituting any “reconsenting” procedures or informing current or previous subjects of significant new findings.
2. See the What, When and How to Report AEs section of the Adverse Event guidance page for more details about how to report significant new findings to the subjects and to the IRB, including how the level of urgency determines how to communicate the info.

Examples of When “Reconsenting” Is Required

• Risk/benefit profile is changed:
  • New risks are identified
  • Increases in risks are identified
  • Decreases in expected benefit are identified
• Research procedures are added that increase risks or burdens of participants.
• Research studies involving participants who may lose the capacity to consent for themselves over the course of the study and will require surrogate consent (i.e. participants who may become increasingly cognitively impaired over time).

• Research studies involving participants who are children at the time of enrollment, but reach the age of consenting for themselves (in California, usually 18 years old) while study procedures or follow-up are still ongoing. See the Children and Minors in Research page for more info. 

• If the Conflict of Interest Advisory Committee (COIAC) determines that the PI has a conflict of interest and enrollment has already begun.

Procedures for “Reconsenting” Subjects Already Enrolled in a Study

When the above changes occur, use the Consent Form Addendum and obtain signed consent when any of the changes discussed above occur. This Consent Form Addendum is a one page simple form that briefly describes what changes have been made since the subject’s last signed consent. The Consent Form Addendum is designed to facilitate the “re-consent” process by emphasizing the revisions. Subjects must sign the updated consent form.

Verbal notification is acceptable for minor changes, unless the sponsor or the SFVAMC require or you as the investigator want that all subjects be notified in writing and sign a Consent Form Addendum for all changes. Document in the subject’s research record after this verbal notification that you have had a consent discussion.

Minor changes are changes that decrease the subject burden or risks related to the study or have no impact on the risks/benefit profile of the study. For example, if you decrease the number of blood draws or office visits, or you make minor changes to the sample size, or you change some of the questions in the questionnaire or add a brief new questionnaire.

Subjects need not be reconsented at all in some cases. This would be when changes occur to the study that do not involve the consent form at all, for example, changes in investigators not listed in the consent form, or changes in procedure do not effect subjects. For example, a subject may have completed the part of the study with changes, or not be enrolled in the arm of the study that includes the changes.

Significant New Findings after Study Has Been Completed

In some cases, important new information about risks or benefits of the study drug or devices or procedures may become available after one, or some or all of the subjects have completed the study. If possible within a reasonable amount of time, previous subjects should be informed verbally or in writing of any significant findings. Some investigators will prepare a newsletter or study update to be sent to previous subjects up to two years after the study has ended.

When and How to “Reconsent” Change in PI

Is Re-consent required for a change in Principal Investigator (PI):

When a New PI is appointed to a study, this may impact existing study documents. Updates to Informed Consent documents may be required, and participants may need to be contacted. The following guidance outlines the scenarios in which study documents must be updated and when re-consent must be obtained from active study participants:

If a study is recruiting new subjects: The Informed Consent document must be updated. New participants must be consented on a revised, IRB approved consent document reflecting the new PI.

If a study has active subjects: It is important to ensure that study participants are made aware of new contact information, if this information has changed as a result of the change in PI. All active participants must be notified about the change in PI either verbally or via email/U.S. letter. Proposed language for communicating the change with participants must be submitted in the modification form.

Re-consent for active participants must occur if:

1. The new PI has a self-reported Conflict of Interest relevant to the study (COI)
2. If one or both of the following Informed Consent Form (ICF) sections is/are no longer accurate:

What happens if I am injured because I took part in this study?

It is important that you tell your study doctor, __________________ [investigator’s name(s)], if you feel that you have been injured because of taking part in this study. You can tell the doctor in person or call him/her at __________________ [telephone number].

Who can answer my questions about the study?

You can talk to your study doctor about any questions, concerns, or complaints you have about this study. Contact your study doctor(s)__________________ [name(s)] at __________________ [telephone number(s)].

When submitting the modification for the new PI in iRIS include:

1. The updated consent form reflecting the PI’s name and contact information
2. Please use the modification form to propose the plan for updating existing participants of the change in PI.
3. If participants will be informed via electronic communication or by U.S. Letter, please include the template communication in the submission as an attachment
4. If participants will be alerted by phone, include copies of the proposed phone script communication.

Understanding Informed Consent

Introduction

Patients have the legal and ethical right to direct what happens to them, and physicians have the ethical duty to involve patients in their health care. The concept of “informed consent” is an important way in which you participate actively in choices about your health care. While such consent may be informal in day-to-day medical care, it becomes more important if you are having a procedure such as surgery – and critically important if you are participating in research.

The concept of informed consent evolved after World War II, during which experiments were performed on prisoners without their consent. The war crimes tribunal established the Nuremberg Code, now accepted worldwide, with ten standards to which physicians must conform when carrying out experiments on humans. The requirements include voluntary informed consent, which protects your right to control your own body. The code also recognizes that you need the opportunity to weigh the risks of a procedure against the expected benefits. Finally, it requires that unnecessary pain and suffering be avoided.

Although the concept of informed consent was developed for research participants, it is now generally considered to be an important component of all aspects of health care.

What You Should Expect

Generally, the complete informed consent process includes the following:

• The physician explains the proposed decision/procedure to you;
• The physician presents reasonable alternatives to the proposed procedure;
• The physician summarizes the risks, benefits, and uncertainties related to each alternative;
• You are encouraged to ask questions and the physician evaluates your understanding of the procedure and risks;
• If you decide to approve the procedure, you provide oral or written consent, depending on the situation.

Once you have consented to a procedure, the physician can only perform the procedure you gave consent for, and only the physician you provided the consent to can perform the procedure.

In order for the consent to be valid, you must be competent to make the decision and your consent must be voluntary. Since you should actively participate in the decision-making process, the physician should explain the procedure in terms you can understand. Ultimately, the decision is yours, not the physician’s.

Oral vs. Written Consent

Most health care institutions have policies that state which health interventions require a signed consent form. These include surgery, anesthesia, and other invasive procedures. Signed consent forms are really the culmination of a dialogue required to help assure your informed participation in the clinical decision.

For a wide range of decisions, such as what medicine will be prescribed and drawing blood for lab tests, written consent is neither required nor needed; however, some meaningful discussion is still needed. Basic consent for such procedures entails physicians telling patients what they would like to do and asking patients if they agree.

When You Are Unable to Participate in Decisions

In most cases, it is clear whether or not patients are competent to make their own decisions. Occasionally, it is not so clear. Patients are under an unusual amount of stress during illness and can experience anxiety, fear, and depression. The stress associated with illness should not necessarily preclude patients from participating in their own care. There are several different standards of decision-making capacity. A patient should be able to:

• Understand his or her situation;
• Understand the risks associated with the decision at hand;
• Communicate a decision based on that understanding.

When this is unclear, a psychiatric consultation can be helpful. If a patient refuses a treatment, the physician cannot assume the patient is incompetent. Competent patients have the right to refuse treatment, including those treatments that may be life-saving. However, refusing treatment may indicate the need to pursue further the patient’s understanding of the risks and benefits of the procedure.

When You Cannot Give Informed Consent

If it is determined that a patient is incompetent to make the health care decision, a surrogate decision-maker must speak for him or her. There is a specific hierarchy of appropriate decision-makers defined by state law. If no appropriate surrogate decision-maker is available, physicians are expected to act in the best interest of the patient until a surrogate is found or appointed.

The Federal Patient Self-determination Act of 1991 and the New York State Healthcare Proxy Act of 1990 provide patients with the opportunity to designate an agent to act as their healthcare proxy in the event that they are no longer capable of making decisions in their own behalf.

Implied Consent

The patient’s consent should only be “presumed,” rather than explicitly obtained, in emergency situations when a patient is unconscious or incompetent and no surrogate decision maker is available. In general, the patient’s presence a hospital or clinic does not represent implied consent for all treatment and procedures. The patient’s wishes and values may be quite different than the values of the physician’s.

Informed Consent in the Context of Research

Informed consent in the research context is similar to informed consent in the clinical treatment setting, but more structured and detailed. Clinical (human subject) research is guided by federal regulations established by the U.S. Food and Drug Administration, including “The Privacy Rule,” known as HIPAA, the “Health Insurance Portability and Accountability Act.” More information about these regulations can be found on the HSS Clinical Trials page. The Hospital for Special Surgery Institutional Review Board (IRB) reviews, approves, and monitors all clinical research at HSS, with the primary responsibility of assuring that in the conduct of meaningful clinical research, the highest ethical standards and scientific integrity are maintained. And furthermore, that the rights, safety, and privacy of our research participants are protected at all times and without compromise.

The physician investigators must provide potential subjects (patients) with a clear written statement of the risks and benefits of the research – in language you can understand – and discuss those risks and benefits with you. You must have the ability to understand this information and evaluate it within the context of your own values. Your consent must be given voluntarily, without coercion or inappropriate inducement. You should understand that if you choose not to participate in the research, this will not affect the medical care you receive.

Because research is conducted over a period of time (as opposed to a one-time procedure) and because patient perceptions and external conditions may change over that time, there are additional ground rules for informed consent beyond those of typical medical and surgical care. It is important for subjects to know that they have the right to withdraw from any research study at any point in the process. Physicians should explain to you their role in the research, i.e., whether they are acting as a health care provider or as an investigator.

According to federal regulations, these are the basic elements of informed consent for human subject research:

• A statement that the study involves research;
• An explanation of the purposes of the research and the expected duration of the subject’s participation;
• A description of the procedures to be followed and identification of any procedures that are experimental;
• A description of any reasonably foreseeable risks or discomforts you may face;
• A description of any benefits to you or others that may reasonably be expected from the research;
• Disclosure of appropriate alternative procedures or courses of treatment, if any, that might be advantageous to you;
• A statement describing the extent, if any, to which confidentiality of records identifying you will be maintained and, if appropriate, that the FDA may inspect the records of the study;
• For research involving more than minimal risk, an explanation as to whether any compensation or medical treatments are available if injury occurs and, if so, what they consist of, or where further information may be sought;
• Contact information for answers to pertinent questions about the research and your rights as a research subject, and whom to contact if you experience a research-related injury;
• A statement that participation is voluntary and that refusal to participate or subsequent withdrawal, after consent, will involve no penalty or loss of benefits to which you are otherwise entitled.

When appropriate, one or more of the following elements of information must also be provided to each research participant:

• A statement that a particular treatment or procedure may involve risks to you (or to the embryo or fetus if you are or may become pregnant) that are currently unforeseeable;
• An explanation of the circumstances under which your participation in the research may be ended by the investigator without regard to your consent;
• Any additional costs to you that may result from participation in the research;
• An explanation of the consequences if you should decide to withdraw from the research and procedures for orderly withdrawal;
• A statement that significant new findings developed during the course of the research that may relate to your willingness to continue participation will be provided to you;
• The approximate number of participants involved in the research study;
• The source and terms of research funding.

Considering Research Participation

If you are considering participation in a research study, be sure to discuss it with your primary care physician. Find out from the researchers whether your day-to-day medical care will be provided by the study’s physicians or whether you will continue in the care of your own physicians – and how the researchers will communicate and coordinate your care with your physicians. Understanding these issues also should be part of informed consent.

Participating in a research study may benefit you directly and immediately but it may not; indeed, it may pose risks to you. However, the findings from the research will be used to help future patients. Research helps improve the scientific understanding of your disease so that other studies can be done and new ideas for treatment developed.

Updated: 6/30/2009

Authors

Betsy M. Iger,
Managing Editor
rheumatology.hss.edu

90,000 I. General Provisions / Consultant Plus

I. General provisions

1. Forms of informed voluntary consent and the donor questionnaire are filled in in accordance with these Instructions.

2. Forms of voluntary informed consent can be filled in by the patient or his legal representative, as well as by printing, including using computer technology, except for the lines “signature of the patient / legal representative” and “Signed in my presence: Doctor” …

3. When filling out the voluntary informed consent form, it is recommended to use fonts, ink (paste) in blue or black.

4. The patient has the right to refuse to complete these forms. In this case, it is allowed to obtain voluntary informed consent not on a form, but in a simple written form in compliance with the requirements of the legislation of the Russian Federation.

5. Forms of voluntary informed consent can be used in the provision of outpatient and inpatient care, as well as in a day hospital.

6. Voluntary informed consent for medical intervention, for anesthetic provision of medical intervention, for surgical intervention, incl. transfusion of blood and its components, for vaccination and for refusal of medical intervention and the donor’s questionnaire (hereinafter – “voluntary informed consent”) is taken before the provision of medical care from each patient or his legal representative, upon admission to inpatient treatment, in a day hospital, for invasive intervention in outpatient settings, as well as in other cases, regardless of gender, age, citizenship, national and religious affiliation, as well as belonging to the assigned contingent.

7. Each form must be certified by the patient’s own handwritten signature or his legal representative, as well as the signature of the doctor who received the patient’s voluntary informed consent.

For the patient’s handwritten signature, his legal

representatives and doctors are intended located at the bottom of the

blank rectangular field, the boundaries of which are indicated by dashed lines

—-

line: | X |.

—-

8. Forms (Appendices N 1-6) are used to obtain voluntary informed consent from persons who have reached 15 years of age, as well as to obtain voluntary informed consent of legal representatives of citizens under 15 years of age and persons recognized as legally incompetent.

9. The “Donor Questionnaire” form is used in the blood center and its branches, in the blood transfusion departments of the CMS / MSC / KB for donors who donate blood and / or its components.

10. Capable persons who have reached the age of 15 (over 14 years 11 months 30 days), sign the forms on their own.

11. Consent to medical intervention in respect of persons under 15 years of age, and citizens recognized as legally incompetent, is given by their legal representatives (parents: mother, father, adoptive parents, guardians or trustees) with indication of full name. O., passport data, family relations after informing them of the results of the examination, the presence of the disease, its diagnosis and prognosis, the methods of treatment, the associated risk, possible options for medical intervention, their consequences and the results of the treatment.

12. In the absence of legal representatives of an incapacitated citizen or whose condition does not allow expressing his will, the decision on the need for treatment is made by a council (the reverse side of the forms is filled in), and if it is impossible to collect a council, the attending (duty) doctor will immediately notify the chief physician of the clinical hospital (KB) or the clinic of the institute, the head of the central medical unit / medical unit, and on weekends, holidays, evening and night time – the responsible doctor on duty and legal representatives.

13. When sending children for sanatorium-rehabilitation treatment and rehabilitation to the Center of Sanatorium-Rehabilitation Treatment and Rehabilitation of the Federal State Institution “DKB N 38 – CEP FMBA of Russia” (formerly to the children’s sanatorium “Istra”) informed voluntary consent to medical intervention must be obtained from representatives of the child directly to the CMSC / MSC / KB (on the form of Appendix N 1). The completed form is handed over to the administration of the Center for Sanatorium and Rehabilitation Treatment and Rehabilitation of FGUZ “DKB No. 38 – CEP FMBA of Russia” with a person accompanying the children.In addition, the informed voluntary consent form can be drawn up by the legal representatives of the child directly upon the delivery of the child to the Center for sanatorium-rehabilitation treatment and rehabilitation.

14. In cases where the citizen’s condition does not allow him to express his will, and the need for treatment is urgent, the issue of informed voluntary consent in the interests of the citizen is decided by the consultation (the back of the forms is filled in), and if it is impossible to collect the consultation, by the attending (duty) doctor with the subsequent notification of the chief doctor of the KB or clinic of the institute, the head of the Central Medical Unit / Medical Center, and on weekends, holidays, evening and night time – the responsible doctor on duty.

15. It is not allowed to refuse treatment or medical intervention by persons suffering from diseases that pose a danger to others, persons suffering from severe mental disorders, or persons who have committed socially dangerous acts, on the grounds and in the manner established by the legislation of the Russian Federation. Additional information regulating the cases in which the refusal of medical intervention is not allowed are stipulated on the back of the form in Appendix No. 4.

16.If the parents or other legal representatives of a person under 15 years of age, or the legal representatives of a person recognized as legally incompetent, refuse medical assistance necessary to save the lives of these persons, the hospital institution has the right to go to court to protect the interests of these persons …

17. Filling out the forms of voluntary informed consent may be postponed in wartime, under martial law and a state of emergency, in case of mass admission to medical institutions of patients affected by factors of a physical, chemical or biological nature, in case of an outbreak of especially dangerous infections.

18. Additional information on issues not covered in this Instruction can be obtained from Monday to Friday (from 09:00 to 16:45 Moscow time) at the FMBA of Russia by phone: (499) 190 3314, or e-mail: fmba @ fmbaros.ru

90,000 Do you want to really understand how the doctor will treat you? Then why are you signing the informed consent form without reading it? /Meduza.io / Blog

This is a common practice in Russia – but it hurts both patients and doctors. And it can be changed.

In Russia, the informed voluntary consent form, which is signed by the patient, has become a formality. A person who allegedly agrees to some kind of intervention in an informed and voluntary manner usually has a poor idea of ​​what the doctor is actually planning to do. This problem exists all over the world, and it negatively affects the results of treatment. However, coping with it is real. See the end of this resource for specific patient advice.

In Russia, you cannot even examine a patient without informed voluntary consent

It used to be that the doctor knew better in any case how to deal with the patient, but he could not fully explain his plan to him.That is, you can try to tell in general terms what will happen – but the decision in the best interests of the patient is still made by the doctor. Over time, and mainly in Western countries, this approach began to change, and one of the main principles of medical ethics was the principle of patient autonomy.

It may seem to the doctor that the best option for the patient is surgery to remove the pain; but it may be important for the patient that after the intervention he will not be able to run, cook, travel or do anything else – very meaningful to him.Therefore, the patient is seriously considering the option not to carry out the operation, but, as an alternative, is ready to take painkillers on a regular basis.

Thus, the approach in which the patient must give his informed consent gradually prevailed. The obligatory nature of this process prescribed in the law protects the patient from interventions that do not suit him (although in Russia a person still has the right to refuse to be informed). And if the patient was not allowed to sign the informed voluntary consent form (IDS), regardless of the justification for the intervention, this gives the patient the right to compensation for moral harm.

By the way, if earlier it was enough for a doctor in Russia to verbally ask a patient whether he agrees to an injection, an operation or any other medical intervention, then since 2012 such consent must be obtained. Even when it comes to a simple examination or survey. According to the law, a healthcare professional must tell about:

• for the purpose of providing medical care;

90,071 methods of medical care;

90,071 associated risk;

90,071 alternatives to medical intervention;

90,071 consequences of medical intervention;

90,071 anticipated results.

And although informed voluntary consent should be obtained before all medical interventions, there are only a few officially approved forms of IDS (that is, much less than interventions with all their features). Moreover, in fact, the most popular form (concerning basic medical interventions such as examination) is approved only for cases when care is provided both on an outpatient basis or in a day hospital. In other words, usually such a form is signed in a city polyclinic, but there are no similar forms for hospitalized patients.Clinics that have to pay for help may use their own CID forms.

Often in Russia the informed consent form itself does not help in any way to inform a person. And even confuses

“In the form in which the informed voluntary consent form exists in the overwhelming majority of institutions, it does not have the function of informing (it is impossible to obtain complete information from this document, on the basis of which a decision can be made),” writes the oncologist, trainer for communication with patients Maxim Kotov.

The first (and sometimes only) time the IDS form is issued and asked to sign before talking with the doctor – and patients sign it without looking. “In private clinics, at best, when signing a contract, administrators briefly say what the patients are signing,” explains Ekaterina Dyukoreva, a pediatrician at DocDeti clinic, in a letter in response to Meduza’s question. – It sounds something like ‘this is consent to examination and medical manipulations.’ As far as I know, the [state] polyclinics do not do that either.<...> In fact, informed voluntary consent, which in general should protect the patient’s rights, meets with a rather strange implementation in our country. In fact, this is a simple formality, one more of a thousand pieces of paper that must be signed, because ‘this is how it should be’. ”

In general, it’s not surprising if you don’t know that, when attached to the city polyclinic, you agreed to 14 groups of medical interventions.

Of course, no one will forcibly inject painkillers or massage you – you can refuse almost everything.However, this is a fairly illustrative example of how this document works in Russia.

In the form of IDS approved by the Ministry of Health, there are not only those interventions that look risky – or for which there are real alternatives (like, in fact, examination or measuring the temperature), but also those about the features of which people usually know little. According to pediatrician Ekaterina Dyukoreva, it would definitely be worthwhile to discuss points nine through twelve with the patient in more detail (see the full list above).

In some cases, the risks of harm to health really exist and are real: “[For example] injections are often accompanied by pain, induration, bruising, and if the technique is violated, abscesses may occur, or the drug will not work as expected,” writes Dyukoreva. – Also, an allergic reaction is possible to any medicine, up to. In addition, on a case-by-case basis, the physician should discuss with the patient the risks and benefits of each particular drug and study. It is difficult here, before the consultation, to single out any risks common to all, which should be said to all patients without exception. “

B contains many incomprehensible words, says Dyukoreva. “And even if it is difficult to imagine complications from or, but a person has the right to at least know what this means!” – the expert writes.

Head physician of the Chaika clinic at the University, otorhinolaryngologist Vladimir Korshok notes that this kind of IDS is a popular phenomenon. “Often the text of the IDS, which is offered to the patient, is a long and complex document, full of legal and medical terms, containing many small tricks that usually fall into this text after the“ amendments of a lawyer ”,” he writes in response to a question “Medusa”.

Usually, both doctors and patients perceive the IDS form as another pointless piece of paper

In many cases, the fact that a patient signs a voluntary informed consent form does not mean that he or she is actually giving voluntary informed consent.

According to the interviewed experts, few of the patients ask additional questions, especially about the first form of IDS, in which a person agrees to basic interventions (in private clinics it may look somewhat different, but the essence remains the same).“Most of our people never read all these ideeski,” Mikhail Laskov, oncologist and founder of Doctor Laskov’s Clinic, explains in a conversation with Meduza. – And even those who read, all the same, their main decision is based on communication with a doctor. They understand that the IDS is not needed to inform them – these pieces of paper are needed to cover the doctor’s priests. ”

“Unfortunately, in Russia there is a practice that [signing the form] IDS … is considered as unnecessary paperwork, hoping that everything was agreed in words, but these papers are needed,“ because the administration demands, ”writes Vladimir Korshok from The Seagull.- At the same time, if any complications arise, it often turns out that the patient did not understand and did not accept the possible risks and if the terms of the transaction would be better spelled out and accompanied by high-quality information (in printed form or, for example, on the clinic’s website page) then many situations where the patient’s expectations were not met could have been avoided. ”

Although, of course, for this, as Korshok notes, the essence of the intervention and the possible risks should be identified as honestly as possible – and the patient should accept or not accept these conditions really voluntarily.

Diving into medical information is good for your health

Various guidelines for physicians emphasize that signing an informed consent form is certainly not the same as obtaining informed consent. Although there is such a substitution of concepts in practice all over the world.

Experts believe that correctly obtained informed voluntary consent has a lot of advantages. This is not just the transmission of some important information – so that the patient makes an informed decision.Obtaining such consent allows the patient to be involved in taking care of his health, to protect his rights. This is a way to increase satisfaction with care, even if complications occur, and also another reason for the doctor to double-check his judgments.

“The patient is part of the treatment team,” explains Svyatoslav Koba, a dentist and head physician at the Dental Fantasy and Belgravia Dental Studio in Novye Cheryomushki, in a telephone conversation with Meduza. – And the better he understands what is happening to him, at what stages what moments are possible, the better he cooperates.And from this, the result is faster, better and more long-term. ”

In reality, not all patients are ready to immerse themselves in medical information and make informed decisions (although this worsens the results of treatment, as well as patient satisfaction). It often happens, for example, that people prefer to give doctors the power to make decisions for them. Moreover, in the process of informing them, according to some studies, it is more important not to know about the risks and alternatives, but to establish trust with the doctor.

“Neither our legislation nor [regulations] oblige patients to read the informed consent form, but oblige us to provide the patient with complete and accurate information about all the risks and complications that may arise both during treatment and in its absence,” explains Olga Tarasova, executive director of the dental clinics Dental Fantasy and Belgravia Dental Studio on Mira Avenue, spoke with Meduza.

At the same time, the doctor will most likely still share some information.“Because a person should understand at least what sensations he will have in the process and after, what is the norm and what is not,” says Svyatoslav Koba.

It is quite difficult to give truly informed consent, because there is really a lot of information

In order for the consent to be truly informed and voluntary, the doctor and the patient must try hard. In this case, non-obvious problems arise. It would seem that the doctor should simply tell the patient everything as it is – and not push his point of view.But in reality it doesn’t work. There is a lot of information, especially when it comes to the treatment of complex diseases like most cancers. A non-medical person may be discouraged by the risks of all possible solutions.

Physicians, of course, can be careful to demonstrate impartiality, but in fact they can lean and unwittingly incline to any one decision. In addition, studies have shown that physicians are often silent so as not to scare the patient – although patients, especially if it is not a serious or chronic illness, generally want more information and more participation in decision-making.

“For example, when treating root canals, I voice the possible complications: perforation of the tooth wall, breaking off the instrument, the ineffectiveness of our treatment, which is not due to the fact that we treat poorly there, – just according to statistics, this exists,” says Svyatoslav Koba. – I tell you that for each option, we have a certain tactics for further actions. And when the patient realizes that the doctor is not hiding anything, but also knows how to behave in case of certain complications, he trusts.This also includes, probably, such screening – if the patient after that says: “Oh, no, I won’t, I’ll leave,” – everyone just happily disperses before the treatment began. ”

Here’s what to expect from a doctor who really wants to inform a patient

In order, despite the difficulties, to obtain truly free and informed consent from the patient, the doctor can use several techniques. Maksim Kotov, an oncologist and patient communications coach, explains in a letter to Meduza that three steps are enough for a doctor.

1st step. Assess the patient’s knowledge level

“First of all, you need to ask the patient what he knows about the proposed procedure or method of treatment / diagnosis,” writes Kotov. – <…> After [this] we can correlate this knowledge with the information that the doctor possesses. By asking the patient what he knows, the doctor also saves time and can move on to the next step. ”

2nd step. Assess the patient’s need for information

“For this, the doctor should ask what the patient wants to know about the proposed method of treatment, as well as give the opportunity to ask questions,” continues Maxim Kotov.- At this stage, the needs may be different: someone wants to know the fullest possible information, and someone does not want to know anything. In the latter case, in spite of the fact that the patient does not want to know anything about the treatment, the doctor needs to tell the thesis about the important points of the treatment. ”

3rd step. Tell everything you need to understand in understandable language

“At the third stage, it is necessary to tell the patient in understandable language without medical terms (or with their explanation) information about the proposed treatment,” Kotov concludes the explanation.- These three steps allow the patient to be informed to the extent that informed consent can be obtained. It is also very important to provide the patient with alternative methods of diagnosis and treatment, explaining the advantages and disadvantages of each, in order to help the patient to make a choice. ”

* * *

There are other rules to help ensure that consent is indeed informed and voluntary. For example, it is recommended to obtain consent for a planned operation in advance, and not on the day of the intervention – otherwise, the person may feel pressure due to the fact that everything has already been prepared.It is also suggested to give a convenient form that will help to better understand the essence of the intervention and weigh the pros and cons, show an explanatory video, ask the patient to repeat what he understood.

All this looks promising and logical, but not all of these techniques have proven effectiveness so far. In any case, the patient should be able to ask questions (doctors sometimes think that patients don’t ask anything because they don’t want to know anything, but in reality people are often just shy).

Since it is far from always possible to provide all the information about the intervention at all (for example, list adverse reactions to chemotherapy drugs), in some countries there are rules that must be followed when informing the patient, although they cannot be said to be very specific. For example, in the USA it is necessary to report what the “average, reasonable person” would like to know – after all, the doctor hardly understands what is fundamentally important for this patient. Often, doctors in connection with this principle are guided by the following rule: talk about all the frequent risks – and serious (albeit rare).

“We have never investigated this issue in courts, so there is no practice on how to do it,” explains oncologist Mikhail Laskov. – And in fact, of course, the doctor cannot remember all the rare complications. In our own clinic [in the clinic] we do not reach a single percentage, including in the form of IDS, although we always tell patients that there are rare complications that can be discussed for a very long time, but the main ones are like that. ”

At the same time, some experts admit that it would be useful to focus on the individual characteristics of the patient when talking about risks (although it is naturally impossible to do this 100%).Still, a cook and an accountant will experience a loss of smell in different ways.

The IDS form may not be a useless piece of paper, but a document that helps to understand everything

90,000 Modern view of voluntary informed consent in the practice of a clinician

23.04.2021

Voluntary informed consent (VIC) is a document, the signature of which by the patient is a prerequisite for medical intervention.A document based on respect for the dignity of the human person and human rights. However, today it is often given a formal meaning. Alexander Grigorievich Chuchalin , Academician of the Russian Academy of Sciences, Vice-President of UNESCO, Director of the Research Institute of Pulmonology, Chairman of the Ethics Council of the Ministry of Health of Russia, member of the Academic Council of the Medsi Group in his report ” Modern practice of voluntary informed consent ”, which he presented during the Academic Council of MEDSI on April 6, 2021.in CDC MEDSI on Belorusskaya. The meeting was devoted to the urgent problems that the year of the coronavirus infection pandemic presented to the world scientific community.

Alexander Grigorievich spoke about the history of the formation of informed consent, raised important topics dedicated to the problems of bioethics, ethical education, which have been increasingly heard in Russia since the beginning of the 90s. last century. The principles of health insurance required the development of such a document as voluntary informed consent.Voluntary informed consent (VIC) is a document that the patient must sign as a prerequisite for medical intervention. But the problem is that in Russia so far this document is not given due importance, and work with it has been reduced to pure formality. At the same time, according to the academician, it reflects a deep respect for human dignity, his autonomy, emphasizing the basic principles of morality. Ethics, according to Academician Chuchalin, is the thinking of a person that allows you to see goodness.Special attention today is paid to the problems that have begun to appear in society over the past 10-20 years. These are artificial intelligence, editing the human genome and new parenting – widely discussed topics that have already entered our lives, but there are no definitive ethical answers to them. And this topic logically included the issues of coronavirus infection, of which there are more and more every day.

Alexander Grigorievich in his lecture touched upon the historical issues of the formation of the problem of DIS in modern health care and medical science.The history of the formation of the concept of DIS is closely related to the international tribunal known as the Nuremberg Trials, the result of which was a legal assessment of fascism. During the process, the activities of the doctors of fascist Germany were separated into a separate office work. In the dock there were 28 doctors headed by Adolf Hitler’s personal physician Dr. Brand, who oversaw the work of medical personnel in the death camps. During the tribunal over the fascist doctors, facts terrifying in their cruelty and inhumanity were revealed.The result of the tribunal’s work was a document known as the Nuremberg Code (1947), the 10 main provisions of which govern the ethics of medical experiments on humans:

1. An absolutely necessary condition for conducting an experiment on a person is the voluntary informed consent of the latter.

2. An experiment must bring positive results to society, unattainable by other methods or methods of research; it should not be casual, inherently unnecessary.

3. The experiment should be based on data obtained in laboratory studies on animals, knowledge of the history of the development of the disease or other problems studied. It must be organized in such a way that the expected results justify the very fact of its holding.

4. When conducting the experiment, it is necessary to avoid unnecessary physical and mental suffering and trauma.

5. The experiment must not result in death or disability.

6. The degree of risk associated with conducting an experiment should never exceed the humanitarian importance of the problem to which the experiment is directed.

7. Participants in the experiment must be protected from the slightest possibility of injury, disability or death.

8. The experiment should only be conducted by scientifically qualified persons.

9. Participants in scientific research should have the right to terminate their participation.

10. During the course of an experiment, the investigator in charge of conducting it should be prepared to terminate it at any stage if the professional considerations, conscientiousness and caution required of him give reason to believe that the continuation of the experiment could lead to injury, disability or death. the subject.

Thus, for the first time in the history of mankind, the principle of free informed consent was proclaimed.Paternalism (from the Latin paternus – “paternal, paternal”) was replaced by respect for dignity and human rights in making decisions about their health, which was carried out by the patient signing a DIS. So, in medicine, there have been qualitative changes in the relationship between a doctor and his patient. The Nuremberg Code had a significant impact on the subsequent development of a number of international documents that played an important role in the formation of the post-war world order.

The Nuremberg Code and the Universal Declaration of Human Rights formed the basis for the preparation of such a document as the Declaration on Bioethics and Human Rights, prepared by UNESCO experts and published in 2005.The Russian philosophers B.G. Yudin and R.G. Apresyan made a great contribution to the preparation of this comprehensive document. According to the Declaration, ethical principles are considered quite broadly, they reflect the all-round human activity.

Academician Chuchalin spoke about the ethical principles of scientific research developed in the United States, known as the Belmont Report (1974). In 1974, the US National Committee for the Protection of the Rights of Participants in Biomedical and Behavioral Research established the fundamental ethical criteria for organizing scientific research.In 1979, the result of the work of specialists was the Belmont Report, the main provisions of which were: respect for a person; mercy; Justice. The Belmont Report is now the foundation of the fundamental principles of research in the United States.

Infectious diseases of the 21st century have posed new ethical challenges for the medical community. Humanity first faced new infections, such as: SARS (2002), MERS (2012), COVID-19, the causative agent of which is SARS-CoV-2.The etiology of the listed viral diseases is associated with a mutation of the coronavirus genome. One of the hotly discussed topics is not only the problem of new infectious diseases, but also newly returning infectious diseases, for example, smallpox, etc. These new challenges to civilization not only emphasize human vulnerability, but also sharpen the question of his being and the ethics of modern society.

As a successful example of the implementation of the concept of voluntary informed consent in practice, Alexander Grigorievich cited the Guide to Informed Consent Compliance published in the United States in May 2020, where the rules for interaction between a doctor and a patient when discussing voluntary information consent are clearly spelled out.This is an extensive document that highlights modern approaches in the interpretation of the definition of “Voluntary Informed Consent”. The situation with the observance of the rules and regulations regarding the DIS in the country is monitored by the Committee for the Protection of the Patient’s Rights.

“This document, which allows a doctor to work more effectively as a clinician, to establish communication with the patient and understand what is happening to him” , – said Alexander Grigorievich.

The relevance of this topic is dictated by the fact that during a pandemic of an infectious disease caused by the SARS-CoV-2 virus, it became necessary to conduct large-scale research.In terms of its scope and intensity of research, there has been no equal in history; they touched upon such sections as the epidemiology of the infectious process, preventive measures, antiviral therapy, therapy of the pneumonic process and methods of intensive care, as well as the testing of new generation vaccines. From an ethical standpoint, conflicts arose that were widely discussed not only in the professional, but also in the public environment.

Before talking with a patient about voluntary informed consent, Academician Chuchalin noted, a doctor must fully possess knowledge of ethical thinking, which consists of five steps: thinking over and concretizing the facts; analysis of values, identification of moral problems, identification of the main problem; thinking over debt, comprehending difficult situations; verification of judgments and conclusion.

All activities of a doctor and medical personnel should be subordinated to the interests of a sick person, stressed Academician Chuchalin. At the same time, it is necessary to move away from the principles of paternalism and implement the principle of DIS. The concept of “voluntary” implies a deep respect for the dignity of the human person, his rights and his freedoms, as well as his autonomy. Voluntary decision-making by a person implies that there is no external pressure on him; he should be free to make his own decisions about his health problems.That is, the definition of “voluntary” implies a sense of respect for the dignity of the human person, his rights and his freedom, as well as his autonomy and responsibility.

Alexander Grigorievich warned his colleagues against a formal attitude to the drafting of the text of voluntary informed consent and noted that DIS plays an extremely important role in modern medical practice, affecting its main directions. First of all, this concerns ethics, designed to distinguish good from evil, which is achieved through an awareness of value.The highest value is human health and being.

They also noted the enormous role of the Russian-American sociologist and culturologist, teacher Pitirim Alexandrovich Sorokin (1889-1968), one of the founders of the theories of social stratification and social mobility, in the formation of modern concepts of the value of human life. PA Sorokin’s work “Social and Cultural Dynamics” reflects his cyclical concept of the history of human society and culture: “… Life, no matter how hard it is, is the highest, most beautiful, most wonderful value in this world…. Turning it into service to duty is another miracle that can make life happy. And, finally, I am convinced that hatred, cruelty, injustice cannot and will never be able to build the Kingdom of God on Earth. Only one path leads to it: the path of selfless creative love, which consists not in prayer only, but above all in action. ”

In conclusion, Alexander Grigorievich emphasized that the ethical challenges of the XXI century. sharply raised the issues of ethical education of society, ethical monitoring of emerging events in the world, preparation of ethical declarations in the conduct of scientific research.To achieve these goals, it is necessary to create a coherent system for making ethical decisions, which should become one of the priorities of Russia’s national security.

Ambulance teams may be allowed not to obtain informed consent from the patient

State Duma adopted in the first reading amendments to the Law “On the Basics of Health Protection of Citizens
in the Russian Federation “, providing for the provision of an ambulance outside a medical organization the possibility of performing medical intervention without obtaining
informed voluntary consent of a citizen or his legal
representative, except in cases where a medical refusal is received
intervention, drawn up in the prescribed manner.

According to the current legislation, an ambulance worker
for each of his actions must receive informed voluntary consent
from the patient’s side. On average, this takes from five to 17 minutes, depending on the condition of the patient. This time could be used directly for the provision of medical care.

“There is no such thing anywhere in the world. Therefore, the United Russia faction, the deputies of the Health Protection Committee, together with professional organizations, prepared
changes to the law “, – said Yuri Kobzev

Kobzev
Yuri Viktorovich

State Duma deputy elected from electoral district 0151 (Taganrog – Rostov region)
…

According to
the draft federal law, an ambulance worker will have
the right to provide assistance to a person without the written procedure of an informed
voluntary consent. “Plus we are clarifying who can
make a decision on the provision of assistance without issuing an IDS. This is an employee
of medical care, appointed by a senior, ”the parliamentarian said.

Legislative
authorization to provide medical care will speed up the process of direct
onsite patient care.“In addition, the
legal protection of ambulance workers, because at the moment they are in conflict with Article 124 of the Criminal
of the Code, which prescribes the mandatory provision of medical care. On the other hand, we must first issue an IDS, ”added Yuri Kobzev.

“Contract for informed consent”

In Russia for several years now there has been such a legal norm as voluntary informed consent to any medical intervention or refusal from it, and GBUZ SP No. 23 DZM is no exception and not executed.This consent is also spelled out in the new law on health protection.

On April 23, 2012, the order of the Ministry of Health and Social Development No. 390-n “On approval of the list of certain interventions for which citizens give informed consent” came into force.

What is an informed consent contract in dentistry?

The Informed Consent Sheet is a new document for both patients and doctors, and it raises many questions from all parties.This agreement describes the conditions that one or another party must comply with. The doctor providing medical care has a great responsibility to the patient for the ability to correctly submit the information that is associated with filling out the informed consent sheet. To do this, each doctor must have a good understanding of what this document is about. The need to issue an informed consent sheet follows from the requirement of Article 20 “Informed voluntary consent to medical intervention and to refuse medical intervention” Federal Law of the Russian Federation of November 21, 2011.No. 323-FZ “On the Basics of Health Protection of Citizens in the Russian Federation”, which states that:

1. A necessary precondition for medical intervention is the giving of informed voluntary consent of a citizen or his legal representative to medical intervention on the basis of complete information provided by a medical worker in an accessible form about the goals, methods of providing medical care, the associated risk, possible options for medical intervention, about its consequences, as well as the expected results of medical care.

2. Informed voluntary consent to medical intervention is given by one of the parents or other legal representative in relation to: a person who has not reached the age of majority, incapacitated, a minor patient with drug addiction (in a state of drug or other toxic intoxication).

3. In case of refusal from medical intervention, the citizen (or his legal representative) must be explained the possible consequences of such refusal.

4. In case of refusal of medical intervention by the legal representative of the person recognized as incapable and necessary to save his life, the medical organization has the right to apply to the court to protect the interests of the patient.

5. Informed voluntary consent to medical intervention or refusal from it is made in writing, signed by a citizen or legal representative and contained in the patient’s medical records.

6.Medical intervention without the consent of a citizen, one of the parents or other legal representative is allowed:

a. For persons suffering from diseases that pose a danger to others.

b. For persons with mental disorders.

c. In relation to persons who have committed a crime.

, When carrying out a forensic medical examination.

7. Compulsory measures of a medical nature may be applied to persons who have committed a crime on the grounds established by federal laws.

In other words, according to this legislation, the patient has the right to receive full information about his state of health, about the expected actions of the doctor, the potential risk and benefits of medical intervention, about the diagnosis and the course of treatment, and this must be explained to the patient in a form that is accessible to him. Further, the patient himself decides whether he agrees to medical intervention or does not agree, in one case or another, if the patient agrees to what is offered to him, then he signs consent, if not, then refusal.All this is done not at all in order to remove responsibility from the doctor or harm the patient’s health, this is an incorrect assumption, but there are also illiterate actions of the doctor or inaction, poor-quality treatment. And it happens that the patient does not take the prescribed medications or even takes some other means without a doctor’s recommendation.

Informing about the possible risks of treatment disciplines the patient to a certain extent and thus makes him responsible for his health.In the event of a conflict between the patient and the doctor, the patient’s informed consent or refusal in writing will help to objectively resolve the dispute.

Many patients and a number of doctors

including, this consent is not taken seriously enough. Most patients sign an informed consent without reading it, and doctors, citing lack of time, do not really explain anything to patients. This should not be, here the interests of both parties should be taken into account in order to ensure the high quality of medical dental care.

GBUZ SP No. 23 DZM

Chief Physician Ter-Abrahamyan D.R.

Recommendations of the Ethics Committee at the State Budgetary Educational Institution of Higher Professional Education MGMSU

Recommendations of the Ethics Committee at the State Budgetary Educational Institution of Higher Professional Education MGMSU on the compilation of Information for the patient and the informed consent form for participation in a clinical thesis

The patient should receive, in writing, complete, objective, reliable and necessary information for making an informed decision about participation in the study, information written in Russian, easily stated and understandable for laymen, well edited, provided with explanations regarding the medical terms used.This information should present medical issues, not hiding the truth, but with delicacy and a sense of tact.

Information for the patient and the informed consent form should be two inseparable parts of a single document (it is recommended to give a single pagination). This document should be considered as written confirmation (and sometimes the only proof in the patient’s hands) of the conditions on which the patient (or, in cases provided for by law, his legal representative) agreed to participate in the study.It is necessary to indicate the voluntariness of participation in the study and the possibility of interrupting it at any time.

Patient information should include the following:

• title of the study;
• characteristics of the goals and objectives of the study, its duration;
• characteristics of the subject of research (for example, a drug), the mechanism of its action, its alleged and already proven properties, etc.;
• study design, the probability of the subject being included in the control group;
• Potential benefits of participation in research and risks associated with research, inconvenience and additional burden compared to traditional therapy (for example, due to additional examination methods), patient responsibilities during the study, the need to avoid using other drugs, certain foods etc.Particularly it is necessary to highlight the problems of participation in the study of pregnant women and lactating mothers, the risks to them, the fetus, infants;
• contact addresses and phone numbers by which the examinee can get additional information;
• information about the confidentiality of information about the subject.

The patient’s informed consent must be evidenced by:

• the fact of the patient’s consent or, in cases provided for by law, his legal representative to participate in the study,
• the fact of giving him the opportunity to ask any questions and get answers to them,
• the fact of the patient’s consent to the use of information obtained as a result of his participation in the research for scientific purposes,

90,071 the fact that he received a copy of the document – information and informed consent, signed by the doctor-researcher and by him personally (or, in accordance with the legislation, his legal representative).

Ministry of Health – on the adoption of a resolution “On establishing the patient’s consent form for complex medical intervention”

04/29/2021

Resolution of the Ministry of Health of the Republic of Belarus “On establishing the patient’s consent form for complex medical intervention” was prepared in pursuance of part five of Article 44 of the Law of the Republic of Belarus of June 18, 1993 No.No. 2435-XII “On Health Care”, according to which a prerequisite for complex medical intervention is the prior written consent of an adult patient or persons specified in part two of Article 18 of the Law.

The purpose of the preparation is to establish the patient’s consent form for a complex medical intervention.

Until now, in the Republic of Belarus there was no uniform form of preliminary informed voluntary consent of the patient to a complex medical intervention.

This decree establishes a form of prior informed voluntary consent of the patient (legal representative, guardian, spouse or one of the patient’s close relatives) to complex medical intervention. This document complies with modern ideas about human rights to receive reliable information about the state of one’s own health and to take conscious actions in relation to one’s own health.

The patient will be able to draw a conclusion about the upcoming procedure, based on the information received from the attending physician – about the purpose of the medical intervention, the predicted results and possible risks during medical intervention, the possible consequences of refusing to carry out this medical intervention.

A sample of the patient’s consent form for a complex medical intervention is here.

According to the message of the official website of the Ministry of Health of the Republic of Belarus

.