By Melinda Young, Author

Implementation of the new Common Rule was officially postponed until July 19, 2018, and now federal agencies have requested a further six-month delay of its effective date, according to an April 20, 2018, proposed rule in the Federal Register(Available at: http://bit.ly/2Jn5gsy.)

The new effective date would be Jan. 21, 2019, providing more time for human research protection programs (HRPPs) to implement the 2018 requirements.

The extra time will give HRPPs an opportunity to revise and improve their program policies and procedures. For example, an effective HRPP needs sufficient resources and a process for evaluating compliance with the institution’s policies and research regulations.

“At a lot of institutions, the terms ‘IRB’ and ‘HRPP’ are used synonymously,” says Debra Dykhuis, executive director of the IRB at the University of Minnesota in Minneapolis.

In establishing an effective and collaborative HRPP, the research institution focused on how human research protection programs include other groups that also touch human subjects research.

“It’s about our responsibility and how we all have a part to play to bring human research protection to the attention of the institution in a new way,” she explains. “We had used the term ‘HRPP’ for a long time, but we felt there was an opportunity to help create an understanding about what that could mean for us.”

It was also about creating a group of various research stakeholders to discuss the issues they have in common and to provide oversight, education, and support of the institution’s human research, she adds.

“We knew there was confusion about the meaning of the term ‘HRPP’ at the U of M, and we did some soul-searching about how we could bring better understanding of the concept to our community,” Dykhuis says.

As a result, the organization formed the HRPP advisory committee that includes key representatives from university programs, departments, organizations, and affiliates. Members represent the research community — social-behavioral and biomedical, research compliance office, sponsored project administration, investigational drug services, conflict of interest committee, legal counsel, IRB, healthcare components, and others.

The group of about 30 people meets once a quarter for 1.5 hours, and meetings are consistently well-attended, Dykhuis says.

Their HRPP development model could be replicated by other institutions adopting the same philosophy of effective and successful team management through systematic collaboration.1

Here’s how the HRPP was developed:

• Establish methods to promote transparency and collaboration. The HRPP committee keeps its members informed through meeting summaries and other information sent to them a few days after the meeting.1

Within the first few meetings, the HRPP committee identified areas to prioritize.

“We asked people to tell us what they thought the value would be in pursuing more work in those areas,” Dykhuis says. “These often turned out to be an opportunity to work together to share information — not as much a driver of the future.”

Committee members prepared for meetings through an agenda distributed several days in advance. Before the first meeting, the agenda asked members to prepare one to three goals for the HRPP to be shared. This ensured that stakeholders would have a voice in the meeting.

The committee realized that it could build something together, bridging the traditional research silos.

“The mission of the committee is to collaborate, coordinate, and evaluate the university’s HRPP with the ultimate goal of ensuring the protection of participants and to uphold ethical standards and improve our practices,” Dykhuis says.

For example, the committee has worked on improving IRB performance transparency. One method is to collect metrics and share the information.

“We collect submission volumes and turnaround times and share these with the entire community,” she says. “We report on how much of our work is reviewed by an external IRB, and we report on metrics involving our quality assurance program and its activities.”

The HRPP committee also has shared with its research community how the organization will address the single IRB requirement under the new Common Rule.

“That touches the IRB, hospital groups, sponsored programs, and the conflicts of interest group,” Dykhuis says.

The HRPP committee created a solution to meeting the NIH single IRB review requirement. The institution’s investigators, subject to the requirement, can choose to use an independent IRB.

“Until our HRPP can be certain we can properly manage serving as the reviewing institution for multicenter clinical trials, we have elected to provide an AAHRPP-accredited independent IRB,” Dykhuis says.

• Identify, evaluate, and prioritize gaps. The committee’s goal is that each of the groups represented on the committee talks together about the issues that would affect the other members of the group, she says.

“An example of an agenda item we’ve had that involved this kind of thing was a discussion about ClinicalTrials.gov,” Dykhuis says. “We had a high compliance rate with registration, but one of the potential gaps identified is how we can support compliance with the updating of results and ongoing requirements.”

There are some new requirements from ClinicalTrials.gov, including timetables for when researchers must post results. This is more of an HRPP issue than an IRB issue, she notes.

“We’re working on how we can work together as an institution to close that gap,” she says. “There is no solution in place yet, but we’ve identified the problem and are evaluating it.”

The HRPP committee also kept members on task by developing a meeting management plan that identified who would facilitate the meeting, manage agendas, and take notes.

• Review and make recommendations. The vice president for research is a representative on the HRPP committee, so recommendations for changes are readily available to university leadership, Dykhuis notes.

“This provides a link for the committee’s discussions to be on the radar of leadership,” she explains. “So when things come up from any representative groups, there’s awareness already there, and things are not bubbling up for leadership in a vacuum anymore.”

• Share accountability and evaluate performance. The HRPP committee’s members include representatives from all areas, so the various research stakeholders share accountability with their respective departments.

Also, the HRPP committee regularly reviews and evaluates its performance on identifying priorities, prioritizing gaps, and in promoting transparency and collaboration. Groups are working together in a brand-new way at the University of Minnesota, to bring the research community and others toward understanding that human research protection is the business of everyone in the research ecosystem, Dykhuis says. “We are a stronger HRPP.”

REFERENCE

1. Jarboe C, Dykhuis D, Anderson L, et al. Building an effective, collaborative, and accountable human research protection program. Poster presented at the Public Responsibility in Medicine and Research (PRIM&R) Advancing Ethical Research Conference, Nov. 5-8, 2017, in San Antonio. Abstract: 36.