This session at the 2015 Advancing Ethical Research (AER) Conference was a follow up to the 2014 AER Conference session "Using Empirical Evidence to Reduce Consent Form Length" presented by Amy Corneli, PhD, MPH, and Jeremy Sugarman, MD, MPH, MA. In last year’s talk, they shared preliminary data about their effective delivery of informed consent (EDICT) study based on interviews questioning what participants thought must be in the informed consent form (ICF) and what could be removed. This year’s follow-up session by Amy Corneli shared the study findings submitted for publication. What was learned can be put to use by any institution seeking to improve their ICFs, and thereby improve subject understanding.
Amy started this year’s talk by sharing some interesting statistics:
- 95% of research stakeholders agreed that ICFs are generally too long
- 96% of these same stakeholders agreed that ICFs should be made shorter in length as long as essential information is retained
I know what you’re thinking…namely, that 90 percent or more of research stakeholders never reach agreement on anything! You’re probably also thinking that what is defined as "essential information" is the tricky point. You’re right!
However, conversations with research participants revealed:
- The most common response by research participants about ICFs highlighted repetitiveness: participants pointed out that while they recognized certain information as being important, it did not bear repeating multiple times.
- The sharing of background knowledge (prior research, other findings, etc.) to the study was considered least valuable by research participants.
Amy shared a strategy to reduce repetition that involves grouping procedures by frequency. For example, instead of listing all procedures for each separate study visit, you might have a list that indicates procedures conducted "at all visits" and "at some visits." Research participants indicated that while they want to know in general what will be done, the fact that a certain procedure is done at visit four versus visit three is not likely to factor into their decision to participate. One-time procedures were also specifically identified with their timeframe.
In Amy’s example, grouping procedures as such took an actual ICF from 2645 words down to 993 words! The fact that the document length has been so significantly decreased increases the likelihood that potential research participants will actually read the ICF, and therefore be more truly informed about their participation.
A similar effort to group risks and side effects realized significant reductions in ICF length as well. Some significant factors include:
Study Design: Is the study blinded? If so, providing risks of each of the potential blinded drugs is even less helpful because sharing the risks profiles individually could help increase the likelihood that the blinding could be broken.
Sponsorship: Would an industry sponsor allow such simplification? What will it take for "industry" to agree to such consolidation?
Language: Is the participant population limited to English-speaking and –reading individuals? (Amy’s study was limited as such. It was recognized that those for whom English is a second language may have greater benefit from some repetition.)
Necessity: Another recommendation is to limit information in the ICF to that considered "need to know" and relegate any "nice to know" information to the appendix.
At my own institution, Cincinnati Children’s Hospital Medical Center, we have had many initiatives intending to simplify ICFs. I intend to share this information with them and see if I can secure support in try these ideas in-house. This could be a win for all!
Mina Busch, program manager, research education and outreach at Cincinnati Children's Hospital Medical Center, is a member of the PRIM&R Blog Squad for the 2015 AER Conference. The PRIM&R Blog Squad is composed of PRIM&R members who blogged here, on Ampersand, to give our readers an inside peek of what happened at the conference in Boston, MA.