AAHRPP: “Driver of Change”

Much of his presentation focused on “a series of blatantly unethical and tragically fatal events,” from the Nazi doctors’ experiments, through the Willowbrook hepatitis studies, U.S. Public Health Service Tuskegee syphilis study, and the deaths of individual research participants at prominent U.S. hospitals and universities. These highly publicized, negative drivers of change ultimately spurred stronger federal regulations governing research involving humans and, in 2001, the founding of AAHRPP.

“Talk about drivers of change, this is the biggest. Nothing is more significant than AAHRPP, the gold standard of human subject protections,” Dr. Prentice told his audience. “Every institution that conducts human subject research should be AAHRPP accredited.”

A Professor Emeritus at the University of Nebraska Medical Center (UNMC) and former Institutional Official for UNMC’s Human Research Protection Program (HRPP), Dr. Prentice was the first Chair of the Secretary’s Advisory Committee on Human Research Protections (SACHRP) and a site visitor for the Office for Protection from Research Risks (OPRR), the predecessor of today’s Office for Human Research Protections (OHRP). He saw, firsthand, that regulations alone could not ensure the necessary protections for research participants.

“The regulations were in place since 1981, but a lot of IRBs didn’t understand what they were, how to apply them, or even why we needed them,” Dr. Prentice says. “That’s why so many places got in trouble” in the late 1990s and early 2000s. 

“Accreditation provides standards and helps organizations evaluate and improve their programs—and organizations welcome that opportunity,” he adds. “I can’t think of anything that has played a more significant role in evolving programs to protect human subjects.” 

Dr. Prentice was an early AAHRPP site visitor and member of AAHRPP’s Council on Accreditation. His successor at UNMC, Bruce Gordon, MD, Assistant Vice Chancellor for Regulatory Affairs and Executive Chair of UNMC IRBs, now fills those same roles at AAHRPP. Both men emphasize the importance of understanding and fulfilling the intent of the regulations instead of taking them simply at face value. 

“These days, much of the focus is on the nuts and bolts of the federal regulations,” Dr. Prentice says. “We need to remember our history and view the regulations as ethical imperatives rooted in the Nuremberg Code and the Belmont Report.”

In Dr. Gordon’s view, ethics should be an organization’s first priority. “IRBs should start by determining the right thing to do,” he says. “Then, they should look to the regulations to help support the ethical decisions.”

He and Dr. Prentice agree that, with accreditation and research protection regulations, today’s HRPPs are equipped to avoid the physical harms of the past but less prepared for newer challenges. “We are much more aware of previous types of perils, but we are not as good at anticipating potential social, economic, and moral harms,” Dr. Gordon says.

“Science often speeds ahead of ethics and regulations,” Dr. Prentice says. “We identify a new technology only to discover we’re not prepared, and the ethics have to play catch up.”

Part of the challenge is that today’s research involving humans often occurs outside traditional disciplines. Biological and social behavioral researchers are trained in the regulations. Statisticians, engineers, and others whose research focuses more on data than people “don’t have the framework, the ‘Tuskegee’ to guide them,” Dr. Gordon says.

Dr. Prentice is determined to continue to do his part to change that. “If it were up to me, every research conference would include a session on our history” complete with a reminder that research involving humans “demands an unconditional commitment to sound research ethics, scientific integrity, and compliance,” he says. “Never forget the past.”