Protecting human research-subjects, contributing to quality

Institutional Review Board members share 5 ‘things to know’ about human research protection

The principle of respect is foundational to the IRB’s work and to the conduct of research involving human subjects.


3/22/2017 | By: Jane Tors |

When talking to members of the Institutional Review Board, it is clear they are passionate about protecting the rights and welfare of human research participants while also contributing to the quality of research being conducted by their colleagues.

All research involving humans must first be reviewed and approved. Twice a month volunteer members of the faculty and the community-at-large come together as the IRB to review human-research proposals. Their work is supported by the Research Integrity team which is part of Research & Innovation at the University.

Four IRB members recently visited with Nevada Today, and five 'things to know' emerged about this well-known, very important, yet occasionally misunderstood research-protection function.

1.    ONE BOARD SERVES THE ENTIRE COMMUNITY.

The University-led IRB is an impressive example of community collaboration, serving all of the region's human-research review and protection needs.

The IRB has served the Veterans Administration hospital in Reno for more than 10 years, and now serves Renown Health and Saint Mary's Regional Medical Center as well. All three health organizations have members on the IRB, which also serves Desert Research Institute, Truckee Meadows Community College, Nevada Department of Health and Human Services and the Nevada Center for Biomedical Research as needed.

"It would not be a good use of time to create a whole structure at each individual institution," said Janet Usinger, who has served on the IRB since 2001 and as its co-chair since 2005.

"UNR has taken a collaborative approach," said the College of Education professor and University of Nevada Cooperative Extension state extension specialist. "It's a tangible example of UNR's attempt to become more integrated with the community."

The advantage of coordinating between multiple institutions, said Bob Fox, a clinical pharmacist at Renown and an IRB member, is a resulting community-wide "commitment to research that meets high standards of integrity and quality."

An important, community-based service of the IRB that pertains to hospitals or healthcare settings is the review of single-patient protocols involving the compassionate use of an investigational drug or a humanitarian device.

2.    HUMAN PROTECTION = HUMAN RESPECT.

With 25 years of IRB experience, Fox said, "I can offer the solid observation that the members of the boards have always had the interests of the research subjects foremost in their deliberations and actions. Sometimes the procedural process of an IRB application seems to obscure the primary reason for the existence of this body. However, when a proposed project is reviewed and a decision is made, the safety and rights of the individuals volunteering for the research are the primary concern."

"When we review a proposal, we look at it as though 'I' am the participant," Usinger said.

"One of the things that the IRB does is it forces researchers to step back and appreciate and respect the people involved in their research," she said.

The Belmont Report, issued in 1978 by the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research, established the principle of respect for persons as the foundation for IRBs. Usinger sees it a guide for life as much as for research: "No matter what role anyone is in, you treat people with respect."

3.    IT'S NOT A GOTCHA BOARD.

"Sometimes the (principle investigator) may think we are picking on small things, but it is a good thing to have someone else look at your protocol," Mostaqul Huq, clinical pharmacy specialist for research at the VA, said. "We always try to help the PI."

"We are friend, not foe," he said.

"It's not a gotcha board," Usinger added. "The board takes its time and takes very seriously the question of how can we improve the work. Can we make suggestions? Can we make directed comments?"

4.    IT'S INHERENTLY MULTI-DISCIPLINARY.

"IRBs are very intentional in how they are designed," Usinger said. "We want experts in the field working with members who are not experts in those fields. We need people who are very knowledgeable about the institution and the field of research, and we need community members and non-scientists as well."

In years past, the University's IRB was divided into two review groups: one to consider social behavioral research and the other to consider biomedical research. Today, the IRB still divides into two groups, but the groups are no longer separated by area of expertise. The Blue Team and the Silver Team review the full gamut of proposals, and the members appreciate this even-more multidisciplinary approach.

"As a social scientist, I've had to learn a great deal. For example, I've had to better understand medicine," Markus Kemmelmeier, professor of sociology and director of the Interdisciplinary Social Psychology Graduate Program in the College of Liberal Arts, said.

5.    WORKING HARD TO STREAMLINE THE PROCESS.

Kemmelmeier joined the IRB process in 2011 as an alternate proposal reviewer and three years ago became a member of the board. While he fully understands the process, he recognizes many researchers "don't know what's on the other side" after they submit their proposal through the online portal.

After a proposal is submitted, the Research Integrity team completes an initial review and determines one of three review paths. Some projects (perhaps a project involving only a verbal interview) may be approved following this staff review. Other projects are designated for an expedited review by staff plus a member of the IRB.

Many research projects are designated for review by the full board. This longer review process is applied to cases such as those involving children, vulnerable populations or medicine. All IRB members read all the proposals, though one member is designated for each and given responsibility for reading the application with extra care and presenting it to the board for discussion. Dividing the IRB into its Blue and Silver teams helps move a large volume of proposals along faster.

"We watch the potential for mission creep," Kemmelmeier said of the IRB role. "We want to be reasonable but at the same time we are protecting the researcher, the participants and, ultimately, the University."

LEARN MORE.

The University's program is accredited by the Association for the Accreditation of Human Research Protection Programs, and the Research Integrity staff and the IRB are gearing up an accreditation assessment this year. The rigorous AAHRPP accreditation is a public affirmation of the commitment to protect research participants and, says AAHRPP, this commitment resonates not only with participants but also with researchers, sponsors, government agencies and the general public.

For more information about Research Integrity and human-research protection at the University, visit unr.edu/research-integrity.

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