Consent

3. Consent

Clear written information and verbal conversations about informed consent to research participation

“Consent” is the time when members of the research team have in-depth conversations with the potential participant to explain more about the study, the risks and potential benefits, and the research procedures.

During “Consent,” details about a specific clinical trial are shared, with the intent of providing enough information to allow a potential participant to be able to decide whether joining the study is the right choice for them.

  • The researcher should leave enough time to answer all questions and determine whether the potential participant understands the nature of the research study.

IRBs and sponsors play an important role in creating understandable consent materials. Boilerplates, templates and required language also benefit from health literacy interventions

“Consent” is considered a process, not just a one-time event.

  • The signed consent form represents the documentation of the consent process.
  • For research studies that take place over weeks, months, and even years, consent should be considered an ongoing process, and may include regular check-ins to re-affirm the participant’s willingness to continue in the study.
    • To that end, important updates that could impact a person’s decision to continue in a study should be provided in a timely manner and in a clear and transparent way.

During “Consent,” study procedures and the overall schedule are to be reviewed in detail. This is an ideal time for research study team members to ask, and listen carefully to learn, about any potential obstacles that could prevent the participant from successfully completing the study.  They can then work together to come up with potential solutions.

Consent forms and related consent discussion scripts should go through usability testing with members of the intended audience.

Guidance on how to develop health literate consent forms can be found here.

Click through the individual tabs to learn more about how your “Consent” research communications can be improved through plain language, numeracy, clear design and cultural considerations

Plain Language

  • During the “Consent” stage, the potential participant may have already heard a bit about research and even about the specific research study. This is the time to explain additional details using plain language and clear communications.
  • The consent process is a teaching opportunity for the communicator that allows for a more thoughtful approach to conveying research information to promote participant understanding. The communicator should strive to simplify complex terms, concepts and procedures using plain language.
  • It is helpful to decide on common and important talking points of the research study, so that they are delivered consistently during the consent process.

Click here to see how one organization1 created a sample document to help study staff deliver consistent key messages to participants.

Numeracy

During the “Consent” stage, numeric concepts can be challenging to explain and hard to understand, especially when presented with other technical information.

For example, consent forms and discussions may include information such as:

  • Prior statistical findings that inform why the study is being done
  • The number of participants to be enrolled, and how they might be assigned to study groups
  • The likelihood that specific study procedure risks may occur
  • The volumes and amounts of samples that will be collected and the frequency of sampling
  • Study medication instructions

Understanding numeric concepts related to time may require extra attention during “Consent,” such as:

  • the visit schedule, including frequency and timing of study visits and procedures
  • the time commitment involved in fulfilling each study visit

Interpreting a Schedule of Events also requires numeracy skills.  A visual representation of the study visit schedule can increase the likelihood that a potential participant has enough information to decide whether they can commit to being in a study that may impact their day to day routine.

clinical trial patient schedule of events

Mapping study activities onto a familiar calendar that includes other events and milestones (like family vacations or celebrations that could impact a participant’s ability to fulfill study requirements) can facilitate conversations to improve study follow-through.

  • Keep in mind that the best approach to an understandable schedule of events might be to include information on ‘what’s typical’ for a study visit and then highlight ‘the special procedures to be aware of’ as noted by Corneli et al, 2017 in the figure below.

Clear Design

During the “Consent” stage, institutional consent form templates should be developed using health literacy principles whenever possible.

When trying to conform to an existing template, it is still possible to integrate some health literacy principles.

For example:

  • using headers and sub-headings to break up information within the allowable text boxes
  • Presenting information in organized tables or using graphics when permitted
  • including enough white space to make the information easier to read and follow.

See one institution’s2 template here.

Consider what other supportive tools you might use to facilitate a productive consent discussion, such as:

  • study schedules, timelines and/or calendars
  • pamphlets that describe specific study procedures
calendar

Cultural Considerations

During the “Consent” stage, understanding how the study population typically approaches decision making and the role of community or other authorities is important.

  • For example, a patient may defer to their physician during a clinical encounter if that physician is the one explaining the research and obtaining consent.
    • The patient may be uncomfortable asking important and relevant questions or want to avoid “disappointing” their doctor.
  • A young adult may defer to his father, or a woman to her husband, for permission to enroll.
  • Consent of the community ‘elder’ may be required in some communities.

Researcher understanding of decision-making is advanced by reviewing the consent form and the proposed process for consent with representatives of the study population.

“Teach back” techniques, which involve a process of active listening whereby a participant is asked to verbally demonstrate their understanding of the information presented to them, can be used throughout the clinical trial life cycle in order to facilitate communication about research information and concepts. “Teach back” is especially helpful in the context of research informed consent because:

  • it is often unclear if the participant has understood the material even if he or she consents,
  • literacy difficulties may not be obvious,
  • many research informed consents contain statements that are lengthy and complex, have unfamiliar medical and legal terminology, and have risk information that requires numeracy skills. (Tamariz et al, 2012)

An approach to consent that takes into account cultural humility is one that leaves enough time for a one-on-one conversation to occur, and all questions to be answered (Flory and Emanuel, 2004).

  • A study enrollment survey may reveal the strengths and weakness of a study’s processes, and result in updates to better reflect the needs of the study population.

An example of a study enrollment survey1 can be found here.

Developing a detailed locator form and reviewing it with each participant after consent has been obtained allows the study team to collect enough information about the participant in order to more successfully find them if needed in the future.

  • reviewing the locator form with each participant after consent has been obtained, is another way to convey the importance of the study and how valued the participant’s contributions are.

An example of a study locator form can be found here.

Scroll through the life-cycle:

Discovery > Recruitment > Consent > On Study > End of Study

1. Michael J Fox Foundation
2. University of Arkansas for Medical Sciences IRB

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