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Apr2020

On October 23, 2019, PRIM&R hosted a webinar, Real-World Approaches to Informed Consent under the Revised Common Rule. This webinar served as a check-in on how the human subjects research oversight community is adapting to the new requirements, particularly the revised Common Rule's implications for informed consent. Presenters Karen Blackwell, MS, CIP; Patrick Herbison, MEd, CIP, and Ann Johnson, PhD, MPH, covered challenges and successes pertaining to informed consent requirements in the revised Common Rule and helped attendees identify strategies to benefit their organizations in adapting to the regulatory changes.

After the webinar, the speakers responded to attendee questions time didn’t permit us to address live. We’re pleased to share those responses with the readers of Ampersand.

How do you help IRB members to evaluate the key information section in the consent form? How do IRB members know the key information as written is good enough and suitable?

Patrick Herbison (PH): We provided training to the IRB members about the new key information section, the new elements, and our new consent format. Our key information section contains a short sentence or two about each element, so IRB members don’t have to determine which are most important. They review the key information section for consistency with the protocol and clarity.

Karen Blackwell (KB): We ask our members to consider the overall purpose and key elements of the study as well as the principal investigator’s responses found in our supplemental application (the top 3–5 risks, advantages, drawbacks, and other information participants should consider). Members who are clinicians often have a good idea about the type of summary information that would be provided in a clinical setting. This is also an area where our community and non-scientist members are particularly helpful in offering the perspective of a potential enrollee.

Any guidance about the combined ICF & HIPAA?

PH: In the Jefferson consent template, the HIPAA section is included and is one of the 5-6 sections referenced in the key information section but fully addressed later in the detailed section of the template.

KB: At KUMC, we typically would not address HIPAA or privacy issues in the key information for a clinical trial unless the board thinks some aspect of data security is unusual and particularly risky. This hasn't been the case to date.

The regulations says to implement key info for any consent document, so would using it only for longer consent documents be a violation?

PH: Since the regulations are vague, it is somewhat open to interpretation. A 20-page consent beginning with a 3-page key information section might be acceptable. But for a simple study, a full consent that can address all the elements in 3 pages may also be considered acceptable.

KB: This is an example of where we found the preamble to the Revised Common Rule to be very helpful. The entire text of the regulations is posted on the OHRP website, and pages 7213-7214 discuss the key information requirement. Those pages explain that the key information requirement should be adapted to be appropriate to the individual study. They say that for a relatively simple study with limited risks or benefits, all the information provided might satisfy the requirement, and the entire consent form could be relatively short. Institutions certainly may differ on their interpretation of the commentary. I’m aware of other institutions who require a key information section if the consent form is longer than three pages. Since studies with shorter consent forms are generally minimal risk and since our institution includes HIPAA in the consent form, we were comfortable with using a cut-off of 8 pages or longer.

Where would the ‘10 top things to know about a study’ be placed on the consent form template?

PH: As near to the beginning as possible, especially if it is intended to act as the Key Information section.

KB: The idea of “top 10 things” came up during our focus groups with patients and advocates as a way to help our study teams conceptualize the goal of the key information section. We don’t actually use that term in our consent documents; instead, it is a helpful guide in considering what to include.

In online research, the new policies are difficult to implement where we have no face-to-face interaction with the participant. Also, a minor change means thousands of dollars spent to make changes in an online format. Will HRPP look into making policies for online research protocol?

Key information - the previous speaker suggested not dividing into key versus 'not-key' but rather simple and detailed. So how does the 'key information' section presented by University of Kansas fit in?

KB: This is a great example of where institutions may differ in approach. Our current consent templates have the labels “Key Information” and “Detailed Information” because those terms used in the regulations. But Patrick makes an excellent point that perhaps labeling some information as “key” means the other information is less vital. I’m considering taking that perspective to our board to get their opinion.

With sponsored studies, the results will be de-identified, which means that it has limited utility for clinicians because they cannot verify that the results actually pertain to the patient.

Ann Johnson (AJ): This is true. One of the considerations for returning research results is whether the results can be individual or can only be reported in aggregate. Though participants have certainly voiced that they find value in having individual-level results, they have also voiced value in aggregate results, knowing how they personally contributed to the study overall. It will be important to consider ways to disseminate both types of results.

Is the nonmedical IRB at Kansas also dividing their consent forms into regulatory materials and pi supplements?

KB: To clarify, the separation of regulatory issues and PI supplements is used in our IRB application forms and not in our consent forms.

Any thoughts on the need to monitor compliance with the requirement to post clinical trial consent form 46.116 (2)

KB: I’m guessing we’ll be learning more about this requirement in the near future. At our own institution, we have a person dedicated to the task of helping our investigators with clinicaltrials.gov. She monitors our studies listed in the system and send out email reminders to PI’s about approaching deadlines.

For the risks, would putting percentages for them be helpful, instead of a large list under different categories? Could they be in a table as an easier way to convey them?

PH: I have seen it done both ways. Some argue that grouping by frequency is not specific enough. Other argue that some participants may not understand percentages. It comes down to preference, which is often determined by the sponsor.

AJ: While grouping risks by numerical frequency makes sense to many in the scientific community, I worry that comprehension among the general public is still low when this method is used. It can be difficult for the general public to understand percentages and probabilities. It would be interesting to look at the literature on this and gain perspective into how participants see this.

My daughter was involved in many research studies for cancer for hope it would help her but also to help those that may develop the type of cancer she had. One of the big things she always asked her provider was whether she was on the placebo or how the cells would be used. It is important to participants to know that they are doing the better good of humanity.

AJ: I feel like my answer to the aggregate results question above reinforces the last sentence of this audience member’s comment.

What about results posted on clinicaltrials.gov or papers published in journals?

AJ: I feel that ClinicalTrials.gov was intended to be a method of research results transparency, and in that way could be viewed as a forum for returning research results to the public. However, I feel that this is a passive approach that may not be meaningfully accessible to the lay public. I don’t feel that most of the lay community would know to visit this site. Another aspect of returning results to consider is also reading level. Much of the language posted on ClinicalTrials.gov and in academic journals is not at a reading level of the general public, limiting the usefulness of these avenues.

Should the "Key Info" section of consent form be written as a "stand-alone" section that should be sufficient by itself without the detailed section of consent?

PH: For a simple study, the key information section could be stand alone. However, as soon as the study involves greater risk or PHI, then several of the sections will require more detailed information.

Karen, when you consider the length of the consent form (8 pages) and when the need for key information is triggered, does the page limit include signature pages or just the body of the consent?

KB: For the sake of simplicity, we judge by the entire document. If the whole document (including HIPAA and signature blocks) is 8 pages or longer, then we require the key information section.

PRIM&R thanks Ms. Blackwell, Mr. Herbison, and Dr. Johnson for sharing their expertise.

The recording of this webinar (and recordings of all past PRIM&R webinars) is available for purchase. If you would like to purchase the webinar for group viewing, please download the order form (PDF) and send it to registration@primr.org.

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