CTTI TOOLS AND RECOMMENDATIONS CAN HELP RESEARCHERS MEET NEW REQUIREMENTS FOR INFORMED CONSENT DOCUMENTS AND CENTRAL IRBS
This year the US Department of Health and Human Services released long-awaited updates to the Federal Policy for the Protection of Human Subjects, better known as the Common Rule. Originally issued in 1991, the Common Rule governs a large proportion of U.S. research involving human participants. CTTI offers resources and tools that can help investigators seeking to understand and implement some of these new requirements, including recommendations that closely parallel key Common Rule standards for informed consent documents and the use of central institutional review boards (central IRBs).
Informed Consent Documents
The revised Common Rule states that informed consent documents (ICDs) “…must begin with a concise and focused presentation of the key information” that is most likely to help prospective study participants understand the reasons for or against participating in a trial. CTTI’s recommendations for using shorter, simpler informed consent documents that utilize a “tiered approach” to presenting information and incorporate health literacy and reading level assessments provide a structured path that can help in creating ICDs that satisfy Common Rule requirements:
SIMILARITIES BETWEEN COMMON RULE REQUIREMENTS & CTTI RECOMMENDATIONS FOR INFORMED CONSENT DOCUMENTS
New Common Rule Requirements for Informed Consent Documents (2017)CTTI Recommendations for Informed Consent Documents (2013)Concise and focused presentation of key information most likely to assist a prospective subject or legally authorized representative in understanding the reasons why one might or might not want to participate in the research.
Information in this part of the ICD must be organized and presented in a way that facilitates comprehension. Use of tiered approach, including:
- Section that includes only elements required by federal regulations
- Additional information in chapter format
- 1-2 page summary of the study
Draft ICDs should be evaluated with:
- Standardized health literacy/plain language assessments
- Reading level assessments
- Usability testing with comparable patients
Source: Federal Policy for the Protection of Human Subjects https://www.federalregister.gov/documents/2017/01/19/2017-01058/federal-policy-for-the-protection-of-human-subjects Source: CTTI Recommendations: https://ctti-clinicaltrials.org/files/ctti-informedconsent-recs.pdf
Use of a Single or Central IRB
Another facet of the revised Common Rule that harmonizes with CTTI recommendations relates to the use of single IRBs for oversight of research activities in multicenter trials. In 2013, CTTI recommended the use of a central IRB (in other words, a single IRB of record for all research sites participating in a clinical study) in order to improve quality and efficiency. Although the Common Rule does not require all multisite trials to use a central IRB, it does mandate that U.S. institutions involved in cooperative research in the United States (with certain exceptions) use a single IRB and notes that
When working optimally, we expect the central IRB model will work more efficiently and require less personnel time and fewer resources for tracking and implementing IRB changes and approvals, thereby eliminating the potential for unnecessarily duplicative reviews.
CTTI offers several tools that can assist research sites, sponsors, and IRBs in successfully navigating the challenges of using a central IRB model, including a template IRB authorization agreement; an evaluation checklist that helps sites assess readiness, helps sites or sponsors select a central IRB, and helps central IRBs to assess research sites; and a considerations document that delineates the central IRB’s responsibilities versus the site’s institutional obligations.
For complete listings of publicly available CTTI implementation tools and recommendations, visit the CTTI website.
