Needed: Stronger partnerships between researchers and IRBs

Recently, I am across an op-ed piece about breaches of conduct in medical research that, I’m sure, you will find as disturbing as I did. As the former chair of an institutional review board (IRB), I was sickened to learn that, despite federal mandates that universities adhere to the Belmont Report principle to do no harm, violations of those regulations continue to occur.

When I was an IRB chair, we routinely reviewed clinical trials that were supervised by a data and safety monitoring board (DSMB), as well as other studies exempt from DSMB oversight. Then, as now, I was concerned that universities, relying on the honor code, have depended on principal investigators to report irregularities that occur while conducting research studies.

In pursuing scientific discovery, academic and scientific communities rely heavily on human volunteers when conducting research. However, it has become evident in some instances that publishing novel findings has taken priority over protecting human subjects. Belmont Report “do no harm” guidelines notwithstanding, some researchers are failing to show allegiance to this principle.

Nurses and other health care providers are well positioned to advocate for the highest ethical treatment of human volunteers. The challenge is how to structure this advocacy in a systematic manner that safeguards against potential abuses. In my view, academic centers do not have adequate resources to monitor research protocols. Consequently, investigators are left to grapple with ethical issues that, if not addressed properly, may result in unintentional harm to research subjects.

Advocating on behalf of human volunteers in research studies is tantamount to the advocacy nurses provide patients. Far too often, the consent forms used in conducting research are too complex for volunteers to comprehend, particularly as they relate to potential risks and benefits of a research study, as well as its method and design. Hence, it is incumbent upon investigators to do due diligence in creating forms that are clear and comprehensible.

Additionally, I propose that institutional review boards charged with overseeing research studies: 1) increase the frequency of their monitoring, and 2) that they deploy sufficient personnel to provide necessary oversight while avoiding unnecessary interference with execution of research studies. In other words, a partnership that benefits both investigators and research participants is needed.

From personal experience, I know it is easy for some investigators to regard the IRB as an adversary rather than the quality-assurance arm of their studies. But to ensure that protection of research volunteers is more than just a philosophical principle and that all volunteers who participate in research are well protected, I propose that stronger partnerships be forged between investigators and the institutional review boards to which they are accountable.

For Reflections on Nursing Leadership (RNL), published by the Honor Society of Nursing, Sigma Theta Tau International. Comments are moderated. Those that promote products or services will not be posted.