Purpose and Applicability
These consent TIPSHEETs provide researchers with a summary of the most important points in the GUIDANCE Consent [1]. Researchers are encouraged to use the TIPSHEETs to ensure the most important aspects of consent are included in their consent processes and forms. More detailed information about each topic can be found in the GUIDANCE Consent and other resources that are cross-referenced here. The TIPSHEETs are available in web format or as a downloadable PDF document [2].
TIP SHEET Consent: A Meaningful Consent Process
TIP SHEET Consent: A Meaningful Consent Process |
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Facilitating Informed Decision-Making(Details: Consent Overview [3]) What information is provided
How information is providedPresentation of consent information must facilitate comprehension. Refer to HSD’s Consent Resources [4] webpage for tools to build a participant-focused consent process and form.
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The Consent Process(Details: Consent Overview [3]) Allow adequate time for subjects to consider participation
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Key Information(Details: Key Information guidance [5] and Key Information examples [6]) The consent process must begin with a concise and focused presentation of the Key Information that a reasonable person would want to know in order to make a decision about whether to participate in research. A separate Key Information section is only required if the consent form has more than 2,000 words. To identify Key Information, ask:
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TIP SHEET Consent: Written Consent Materials
TIP SHEET Consent: Written Consent Materials |
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Written Consent Materials(Details: Consent Considerations [3]) Written consent materials should be designed as teaching tools that provide information in a thoughtful, meaningful way rather than serving as a checklist of regulatory requirements. The regulations do require certain general requirements and elements of consent to be present, but researchers have flexibility in how to satisfy these requirements. The Designing the Consent Process [7] guidance provides a list of general requirements and elements of consent and the criteria for waiving consent, altering elements, and waiving documentation. |
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Structure and Format
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Waiver of Documented Consent(Details: Documentation of Consent [8] and Designing the Consent Process [9]) If documentation of consent has been waived by the IRB, an oral consent process may be appropriate (i.e., there is no written form provided to subjects). Or, subjects may be provided with consent information using an information statement which does not require any signatures. |
Documented Consent(Details: Documentation of Consent [8]) If consent documentation cannot be waived:
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TIP SHEET Consent: Population-Specific Considerations
TIP SHEET Consent: Population-Specific Considerations |
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Vulnerable Populations and Consent(Details: Protected and Vulnerable Populations [13])
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Subjects with comprehension barriers or who cannot write or speak(Details: Subjects with Comprehension Barriers [14])
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Subjects with diminished or fluctuating consent capacity(Details: Subjects with Diminished or Fluctuating Consent Capacity [16]) |
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Protected Populations(Details: Vulnerable and Protected Populations [13])
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TIP SHEET Consent: Assent & Legally Authorized Representative
TIP SHEET Consent: Assent & Legally Authorized Representative |
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Subjects with Diminished or Fluctuating Consent Capacity(Details: Subjects with Diminished or Fluctuating Consent Capacity [16]) Assent from these subjects should also be sought, unless the subject is incapable of providing it or it is otherwise inappropriate to obtain assent. Researchers are responsible for:
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Assent(Details: Assent [24]) Assent is a subject’s affirmative agreement to participate in research. Failure to object should not be equated with an active willingness to participate. It is HSD policy that assent must be obtained from children or adults with diminished decision-making capacity when the individuals are capable of providing assent and it is appropriate. There are no regulatory requirements for particular elements, or for documentation of assent. It is up to the IRB to determine whether the researcher’s proposal for assent is appropriate. Researchers and the IRB must first determine whether subjects are capable of providing assent and then design an assent process (and form) that is appropriate for subject group’s capacity to understand the research and their experience if they participate. Generally, a subject’s dissent should be respected, with some exceptions outlined in the Assent guidance [24]. |
Child Assent(Details Assent [24])
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TIP SHEET Consent: Reconsent and Ongoing Subject Communication
TIP SHEET Consent: Reconsent and Ongoing Subject Communication |
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Reconsent and Ongoing Subject Communication(Details: Reconsent [25]) |
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Verbal DiscussionThis method may be appropriate for information that: (1) is simple; (2) does not change risks or benefits; and/or (3) is not likely to affect subject willingness to participate. Examples
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Letter or EmailThis method may be appropriate when the information: (1) is easy to understand; (2) is not likely to affect willingness to participate; and/or (3) is important for subjects to have in writing for future reference. Examples
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AddendumThis method may be appropriate when information: (1) is complicated or important; (2) may impact willingness to participate; and/or (3) consent for the new information is required but does not rise to the level of requiring review of the entire study with a full reconsent. Examples
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ReconsentThis method requires the most time and effort. It is appropriate when: (1) there is no time sensitivity; (2) the information is complicated; and/or (3) the information affects many aspects of the study. Examples
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Providing Materials to the IRBWhen new or revised information is reported to the IRB as a Modification or Report of New Information (RNI) in Zipline, researchers are prompted to consider whether subjects need to be informed about the changes.
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TIP SHEET Consent: The IRB Approval Process
TIP SHEET Consent: The IRB Approval Process |
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Regulatory Oversight(Details: Regulatory Oversight [26])
Human Subjects Regulations guidance [27] Consent Requirements and Waivers guidance [28] |
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Prior IRB Approval
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What to Submit
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Documentation of IRB Approval
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TIP SHEET Consent: Related Considerations
TIP SHEET Consent: Related Considerations |
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Consideration |
Summary Information |
ClinicalTrials.gov | There are additional consent requirements for studies that meet the definition of an applicable clinical trial [29]. |
Deception | Some research may require deception by deliberately misleading subjects about some aspect(s) of the research. Most often, the subject is deceived about the true purpose of the study in order to avoid biasing the results. Deception imposes special responsibilities on the researcher because it conflicts with the fundamental ethical principle that subject make an informed, voluntary decision to participate in research. Researchers are responsible for:
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Genomic Data Sharing | Some funders require submission of genomic data to NIH-designated repositories. When this requirement applies, specific consent language must be included in the consent process.
Genomic Data Sharing Guidance [31] |
HIPAA Authorization or Waiver | Research consent and HIPAA authorization, and/or waivers for both, are generally obtained, or granted, concurrently for studies that include access to PHI.
HIPAA [33] |
Mandatory Reporting |
Some types of research increase the likelihood that subjects will disclose information that triggers mandatory reporting requirements (e.g., child or elder abuse). Consent materials must inform subjects about the possibility of mandatory reporting when there is a reasonable possibility that mandatory reporting circumstances or events will be encountered during the research. |
Privacy and Confidentiality | Consent materials must inform subjects about the extent to which their participation will remain confidential (or not). If subject identifiers are collected, researchers must retain them according to applicable records retention policies. Subjects should not be told that identifiers will be destroyed at the end of the study if records retention requirements prohibit the destruction before the end of the retention period. Additional guidance can be found on the webpage, Designing the Consent Process [35]. Researchers should use the Data Security Protections [36] to identify the correct level of protections. Exceptions to the protections associated with any particular level can be requested in the IRB Protocol with appropriate justification. |
Recruitment |
Recruitment processes and materials such as advertisements, announcements, social media postings, and cold contact letters are generally considered to be part of the consent process and must undergo review by the IRB. With the exception of cold contact [38] materials, researchers are encouraged to submit descriptions of recruitment materials rather than the materials themselves. However, the IRB may request any recruitment materials if they are needed for the review.There is additional guidance and information about recruitment in the instructions embedded in the IRB Protocol [39] application form. |
Return of Individual Results |
Researchers should make every effort to return research results that are clinically actionable, valid, and suggest life-threatening or severe health consequences if not treated or addressed quickly. Other clinically actionable results should be offered if this can be accomplished without compromising the research and in compliance with applicable regulations such as CLIA laboratory certification. Any plan to return results must be summarized during the consent process. |
Significant Financial Conflict of Interest (FCOI) |
The lead researcher is responsible for ensuring that all members of the research team are aware of, and comply with, UW Policy GIM 10 [41]. Any requirements described in a Financial Conflict of Interest Management Plan must be incorporated into the research.It is HSD policy that subjects be informed about the presence of a FCOI during the consent process and that any other consent-related measures in the Management Plan must be incorporated into the IRB application (e.g., if research staff with a conflict are not allowed to obtain consent from subjects). |
Subject Payment | The primary ethical issue with subject payment is undue influence: the concern that payment will inappropriately influence subjects’ decisions about participating in research and about staying in the study once enrolled. The IRB Protocol requests that researchers describe: the purpose of the payment (reimbursement, compensation, incentive); the total amount of payment; the schedule/timing of the payment; and whether it will be pro-rated if only some of the procedures are completed.If subjects earn $600 or more in research payments from UW during the calendar year, the UW reports that to the IRS as “miscellaneous income” and subjects must be informed of this. Subjects’ Social Security Numbers (SSN) may need to be collected in order to receive payment (UW Financial Management requirements [43]). Researchers and the IRB should consider whether the consent process/form should inform subjects about the collection of SSN. The key issue is whether this information is important to the specific subject population.
Subject Payment [44] |
Version Information
Open the accordion below for version changes to this guidance.
Version History
Version Number | Posted Date | Implementation Date | Change Notes |
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1.5 | 03.28.2024 | 03.28.2024 | Update GDS worksheet reference; add reference to HSD Consent Resources webpage |
1.4 | 11.29.2023 | 11.29.2023 | Update hyperlinks |
1.3 | 06.01.2023 | 06.01.2023 | Update references to Designing the Consent Process guidance and new templates |
1.2 | 12.29.2022 | 12.29.2022 | Update reference from GUIDANCE Electronic Consent Signatures to INSTRUCTIONS UW E-Signature Tools |
1.1 | 03.03.2022 | 03.03.2022 | Add tip sheet for “Reconsent and Ongoing Subject Communication” |
Previous versions | For older versions: HSD staff refer to the SharePoint Document Library; Others – contact hsdinfo@uw.edu [45]. |
Keywords: Consent