Consent

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 ^[41].
• Exception from Informed Consent (EFIC supplement ^[42]), 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 ^[43]).
• Clinical use of Humanitarian Use Devices ^[44].

Definitions

Informed consent for research must be legally effective ^[46] and obtained before the subject can participate in any study-related activities. It should include an active process of sharing information between the researcher and potential subject and an affirmative agreement by the subject 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 subjects 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 ^[28] 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 subjects with printed consent materials if the study is a low risk, one-time interview with adults. If subjects will participate in the study remotely (e.g., low risk computer surveys) then providing the subjects with an electronic information statement ^[47] 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 ^[10]) unless the IRB determines any requirements can be waived.

Assent is obtained from subjects who are unable to provide legally-effective informed consent on their own behalf because they are minors or have diminished decision-making capacity. Subjects 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 subject. 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 ^[16] for more information.

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

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 subject 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 ^[48] (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 ^[49]), in addition to other applicable requirements. The guidance, Designing the Consent Process ^[50] 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 ^[51], 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 ^[52], Mandatory State Reporting ^[53], and the sections in this guidance on consent using a legally authorized representative ^[17] and the Washington State law on audio recording ^[38] 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 ^[54]).

HSD/UW IRB policy

HSD/UW IRB policies related to consent can be found in this guidance, the guidance on Designing the Consent Process ^[50], and the worksheet Consent Requirements and Waivers ^[55].

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 subjects in their research and for providing subjects with information about the research prior to their agreement to participate. Review the section on Information for subjects ^[56] 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 subjects 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
• The study is fully or conditionally approved by the IRB on or after January 21, 2019 (the date when this regulatory requirement was enacted).
• 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 subject population, and on the other information presented as part of the consent process and/or form. Federal guidance ^[59] stresses that the Key Information should be meaningful within the context of the study and has therefore avoided strictly defining what information should be included. However, the guidance does generally expect that Key Information include a concise explanation of the following elements:

Primary factor: the subject population. Key information is intended to be the information that is most likely to assist the specific subject 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 subjects’ 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:

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. However, 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 ^[55], those elements do not need to be repeated later in the form or consent process. Review our Key Information examples ^[58].

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 subjects 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 subjects.

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 ^[58].

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 subject are presented to a potential research participant as part of the informed consent process (45 CFR 46. 116 (b) (2) ^[61]; 21 CFR 50.25(a)(2) ^[62]). 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 ^[63] and SACHRP guidance ^[64], 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 subjects 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 ^[67]. 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 subjects (adapted from OHRP Comparative Effectiveness Guidance ^[68]).

 
Additional Considerations
Risk statements in consent forms should be simplified such that the information included is understandable and relevant to the subject population. Detailed descriptions of all potential risks are counterproductive if they do not provide potential subjects with useful information and may inadvertently distract subjects from relevant data. (SACHRP recommendations ^[69])

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 ^[70])

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 subject or the subject’s care provider to choose the procedure or treatment that will be provided to the subject.

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” ^[68].

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 subjects 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 subjects will receive significant payment for participation (Subject Payment guidance ^[71]). 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 subject’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 subjects 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 subjects (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 subject may be vulnerable to being unduly influenced or coerced to participate in research is contextual and dependent upon the individual subject’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 subject 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 subject, 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. subjects 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 subject 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 subjects 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 ^[72]:

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 ^[73] for a discussion of who qualifies as a child. Review the assent section of this guidance ^[16] 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 ^[74]).

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 ^[73]; Children worksheet ^[74]).

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 ^[74] 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 subjects as a complex or special rather than vulnerable population, because pregnancy itself does not impair a subject’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 ^[75] and Neonates ^[76].

Prisoners

Prisoners are a federally designated “protected population” with additional regulatory requirements and protections described in Subpart C of the Common Rule (Prisoners guidance ^[77]). 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 ^[39]). 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 ^[39]). 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 subject 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 ^[78], 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 subject’s affirmative agreement to participate in research. It must be accompanied by parent/guardian permission ^[79] or the consent of a legally authorized representative (Use of a LAR ^[17]). Alternatively, assent, LAR consent, and/or parental permission may be waived by the IRB. It is HSD policy that researchers must obtain assent from subjects 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 subjects must provide the IRB with justification about why obtaining assent is not appropriate.

Assent determinations. The IRB must determine whether the prospective subjects are capable of providing assent and, if they are, whether the proposed assent process is adequate for helping subjects decide whether they want to participate in the research (Consent Requirements and Waivers worksheet ^[55]). 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 ^[55]). These determinations will depend on several factors including the age, maturity of a minor, psychological state, and/or cognitive capabilities of the prospective subjects. The decision may apply to all subjects in the study or may differ by individual subject or group of subjects.

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 subject 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 subjects 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 subject 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 subject 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 ^[46] from the now-adult subject 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 ^[80] 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) ^[81] provides consent on their behalf. In addition, researchers must obtain some type of assent from the subject, when the individuals are capable of providing assent (assent ^[16]). A careful balance of the Belmont Ethical Principles is vital to enrolling subjects with diminished consent capacity. So long as the additional protections afforded by LAR consent are in place to offset the subject’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 ^[82] 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 ^[79] 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.

Subjects 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 subject. The researcher may need to take additional steps to ensure the subject 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 subject(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 subjects 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 subjects are adequately informed and are providing truly voluntary consent.

In keeping with the Belmont Principle of Justice that selection of subjects 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 subject populations. This is particularly important when the study may offer significant benefit to the individual subjects or subject population.

Anticipated involvement of subjects with limited English proficiency

For research intended, or likely, to involve subjects who are not fluent in English, researchers are responsible for ensuring all consent information and materials are presented in a language understandable by the subjects 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 subjects 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 subjects’ language, interpretation services should be made available throughout the course of the research.

Translation. Researchers must describe in the IRB application how translations will be obtained for consent and all study materials that will be presented to subjects (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 subject 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 ^[83] 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/ ^[84]
  • Dynamic Language ^[85]. 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.

Unexpected involvement of subjects with limited English proficiency

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 limited English proficiency in a study for which no consent form in the subject’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.
 
Because this method is only intended for unanticipated enrollment of an individual with limited English proficiency, the IRB does not need to approve the use of the short form method in advance. Researchers who use the short form method should assess whether they are likely to encounter additional subjects who require languages other than English. If so, translated materials should be prepared and submitted for review.
 
It is HSD policy that:

• The short form method may only be used when an appropriately qualified interpreter will be available to the subject throughout their participation in the research.
• For research that involves more than minimal risk, the short form method may only be used for studies that provide the prospect of direct benefit ^[86] that is not available outside the research context.
• Ancillary benefits of research participation, such as additional follow-up visits or free diagnostic tests are not considered direct benefits.
• Randomized clinical trials involving an investigational arm compared with standard of care or placebo are eligible for use of short form consent provided that the investigational arm provides prospect of direct benefit that is not available outside the research context.
• Comparative effectiveness trials are not eligible to use the short form because they do not generally provide a benefit that is unavailable outside of the research context.

Short Form Requirements

• 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 subject in the subject’s language, with Key Information being presented first. The short form written consent form must be translated into the subject’s language so that literate subjects 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 [Consent Templates ^[4]]. Contact hsdinfo@uw.edu ^[87] if the language you need is not posted. The short form written consent form is signed by the subject and a witness. A copy of the form is provided to the subject.
• Summary document. The IRB must approve a written summary of the information that will be presented orally to the subject during the consent process. This summary is almost always the 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, but it is not signed by the subject. A copy of the form is provided to the subject.
• Witness. The short form process requires a witness to the oral presentation of the consent information and the subject’s voluntary participation. The witness must be impartial (i.e., not a member of the research team), an adult, and fluent in both English and the subject’s primary language. The interpreter may serve as the witness provided that they are not a member of the research team.