What are the key elements of informed consent in healthcare. How does informed consent protect patient autonomy. When can exceptions to informed consent be made. What special considerations apply to informed consent for minors and blood transfusions.

The Fundamentals of Informed Consent in Medical Practice

Informed consent is a cornerstone of ethical medical practice, serving as both a legal requirement and a moral imperative. It embodies the principle of patient autonomy, ensuring that individuals have the right to make decisions about their own healthcare based on a clear understanding of the proposed interventions.

What exactly does informed consent entail? At its core, it is a process whereby healthcare providers educate patients about:

• The nature of a proposed procedure or treatment
• The potential risks and benefits associated with it
• Any reasonable alternatives available
• The risks and benefits of those alternatives

This information exchange allows patients to make voluntary, informed decisions about their care.

Legal and Ethical Foundations

Why is informed consent so crucial in healthcare? It stems from the fundamental right of individuals to have control over what happens to their bodies. This principle is deeply embedded in both medical ethics and legal frameworks across the United States.

How do healthcare providers ensure they’re meeting the standards for informed consent? The Joint Commission, a key healthcare accreditation organization, mandates that all elements of the informed consent discussion be documented in the patient’s medical record. This documentation serves as evidence that the process was carried out thoroughly and appropriately.

Key Components of Informed Consent Documentation

When documenting informed consent, healthcare providers must include specific elements to ensure a comprehensive record. What are these essential components?

1. A clear description of the nature of the procedure
2. An explanation of the risks and benefits associated with the procedure
3. A discussion of reasonable alternatives
4. The risks and benefits of those alternatives
5. An assessment of the patient’s understanding of points 1 through 4

How does this documentation protect both patients and providers? It serves as a record of the shared decision-making process, demonstrating that the patient was given all necessary information to make an informed choice.

The Provider’s Role in Informed Consent

What responsibilities do healthcare providers have in the informed consent process? Beyond simply presenting information, providers must:

• Ensure patients feel they are active participants in the decision-making process
• Avoid making patients feel coerced or pressured to agree
• Provide a clear recommendation based on their professional judgment
• Explain the reasoning behind their recommendation

This approach balances the provider’s expertise with the patient’s right to autonomy.

Legal Standards for Informed Consent

How do legal systems determine if informed consent has been adequately obtained? The standard varies by state, but there are three primary approaches:

1. Subjective Standard

This approach asks: What would this specific patient need to know to make an informed decision? It takes into account the individual’s unique circumstances and understanding.

2. Reasonable Patient Standard

Under this standard, the question becomes: What would an average patient need to know to be an informed participant in the decision? This is the most commonly used standard in many states, as it provides a balance between individual needs and practical implementation.

3. Reasonable Physician Standard

This standard considers: What would a typical physician say about this procedure? It relies on professional norms and standards of practice.

Which standard applies in a given situation? It’s the healthcare provider’s responsibility to determine the appropriate approach based on the specific circumstances and state laws.

Exceptions to Informed Consent Requirements

Are there situations where informed consent isn’t required? Yes, several exceptions exist:

1. Patient Incapacitation

When a patient is unable to make decisions due to mental or physical incapacity, informed consent may not be possible. In these cases, healthcare providers may need to rely on previously expressed wishes, advance directives, or decisions made by legal surrogates.

2. Life-Threatening Emergencies

In situations where immediate action is necessary to save a life and there isn’t time to obtain consent, healthcare providers may proceed without it. This is based on the presumption that a reasonable person would consent to life-saving treatment if they were able.

3. Voluntary Waiver of Consent

In some cases, a patient may choose to waive their right to informed consent, trusting their healthcare provider to make decisions on their behalf. This should be clearly documented to protect both the patient and the provider.

Determining Decision-Making Capacity

How do healthcare providers handle situations where a patient’s decision-making capacity is unclear? In these cases, a psychiatric evaluation may be requested to assess the patient’s competency. If a patient is found to lack decision-making capacity and hasn’t designated a surrogate decision-maker, providers must follow state-specific laws to determine the next legal surrogate. In some cases, a court-appointed legal guardian may be necessary.

Informed Consent and Minors: Special Considerations

How does informed consent apply to children and adolescents? Generally, individuals under 17 cannot provide informed consent for medical procedures. Instead, parents or guardians must give “informed permission” for treatments or interventions involving minors.

Are there exceptions to this rule? Yes, legally emancipated minors can provide their own informed consent. What qualifies a minor as emancipated? While laws vary by state, common criteria include:

• Being under 18 and married
• Serving in the military
• Demonstrating financial independence
• Being a mother (regardless of marital status)

Why is it crucial for healthcare providers to understand state-specific laws regarding minors and informed consent? These laws can vary significantly, and providers must ensure they’re complying with local regulations to protect both themselves and their patients.

Informed Consent in Blood Transfusion: A Case Study

How does informed consent apply in the specific context of blood transfusions? This medical procedure highlights some of the challenges and nuances of the informed consent process.

Challenges in Obtaining Consent for Transfusions

What difficulties do healthcare providers face when seeking informed consent for blood transfusions? Common issues include:

• Incomplete explanations of benefits
• Omission of certain risks
• Difficulty in conveying complex medical information in an understandable way

How can these challenges be addressed? Studies have shown that involving experts from transfusion units in the consent process can significantly improve patients’ understanding of the risks and benefits.

The Role of Physician Education

Why is ongoing education about transfusion medicine crucial for healthcare providers? Many new graduate physicians have knowledge deficits in this area, which can impact their ability to obtain truly informed consent. However, physicians who have received specific education in transfusion medicine demonstrate a better understanding of the subject.

Given that most physicians will need to obtain informed consent for a transfusion at some point in their careers, should transfusion medicine education be more widely emphasized? This question highlights the ongoing need for medical education to evolve alongside clinical practice to ensure the highest standards of patient care and informed consent.

Ensuring Effective Informed Consent: Best Practices

How can healthcare providers ensure they’re obtaining truly informed consent? Here are some best practices to consider:

Clear Communication

Why is clear communication essential in the informed consent process? It ensures that patients fully understand the proposed procedure, its risks, and alternatives. Healthcare providers should:

• Use plain language, avoiding medical jargon when possible
• Encourage patients to ask questions
• Verify patient understanding through teach-back methods

Comprehensive Documentation

How can thorough documentation protect both patients and providers? By creating a clear record of the informed consent process, including:

• The information provided to the patient
• Any questions asked and answers given
• The patient’s expressed understanding and decision

This documentation serves as evidence of a proper informed consent process if questions arise later.

Cultural Sensitivity

Why is cultural sensitivity important in obtaining informed consent? Different cultures may have varying perspectives on medical decision-making, autonomy, and the role of family. Healthcare providers should be aware of these potential differences and adapt their approach accordingly, while still ensuring that the patient’s individual rights are respected.

Use of Decision Aids

How can decision aids enhance the informed consent process? Tools such as informational videos, interactive apps, or printed materials can help patients better understand complex medical information. These aids can supplement, but should not replace, direct communication with healthcare providers.

The Future of Informed Consent in Healthcare

How might the practice of informed consent evolve in the coming years? Several trends and innovations are shaping the future of this crucial aspect of healthcare:

Digital Consent Processes

What role will technology play in obtaining informed consent? Digital platforms are increasingly being used to:

• Provide patients with detailed information about procedures
• Allow patients to review consent documents at their own pace
• Facilitate secure electronic signatures
• Store consent records securely and accessibly

These digital tools can enhance the efficiency and effectiveness of the consent process, but they must be implemented carefully to ensure they meet legal and ethical standards.

Personalized Consent

How might informed consent become more individualized? As medicine moves towards more personalized treatments, informed consent may also become more tailored to individual patients. This could involve:

• Using genetic information to provide more accurate risk assessments
• Considering a patient’s personal values and preferences in decision-making
• Adapting the consent process to match a patient’s health literacy level

Ongoing Consent

Will the concept of a one-time consent evolve? There’s growing recognition that informed consent should be an ongoing process, especially for long-term treatments or clinical trials. This approach allows for:

• Regular reassessment of a patient’s understanding and willingness to continue
• Updates to consent as new information becomes available
• Opportunities for patients to ask questions and express concerns throughout their treatment

Artificial Intelligence and Informed Consent

How might AI impact the informed consent process? As AI becomes more prevalent in healthcare, new questions arise:

• How to explain AI-driven diagnostic or treatment recommendations to patients
• Ensuring patients understand the role of AI in their care
• Addressing concerns about data privacy and algorithmic bias

These challenges will require ongoing dialogue between healthcare providers, ethicists, legal experts, and patients.

Ethical Dilemmas in Informed Consent

What ethical challenges do healthcare providers face in obtaining informed consent? Several complex situations can arise:

Balancing Beneficence and Autonomy

How do providers navigate situations where a patient’s choice conflicts with what the provider believes is in their best interest? This tension between respecting patient autonomy and the medical principle of beneficence (doing good for the patient) can be challenging. Providers must carefully balance their professional judgment with the patient’s right to make their own decisions, even if those decisions seem unwise from a medical perspective.

Consent in Clinical Trials

What special considerations apply to informed consent in research settings? Clinical trials often involve greater uncertainty about risks and benefits compared to established treatments. How can researchers ensure participants fully understand the experimental nature of the treatment and the possibility that they may receive a placebo? This requires careful explanation and ongoing communication throughout the trial.

Therapeutic Misconception

How do providers address the ‘therapeutic misconception’ in clinical trials? This occurs when research participants mistakenly believe that the primary purpose of a clinical trial is to benefit them personally, rather than to gather data to help future patients. Clear communication about the goals of research and the distinction between research and treatment is crucial.

Consent and Mental Health

What challenges arise in obtaining informed consent from patients with mental health conditions? Conditions that affect cognitive function or decision-making capacity can complicate the consent process. How do providers balance respect for autonomy with the need to protect vulnerable patients? This often requires careful assessment of decision-making capacity and, in some cases, involvement of mental health professionals or legal guardians.

Consent in Emergency Situations

How do healthcare providers handle consent in emergencies where immediate action is necessary? While exceptions to informed consent exist for life-threatening emergencies, providers may face difficult decisions in less clear-cut situations. How much time can be spent seeking consent without jeopardizing the patient’s health? These situations require quick thinking and sound ethical judgment.

Cultural and Religious Considerations

How do providers navigate situations where cultural or religious beliefs impact medical decision-making? Some patients may have beliefs that conflict with recommended medical treatments. How can providers respect these beliefs while ensuring patients have access to all relevant information? This requires cultural sensitivity, clear communication, and sometimes involvement of cultural mediators or religious leaders.

These ethical dilemmas highlight the complexity of informed consent in modern healthcare. They underscore the need for ongoing education, clear guidelines, and thoughtful consideration of individual circumstances in every case.

Informed Consent – StatPearls – NCBI Bookshelf

Parth Shah; Imani Thornton; Danielle Turrin; John E. Hipskind.

Author Information and Affiliations

Last Update: June 11, 2022.

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

4. Cryoprecipitate

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

  • A febrile nonhemolytic reaction is an increase in temperature of at least 1° Celcius during or shortly after a transfusion. It is caused by an inflammatory response to cytokines from the donor.

• Mistransfusion

  • This can occur if blood products are labeled incorrectly. This can be avoided by making sure the blood bank and the health care worker initiating the transfusion check the blood product to assure it is for the correct patient.

• 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

  • Delayed hemolytic reactions occur more than 24 hours after a transfusion is completed. They usually occur days to weeks after the transfusion. The symptoms of a delayed hemolytic reaction are often gradual and less severe compared to an acute 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.

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Disclosure: Parth Shah declares no relevant financial relationships with ineligible companies.

Disclosure: Imani Thornton declares no relevant financial relationships with ineligible companies.

Disclosure: Danielle Turrin declares no relevant financial relationships with ineligible companies.

Disclosure: John Hipskind declares no relevant financial relationships with ineligible companies.

Informed Consent Requirements | National Institute of Justice

Informed consent is a process in which the researcher provides sufficient information, in an understandable format, to the research subjects so that they can make a voluntary decision whether or not to participate in the study. The informed consent process is fundamental in ensuring respect for persons and should serve to educate the subject about the research, the benefits and risks, and the voluntary nature of their participation. The informed consent should be in language understandable by the study subjects. The informed consent should also be revised when deficiencies are discovered or when additional information will improve the process. The regulations under section 28 CFR §46.116 describe the elements or information that must be contained in the informed consent provided to the study subjects. Below is a brief listing of the basic items to be included in the informed consent:

• A statement that the study involves research.
• The name(s) of the funding agency(ies).
• An explanation of the purposes of the research.
• The expected duration of the subject’s participation.
• A description of the procedures to be followed and what the subjects will be required to do in the study.
• Identification of any procedures which are experimental.
• A description of any reasonably foreseeable risks or discomforts to the subject. Risks are not limited to physical injury, but also include psychological, social, financial, legal, and others.
• A description of any benefits to the subject or to others that may reasonably be expected from the research; there may be none other than a sense of helping the public at large when balanced by the appropriate level of risk.
• A disclosure of appropriate alternative procedures or courses of treatment, if any, that might be advantageous to the subject. In most NIJ studies the alternative will be to not participate in the study.
• A statement describing the extent to which confidentiality of records identifying the subject will be maintained. For studies sponsored by NIJ the subject should be informed that private, identifiable information will be kept confidential and will only be used for research and statistical purposes. If, due to sample size or some unique feature, the identity of the individual cannot be maintained, the subjects need to be explicitly notified. If the investigator intends to disclose any information, the subject needs to be explicitly informed what information would be disclosed, under what circumstances, and to whom. The subject must be informed of any potential risks which may result from this disclosure and must explicitly provide prior written consent.
• For research involving more than minimal risk[1], 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.
• An explanation of whom to contact for answers to questions about the research and research subjects’ rights, and whom to contact in the event of a research-related injury to the subject. This should include name and telephone number or other appropriate methods.
• A statement that participation is voluntary, that refusal to participate will involve no penalty or loss of benefits to which the subject is otherwise entitled, and that the subject may discontinue participation at any time without penalty or loss of benefits to which the subject is otherwise entitled.

28 CFR §46.117 Documentation of Informed Consent

As a general rule, informed consent should 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.

An IRB may waive the requirements to obtain a signed consent form as described in section 46.117(c) if it determines:

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 written consent documentation requirement is waived, the IRB may require the investigator to provide subjects with a written statement regarding the research and obtain their oral consent to participate.

Date Published: November 19, 2007

requirements from September 1, 2022

Obtaining consent to the processing of personal data refers to the process by which it is possible to obtain direct permission from individuals before processing their data.

While this document is one of the legal grounds for processing a citizen’s information, there are a number of situations in which consent is not required.

One of the most important criteria for the consent of a citizen to the processing of his personal data is the unambiguity and obviousness of such approval.

The request for consent must contain information about the purposes for which personal data will be used, as well as details of the company processing them.

The consent itself must be freely expressed, informed, specific, substantive, conscious and unambiguous.

The law defines as a personal data operator any natural or legal person who works with personal information.

For example, if users can register on the site, leave a request for a call, place an order, purchase a product, subscribe to a newsletter, etc., and for this they transmit data with which they can be identified, then the owner such a site falls under the regulation of the law “On the protection of personal data”.

It is also important to take into account that any employer is considered a personal data operator, therefore, for each employee, appropriate consent is required.

Requirements for consent to the processing of personal data have changed

From September 1, 2022, new rules apply to the consent form for the processing of personal data, for violation of which operators are liable.

Consent must be “specific, specific, informed, conscientious and unambiguous”.

The operator is not entitled to collect information if it does not relate to the specific purposes of its processing.

Separately, it should be noted that it is not allowed to receive excessive personal information, that is, not related to a specific operation: for example, when ordering shampoo in an online store, information about a citizen’s passport data will be redundant.

Innovations of September 2022 – what exactly should be in the consent to the processing of personal data

The consent form for the processing of personal data must contain the following information:
• FULL NAME. citizen, his address, as well as information about the identity document;
• If a citizen acts through a representative – information similar to paragraph 1, as well as details of a document confirming the authority of the person;
• Name/full name personal data operator;
• Purpose of personal data processing;
• List of data for which consent is provided;
• In the event that the processing is carried out on behalf of the operator – name / full name. and the address of the person concerned;
• Validity of consent to the processing of personal data, as well as the method of its withdrawal;
• Signature of the citizen who gave consent.

What are the types of consents, what types of data are given

The most important requirement for the document is the ability to identify the person who gave the consent, as well as establishing a list of information and purposes for which the consent was given.

There are several types of consents to the processing of personal data, which include:
• Consent in writing;
• Consent in a simple electronic form;
• Consent in qualified electronic form.

In addition to various types of consents, there are also several types of personal data themselves: general (full name, information about documents, address, etc.), biometric (information that characterizes the physiological and biological characteristics of a person, on the basis of which you can to establish his identity), special (information about the state of health, religion, political views, nationality, race, etc.).

In addition, from March 1, 2021, new rules for interacting with data that are publicly available will apply.

By publicly available data we mean personal data that is disclosed to an indefinite circle of persons (for example, published on the Internet).

Consent is also required for the processing of such data. Such consent must be made separately from other consents.

From September 1, 2021, Roskomnadzor imposes special requirements on the content of consent to the processing of publicly available personal data.

It is worth noting that if it is necessary to transfer the received data to third parties, the consent must expressly indicate this possibility.

In view of the fact that the wording of consent is only being developed, Roskomnadzor offers to use a service that allows the operator to prepare a template for the consent form for the processing of personal data authorized by the subject of personal data for distribution, taking into account the professional specifics of the operator’s activities.

Consent to the processing of publicly available personal data can be given in two ways:
1. Directly by the subject of personal data to the operator.
2. From March 1, 2022 – through the information system of Roskomnadzor in accordance with this order.

Features of consent to cross-border transfer of personal data

This type of transfer of data about citizens is a procedure in which information is transferred to the authorities of a foreign state, as well as to a foreign individual or legal entity.

The law establishes a number of requirements that such a transfer may only take place with consent; international treaty; execution of an agreement with the participation of a citizen; protection of the life and health of the citizen himself or other persons if it is impossible to obtain consent in writing.

In cases where a company operates on the Internet without having a physical presence in Russia, if its activities are directed to Russia, it must comply with the requirements of the law.

That is, it is possible to collect, process and store a database of personal data about Russian citizens only on servers located in the Russian Federation. If the site is located on a foreign hosting, and at the same time data on citizens of the Russian Federation are collected and processed, the domain may be included in the register of violators of the rights of data subjects. The registry is maintained by Roskomnadzor.

The main feature of this type of transfer is that, in addition to informing the citizen about the upcoming transfer, it is necessary to notify Roskomnadzor, as well as to ensure the protection of the personal data transfer channel.

What to do first

In order to strictly comply with legal requirements, the following can be recommended:
• place on your site an agreement on the processing of personal data, after reading which the user of the site can express his consent to the processing of personal data;
• Request only necessary data. For example, a simple e-mail newsletter subscription is unlikely to require passport data;
• provide individuals with information about what data about him is stored in databases, why the data received from him is processed and to whom they are transferred;
• delete all information about the user after receiving the appropriate request;
• store personal data in a place that excludes access by third parties;
• develop a regulation on the processing of personal data, which must be signed by employees;
• Register as a personal data operator with Roskomnadzor.

In addition, the personal data operator needs to update the consent templates taking into account new legal requirements.

It is necessary to formulate the text of consent in such a way that it contains information about the purpose of data processing in each specific case.

Taking into account that the goals can be different, it is possible to draw up different templates: general and a number of special ones.

rules and nuances of design – Kontur.Extern

September 26, 2022 21 198

Consent to the processing of personal data – a written or digital document that confirms the voluntary decision of a citizen to transfer his personal information to the operator for certain purposes. According to Law No. 152-FZ, the operator must receive it in most cases. Let’s figure out when a permit for processing PD is required, and what are the requirements for it in 2022.

Contents

• What does the law say
• In which cases consent to processing is not required
• How to draw up a document
• How to apply for permission to distribute PD

Consent to the processing of personal data in 2022 must be specific, substantive, informed, conscious and unambiguous (Article 9 of Federal Law No. 152-FZ of July 27, 2006). This means that it contains:

• the specific purpose of processing – for example, to formalize an employment relationship;
• list of PD – for example, full name, date of birth, information about education, place of work, address;
• list of actions with personal data – for example, collection, storage;
• place and methods of processing PD – address of the operator, automated or non-automated processing;
• duration of the consent;
• name, full name, address of the person who processes the PD, if the operator entrusts it to another person;
• clearly expressed consent of the citizen – signature, tick or other mark.

By default, any actions with personal information without the consent of the subject or legal grounds are not allowed (Art. 6, 9152-FZ). At the same time, the document for the distribution of PD is drawn up separately (Art. 10.1 152-FZ).

Consent is obtained specifically for each purpose. That is, the operator will have several documents. This follows from part 4 of Art. 9 152-FZ, where the purpose is indicated in the singular, as well as from the requirement not to store information for incompatible purposes in one database (part 3 of article 5 152-FZ).

You can work with personal data only on legal grounds (Art. 5 152-FZ). Processing without the permission of the subject is allowed in cases provided for by international treaties or regulatory legal acts (part 1 of article 6, part 2 of article 10, part 2 of article 11 152-FZ). For example:

• personal information is processed with the participation of an individual in a lawsuit;
• a citizen registers on the State Services portal;
• information is needed to fulfill the terms of an agreement with a PD subject;
• special personal data, for example, about the state of health, are processed in accordance with labor, social or pension legislation.

A citizen has the right to revoke the given consent to PD processing at any time. In this case, actions with his personal information can only be continued if there are the above legal grounds. The obligation to prove the legality of processing: to provide the consent of a citizen or a separate rule of law, is assigned to the operator (part 2 of article 9152-FZ).

Employers should remember that the processing of biometric personal data of employees within the framework of labor relations is possible only with the written consent of the employee (Article 11 152-FZ). It is not needed for special and public PD. This means that full name, information about education are processed freely. But video surveillance of an employee is possible only with his written permission.

The law allows obtaining the consent of an individual to process his PD in any form. The main thing is to confirm that it exists and is given precisely by the subject of personal data or his representative (part 1 of article 9152-FZ). That is, theoretically, consent can be issued even in the form of a recording on a voice recorder, if the identity of a citizen is accurately identified by it.

If, according to the Law, consent must be made in writing – for example, for the processing of biometric data, then an electronic document with an electronic signature (ES) is recognized as equivalent to a paper original with a personal signature of the subject (part 4 of article 9 152-FZ). The main thing is that the electronic signature complies with the requirements (Order of the FSB of Russia dated December 27, 2011 No. 796).

A convenient service for preparing and submitting reports via the Internet. We give access to External for 14 days!

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There is no approved consent form for PD processing. General requirements for its content are given in Article 9 152-FZ.

Many samples of consent are available on the Internet, for example, on the website of the Roskomnadzor Office of the Siberian Federal District. They must be used carefully, taking into account changes in Law 152-FZ:

• one purpose of processing – one consent;
• permission to distribute PD is issued separately.

A person who processes PD on behalf of an operator does not receive the consent of the subject (part 4 of article 6 of 152-FZ).

In some cases, the operator discloses personal data to an indefinite circle of persons. For example, it publishes a customer review on the website containing full name, email and other personal information. Or helps the customer to get a loan and sends an application on his behalf to various banks and MFIs.

This is called the dissemination of personal data, for which you need to obtain a separate consent of the subject of the PD (part 1 of article 10.1 of 152-FZ). The requirements for the content of such a permit are determined by Roskomnadzor (Order No. 18 dated February 24, 2021).

Submit all reports via the Internet – with tips and error checking

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Consent to distribution can be issued in two ways (part 6 of article 10. 1 152-FZ):

• transferred by the subject directly to the operator;
• filled out using the information system of Roskomnadzor.

In the first case, the operator can get a document template on the Roskomnadzor website. To prepare a permit adapted for a specific activity, you will need a verified account on the portal of the State Services of an organization, individual entrepreneur or individual.

A request is generated on the Roskomnadzor portal through the ESIA. As a result, the operator gets access to the consent form for the distribution of PD, which he fills out taking into account his specifics. The finished template can be sent for verification to Roskomnadzor and receive its recommendations.

The consent form for the distribution of PD can be prepared using the information resource of Roskomnadzor.

If the operator decides to develop his own form, then he must indicate in it the mandatory items according to Order No.