You spent many hours and many dollars to get your consent form right. Yet the Institutional Review Board (IRB) edited it anyway. What, if anything, can you do to prevent the IRB’s redlining before it starts?
First, take a deep breath: Remember that the IRB’s edits can shield your study from the costs and delays of audit findings and corrections. You benefit if your IRB offers a comprehensive, compliance-based consent form analysis and fact-check of your consent form.
That said, in the short run the IRB’s consent form revisions might not feel like a boon if they leave you wading through a morass of changes before study start-up.
The good news is that you can fix the problems that trigger IRB edits.
Here are two of the most common issues that lead to IRB revisions in consent forms—with practical guidance for preventing them.
Problem #1: Misrepresentations of study procedures
The procedures sections of consent forms are often pockmarked with mistakes. These issues generally fall into one of two categories:
- Misinformation about procedures. For example, a consent form might state that a procedure occurs at Visit 10 when, per protocol, it’s at Visit 11.
- Missing procedures. Consent forms frequently omit descriptions of activities such as questionnaires, fasting, and washouts of participants’ standard-of-care medication.
The fix: Shorten the consent form—and minimize errors—with a generalized list of all study procedures instead of visit-by-visit lists.
The root cause of many of these errors is the procedure section’s complexity and length: A visit-by-visit breakdown of procedures becomes a thicket of unnecessary information and fact-checking mistakes.
Visit-by-visit procedure narratives are not required by regulations, law, or industry guidance1, and few participants, if any, have ever decided to be in a study because a blood draw occurs Day 8 instead of Day 9.
Learn how to create a generalized list of procedures here.
Of course, in streamlining the procedures section, don’t leave out relevant information. If the protocol says a participant will undergo a procedure during the study, then the consent form should note and describe that activity.
Finally, include an expert’s fact-check before IRB submission as part of your organization’s consent form development process.
Problem#2: Legalese and other complex wording
Organizations frequently lace consent forms with legalese, particularly in HIPAA authorizations, confidentiality sections, and sections describing polices for study-related injuries. Also common: technical and medical terminology that requires a life sciences background to interpret.
The fix: Don’t let physicians and attorneys have the final word(ing).
Although you might rely on your legal and medical experts to prepare consent forms, you can require that they prepare information in nontechnical terms. Remind them that compliance is at stake: regulatory guidance advises that consent forms should use non-technical lay language.2
Other tips to rein in complexity:
- Use short sentences with fewer than ten words
- Organize long paragraphs into bulleted lists (like this one)
- Offer layperson-friendly synonyms for complex terminology3
- Never copy text directly from a protocol or investigator’s brochure
In preparing your consent form, use resources you already have—the skills of your organization’s staff and available IRB services—or retain a medical writing consultant. Up-front investment can reduce consent form redlining later on—and keep your start-up deadlines intact.
1 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).
2 See the following:
- International Conference on Harmonisation, Guideline for Good Clinical Practice, ICH GCP 4.8.6. Retrieved from http://ichgcp.net/48-informed-consent-oftrial-subjects
The language used in the oral and written information about the trial, including the written informed consent form, should be as non-technical as practical and should be understandable to the subject or the subject’s legally acceptable representative and the impartial witness, where applicable.
- S. Food and Drug Administration (FDA) (2014). A Guide to Informed Consent – Information Sheet: Guidance for Institutional Review Boards and Clinical Investigators. Retrieved from http://www.fda.gov/RegulatoryInformation/Guidances/ucm126431.htm
The IRB should ensure that technical and scientific terms are adequately explained or that common terms are substituted. The IRB should ensure that the informed consent document properly translates complex scientific concepts into simple concepts that the typical subject can read and comprehend.
- Office for Human Research Protections (OHRP) (1993). Tips on Informed Consent. Retrieved from http://www.hhs.gov/ohrp/policy/ictips.html
The procedures used in obtaining informed consent should be designed to educate the subject population in terms that they can understand. Therefore, informed consent language and its documentation (especially explanation of the study’s purpose, duration, experimental procedures, alternatives, risks, and benefits) must be written in “lay language”, (i.e. understandable to the people being asked to participate).
3 As examples, see the following:
- Quorum Review IRB. Simplified Assent Form Language Toolkit. Retrieved from http://www.quorumreview.com/simplified-assent-form-language-toolkit-whitepaper/
- Centers for Disease Control and Prevention (2015). Everyday Words for Public Health Communication. Atlanta, GA. Retrieved from http://www.cdc.gov/other/pdf/everydaywordsforpublichealthcommunication_final_11-5-15.pdf
- Agency for Healthcare Research and Quality (2009). How To Improve Informed Consent and Authorization: Chapter 2. Rockville, MD. Retrieved from http://www.ahrq.gov/funding/policies/informedconsent/ictoolkit2.html