Facilitating Informed Decision-Making

(Details: Consent Overview)
Research consent must be designed from the perspective of the subject population to ensure informed decision-making.

What information is provided

• Emphasize the Key Information that would be most likely to influence the subject’s decision to participate.
• It is not necessary to describe every procedure a subject will undergo at the time of the consent interaction.
• After enrollment, the consent process can be supplemented with a detailed timeline of procedures or other information.

How information is provided

Presentation of consent information must facilitate comprehension. Refer to HSD’s Consent Resources webpage for tools to build a participant-focused consent process and form.

• Provide information in a logical sequence that allows for real-time discussion between subject and study staff.
• Communicate using plain language that is familiar and at an appropriate reading level.
• Simplify complex information by using shorter words and sentences.
• Avoid medical or technical jargon.
• Speak and write in an active voice and conversational style. (e.g., passive “A drug will be given.” versus active “You will be given a drug.”)
• Consider the perspective of the subject population.
  • The information provided should describe the pros and cons of enrolling in the research for those particular subjects.
  • Describe what participation means for the subjects. For example, if subjects will be randomized, tell subjects what that means for them:
    • they cannot choose the group they’re in;
    • they will not be assigned to a group based on what is best for them;
    • if they prefer to be in a certain group, they may not want to participate.

The Consent Process

(Details: Consent Overview)
Consent is a continuous, dynamic, and interactive process. The process usually begins with the information presented in recruitment materials, includes the consent interaction, and continues in post-enrollment communications. Subjects consider throughout a study whether they wish to continue participation.

Allow adequate time for subjects to consider participation

• Allow adequate time while the researcher reviews the consent form with subjects.
• Give subjects the option to take some time between reviewing the consent form with the researcher and actually providing consent for participation. Going home to think about it, talking with family and friends, or consulting with their personal physician all may help subjects make a decision.
• This is particularly important for complex studies, high-risk studies, protected or vulnerable populations and other groups that may experience a comprehension barrier (e.g., subjects with visual impairments; subjects with limited English proficiency).

Key Information

(Details: Key Information guidance and Key Information examples)

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:

• What are the main reasons a subject would, or would not, want to enroll?
• What is the research question and why might it be relevant for the subject?
• What information about the subject will be collected? What activities (procedures) will the subject be asked to do?
• How will their experience as a research subject in this study differ from treatment they might receive as a patient outside of the study?
• What aspects of the study are likely to be unfamiliar, diverge from expectations or require special attention? (e.g., “Being in this study means you will have to come to the clinic more often than you regularly do.”)

Written Consent Materials

(Details: Consent Considerations)

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 guidance provides a list of general requirements and elements of consent and the criteria for waiving consent, altering elements, and waiving documentation.

Structure and Format

• The consent form 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 required for consent documents greater than 2000 words. Otherwise, the consent form is considered to meet the requirements of being “concise and focused”.
  • Use the valuable “real estate” of the first page of the consent form to provide information subjects are most interested in (i.e., Key Information) rather than administrative details about the study (e.g., researcher titles and funding information).
• Make headings subject-focused rather than serving as a regulatory checklist.
  • Why might I want to participate?
  • Why might I not want to participate?
  • How will information about me be kept confidential?
  • Who can answer my questions about the study?
• Consider alternatives to dense blocks of text.
  • Present information in side-by-side comparison tables (e.g., pros/cons of participation).
  • Use diagrams or flow-charts to demonstrate the different steps or phases of participation.
  • Use icons or color to emphasize particular topics.

Waiver of Documented Consent

(Details: Documentation of Consent and Designing the Consent Process)
Most minimal risk studies will qualify for a waiver of documentation of consent which allows for greater flexibility in the consent process and form. (Waiver criteria: Designing the Consent Process)

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)

If consent documentation cannot be waived:

• The subject, legally authorized representative, or parent/guardian must sign and date the IRB-approved consent form and receive a copy of the consent form.
• The researcher must print their name and date the consent form.
• In some circumstances, a witness signature may be required (e.g., if using short form consent).
• The signature may be hand-written, electronic, or in some other format, as approved by the IRB.
• If obtaining an e-signature, UW ITHS REDCap and UW eSignatures (DocuSign) have been vetted by the UW as meeting the federal and Washington State definitions of a “legally valid” electronic signature. (Details: UW E-Signature Tools; Electronic Signatures; Electronic Consent: What You Need to Know tutorial)

Vulnerable Populations and Consent

(Details: Protected and Vulnerable Populations)
When prospective subjects are at risk of being unduly influenced or coerced to participate in research, or have diminished capacity to consent, additional safeguards must be considered to ensure consent comprehension and protect subject autonomy and voluntary participation.
Some of the best tools for minimizing, or appropriately managing, the possibility of undue influence or coercion are to:

• Conduct a consent process that allows subjects adequate time to consider participation and have their questions answered.
• Ensure the consent process and materials include Key Information that is relevant to the subject population and in sufficient detail.

Subjects with comprehension barriers or who cannot write or speak

(Details: Subjects with Comprehension Barriers)

• Consent information must be presented in a language that is understandable to subjects.
• Translation, interpretation, or other accommodations may need to be provided and remain available throughout the subject’s participation in the research.
• Researchers should carefully consider the purpose of the research and the scientific question when considering the inclusion and exclusion of these subject populations, especially when the study may offer significant benefit to the individual subjects or subject population.
• The short form consent process may be appropriate for the occasional and unexpected enrollment of non-English speaking subjects when there is no translated consent form and there is insufficient time and opportunity to obtain a written translation.
• If possible, an electronic copy of the consent form that can be used with a screen reader should be provided to visually impaired subjects.

Subjects with diminished or fluctuating consent capacity

(Details: Subjects with Diminished or Fluctuating Consent Capacity)

• Assent and Legally Authorized Representative tipsheet

Protected Populations

(Details: Vulnerable and Protected Populations)

• Research with children requires obtaining permission from a parent or guardian and assent from the child. Permission may be required from one parent, both parents, or it may be waived or altered by the IRB. Documentation of permission may also be waived by the IRB.

  Children worksheet   Assent and Legally Authorized Representative tipsheet

• Research with pregnant women and neonates may require the consent of only the pregnant woman or of the pregnant woman and the father. Information about the reasonably foreseeable impact of the research on the fetus or neonate must be included in the consent process.

  Pregnant Women worksheet   Neonates worksheet

• Prisoners participating in research must be informed in advance that participation in the research will have no effect on their parole or early release. Allowing adequate time for consideration and discussion of the consent process is particularly important for prisoner populations. The consent process must provide a clear and accurate description of confidentiality protections, given the institutional limitations that may exist.

  Prisoners worksheet   Prisoners guidance

Subjects with Diminished or Fluctuating Consent Capacity

(Details: Subjects with Diminished or Fluctuating Consent Capacity)
It may sometimes be appropriate for a legally authorized representative (LAR) to provide consent on behalf of a subject with diminished decision-making capacity. These impairments may be permanent, temporary, progressive, or fluctuating and the plan for consenting these populations will depend on these particulars.

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:

• Assessing for impaired consent capacity in the subject population, including changes over time.
• Describing in the IRB Protocol the process for determining consent capacity.
• Assessing whether the need to obtain LAR consent is a likely possibility.
• Assessing whether subjects are capable of providing assent and/or whether it is appropriate.
• Describing in the IRB Protocol the process for obtaining standard consent from a subject if they re-gain the capacity to consent during participation.

Assent

(Details: Assent)

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.

Child Assent

(Details Assent)

• The assent process/form should take into account:
  • The nature of the research.
  • The age, maturity, psychological state of the children.
• The content of the assent processes/forms will differ depending on the age of the children:
  • Younger children. Assent processes/forms should focus on the aspects of the research that the children would be mostly likely to understand and be interested in.
    • Why is the research being done? What will they do? How long will it take? Will there be pain or discomfort? Will they be paid, or receive a gift for participating?
  • Adolescents. Assent processes/forms may be similar to those designed for adults. It might make sense to use a single form to obtain parental permission and adolescent assent.
• Just like consent, assent is a continuous, dynamic, and interactive process.
  • A child enrolled in longitudinal research may need to be re-assented as their capacity to understand increases.
  • If the child reaches the legal age of consent while enrolled, adult consent must be obtained for any ongoing interactions, interventions, or continued analysis of identifiable specimens or data, unless the IRB has granted a waiver of consent.

Reconsent and Ongoing Subject Communication

(Details: Reconsent)
Subjects may need to be informed of new information or consent may need to be revisited due to fluctuating consent capacity or because a child subject has reached the age of majority (Assent and Legally Authorized Representative tipsheet). In these situations, it is important for subjects to be able to reaffirm their willingness to participate in research.

Verbal Discussion

This 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

• • Eliminating certain procedures from study visit
  • Payment method being changed from cash to gift card

Letter or Email

This 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

• • A new questionnaire is added that does not change the type or scope of questions already being asked
  • Informing subjects of a new principal investigator
  • Informing subjects they can use a commercial lab for blood draws

Addendum

This 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

• • New measures being added include sensitive mental health topics subjects did not previously consent to
  • New genetic analysis is added to samples already being collected for the study
  • New risks are identified or there is an increase in frequency or magnitude of previously described risks
  • A decrease in anticipated benefits is identified
  • New/alternative therapies are identified

Reconsent

This 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

• • Subjects are moving into a new study phase with very different procedures
  • Many changes are being made to the study
  • A child subject reaches the age of majority
  • Changes in cognitive functioning or mental/physical health now allow the subject to replace LAR consent with consent on their own behalf
  • There is a significant delay between the initial consent process and the start of the study
  • A consent refresher may be needed during a longitudinal study
  • There are concerns about the way consent was obtained (e.g., wrong version of consent form was used; study staff were not properly trained)

Providing Materials to the IRB

When 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.
Researchers must provide a description of the method and process by which subjects will be informed about the new information (e.g., in the section of the IRB Protocol titled, Ongoing process, new information, and reconsent; in correspondence; in the SUPPLEMENT RNI).
In addition, researcher should upload in Zipline:

• The text of any written correspondence that will be sent to subjects
• Any consent addendum(a)
• Any revised consent form(s)

Regulatory Oversight

(Details: Regulatory Oversight)

• All UW research must comply with the Common Rule general requirements and elements of consent. Other agencies (e.g., FDA, DOJ, DOD) will have additional requirements that apply when the study receives funding or support from them.
• Local laws in the jurisdiction where the research will occur, and institutional policies may also shape the consent process and document.
• Researchers are responsible for identifying applicable state or other local laws when the research is conducted outside of Washington State, including internationally.

Human Subjects Regulations guidance   Consent Requirements and Waivers guidance

Prior IRB Approval

• All consent processes and materials must be approved by the IRB prior to enrolling subjects. This is true for new consent processes/forms as well as for any modification to existing processes/forms.

What to Submit

• Procedures for obtaining consent and, if applicable, documenting consent must be described in the IRB Protocol. This includes procedures for screening and recruitment.
• All written and oral consent materials must be submitted as part of the Zipline application.
• Guidelines about which recruitment materials must be submitted and which can simply be described in the application are provided in the IRB Protocol.
• Translated version of all consent materials that will be provided to subjects in written form must be approved by the IRB before using them with subjects.
• Translated versions should be submitted for any English recruitment materials that are required to be submitted as part of the application.
• Translations should be provided to the IRB after the English versions are approved, either as part of the initial review or with a subsequent modification.

Documentation of IRB Approval

• The consent and consent documentation procedures described in the IRB Protocol constitute the IRB approved research procedures. Any changes to the consent procedures or materials must be reviewed and approved by submitting a modification prior to implementing them.
• Approved consent materials receive an approval watermark in Zipline regardless of whether consent will be documented.
  • When consent is being documented, it is best practice, though not required, to use the watermarked version of the consent form.
  • Any non-watermarked version must exactly match the content and format of the IRB-approved, watermarked version.

Consideration

Summary Information

Regulatory requirements for clinical trials

• Justifying the use of deception in the IRB Protocol.
• Describing any “de-briefing” procedure that will be used to later inform subjects about the withheld or misleading information, or providing a rationale for why de-briefing is not necessary or appropriate.

Genomic Data Sharing Guidance
Genomic Data Sharing Certification Worksheet

HIPAA

Mandatory State Reporting

UW Records Management Services

Return of Individual Results

SOP Financial Conflict of Interest

Subject Payment