Consent

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Purpose and Applicability

This guidance provides researchers, the Human Subjects Division (HSD), and the UW Institutional Review Boards (IRBs) with an overview of the requirements and best practices for obtaining regulatorily compliant and meaningful consent, parental permission, and assent for participation in research. This information applies to:

• All research reviewed by the UW IRB, including non-UW institutions and sites for which the UW IRB is providing review, unless otherwise indicated.
• UW research reviewed by an external (non-UW) IRB.

The following specialized consent-related topics are covered elsewhere:

• UW research determined to be exempt or reviewed by the Limited IRB process. Details can be found in the guidance on Exempt Research.
• Exception from Informed Consent (EFIC supplement), which may be appropriate when the time frame between recruiting and study procedures is too short for obtaining consent (e.g., emergency medicine studies).
• Emergency or Compassionate Use of investigational drugs or devices for clinical care (not research) (Single Patient Emergency or Compassionate Use).
• Clinical use of Humanitarian Use Devices.

Definitions

Informed consent for research must be legally effective and obtained before the participant can participate in any study-related activities. It should include an active process of sharing information between the researcher and potential participant and an affirmative agreement by the participant that they want to participate. The concept of “implied” or “passive” consent (e.g., parental permission is assumed unless the parent “opts out” of their child’s participation in the research) does not meet the requirements for informed consent for research. Informed consent serves to:

1. provide sufficient details about the study so prospective participants can make an informed decision about whether to participate;
2. facilitate understanding of what has been disclosed; and
3. promote voluntariness about whether to participate.

Consent method. The method by which consent is obtained depends on the specifics of the study and the regulations that govern the research. When documentation of consent can be waived, researchers have greater flexibility in the ways in which they can design the consent process. For example, it may be appropriate to conduct an oral consent process without providing the participants with printed consent materials if the study is a low risk, one-time interview with adults. If participants will participate in the study remotely (e.g., low risk computer surveys) then providing the participants with an electronic information statement would be appropriate. Regardless of the method used (e.g., oral, electronic, in-person), consent processes must include all the applicable regulatory requirements (Regulatory Oversight) unless the IRB determines any requirements can be waived.

Assent is obtained from participants who are unable to provide legally-effective informed consent on their own behalf because they are minors or have diminished decision-making capacity. Participants who have the cognitive capability may provide their assent to participate and a parent/guardian or legally-authorized representative (LAR) may provide consent on behalf of the participant. Alternatively, assent, LAR consent, and/or parental permission may be waived by the IRB. Failure to object should not be equated with an active willingness to participate. Review the section on Assent for more information.

Participant. Unless otherwise indicated, in this guidance the term “participant” refers to: the participant, the parent(s) or guardian of a minor participant, and the LAR for a decisionally-impaired adult participant.

Recruitment. Advertisements, announcements, social media (e.g., Facebook, Twitter) postings, and other recruitment processes and materials are generally considered to be part of the consent process.

Regulatory Oversight

Which regulations apply?

Consent requirements may vary depending on the participant population, federal regulations, state laws, international laws, and institutional polices that apply to the research.

Federal agency consent requirements

It is HSD policy to voluntarily apply the Common Rule (45 CFR 46) consent regulations to all research reviewed by the UW IRB except as described in the HSD Flexibility Policy (GUIDANCE Authority and Responsibilities of HSD and UW IRB), in addition to other applicable requirements. The guidance, Designing the Consent Process provides information about the general requirements and elements of consent as well as the criteria for waiving elements and documentation of consent for the Common Rule, FDA, and other federal regulatory agencies. That guidance also lists the consent requirements for federally-designated protected populations (i.e., pregnant women and neonates, prisoners, children).

State or other local law

State laws in the jurisdiction where the research is being conducted may affect the consent process (e.g., mandatory reporting; age of majority). Refer to the guidance on Human Subjects Regulations, Mandatory State Reporting, and the sections in this guidance on consent using a legally authorized representative and the Washington State law on audio recording for details. Researchers are responsible for identifying applicable state or other local laws when the research is conducted outside of Washington State, including internationally (OHRP webpage for international research).

HSD/UW IRB policy

HSD/UW IRB policies related to consent can be found in this guidance, the guidance on Designing the Consent Process, and the worksheet Consent Requirements and Waivers.

Exempt Research

HSD does not apply consent regulations to research that is determined to be exempt from IRB review. Nor does HSD review and approve consent plans and consent materials for exempt research. Researchers are still responsible for protecting the rights and the welfare of participants in their research and for providing participants with information about the research prior to their agreement to participate. Review the section on Information for participants in the guidance on Exempt Research for full details.

Consent Overview

The Key Information Requirement

The Key Information requirement and its purpose

The Common Rule requires that informed consent must begin with a concise and focused presentation of Key Information that is most likely to assist prospective participants or their representatives in understanding the reasons why they might or might not want to participate in the research. The Key Information must be organized and presented in a way that facilitates comprehension. Although a Key Information section may serve as an abstract or executive summary for a longer consent form, that is not its primary function.

When is Key Information required?

All consent-related materials must include Key Information if the study meets these criteria:

• The study is non-exempt human subjects research reviewed by the UW IRB (per HSD policy, it does not matter whether the Common Rule governs the study); and
• The IRB has not fully waived the requirement to obtain consent; and
• This includes consent forms, online or paper information statements, e-consent information, the short form consent process, oral consent with no written component, parental permission, and LAR consent.

The Common Rule does not require Key Information in assent forms for children and decisionally-impaired adults, however, it is HSD policy to require Key Information when assent forms have more than 2000 words.
Consent materials must have a distinct Key Information section when they are more than 2,000 words (not counting any signatures sections; approximately 5 pages; single-spaced; 1-inch margins). It is HSD policy to consider shorter documents (less than 2000 words) to have met the requirement to present Key Information in a concise and focused manner because of their short length. However, the IRB has the authority to require a separate Key Information section if appropriate.

Content

There is no specific information that must be included in the Key Information. The appropriate information depends on the nature of the study, nature of the participant population, and on the other information presented as part of the consent process and/or form. Federal guidance stresses that the Key Information should be meaningful within the context of the study and in a draft guidance document has provided non-binding recommendations about what information should be included. However, the guidance does generally expect that Key Information include a concise explanation of the following elements:

Key Information Elements

1. voluntary consent is being sought for research;
2. research purpose, expected duration of participation, procedures – including experimental procedures, and whether the study design includes a placebo;
3. the most important, reasonably foreseeable risks or discomforts; *;
4. reasonably expected benefits to the participants or others;
5. appropriate alternative procedures or courses of treatment, if any;
6. for studies in which a treatment is administered as part of the research, a notice that refusal to participate or the decision to withdraw from the study will result in no penalty or loss of benefits to which the participant is otherwise entitled.

*Risks and discomforts in Key Information should be described with the study context and participant perspective in mind. For example, if the most important risks associated with the study are from a blood draw, these risks should be described in Key Information. However, if a blood draw is only one of many procedures and the other study procedures are associated with more significant risks to participants, then information about the blood draw may be left out of Key Information and instead described in a more detailed Risks section later in the consent process or form.

HSD tip. For most biomedical studies, detailed information about compensation for injury, specific protections for privacy and confidentiality, and how data and specimens will be shared and stored does not need to be in the Key Information. Such information can be briefly mentioned in Key Information with a page number reference or hyperlink to a later section of the consent form where it is described in detail.

Primary factor: the participant population

Key information is intended to be the information that is most likely to assist the specific participant population (e.g., end-stage cancer patients; first-year college students; parents of toddlers with autism; prisoners). Identifying this information is the responsibility of the researcher. This may mean that the researcher needs to consult with publications about research participant preferences, disease-focused nonprofit groups, patient interest groups, or other researchers/study staff with experience with the specific population. It may also involve directly consulting selected members of the study population.

When writing Key Information, consider the following questions:

• What are the main reasons a participant will want to join, or not join, this study?
• What is the research question the study is trying to answer and why is it relevant to the prospective participant?
• What aspects of research participation in this study are likely to be unfamiliar to a prospective participant, diverge from a participant’s expectations, or require special attention?
• What information about the participant is being collected as part of this research?
• What are the types of activities (procedures) that participants will do in the research?
• What impact will participating in this research have on the participant outside of the research? For example, will it reduce options for standard treatments?
• How will their experience as a research participant in this study differ from treatment they might receive as a patient outside of the study?
• In what ways is this research novel?
• What is the anticipated time commitment for the participant?

Relationship to the rest of the consent form/materials

A Key Information section may appropriately include a summary of relevant pieces of information that are then explained in greater detail later in the consent form or process. Generally, information that is fully described in the Key Information section does not need to be repeated later in the form or process. Similarly, if the Key Information section includes any of the elements of consent described in the worksheet Consent Requirements and Waivers, those elements do not need to be repeated later in the form or consent process. There may be some limited situations when intentional repetition of information could improve comprehension or clarify complex concepts (e.g., certain risks, alternatives, uncertainty about direct benefits). For example, it may improve comprehension to briefly describe the most serious or common reasonably foreseeable risks in the Key Information section and to repeat that information again, perhaps in greater detail, in the section of the consent form that includes a comprehensive description of reasonably foreseeable risks.

Review our Key Information examples.

Structure and presentation

The Key Information may be in a separate document or in the beginning of the consent form, but it must be presented to participants at the beginning of the consent process. The Key Information requirement applies to the consent process as a whole – not simply to consent documents. In other words, there is flexibility in how the presentation of Key Information is structured if it is organized and presented in a way that facilitates comprehension for prospective participants.

In most cases, when there is a separate Key Information section, it will be relatively short compared to the rest of the consent document or process. For example, complicated clinical trials involving high risk procedures typically involve consent forms of more than 20 pages. In these cases, the federal agencies expect that the Key Information section would be no more than a few pages. However, those agencies have also stressed that the section should be meaningful within the context of the study and have therefore purposely avoided specifying length requirements. Review our Key Information examples.

Identifying and Describing Reasonably Foreseeable Risks in Research

The UW IRB is defining the regulatory term reasonably foreseeable as those risks or discomforts that must be included in the informed consent process because they are both reasonably foreseeable and meet any of several additional criteria. A workable definition of reasonably foreseeable is required to ensure that a description of any reasonably foreseeable risks or discomforts to the participant are presented to a potential research participant as part of the informed consent process (45 CFR 46. 116 (b) (2); 21 CFR 50.25(a)(2)). This is particularly relevant for risks associated with drugs, devices, or complex procedures where the number of risks may be large, and inclusion of all possible risks may detract from an individual’s ability to consider those risks that are relevant to their decision to participate in the research.

The following definition, built upon FDA guidance and SACHRP guidance, should be used to help evaluate which risks the UW IRB considers reasonably foreseeable and, therefore, should be included in the consent form or included as part of the informed consent process.

Reasonably Foreseeable Risks
Reasonably foreseeable risks are those risks that a reasonable person in the target population would find meaningful to their decision to participate in the research. This should include (but not be limited to) any of the following: (a) risks that are more likely to occur; (b) risks that are serious; OR (c) risks that the research is evaluating and that an individual would not otherwise be exposed to if they were to decide not to participate in the research.

(a) “More likely to occur” are risks that are frequent/common or very frequent/very common as described in the table below. Risks expected or known to be very frequent/very common or frequent/common should generally be included in the consent form and/or consent process. The IRB can always exclude frequent/very frequent risks that don’t apply to the target population (for example the study includes an adverse drug reaction with acetaminophen but participants taking acetaminophen are excluded from participating). Conversely, the IRB can require the inclusion of infrequent, rare, or very rare risks that don’t otherwise meet the overall definition above if they determine the target population would find them meaningful to their decision to participate in the research (e.g., rare permanent teeth discoloration).

We recognize that in some cases, there is no written source or data (e.g., drug Investigator Brochure or package insert) to rely on when determining frequency of risks. In those instances, the expert judgement of the researcher, or relevant published literature, would need to be applied when determining frequency. The IRB, in their review, would have the opportunity to check these assumptions.

(b) “Serious” are risks that fall under the FDA’s definition of a Serious Adverse Event (i.e., anything that would result in death, be life-threatening, would require hospitalization to treat, could cause disability/permanent damage, cause birth defects, require an intervention to prevent permanent impairment or damage or other important medical events). For a full description of the definition, visit this FDA webpage. These risks should generally be included regardless of the potential frequency of occurrence. As with ‘more likely to occur’ the IRB has discretion to leave out serious risks that are not relevant to a particular population, may be theoretical or unsupported by the data, or would detract from a participant’s understanding of the more significant risks associated with the primary aim(s) of the research.
For example:

• A drug can be life threatening to children under 5 years of age, but all children are excluded from participating in the study
• A researcher proposes including Stevens-Johnson syndrome (SJS) as a possible risk of the study but there has been no incident of SJS to date
• A study of a novel diabetes drug involves routine blood draws with use of topical lidocaine to numb the area of the needlestick but the very rare risk of anaphylaxis from the lidocaine is excluded (i.e., inclusion is not relevant to a reasonable person’s meaningful decision to participate in the research).

(c) “Risks that the research is evaluating.” If researchers design and conduct a study for the purpose of evaluating a particular risk then the research risk being evaluated has been recognized as a sufficiently possible outcome to be considered “reasonably foreseeable” and should be disclosed to prospective participants (adapted from OHRP Comparative Effectiveness Guidance).

 
Additional Considerations
Risk statements in consent forms should be simplified such that the information included is understandable and relevant to the participant population. Detailed descriptions of all potential risks are counterproductive if they do not provide potential participants with useful information and may inadvertently distract participants from relevant data. (SACHRP recommendations)

For minimal risk procedures, risks or burdens that are immaterial or obvious to potential participants need not be explicitly addressed in the consent form or dialogue. For example, participants need not be told that needle sticks can cause minor pain or that surveys can be boring. There is also no need to specifically state the absence of risk where none exists. (SACHRP recommendations)

Applying the Guidance – Examples

 
When to Describe Risks for Studies Evaluating Medically Recognized Standards of Care
It can be difficult to determine which risks to include in the consent form when the research involves medically recognized standards of care procedures or treatments in addition to, or instead of, any investigational procedures or treatments.

In general, the reasonably foreseeable risks associated with a standard of care procedure or treatment should be described in the consent form when:

• the standard care procedure or treatment is required solely for research purposes;
• the research design dictates the procedure or treatment that will be provided to the subject;
• the research design restricts the ability of the participant or the participant’s care provider to choose the procedure or treatment that will be provided to the participant.

The examples below illustrate how to identify: (1) which risks are research risks and should be described in the consent process/form; and (2) which risks are not research risks and should not be described in the consent process/form. Additional information can be found in the OHRP draft Guidance, “Disclosing Reasonably Foreseeable Risks in Research Evaluating Standards of Care”.

Protected and Vulnerable Populations

Undue influence and coercion

Human subjects regulations require that the consent process minimizes the possibility of undue influence or coercion and notes that some populations of participants are considered especially vulnerable. The regulations designate three “protected populations” (pregnant women, prisoners, children) that each have additional required protections. Other vulnerable groups may also require additional protections against the potential for coercion or undue influence.

Undue influence may occur through an excessive offer of something valuable or desirable that influences decision-making in inappropriate ways. Undue influence is often scrutinized by the IRB when participants will receive significant payment for participation (Payment guidance). There are other situations when concerns about undue influence may arise. Federal regulatory guidance concedes that there is no bright line between mere influence and undue influence and so it is up to the IRB to make that distinction.

A study benefit might raise concerns about undue influence when it is likely to: 1) inhibit a potential subject’s adequate consideration of, and reflection about, important study features such as risks, burdens, and discomforts; or 2) impair a potential participant’s understanding of the research and their participation in it.

Coercion occurs when an overt or implicit threat of harm is intentionally presented by one person to another to obtain compliance. Prior to implementation of human subjects research regulations, there were many instances of participants being coerced into research. Regulatory protections and IRB oversight have reduced the likelihood of coercion in research, but it is still something researchers and the IRB should be cautious about, particularly when researchers are in a position of power over participants (e.g., physician and patient or professor and student).

Minimizing the potential for undue influence or coercion. It is important to remember that the IRB is tasked with minimizing, not eliminating the possibility of undue influence or coercion. Whether a participant may be vulnerable to being unduly influenced or coerced to participate in research is contextual and dependent upon the individual participant’s situation, yet the IRB approves research on a population-level.

There will be some situations where identification of the potential for unduly influencing a participant group or groups will be clear, as will the steps for minimizing that potential. For example, when there are power dynamics involved (e.g., professor/student; supervisor/employee), it may be appropriate to ensure the consent process is conducted by someone outside the power dynamic. It may also be important to ensure that the person in power is not aware of which of their students, supervisees, etc. participated and which did not. For many other situations, rather than trying to anticipate what might be unduly influential for every individual participant, the IRB should make use of existing minimization tools including some of the other regulatory consent requirements and protections that have been described in this guidance. These include ensuring that:

1. participants have adequate time to consider and discuss participation prior to giving consent; and
2. consent processes and materials are understandable and include Key Information in sufficient detail for the specific participant population to be able to make an informed decision about participation.

The IRB should pay particular attention to the way a study’s benefits are described. Known benefits should be accurately described and not exaggerated. Potential or uncertain benefits should be described clearly as to what is known about the uncertainty or likelihood of the potential benefits. A meaningful consent process enables prospective participants to decline participation in research that they judge to be harmful or inappropriate according to their own interests, values, and obligations.

Examples of undue influence and coercion adapted from an Advarra IRB blog post:

Children

Children are a federally designated “protected population” with additional regulatory protections and requirements described in Subpart D of the Common Rule. When children participate in research, parent/guardian permission and child assent are sought rather than consent.

Review our guidance on Involvement of Children in Research for a discussion of who qualifies as a child. Review the assent section of this guidance for details about when assent must be obtained and for guidance about designing the assent process and form.

Parent/guardian permission

Definitions. Permission is the agreement of parent(s) or guardian(s) to a child’s participation in research. A parent is defined as the child’s biological or adoptive parent and a guardian is an individual who is authorized under applicable State or local law to consent on behalf of the child to general medical care. In general, one or both parents or guardians must be provided with the same information that is provided during an adult consent process, unless the regulatory criteria are met for waiving permission or waiving or altering elements of permission (Children worksheet).

One or two parent permission. The permission of one or both parents may be required depending on the children’s risk level category as determined by the IRB (Involvement of Children in Research guidance; Children worksheet).

Waivers and alterations. Parental permission can be waived or altered, and documentation of permission can be waived, under the same criteria for waiving or altering consent and consent documentation. [For FDA-regulated research, parental permission can only be waived under the minimal risk criteria.] Review the Children worksheet for a full description of waiver criteria.

Pregnant women and neonates

Pregnant women and neonates are a federally designated “protected population” with additional regulatory requirements and protections described in Subpart B of the Common Rule. However, bioethicists now tend to view pregnant participants as a complex or special rather than vulnerable population, because pregnancy itself does not impair a participant’s ability to comprehend an informed consent process. Some research with pregnant women may have additional complexities such as weighing the risks and benefits of both the pregnant woman and the fetus or mitigating risk of exploitation in some specific contexts. However, these potential complexities are dependent upon the specific research design and are not necessarily applicable to all studies enrolling pregnant women. It is noteworthy that, in the 2018 revision to the Common Rule, pregnant women were removed as an example of a population that is potentially vulnerable to coercion or undue influence. Subpart B consent requirements for pregnant women and neonates are listed in the worksheets on Pregnant Women and Neonates.

Prisoners

Prisoners are a federally designated “protected population” with additional regulatory requirements and protections described in Subpart C of the Common Rule (Prisoners guidance). These protections, and restrictions about the types of research in which prisoners may participate, were put into place to prevent a return to past research practices that exploited prisoners by exposing them to an unfair burden of risks, coercive and unduly influential enrollment practices, and an absence of informed consent procedures. However, these same protections can unfortunately restrict prisoners’ autonomy to independently weigh what risks they are willing to assume and possibly limit their access to potentially beneficial research.

Designing consent with prisoners. Poor reading and communication skills tend to be more common in prison populations (Committee on Ethical Considerations for Revisions to DHHS Regulations for Protecting Prisoners in Research, 2006). This creates challenges for obtaining informed consent because the process typically relies heavily on written materials. For example, it has been shown that undue influence was significantly higher among prisoners with lower educational attainment and those who had spent a longer time in prison (Ravi et al., 2018). This makes it particularly important that the Key Information about a study be tailored to the prisoner population and communicated in language that is understandable to them. Allowing adequate time during the consent process for discussion and opportunities for the participant to ask questions becomes extremely important when enrolling prisoners. Providing a clear and accurate description of confidentiality measures should also be discussed in detail, given the confidentiality limits that may exist in prisons because of institutional policies. As is noted in Consent Consideration # 5, with the appropriate protections in place, prisoners may still be able to take advantage of opportunities to share in the risks and benefits of research.

Assent

Assent is a participant’s affirmative agreement to participate in research. It must be accompanied by parent/guardian permission or the consent of a legally authorized representative (Use of a LAR). Alternatively, assent, LAR consent, and/or parental permission may be waived by the IRB. It is HSD policy that researchers must obtain assent from participants who are minors or decisionally-impaired adults, when the individuals are capable of providing assent and when it is appropriate to do so. Researchers who do not plan to obtain assent from these participants must provide the IRB with justification about why obtaining assent is not appropriate.

Assent determinations. The IRB must determine whether the prospective participants are capable of providing assent and, if they are, whether the proposed assent process is adequate for helping participants decide whether they want to participate in the research (Consent Requirements and Waivers worksheet). If the IRB determines that assent is possible, the IRB may nonetheless waive the assent requirement under the same criteria for waiving consent (Consent Requirements and Waivers worksheet). These determinations will depend on several factors including the age, maturity of a minor, psychological state, and/or cognitive capabilities of the prospective participants. The decision may apply to all participants in the study or may differ by individual participant or group of participants.

Assent requirements. Researchers are asked to describe their plans (if any) for obtaining and documenting assent in the IRB application. The assent process and any materials should provide information that is relevant for the participant population considering their capacity for comprehension and the research procedures. There is no regulatory requirement to provide all the standard elements of consent during the assent process. There is also no requirement to document assent with an assent form, although researchers should have some way of recording that they obtained assent.

Assent outcomes. Potential participants may express an active willingness to participate, may simply fail to object, or may dissent (express unwillingness to participate). Failure to object should not be equated with an active willingness to participate. In general, dissent should be respected. A disagreement between a parent(s)/LAR and the potential participant may arise for many reasons and every effort should be made to reach consensus between the parent(s)/LAR and potential participant. However, the IRB may allow the parent(s)/LAR wishes to prevail over the potential participant’s dissent when the potential participant may directly benefit from the research. In these cases, it may be more appropriate to waive assent, rather than ask the participant and then not take their wishes into account. A potential participant’s assent cannot override a “no” from a parent or LAR unless the IRB has waived the requirement for parental permission or completely waived consent.

Child assent

Design. When designing the assent process and, if applicable, assent form, researchers should consider the nature of the research as well as the age, maturity, and psychological state of the children. When the research involves adolescents whose capacity to understand resembles that of adults, the assent procedure and form would be similar to one designed for adults. In some cases it may be appropriate to use a single form to obtain both parental permission and child assent. For younger children, researchers should focus the assent process and information on the aspects of the research that the children would be mostly likely to understand and be interested in. This would likely be a short description of what the experience would be like, how long it would take, and whether there would be any pain or discomfort as a result of participating. For studies that span several age groups, it may be necessary to design multiple assent procedures and/or forms based on the comprehension capability of the different groups.

Longitudinal research and children who reach the age of majority. The assent process should be viewed as ongoing throughout the duration of the research. If a participant enrolls in research at a young age and remains enrolled for many years, it may be necessary to re-assent as the child’s capacity to understand increases. If the child reaches the legal age of consent while enrolled, the regulations about child participants no longer apply. In these cases, unless the IRB has waived the requirement, the researcher must obtain legally effective research consent from the now-adult participant for any ongoing interactions or interventions or continued analysis of identifiable specimens or data.

Diminished or Fluctuating Consent Capacity and use of a Legally Authorized Representative (LAR)

Presumption of capacity to consent

Individuals who have reached the age of legal consent in the jurisdiction in which the research is being conducted are presumed to have capacity to give informed consent for research. In the absence of indications to the contrary (e.g., a diagnosis of advanced dementia; impaired decision-making ability due to a stroke in specific brain areas), such capacity can be assumed without further evaluation of documentation unless required by the IRB.

Nature of decision-making impairments

Decision-making impairments may be permanent, temporary, progressive, or fluctuating. Also, the capacity to consent is protocol-specific and situation-specific. For example, an individual may have the capacity to make the research participation decision for a low-risk study in usual circumstances but not have the capacity in a stressful situation to understand and evaluate a high-risk study. In other words, the presence of a cognitive impairment or cognitive-state-altering circumstances does not necessarily mean that the person is incapable of an informed consent decision. However, the IRB will expect the researcher to assess the impact of the circumstances on the person’s decision-making ability about the specific participation decision.

Legally-authorized representative

If an adult’s capacity to consent is reduced, then they can participate in the research only if a legally-authorized representative (LAR) provides consent on their behalf. In addition, researchers must obtain some type of assent from the participant, when the individuals are capable of providing assent (assent). A careful balance of the Belmont Ethical Principles is vital to enrolling participants with diminished consent capacity. So long as the additional protections afforded by LAR consent are in place to offset the participant’s diminished autonomy, it is possible that individuals with reduced consent capacity can still participate in research.

Who can be a LAR is determined by the laws of the jurisdiction in which the research is conducted. There are no Washington State laws that directly address the use of LARs in research. However, Washington State law RCW 7.70.65 defines who may serve as a LAR for providing informed consent for health care. Established legal opinion has determined that it is appropriate to apply this definition of LAR for research consent as well.

For information about who can be LAR for a minor, review the section on Parent/Guardian Permission in Protected and Vulnerable Populations and RCW 7.70.65(2) which describes the somewhat different requirements for an LAR for minors in Washington State, when the parents are not available.

IRB approval and authority

Prior IRB approval of using LARs to obtain consent is not required by federal regulations. However, the IRB has the authority to limit, or explicitly not allow the use of LARs to obtain consent when such limits or prohibition is appropriate for a specific study.

Participants with Comprehension Barriers (e.g., language, literacy, visual impairment) or Who Cannot Write or Speak

Researchers may encounter individuals who are interested in participating in research and have the cognitive ability to consent on their own behalf, but who have limited ability to understand or read consent information presented in English, or to sign a consent form.

The consent process for these individuals must meet the same regulatory requirements as for any other consent process. This includes the requirement for consent information to be presented in a language that is understandable to the participant. The researcher may need to take additional steps to ensure the participant comprehends the consent process, has adequate opportunity to ask questions, and voluntarily agrees to participate. Accommodations for the consent form or process will be specific to the needs of the particular participant(s).

The IRB must approve the consent plan, including the process that will be used to ensure that oral and written information will be in a language understandable to participants throughout the study and at an appropriate reading and comprehension level. The IRB has the authority to require revisions or additions to the consent process to ensure that all participants are adequately informed and are providing truly voluntary consent.

In keeping with the Belmont Principle of Justice that selection of participants should be equitable in terms of fairly distributing the risks and benefits of research, researchers should carefully consider the purpose of the research and the scientific question when considering the inclusion and exclusion of these participant populations. This is particularly important when the study may offer significant benefit to the individual participants or participant population.

Anticipated involvement of participants with non-English language preference

For research intended, or likely, to involve participants who are not fluent in English, researchers are responsible for ensuring all consent information and materials are presented in a language understandable by the participants and in a way that accurately conveys the information. Remembering that consent is a process, researchers must have a plan for ongoing communication between the research team and the participants throughout their participation in the research.

Interpretation. Researchers must describe in their IRB application how and when interpretation will be provided and the qualifications of the interpreter(s) (e.g., certifications, experience, familiarity with research-related vocabulary in English and the target language). If no member of the research team is fluent in the participant’s preferred language, interpretation services should be made available throughout the course of the research.

When working with interpreters, consider the following:

• If the participant’s family members or friends will be asked to serve as interpreter, the researcher should think carefully about privacy and confidentiality issues, particularly for research that involves health or other sensitive topics. They should also ensure that the interpreter will accurately convey the information (e.g., Are they capable of interpreting complicated biomedical information?).
• It is almost never appropriate to use children as interpreters. Exceptions may rarely be allowed when the children are considered adults in the local setting, the risks are low, there are no alternatives, and there are no potential conflicts of interest.
• Researchers should discuss the consent process, including the HSD Consent Considerations, with interpreters before conducting consent. For example, how will the researcher and interpreter determine whether the participant truly understands the consent information?

Translation. Researchers must describe in the IRB application how translations will be obtained for consent and all study materials that will be presented to participants (e.g., surveys). The qualifications of the translator must also be described. Translated documents must be: 1) linguistically accurate; 2) at an appropriate reading level for the participant population; and 3) culturally sensitive for the locale in which they will be used. The IRB review focuses on whether the translation method is appropriate rather than approving the translated text.

• Translated materials that must be provided to the IRB. It is HSD policy that researchers obtain and provide the IRB with translations for all consent materials that will be provided to the participant in written or electronic form. The IRB may request translated versions of any other materials.
• The IRB will request that researchers fill out the, Translation Attestation for studies that are greater than minimal risk or if they otherwise deem it necessary. Researchers should only submit this form in response to a request from the IRB.
• Who does the translation? HSD does not require researchers to use a specific translation service.

  Possible translation services

  • The American Translators Association maintains two online directories: Directory of Translation and Interpreting Services (by individual); Directory of Translation and Interpretation companies. http://www.atanet.org/onlinedirectories/
  • Dynamic Language. UW Medicine uses and recommends this local translation service, which is experienced in working with UW researchers (including biomedical researchers) and with invoicing to UW budgets.
  • Native speakers who have demonstrated proficiency in English, including knowledgeable members of the research team, academics at other institutions, bi-lingual tribal leaders, etc.
  • Graduate students or instructors in foreign language programs.

Unanticipated involvement of participants with a non-English language preference

The regulations allow an alternative method of obtaining and documenting consent called short form consent. This method is intended to be used only for the infrequent and unanticipated enrollment of an individual with a non-English language preference in a study for which no consent form in the participant’s language has been prepared and there is insufficient time and opportunity to obtain an appropriate written translation of the IRB-approved English consent forms.
 
It is UW policy that:

• The short form method may only be used when an appropriately qualified interpreter will be available to the participant throughout their participation in the research.
• For minimal risk research that is not FDA regulated, the IRB does not need to approve the use of the short form method in advance, and no additional steps are required following use of the short form.
• For research that is more than minimal risk or is FDA regulated, the short form method may only be used with advance approval from the IRB. The appropriateness of the short form method for the research and target study population is generally assessed by the IRB at the time of initial review. If not assessed at the time of initial review, a study modification must be submitted requesting use of the short form method. The IRB will determine if there is sufficient justification for obtaining participant consent without waiting for translation of the consent form and consider if use of the short form in this circumstance will provide the participant with sufficient opportunity to understand the information presented.

  In addition, the following steps must be taken after a participant is enrolled using the short form method:

• The use must be reported to the IRB asap (no later than 30 days after use) as a Study Modification with the study consent form translated into the participant’s language.
• Once the translated consent form has been reviewed and approved by the IRB, it must be provided to the participant within 2 weeks of IRB approval. The consent form does not have to be provided to the participant in person. It could, for example, be sent by email. It does not require any signature. The translated consent form must thereafter be kept up to date.

Short Form Consent Process

• Short form written consent form. This generic document states that the required elements of consent (unless waived by the IRB) have been presented to the participant in their language of preference, with Key Information being presented first. The short form written consent form must be translated into the participant’s language of preference so that literate participants have the opportunity to read it. A pre-approved English version of the short form and translations in common languages spoken in King County are posted on the HSD website [UW Consent Templates]. The UW short form should be used by UW studies and for sites that are relying on the UW IRB for review unless this conflicts with the policy of the relying site institution. Contact hsdinfo@uw.edu if the language you need is not posted. The short form written consent form is signed by the participant and a witness. A copy of the form is provided to the participant.
• Summary document. The IRB must approve a written summary of the information that will be presented orally to the participant during the consent process. This summary is almost always the IRB-approved English version of the consent form that is presented by a member of the research team through use of a qualified interpreter. The summary document is signed by the witness and the person obtaining consent. A copy of the form is provided to the participant, but it is not signed by the participant.
• Witness. The short form process requires an observer to the oral presentation of the consent information and the participant’s voluntary participation.
• They must be an impartial adult (i.e., not a member of the research team and not an advocate for either the researcher or the participant).
• They should have sufficient proficiency in the language of the oral presentation to be able to attest to the information that was presented orally to the prospective participant. The interpreter may serve in this role provided that they are not a member of the research team. The interpreter should be asked about serving as an impartial observer before starting the consent process. If the interpreter is unable or unwilling to serve in this role and there is no other impartial adult with sufficient language proficiency available, the researcher may forego the language proficiency requirement provided that:
• The study offers the prospect of direct benefit to the participant.
• The attempt to identify an impartial adult with language proficiency to serve as witness is documented.
• They must be present physically or by phone or video conference for the oral presentation and signing of the forms. The purpose of this role is generally to attest to: 1) the voluntariness of the participant’s consent; 2) that the consent information was accurately communicated; and 3) that the participant’s questions were answered.

Participant with low literacy

It is HSD policy to generally apply the guidelines described in the FDA Guidance on Informed Consent when enrolling participants who are illiterate or who have low literacy.

Participant with visual impairments

The consenting process described above for illiterate individuals may be used, but it is preferable to provide the participants with an electronic copy of the materials which can then be examined by using an electronic device (e.g., computer) with a screen reader. In general, the use of Braille-based materials is discouraged.

Participant who cannot write a signature on a consent form

A participant may be unable to physically sign a consent form due to some impairment (e.g., injury to hands). in these cases, the participant may “sign” the form by marking an X on the signature line. An impartial witness should witness the mark and sign the form. If the participant cannot use their hands at all, the IRB will consider alternative methods of documenting consent.

Electronic Consent

Electronic informed consent (“e-consent”) refers to the use of electronic systems and processes that employ some type of electronic media (including text, graphics, audio, video, podcasts, passive and interactive websites, biological recognition devices, card readers, etc.) to convey consent information and/or to document informed consent. These may be used in place of, or in combination with, paper-based consent methods.

Paper vs. e-consent – choosing the appropriate method

E-consent processes are invaluable when it is not possible to have an in-person interaction with a participant. E-consent can take many different forms including, consent information or documents that are delivered electronically (e.g., email, text message); passive or interactive websites; social media platforms; audio; video; podcasts; or any combination of these. E-consent may also be useful and appropriate for in-person consent interactions. For example, a consent form may be emailed in advance to a potential participant, followed by an in-person meeting in which the study is discussed, after which an electronic signature is obtained.

E-consent allows for using images, animations, embedded comprehension checks, and other technological tools that can improve consent comprehension. However, there are also potential limitations to using e-consent. The participant population will require infrastructure (e.g., reliable internet connection), hardware (e.g., smartphone, computer), and technological experience in order to benefit from the potential advantages of e-consent.

When choosing whether to employ paper-based consent or e-consent, it is important to understand the needs and capabilities of the participant population(s). To ensure participant comprehension, it might be necessary to provide consent using a combination of both paper-based and electronic methods.

Facilitating comprehension and the opportunity to consider participation

When consent is not an “in-person” process, the researcher and the IRB must consider how participants will be provided with an opportunity to ask questions and have the research team answer them (if appropriate) and/or whether alternative ways of facilitating comprehension may be appropriate. For example, this may be accomplished through telephone calls, electronic messaging (examples: email, text messages), video conferencing, live chat, or other methods. Regardless of the participant’s location, there may also be optional information (for example, hyperlinks or help text) embedded in the electronically delivered material to aid in comprehension of key study elements. Similarly, participants may be asked questions embedded during the electronic process to gauge their comprehension.

Regulatory requirements for e-consent

Electronic delivery of consent information must meet the same human participants regulatory requirements as paper-based delivery of the information. This includes ensuring the information is accessible by participants for the duration of the research and is easily retrievable for auditors and monitors.
FDA-regulated research. Use of electronic systems, archiving, and retention of consent materials must meet the FDA “Part 11” requirements. The Part 11 regulations are separate from the FDA’s human subjects regulations and have nothing to do with IRB review and approval. Part 11 compliance is the responsibility of the researcher.

• The Part 11 requirements are outlined in the FDA Guidance for Industry: Part 11, Electronic Records; Electronic Signatures – Scope and Application (September 2003).
• The UW-ITHS-supported non-mobile version of REDCap meets the FDA’s Part 11 electronic system requirements. However, to fully comply with Part 11, researchers must also implement all other procedural requirements for Part 11 (e.g., limiting system access to only authorized users).

Electronic Documentation of Consent (e-signature)

Review Documentation of Consent.

Documentation of Consent

Documentation of Consent. Prior to initiating any research activities, including screening procedures or extracting information from records, federal regulations require that the participant sign the IRB-approved consent form and that a copy of the consent form be provided to the participant. HSD considers it best practice for the participant to receive a copy of the consent form that they have signed and dated, but it is not a regulatory requirement.

Waiver of documentation of consent. Alternatively, the IRB may grant a waiver of documentation of consent if the criteria are met (Conditions for waiving documentation of consent). Most minimal risk studies will qualify for a waiver of documentation of consent. If a waiver is granted, none of the requirements listed below in this section apply to the study.

Researchers must provide the IRB with a written description of what participants will be told during the consent process, even if consent will not be documented (i.e., no consent form). The process and information presented must include the general requirements and elements of consent as described in the guidance on Designing the Consent Process. HSD recommends, and the IRB may require, that researchers provide participants with a written description of the consent information (e.g., information statement) even when a waiver of consent documentation has been granted (i.e., no consent form).

Required Signatories

Standard Consent

Participant. The participant is required to sign and date the consent form to document that all their questions have been answered and they agree to participate in the research.

When a legally authorized representative (LAR) or parent/guardian provides consent, the participant’s name should be printed on the participant’s signature line. Ideally there should be a designated line for the LAR or parent/guardian signature and date, but this information can be added anywhere in the signature area of the consent form. The LAR or parent/guardian name and relationship to the participant should also be recorded in the signature area.

Researcher. It is HSD policy that for greater than minimal risk research, the consent form must contain the legible name of the person who obtained consent from the participant. The person’s signature is not required. The name may be placed on the consent form in advance of the consenting interaction. It is best practice to date the form at the time when consent is obtained. By placing their name on the consent form, the researcher is confirming that they provided the participant with information about the study, that the participant was given sufficient time to consider participation, that the researcher answered all the participant’s questions, and that the participant indicated they understood the nature of the study, including the risks and benefits of participating.

Witness. Witness signatures are required by federal regulations in limited circumstances (e.g., when using short form consent) or may be required by the IRB to ensure an adequate informed consent process. A witness signature documents that the requirements for consent have been satisfied and that consent was voluntarily given by the participant.

Short Form Consent

Review HSD policy before using the short form process. When it is allowed, the short form process includes the short form itself and a summary document and must involve an impartial (not a member of the research team) adult witness who is fluent in both English and the participant’s primary language.

Short form written consent form. Use one of the HSD provided translations or contact HSD if the language you need is not provided. The short form is signed by the participant and the witness. A copy is provided to the participant.

Summary document. This is a written summary of the information that will be presented orally to the participant during the consent process and is usually the English version of the full consent form. The summary document is signed by the person obtaining consent and the witness. A copy is provided to the participant, but the participant should not sign it.

Verification of identity

This refers to the process for confirming that the individual who provided the signature is the participant. This can be accomplished in a number of ways such as: the research team visually witnesses the signature; participants share some form of official identification with the research team (e.g., scanned copy or digital photo); the participant answers security questions (similar to questions sometimes used by banks).

• General principle. A signature that is personally witnessed by a member of the study team, either in-person or visually using a video conferencing service (e.g., Zoom, Facetime, Skype) is generally considered sufficient verification and documentation of a participant’s identity. In all other circumstances, federal Common Rule guidance encourages researchers and the IRB to apply a risk-based approach to determine if more formal verification is required. For example, how likely is it that someone other than the participant would provide the consent and signature, and how risky would that be to the actual participant and to the integrity of the study?
  • Examples where more formal verification might be appropriate include: 1) a study that involves giving alcohol to participants (verify age); 2) a longitudinal study where it is necessary to ensure that the same person is providing information over time; and 3) a study involving access to sensitive data such as a person’s mental health or sexually-transmitted infection (STI) records.
• FDA-regulated research. The FDA requires verification of identity when electronic signatures (per the FDA definition of e-signature) are used to document consent. Review Approvable Methods for Obtaining Electronic Signature for details but briefly:
  1. UW eSignature (DocuSign) is not valid for FDA-regulated research; and
  2. FDA considered the UW ITHS REDCap signature tool a “hand-written” signature so the identity verification requirements do not apply.

Signature format

• Handwritten signature using a permanent method (e.g., ballpoint pen).
• Electronic signature (e.g., REDCap or DocuSign).
• Other formats. Review Participant With Comprehension Barriers or Who Cannot Write or Speak for alternative formats.

Approvable methods for obtaining handwritten signatures

• The participant signs the consent form in the presence of the researcher. The research may begin immediately.
• The participant receives the consent form by mail or email, the consent discussion occurs by phone or video, the participant signs the form and texts or emails a photo of the signature to the researcher, and the participant mails the signed consent form to the researcher. The research may begin as soon as the researcher receives the photo of the signature.
• The IRB may approve other methods so long as they meet regulatory requirements and are consistent with any applicable local law.

Approvable methods for obtaining electronic signatures

There are many electronic alternatives to a handwritten signature, including: electronic signatures using tools such as DocuSign or REDCap; digital signatures; computer-readable ID cards; biometrics; or username and password combinations. Watch HSD’s tutorial, Electronic Consent: What You Need to Know for an overview.

There are two electronic signature tools that have been vetted by the UW and its legal counsel as meeting the federal and Washington State definitions of a “legally valid” electronic signature. Review the instructions for using UW E-Signature Tools for more information.

• UW ITHS REDCap is a tool provided and supported by the UW Institute of Translational Health Sciences (ITHS).
  • NOTE: The ITHS REDCap Mobile software application does not support a “legally valid” electronic signature under federal and Washington State law.
• UW eSignatures (DocuSign) is an electronic signatures service provider, centrally managed and supported by UW-IT.
  • DocuSign is not valid for FDA-regulated research (details in Requirements specific to electronic consent documentation).

Using a non-UW installation of REDCap may be permitted, so long as it meets all of the requirements outlined in the supplement, Other REDCap Installation and a copy is provided with the IRB application.

Using an e-signature method not vetted by the UW is permitted on a case-by-case basis. The researcher must provide (as part of their Zipline application) a signed Other E-signature Attestation Letter confirming the signature system meets all the applicable e-signature laws in the jurisdiction where the signature will be obtained and follows best practices for technical security. This letter must be signed by the Chief Information Officer, Chief Information Security Officer, or other individual at the company/institution with sufficient authority and subject matter expertise to make the above attestation. HSD and the UW will not vet other e-signature methods.

Regulatory requirements. Electronic documentation of consent must meet the same requirements as for handwritten signatures in addition to the following requirements that are specific to electronic consent documentation:

HSD and/or IRB approval. It is HSD policy that that IRB approval must be obtained in advance for the use of any e-signature or electronic signature capture system (e.g., DocuSign, UW ITHS REDCap).

Approval watermark

The UW IRB system (“Zipline”) automatically places a watermark on consent forms when IRB approval is granted. It is best practice (but not required) for researchers to use the Zipline watermarked version of the consent form. Any non-watermarked version used must match exactly the content and format of the IRB-approved watermarked version.

Records retention and access

The original signed consent form, regardless of format (e.g., paper, electronic) is considered a research record and federal regulations require researchers to retain consent forms for a minimum of three years after completion of the research. Washington State records retention periods are much longer (UW Records Management website).

Signed consent materials must be easily retrievable for auditors and monitors.

Reconsent and Ongoing Participant Communication

Throughout the course of a study, participants may need to be informed about new information or consent may need to be revisited due to fluctuating decision-making capacity [Diminished or Fluctuating Consent Capacity and use of a Legally Authorized Representative (LAR)] or because a child participant has reached the age of majority (review the section on Children under Protected and Vulnerable Populations). In these situations, it is important for participants to be able to reaffirm their willingness to participate in research.

The regulations do not provide details about how new information should be provided and do not specifically mention “reconsent”, although the Secretary’s Advisory Committee on Human Research Protections (SACHRP) provides recommendations on reconsent. Ultimately, it is up to the IRB to determine whether reconsent is required and to identify the most appropriate method for communicating new or revised information. In making this determination, the IRB should consider:

• Study status (procedures: not yet begun; ongoing; limited to long-term follow-up; complete)
• Time sensitivity of the information
• Magnitude of the changes and their likelihood to influence a participant’s decision to continue participation
• Enrollment of any participants with non-English language preference

Methods for providing new information to participants. These methods are based on the SACHRP recommendations and an article from WCG IRB. The UW IRB may consider alternative methods.

Verbal discussion. This method may be appropriate for communicating information that: (1) is simple; (2) does not change the individual participant’s anticipated risks or benefits; (3) is not likely to affect a participant’s willingness to continue participation; and (4) does not require documentation that participants are willing to remain in the study.

Letter or email. Sending the new information in a letter or by email may be appropriate when: (1) the information is easy to understand; (2) the information is not likely to affect a participant’s willingness to participate; and (3) it is important for participants to have the information in writing for future reference.

Consent addendum. This method may be appropriate for complicated or important information that requires consent because it (1) may impact a participant’s willingness to continue participation; but (2) does not require a full reconsent and review of the entire study. An addendum tends to be the least burdensome for participants as it allows them to focus on the new information as they consider whether they want to continue participation. For this reason, HSD recommends the use of a consent addendum, rather than a re-review of the entire consent form, for most situations.

Reconsent. This method requires the most time and effort and should be used when (1) there is no time sensitivity; and (2) the new information is complicated and/or affects many aspects of the study. A full reconsent is required when a LAR consent or parental permission is being replaced by the participant consenting on their own behalf.

Additional considerations.

Study status. In many cases, multiple approaches will be required depending on where participants are in the course of the study. For example, if new risks are identified for a study in which enrollment is ongoing, it might be appropriate to provide participants who have already been enrolled with an addendum while also updating the consent form for participants who have not yet been enrolled.

Revised consent form. Changes to the consent form do not necessarily require researchers to inform all enrolled participants. Researchers should use the information in this guidance to assess the new/revised information and determine what, if any, method should be used to inform participants of new information and/or obtain reconsent. Note that some sponsors or funders may require a full reconsent for any change to the consent form. In these cases, HSD defers to the sponsor/funder.

Waiver of documentation of consent. The IRB should assess the criteria for waiving documentation of consent when reconsent is being obtained whether it is an addendum, or full consent, or some alternative method.

Washington State Law and Consent

Washington State Law on Consent for Audio Recording (RCW 9.73.030)

When an audio recording will capture a private communication or conversation between two or more individuals, Washington State law requires that consent must be obtained from all individuals who will be recorded. The law applies if any participant in the conversation or communication is in Washington State at the time of recording.

Private refers to situations in which an individual can reasonably expect privacy, such as a confidential interview with a research participant or a conversation between doctor and patient. In some circumstances, it can be challenging to determine whether a communication or conversation is private. This will be assessed by HSD staff as part of the HSD/IRB review process.

Communication or conversation means audio only and does not refer to visual recording. However, the State law applies to video recordings that include audio.

Consent may be obtained from a legally authorized representative when appropriate. If a child will be recorded, permission should be obtained from a parent or guardian.

Consent methods. The Washington State law consent requirement for audio recording may be satisfied using various methods:

1. Written consent. This can be a short statement signed by participants (included with research consent or separately). This option is generally appropriate when the research plan is to obtain documented consent from research participants.
2. Recording verbal consent with the communication or recording an announcement that the conversation is being recorded. This option is generally appropriate when the research plan is to obtain verbal consent and the IRB approves a waiver of the requirement for documented consent under human subjects regulations.

Consent should consider the individuals’ preferred language(s), literacy, and whether individuals may be subject to coercion if they decline to be recorded (e.g., an employee unable to perform their job duties in an area being recorded).

Recording in a healthcare setting.

• HIPAA requirements: When in a healthcare setting, recordings are likely to capture Protected Health Information (PHI). If PHI will be captured on the recording, HIPAA Authorization must be obtained from the participant unless the IRB approves a Waiver of HIPAA Authorization. Refer to HSD’s HIPAA Guidance for more information about HIPAA requirements.
• UW Medicine approval: UW Medicine policy requires approval from the applicable UW Medicine entity’s Chief Executive Officer or Executive Director when audio recordings will be made for research purposes in a UW Medicine clinical setting. Refer to the Audio Recordings in a Clinical Setting policy and FAQ on the UW Medicine Compliance website for more information about this requirement. The IRB may request documentation of UW Medicine approval.

Related Materials

Other Consent Materials

Consent Examples
Consent Templates
EXAMPLE Key Information
GUIDANCE Consent Elements for Externally Reviewed Studies
GUIDANCE Designing the Consent Process
INSTRUCTIONS UW E-Signature Tools
TEMPLATE Translation Attestation
TIPSHEET Consent
TUTORIAL Electronic Consent: What You Need to Know
WORKSHEET Consent Requirements and Waivers

Help Materials for HSD Staff and IRB Members

SOP Consent [HSD staff and IRB member access only]
WORKSHEET Consent Review for IRB Members [HSD staff and IRB member access only]

Other Materials Referenced in this Guidance

CHECKLIST Exception from Informed Consent
GLOSSARY Capacity to Consent
GLOSSARY Exempt Research
GLOSSARY Legally Authorized Representative
GLOSSARY Legally Effective Research Consent
GUIDANCE Authority and Responsibilities of HSD and UW IRB
GUIDANCE The Belmont Report
GUIDANCE Exempt Research
GUIDANCE HIPAA
GUIDANCE Humanitarian Use Devices (HUDs)
GUIDANCE Human Subjects Regulations
GUIDANCE Involvement of Children in Research
GUIDANCE Mandatory State Reporting
GUIDANCE Prisoners
GUIDANCE Subject Payment
REQUEST External IRB Review
SUPPLEMENT Other REDCap Installation
TEMPLATE Other E-signature Attestation Letter
WEBPAGE Reliance on a Non-UW IRB
WEBPAGE Single Patient Emergency or Compassionate Use
WORKSHEET Children
WORKSHEET Neonates
WORKSHEET Pregnant Women
WORKSHEET Prisoners

References

• 45 CFR 46.116 [pre-2018 requirements and 2018 requirements]
• 45 CFR 46.117 [pre-2018 requirements and 2018 requirements]
• 45 CFR 46.204 – .205
• 45 CFR 46.305
• 45 CFR 46.408
• 21 CFR 11
• 21 CFR 50.20
• 21 CFR 50.27
• 21 CFR 56.109
• 21 CFR 50, Part D
• OHRP Draft Guidance on Disclosing Reasonably Foreseeble Risks in Research Evaluating Standards of Care, 2014
• OHRP, Guidance on Institutional Review Board Review of Clinical Trial Websites; September 20, 2005.
• OHRP Guidance Documents on Informed Consent, from the OHRP website https://www.hhs.gov/ohrp/regulations-and-policy/guidance/informed-consent/index.html
• OHRP, “Obtaining and Documenting Informed Consent of Subjects Who Do Not Speak English”, memorandum; November 9, 1995.
• OHRP, “Simplifying Informed Consent”, webinar https://www.hhs.gov/ohrp/education-and-outreach/online-education/videos/simplifying-informed-consent-ohrp
• FDA, Guide to Informed Consent Information Sheet, July, 2014
• FDA and OHRP Guidance, “Use of Electronic Informed Consent: Questions and Answers”, December, 2016
• FDA Guidance, “Adverse Reactions Section of Labeling for Human Prescription Drug and Biological Products – Content and Format” January 2006
• FDA Guidance, “Part 11, Electronic Records: Electronic Signatures – Scope and Application”, August 2003
• FDA Guidance on Conduct of Clinical Trials of Medical Products during COVID-19 Public Health Emergency (updated July 2, 2020)
• FDA. “Guidance for Industry. E6 Good Clinical Practice: Consolidated Guidance”, April 1996, section 4.8.9.
• FDA – Reporting Serious Problems to FDA, “What is a Serious Adverse Event?”, 2016
• Meeting of the Secretary’s Advisory Committee on Human Research Protections, Key Information videotape, July 10-11, 2018
• SACHRP Recommendations, “Attachment A – Addressing Ethical Concerns Regarding Offers of Payment to Research Participants”, October 18, 2019
• SACHRP Recommendations, “Attachment A – Guidance on Applying the Regulatory Requirements for Research Consent Forms: What Should and Should Not be Included?”, July 2011
• SACHRP Recommendations, “Attachment A – Recommended Guidance on Minimal Risk Research and Informed Consent”, 2015
• SACHRP Recommendations, “Attachment A1 – Reconsent Appendix 1. New Information Provided to Previously Enrolled Subjects”, May 4, 2020
• SACHRP Recommendations, “Attachment A2 – Reconsent Appendix 2. Additional Information Scenarios and Suggested Options”, May 4, 2020
• SACHRP Recommendations, “Attachment A – SACHRP Commentary on the FDA Draft Guidance Entitled, ‘Informed Consent Information Sheet; Guidance for IRBs, Clinical Investigators and Sponsors’”, February 11, 2015
• CIOMS III – Core Clinical Safety Information, “Guidelines for Preparing Core Clinical-Safety Information on Drugs”, 1995
• 15 U.W. Code Chapter 96 – The Electronic Signatures in Global and National Commerce Act (E-Sign Act)
• National Conference of Commissioners of Uniform State Laws, Uniform Electronic Transactions Act (UETA), (1999)
• Revised Code of Washington (RCW) Chapter 19.360, Electronic Signatures and Records
• Chapter 1.80 Revised Code of Washington (RCW) Uniform Electronic Transactions Act (Washington’s adoption of UETA)
• Committee On Ethical Considerations for Revisions to DHHS Regulations for Protecting Prisoners in Research, “Ethical Considerations for Research Involving Prisoners” (2006)
• Dickert et al., “Reframing Consent for Clinical Research: A Function-Based Approach”. American Journal of Bioethics, 17:12, 3-11 (2017)
• Dickert et al., “Partnering with Patients to Bridge Gaps in Consent for Acute Care Research”. The American Journal of Bioethics, 20(5), 7-17 (2020)
• Gelinas, L. “The Many Faces of ‘Coercion’ and ‘Undue Influence'”. Advarra Blog, Dec 2, 2020 https://www.advarra.com/blog/the-many-faces-of-coercion-and-undue-influence/
• Kraft et al., “Comprehension and Choice Under the Revised Common Rule: Improving Informed Consent by Offering Reasons Why Some Enroll in Research and Others Do Not”. The American Journal of Bioethics, 17:7, 53-55 (2017)
• Ravi et al., “Financial Payments for Participating in Research while Incarcerated: Attitudes of Prisoners”. IRB Ethics & Human Research, 40:6, 1-6 (2018)
• The Belmont Report: Ethical Principles and Guidelines for the Protection of Human Subjects of Research. The National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research, April 18, 1979
• The PHASES Working Group, Pregnancy and HIV/AIDS: Seeking Equitable Study, “Ending the evidence gap for pregnant women around HIV and co-infections: A call to action” (2020)
• WCG IRB Insights, “Providing Research Participants with New Information: Is ‘Re-Consent’ Always Necessary?” https://www.wcgirb.com/insights/providing-research-participants-with-new-information-is-re-consent-always-necessary/
• Wilfond and Kraft, “Attending to the Interrelatedness of the Functions of Consent”. The American Journal of Bioethics, 17:12, 12-13 (2017)

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Keywords: Consent