WHY HRPP?

While helping client institutions prepare for AAHRPP site visits, one of the points I try to make is focused on the name of the organization - the Association for the Accreditation of Human Research Protection Programs. It is not the Association for the Accreditation of IRBs. That difference highlights the change in how we perceive what we do that has taken place over the past decade.

In the beginning, in the mid-70s when national attention first started being paid to research involving human subjects, it was thought that requiring IRB review of human subjects research would solve the problem of unethical research. For twenty years the task of protecting human subjects fell to IRBs and institutions felt that they had fulfilled their ethical responsibilities by having IRBs and requiring IRB review of research.

In the late 90s, two studies of the IRB system and a tragic event caused people to start questioning whether that was enough. The two investigations, one by the then Government Accounting Office and the other by the Inspector General of the Department of Health and Human Services, came to similar conclusions - the IRB system, in addition to being overburdened and under-resourced, was flawed and in need of revision. The system was too paper-driven and too "upfront". IRBs reviewed protocols but had no knowledge of what was happening after they approved the research. In addition, the federal regulatory agencies, especially the then Office for Protection from Research Risks, were also not monitoring what was really going on in the research world. Shortly after these investigations were published, Jesse Gelsinger died. His death, at one of the most prestigious research institutions in the country in an IRB-approved research study, also highlighted the flaws in the IRB system.

So, a lot of thought and discussion went into what was wrong with the system and what could be done to improve it. It was clear that IRB review was not enough to ensure ethical research. The IRB has a crucial role to play, but does not have sole responsibility for protecting subjects. The institution, through its policies and procedures, establishes an ethical framework for the conduct of research involving human subjects. The IRBs role is to provide independent, objective prior review of the research to ensure that the investigator has addressed all of the necessary ethical concerns in designing the research. Ultimately, it is the investigator who is responsible for the ethical conduct of the research.

What is required is an overall program of subject protection where responsibility was shared by the entire institution - an HRPP. An HRPP is a comprehensive and organized system to ensure the protection of human subjects participating in research. The HRPP is based on shared responsibility and accountability. It is only by having an effective HRPP that an institution can fulfill its ethical responsibility.

As someone who has been in this "business" for almost 30 years, I have seen this change take place and I sincerely believe that it is a change for the better. It is only through effective HRPPs that research institutions can fulfill their mission to advance human knowledge while meeting the highest ethical standards.