As part of PRIM&R’s webinar series on the revised Common Rule, two members of our community were selected to write a series of blog posts about the webinars, what they learned from them, and how the information is applicable to their work. Now that the webinar series has concluded, we’re pleased to share their thoughts over the next few weeks.
Many of us have read the Common Rule revisions around informed consent and scratched our heads. What exactly does it mean that “informed consent must begin with concise and focused…key information that is most likely to assist in understanding reasons one might or might not participate”?
Presenter Jeremy Corsmo, MPH, CIP, CHRC hit the nail on the head in PRIM&R’s recent webinar, Focus on the Revised Common Rule: Informed Consent, when he said that this new requirement for key information seems to be what IRBs have been asking for to combat the ever increasing length and complexity of consent forms. The idea of a “concise” and “focused” document is something I, and I am sure many of you, have tried instilling in study coordinators and researchers for years by teaching them “need to know” versus “nice to know.” Now, instead of a nebulous mantra that was difficult to enforce, we have a mandate.
Yet, there are many valid questions concerning this new requirement. Do the descriptions in the key information section represent a summary and are they expected to be repeated and expounded upon later in the consent document or does the key information stand on its own? Will this new section come to overshadow the traditional consent document? How long or short should this section be? The preamble mentions that even in a complex trial, such as a multi-arm cancer study, it would expect no more than a few pages.
It is evident to me that for now we may have to use our own interpretation of the regulations, as the Office of Human Research Protections (OHRP) has not yet issued guidance on what this new section should entail. Since waivers or alterations are not allowed for this section it will be crucial that we, as IRB professionals, attempt to explain this requirement with the level of assuredness that our researchers have come to expect from us. We can’t expect “key information” to be a panacea—in fact, the concept is accompanied by existential questions surrounding how it benefits subject autonomy—but with guidance and adequate institutional templates we can get ever closer to creating informed consent documents, and an accompanying process, that will increase subject understanding.
Some institutions have already begun developing a key information template. Since there are still some unanswered questions surrounding who gets to decide what key information is, I have been reluctant to start crafting a template or guide at my own organization. However, I have started to keep an eye out for consent documents submitted through my own IRB that appear to embody what I envision this new section will look like.
My hope is that key information will become the vehicle that drives greater subject understanding and gives reviewers some relief. I look forward to seeing how the guidance around and the implementation of this section develops.
Amelia Walch-Patterson, MPH, CCRC, was selected to cover the biomedical bundle of PRIM&R’s webinar series, Focus on the Revised Common Rule. She is the team lead for the Human Research Protection Program at Ochsner Clinic Foundation in New Orleans. She has served as an IRB member since 2012 and joined the Ochsner HRPP team in 2015 after working as a research coordinator and QA specialist for pharmaceutical trials since 2010. In her current role she oversees the daily IRB operations, instructs new study coordinators during onboarding, and assists the QA team during extensive reviews. She has been a PRIM&R member since 2015.