What are the key elements of informed consent in healthcare. How does informed consent impact patient autonomy and medical decision-making. When can informed consent be waived in medical situations. What special considerations apply for informed consent with children and blood transfusions.

The Foundations of Informed Consent in Healthcare

Informed consent is a cornerstone of ethical medical practice, rooted in the fundamental principle of patient autonomy. It represents more than just a legal formality; it’s a critical process that empowers patients to make educated decisions about their healthcare. But what exactly does informed consent entail?

At its core, informed consent is the process by which healthcare providers educate patients about the risks, benefits, and alternatives of a proposed medical procedure or intervention. This information exchange is crucial for patients to make voluntary, well-informed decisions about their medical care. The process hinges on the patient’s competence to understand and process the information presented.

Why is informed consent so important? It serves several vital functions:

• Respects patient autonomy
• Protects patients’ right to make decisions about their own bodies
• Ensures transparency in medical decision-making
• Fosters trust between healthcare providers and patients
• Serves as a legal safeguard for both patients and medical practitioners

Essential Elements of Informed Consent Documentation

Proper documentation of informed consent is not just good practice; it’s a requirement. The Joint Commission, a prominent healthcare accreditation organization in the United States, mandates that all elements of informed consent be documented “in a form, progress notes or elsewhere in the record.” But what specific information needs to be included?

The five required elements for documenting informed consent discussions 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

How can healthcare providers ensure they’re meeting these documentation requirements? Here are some practical tips:

• Use standardized forms that cover all required elements
• Document conversations in detail in patient progress notes
• Utilize electronic health record systems with built-in informed consent modules
• Implement a double-check system where another healthcare provider reviews the documentation

Legal Standards for Adequate Informed Consent

The legal landscape surrounding informed consent can be complex, with standards varying by state. How do courts determine if informed consent was adequately obtained? There are three main legal approaches:

1. Subjective standard: What would this specific patient need to know to make an informed decision?
2. Reasonable patient standard: What would an average patient need to know to be an informed participant?
3. Reasonable physician standard: What would a typical physician say about this procedure?

Which standard is most commonly used? Many states have adopted the “reasonable patient standard” as it focuses on what a typical patient would need to know to understand the decision at hand. This patient-centered approach aligns well with modern principles of patient autonomy and shared decision-making.

However, it’s crucial to note that regardless of the standard used, the onus is on the healthcare provider to determine which approach is appropriate for a given situation. This responsibility underscores the importance of thorough documentation and clear communication throughout the informed consent process.

Exceptions to Informed Consent: When Does It Not Apply?

While informed consent is a crucial aspect of medical practice, there are situations where it may not be required or possible to obtain. What are these exceptions, and how should healthcare providers navigate them?

The main exceptions to the requirement for informed consent include:

• Patient incapacitation: When a patient is unable to make decisions due to mental or physical incapacity
• Life-threatening emergencies: Situations where there’s inadequate time to obtain consent due to immediate risk to life
• Voluntary waived consent: Cases where a patient explicitly waives their right to give informed consent

How should healthcare providers handle situations where a patient’s decision-making capacity is in question? In such cases, it may be necessary to request a psychiatric evaluation to determine the patient’s competency. If a patient is found incompetent and hasn’t designated a decision-maker, healthcare providers must follow the state-mandated hierarchy of surrogate decision-makers.

In extreme cases where no legal surrogate can be identified, it may be necessary for a court to appoint a legal guardian. This process ensures that even when patients cannot make decisions for themselves, their rights and best interests are still protected.

Informed Consent and Minors: Navigating the Complexities

The issue of informed consent becomes more complex when it involves minors. How does the consent process differ for children, and what special considerations apply?

Generally, children under the age of 17 cannot provide informed consent for medical procedures. Instead, parents or legal guardians must give what’s termed “informed permission” for treatments or interventions. This distinction acknowledges the legal and ethical complexities of medical decision-making for minors.

However, there are exceptions to this rule. Emancipated minors, for instance, can provide their own informed consent. But what qualifies a minor as emancipated? While laws vary by state, some common criteria include:

• Minors under 18 who are married
• Those serving in the military
• Individuals who can prove financial independence
• Mothers of children (whether married or not)

It’s crucial for healthcare providers to be familiar with their state’s specific laws regarding minors and informed consent. These laws can have significant implications for how medical care is provided to young patients and how decisions are made on their behalf.

Informed Consent in Blood Transfusions: A Special Case

Blood transfusions present a unique scenario in the realm of informed consent. Why are they considered a special case, and what challenges do they present?

Obtaining informed consent for blood transfusions requires a thorough understanding of transfusion medicine and the ability to communicate complex information effectively. However, research has shown that there are often deficiencies in the explanation process, where benefits may be overstated and risks omitted.

How can the informed consent process for blood transfusions be improved? Studies have demonstrated that involving experts from transfusion units in obtaining consent results in patients having a better understanding of the risks and benefits. However, this approach may not always be practical or efficient.

The knowledge gap among healthcare providers presents another challenge. New graduate physicians often have a deficit in transfusion medicine knowledge, while those with previous education in this area display better understanding. This discrepancy highlights the need for more comprehensive education in transfusion medicine for all physicians, as most will need to obtain informed consent for a transfusion at some point in their careers.

Enhancing the Informed Consent Process: Best Practices and Future Directions

Given the complexities and challenges surrounding informed consent, how can healthcare providers improve their practices? Here are some strategies to enhance the informed consent process:

• Use plain language: Avoid medical jargon and explain concepts in terms patients can easily understand
• Employ visual aids: Diagrams, videos, and interactive tools can help patients better grasp complex information
• Encourage questions: Create an open environment where patients feel comfortable asking for clarification
• Assess understanding: Use teach-back methods to ensure patients have truly grasped the information
• Provide time for reflection: When possible, allow patients time to consider their options before making a decision
• Continual education: Regularly update healthcare providers on best practices for obtaining informed consent

What does the future hold for informed consent? As healthcare evolves, so too must the informed consent process. Some potential developments include:

• Digital consent forms: Interactive, multimedia consent forms that can adapt to patient literacy levels and preferences
• AI-assisted explanation: Artificial intelligence tools that can help explain complex medical concepts in personalized ways
• Virtual reality simulations: Immersive experiences that allow patients to better understand proposed procedures
• Blockchain for consent tracking: Secure, decentralized systems for recording and managing consent across healthcare systems

By embracing these innovations and continuously striving to improve communication and understanding, healthcare providers can ensure that informed consent remains a meaningful and effective cornerstone of ethical medical practice.

The Role of Cultural Competence in Informed Consent

In our increasingly diverse society, cultural competence plays a crucial role in the informed consent process. How does cultural background impact informed consent, and what can healthcare providers do to ensure effective communication across cultural boundaries?

Cultural beliefs and values can significantly influence how patients perceive medical information, make decisions, and interact with healthcare providers. For instance, in some cultures, family members play a central role in medical decision-making, which may conflict with Western notions of individual autonomy.

To navigate these cultural complexities, healthcare providers should:

• Develop cultural awareness: Understand how cultural factors might influence patient decision-making
• Use professional interpreters: When language barriers exist, rely on trained medical interpreters rather than family members
• Respect cultural practices: Be open to incorporating cultural or religious practices into the consent process when appropriate
• Avoid stereotyping: Recognize that cultural background is just one factor influencing a patient’s perspective
• Practice active listening: Pay attention to both verbal and non-verbal cues that may indicate cultural concerns or misunderstandings

By integrating cultural competence into the informed consent process, healthcare providers can ensure that all patients, regardless of their cultural background, can make truly informed decisions about their care.

Informed Consent in Clinical Trials: Additional Considerations

Clinical trials present unique challenges when it comes to informed consent. How does the process differ for research participants, and what additional safeguards are in place?

In clinical trials, informed consent goes beyond the standard medical procedure consent. It must address:

• The experimental nature of the treatment
• Potential risks that may be unknown or uncertain
• The possibility of being assigned to a placebo group
• The right to withdraw from the study at any time
• How personal data will be used and protected

To ensure ethical conduct of clinical trials, additional oversight is provided by Institutional Review Boards (IRBs) or Ethics Committees. These bodies review and approve the informed consent process and documents for each study.

Moreover, for vulnerable populations such as children, prisoners, or individuals with cognitive impairments, additional protections and considerations apply. In these cases, the informed consent process may involve legal guardians or patient advocates to ensure the participant’s rights and well-being are protected.

The Impact of Technology on Informed Consent

As technology continues to reshape healthcare, how is it changing the informed consent process? Digital tools and platforms are increasingly being used to facilitate and enhance informed consent:

• Electronic consent forms: Allow for easier storage, retrieval, and updating of consent documents
• Multimedia presentations: Can provide more engaging and comprehensive information about procedures
• Decision aids: Interactive tools that help patients weigh risks and benefits
• Telemedicine consent: Enables remote obtaining of consent, expanding access to care

While these technological advancements offer many benefits, they also raise new challenges. How can healthcare providers ensure that digital consent processes are as effective and legally valid as traditional methods? Some considerations include:

• Ensuring digital accessibility for all patients, including those with disabilities or limited technological literacy
• Maintaining the security and privacy of electronically stored consent documents
• Developing standardized protocols for obtaining and documenting consent in telemedicine settings
• Balancing the use of technology with the need for personal interaction and discussion

As healthcare continues to evolve, the informed consent process must adapt to new technologies while maintaining its core principles of patient autonomy, understanding, and voluntary decision-making.

Ethical Dilemmas in Informed Consent

Despite clear guidelines and best practices, healthcare providers often face ethical dilemmas when obtaining informed consent. What are some of these challenging scenarios, and how can they be navigated?

One common dilemma arises when a patient’s decision conflicts with what the healthcare provider believes is in their best medical interest. In such cases, providers must balance their duty to respect patient autonomy with their obligation to provide the best possible care.

Another challenging situation occurs when family members disagree with a patient’s decision. How should healthcare providers handle such conflicts while still respecting the patient’s autonomy?

Ethical frameworks and professional guidelines can help navigate these complex situations. Key principles to consider include:

• Respect for patient autonomy
• Beneficence (doing good)
• Non-maleficence (avoiding harm)
• Justice (fairness in healthcare distribution)

In particularly complex cases, healthcare providers may benefit from consulting with hospital ethics committees or legal advisors. These resources can provide valuable perspectives and help ensure that decisions are made in an ethical and legally sound manner.

Ultimately, while informed consent can present challenging ethical dilemmas, it remains a crucial safeguard for patient rights and a cornerstone of ethical medical practice. By approaching these challenges thoughtfully and systematically, healthcare providers can ensure that the informed consent process serves its intended purpose of empowering patients to make informed decisions about their care.

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 21 200

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.