Kay Neth

by Kay Neth

Include a single list of all procedures planned for the study (instead of visit-specific lists)

How to Simplify Your Consent Form: Study Procedures

This is the first of six blog posts covering research-based approaches on How to Simplify Your Consent Form. Complex consent forms present challenges for participants, sponsors, and researchers alike. This blog series provides research-based approaches for shortening and simplifying complex consent forms.

Suppose a protocol unfolds over the course of 30 days and 10 visits to the study center. The research requires several procedures, some of which occur at more than one visit. How should the consent form provide this information to prospective participants?

  • One option is a visit-by-visit breakdown of what happens in the study, resulting in a series of visit-specific lists of procedures: A “Visit 1” section lists the procedures occurring at Visit 1, a “Visit 2” section lists the procedures occurring at Visit 2, and so on, until the final Visit 10. If a procedure occurs at more than one visit, then the consent form repeatedly references it in each applicable visit-specific section.
  • The other approach is a streamlined, generalized list of procedures—a single list of all procedures in the study.

You can see an example of each approach listed in this document in the Appendix section -“Procedures in consent forms: Comparing a visit-by-visit breakdown of procedure with a single procedures list” of the How to Simplify Your Consent Form eBook.

Many consent forms present a visit-by-visit breakdown of the study—although this thoroughness (and repetitiveness) is not required by regulation and does not necessarily enhance the reader’s decision-making process or understanding of the research. (Read below for why.) Visit-by-visit breakdowns also increase the possibly of errors or, as the study evolves, a need for future amendment-related changes to the consent form.

To simplify your consent form while still providing prospective participants with relevant information about the study, consider using a single list of all study procedures instead of a visit-by-visit breakdown. The use of a generalized list of procedures presents opportunities to structure the consent form in a way that streamlines the document, emphasizes other important information about the study (such as randomization and the study product), and benefits prospective participants.

The challenges of a visit-by-visit breakdown

Organizations devote effort and time to produce visit-by-visit lists of procedures in consent forms. Participants then must devote effort and time to parse them. Yet all this time and effort might not add value in enhancing key aspects of the informed consent process—choice, compliance, and comprehension:

  • Choice, based on relevant information: A reader’s decision to take part in a study is unlikely to hinge on the specific timing of visits and procedures.
  • Compliance: Consent regulations and established guidance do not require a detailed, repetitive, visit-by-visit breakdown of procedures.[i]
  • Comprehension: The visit-by-visit breakdown becomes the longest part of the consent form, overshadowing, burying, or drawing attention away from sections that describe concepts potentially unfamiliar to lay readers, such as randomization, blinding, and the placebo. Readers might miss specific procedures amid the deluge of visit-specific information. And the visit-specific sections add pages to what is likely already a long document, setting the stage for skimming text or not reading it at all.

For sponsors and sites, listing procedures visit-by-visit presents different challenges—namely, fact-checking the information to ensure it is accurate and updating it when, say, an amendment changes the number of visits at which a specific procedure is planned. (Many corrections Quorum makes to consent forms before review involve edits to revise visit-by-visit lists of procedures to correctly reflect the protocol. And in reviewing amendments, Quorum processes many consent form changes related to what is an otherwise minor adjustment in the timing of a visit or procedure.)

Before you add a visit-by-visit description of procedures into the consent form, ask whether it adds value in supporting the participant’s decision to take part in the study.

Organizations might include a visit-by-visit breakdown in consent forms anticipating that participants will refer to it during the study to prepare for visits. But that use is outside of what a consent form is intended to do: Provide participants with information needed to decide whether to take part in a study, and document the informed consent process as well as any decision to take part (via the participant’s signature).

Moreover, a consent form with pages of procedures is an unwieldy reference document.

If you think more information about the timing of procedures is valuable for participants during the study, you can adopt a “tiered” approach—provide participants with a separate document (at the end of the consent form or apart form it) that presents procedures in a table format, comparable to the schedule of procedures included as an appendix in protocols (but written and presented with the lay reader in mind). Note that as participant material, this document would require review by the Institutional Review Board/Research Ethics Board.

How to structure your consent form around a generalized list of procedures

A generalized list of procedures is not a way of sidestepping consent requirements or limiting the information that is provided participants—rather, it is a way of presenting key information to prospective participants while providing a document that readers can more easily scale and comprehend.

A streamlined procedures section can help bring to the fore important concepts that are sometimes difficult for lay readers to understand—such as the differences between the goals of research versus therapy/health care; randomization; placebo; risks versus benefits; and the right to withdraw from the study at any time.

And a simplified consent form helps set the stage for a clear, accurate document, more participant engagement in the consent process, and more time and opportunity to discuss the study with research staff before deciding whether or not to take part.

In the How to Simplify Your Consent Form eBook, see Appendix section -“Procedures in consent forms: Guidance and sample language” for information you can to leverage in organizing your consent form around a generalized list of procedures. To summarize some of the basics:

  • Before the generalized list of procedures:
    • Tell readers about study duration/visits, the study product and comparators/placebo, dosing, randomization, and blinding.
    • Inform readers that those procedures can occur at more than one visit and that the research staff can provide information about the timing of procedures.
  • Before or after the list of generalized list of procedures. Note participant responsibilities or other information about what occurs during the study that was not already addressed in the consent form—such as washouts and dietary restrictions.
  • The generalized list should discuss all procedures in the study, including the name of each procedure and a brief, nontechnical, layperson-friendly description of what each procedure involves.

Sometimes, the timing or frequency of a specific procedure is relevant to the prospective participant’s decision-making (because the frequency of the procedure results in increased risk, discomfort, or inconvenience to participants). For those studies, the consent form can include in a generalized list of procedures that, where appropriate, calls out the frequency of that specific procedure.

To see more examples, supporting documentation, and to read the full eBook How to Simplify Your Consent Form, click here.

[i] Regulations and guidance indicate the consent form must provide an “explanation” or “description” of study procedures. See ICH GPC 4.8.10(d), 45CFR46.116(a)(1); 21CFR50.25(a)(1); and TCPS2 3.2(b).

In July 2014, the FDA issued draft guidance (Informed Consent Information Sheet Guidance for IRBs, Clinical Investigators, and Sponsors: Draft Guidance) indicating that a visit-by-visit description of procedures, if included at all, could be presented in a chart format as an “addendum” to the consent form: “If describing every procedure would make the consent form too lengthy or detailed, FDA recommends providing the general procedures in the consent form with an addendum describing all study procedures. It may be helpful to provide a chart outlining what happens at each visit to simplify the consent form and assist the subject in understanding what participation in the clinical investigation will involve. FDA believes that removing procedural details from the consent form will reduce its length, enhance its readability, and allow its focus to be on more important content, such as the risks and anticipated benefits, if any.”

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