The Research Participant Advisory Group’s Ongoing Partnership with Cincinnati Children’s and UC Institutional Review Boards

While the Research Participant Advisory Group (RPAG) works with individual researchers to provide feedback on individual studies, another critical role of the RPAG has been to partner with institutional research leadership and divisions over the years to improve institutional research practices across the Academic Health Center. One such on-going relationship has been with the Institutional Review Boards (IRBs) for Cincinnati Children’s and the University of Cincinnati (UC), where the members of the RPAG have played a role in improving and ensuring high ethical standards in research practices across both institutions.

The RPAG is comprised of research participants and community members who receive research ethics training and provide feedback based on their lived experiences. The RPAG consists of:

• Cincinnati Children’s Research Participant Advisory Council (CCHMC RPAC)

• West End Community Research Advisory Board (WE C-RAB)

• University of Cincinnati Research Participant Advisory Council (UC RPAC)

CCHMC RPAC working in small focus groups on the Informed Consent Template: Common Rule Key Information Section

Cincinnati Children’s has been partnering with the CCHMC RPAC and WE C-RAB since the inception of these groups. Early on, this partnership included the co-creation of the Key Information section of CCHMC’s informed consent template, revamping of the assent template, as well as creating an IRB-approved community version of CITI training for community researchers, among other endeavors. After the creation of the UC RPAC in 2024, a more direct relationship was established as well with UC’s IRB rounding out a way for direct, structured engagement between the IRBs and its constituents – patients, families and community – across the Academic Health Center. Below are four recent examples of how the IRBs have sought the expertise and perspective of research participants and community members.

Cincinnati Children's IRB

Children’s IRB Director, Rocky Byington, has come to the CCHMC RPAC wanting to understand what research participants think about compensation when participating in a study. He has facilitated multiple conversations asking their opinion about such things as the tax implications of compensation, as well as what form of compensation they would like to receive – for instance whether it should be ClinCard, gift cards or non-monetary gifts like food, storybooks or school supplies. What he learned from the CCHMC RPAC members is that having choices, such as the option for a ClinCard or non-monetary gift, is what is most important. “The value of coming to these groups is gaining better understanding and acknowledgement of the local hurdles and barriers related to research participant compensation. This will help us as we continue to explore options,” said Rocky.

In another meeting, Rocky explained how participants’ data could be used in future research and how identifiable data is protected. He asked the members if the informed consent form adequately conveys how a participant’s data may be shared. CCHMC RPAC members expressed that they would want to know more details with some suggesting bolded key phrases and possibly a link to learn more information.  

StrokeNet Central IRB

At the UC RPAC, a similar conversation has been held. Mike Linke, the chair of the StrokeNet Central IRB, shared about Public Use Data Sets (PUDS) and how de-identified participant study data is stored. He asked whether participants should be given the choice to opt out of their de-identified data being shared in a PUDS. Some members felt uncomfortable with not giving an option to opt-out; they’d want to know if their data was being used, even if it’s de-identified. Others were worried that it would affect the data integrity if some participants opted out while others in the study opted in. In the end, members unanimously agreed that the opt-out should be included and that PUDS are helping research move in the right direction.

Angela Braggs Brown presenting about Waiver of Informed Consent to the UC RPAC

UC Human Research Protection Program (HRPP)

Lastly, Angela Braggs-Brown and Kareemah Mills, senior director and director of the UC Human Research Protection Program (HRPP), asked the UC RPAC members about the ethical considerations of informed consent. If the study involves a treatment protocol during an emergency room visit, for example, there might not be time to adequately gain informed consent before administering the treatment. UC RPAC members filled out a survey, and sent the survey to their family and friends, responding to different scenarios, giving their opinion on when waiving informed consent is ethical to them. Most felt that it was never acceptable to not get informed consent before someone participates in a minimal-risk study. The fear was that there is already distrust and skepticism from the community about medical research, and this may feel like another misuse of their medical experiences. They did agree that there are some emergencies and public health crises that would allow IRB and researchers to waive informed consent, but most situations should require it.

As researchers and institutions, it can be easy to lose sight of the general public’s experiences and perspectives when considering bigger policy issues or ethical concerns. What feels acceptable to a researcher might feel like a breach of trust to a community member. The RPAG has provided the forum to bridge the gap between these perspectives and allow participants to help inform institutional research conversations and policies.

If you are interested in utilizing one of the RPAGs, please contact Julie Wijesooriya at Julie.Wijesooriya@cchmc.org.