By Melinda Young, Author

The Secretary’s Advisory Committee on Human Research Protections (SACHRP) expects later this year to finalize guidance related to the new Common Rule, including information on how IRBs and researchers can make informed consent forms more pertinent to what participants need to know.

“One of our main points we want to make is that the informed consent process has gotten rather stagnant, and nobody changes it, so this is a really good opportunity to make the consent process more meaningful,” says David Forster, JD, MA, CIP, chief compliance officer at WIRB-Copernicus Group in Princeton, NJ. Forster is the co-chair of the SACHRP subcommittee on harmonization.

“There have been years of complaints about how informed consent forms are too long and they don’t help understanding,” he says. “The new Common Rule has a statement that this must address what subjects want to know and have it organized in a way that’s best presented for the subject.”

At the July 10 meeting, SACHRP members discussed informed consent and the types of information that should be included in guidance on revising informed consent forms.

The goal of the new regulations is to make informed consent forms more subject-oriented, Forster says.

A revised consent form should have a short section of key information at the beginning that includes the main points, Forster says.

“We haven’t decided on which questions are the ideal questions yet,” Forster says. “We think the questions can be used to help frame the key information that’s put in a consent form.”

This information could be presented as a series of questions or bullet points. “We’re trying to come up with a tool that best identifies the key information,” he adds.

One working list of questions that SACHRP has considered, but still is revising, includes the following:

  • What is the information a prospective subject needs in order to make a well-informed choice about whether to participate?
  • What are the main reasons a subject will want to join this study?
  • What are the main reasons a subject will not want to join this study?
  • What is the research question the study is trying to answer? Why is it relevant to the subject?
  • What aspects of research participation or this particular study are likely to be unfamiliar to a prospective subject, confound expectations, or require special attention?
  • What information about the subject is being collected as part of this research?
  • What types of activities will subjects perform for the research?
  • What impact will participating in this research have on the subject outside of the research? For example, will it reduce options for standard treatments?
  • How will the subjects’ experience in this study differ from treatment outside of the study?
  • In what ways is this research novel?

SACHRP also has considered questions submitted by other experts in human research protection.

Ensuring Consistent Compliance

The SACHRP committee members also discussed how any list of questions they might produce for guidance will soon become some IRBs’ checklist. But the value of the guidance is to help research programs shift away from the risk-benefit paradigm and into how the research will change someone’s life and impact them, according to a video of the meeting. (The video can be found at: https://videocast.nih.gov.)

IRBs and researchers will want guidance, and it’s necessary to ensure consistent compliance, Forster notes.

“Without any guidance, people are going to be very inconsistent in how they interpret these new consent requirements and how they put them into practice,” he says. “What we’re hoping to do is get a significant step toward best practices in how to understand the new consent requirements and implement them.”

SACHRP reviewed best practice examples from various universities and SACHRP subcommittee members and acquaintances.

Many IRBs already have worked on changing their informed consent forms because of the uncertainty in late 2017 about when the new Common Rule would be implemented.

“I think our IRB and a lot of others actually prepared a lot of materials because there was such uncertainty of whether the Common Rule would go into effect six months ago,” Forster explains. “We created new standard operating procedures and worksheets and training for IRB members.”

When SACHRP finalizes its guidance before the Common Rule is implemented on Jan. 18, 2019, the research protection world should read it and use what they can, he says.

“One of the points we really want to stress is this guidance has to get to the people who write consent forms and to the people who perform the consent process — it can’t just be aimed at IRBs,” Forster says. “It has to get to everyone involved in the consent process.”