Science Directions

At scientific conferences I have attended over the past year, the topic of institutional review boards (IRBs) has often been the focus of conversations. IRBs are the backbone of a university's approval of the research conducted by its scientists--they are committees composed of academic peers and public members who review research proposals to ensure that they meet high standards of research ethics.

When conversation turns to IRBs the tone is often one of frustration. Some investigators are reporting difficulty getting their research protocols approved in a timely manner, and institutions are increasingly reporting IRB workloads that strain their material and human resources. These concerns have led some to ask whether present-day IRBs adequately serve their institutions and scientists.

Why does there seem to have been a precipitous shift in this aspect of the research enterprise? The IRB system was designed to provide local oversight for researchers within academic institutions. But times have changed. Unparalleled scientific advances are allowing scientists to ask new and more complex questions than ever before. At the same time, increased pressures from taxpayers for accountability from researchers and research institutions have strained our research review system.

What are the challenges?

The most visible change is an increase in the sheer volume of research being conducted today. This makes it difficult to ensure that IRBs can adequately review proposals in a timely manner, or that any single IRB can provide the range of necessary expertise. The increasingly multidisciplinary and collaborative research climate adds a new dimension of complexity to IRB review tasks. In addition, a number of larger research universities have found themselves with multiple IRBs, and assignment of research proposals, especially multidisciplinary ones, to relevant review panels is sometimes difficult and not always appropriate.

Protecting research participants from the potential risks involved in cutting-edge biomedical research fields has resulted in inflexible uniform regulations that may sometimes be inappropriate for the behavioral and social sciences. Some believe that, fearing federal sanctions, IRBs have become increasingly cautious in approving behavioral research protocols and sometimes demand more stringent precautions than the research design or subject matter warrants.

The kind of institutional review required in this new scientific era could not and should not be done on a shoestring budget. Yet, this is exactly how many universities would characterize their situation--funds for staffing the IRBs are often inadequate and faculty members who serve on these groups are overextended. As scientists and taxpayers, we need to make sure that institutions have adequate resources to properly assign, review and evaluate research proposals. We need to ensure that sound research is not impeded by regulatory concerns while satisfying the public's reasonable desire for protection from research risks.

This means that IRBs need the same kind of support that we provide to other aspects of university infrastructure such as libraries, computing facilities and the like without blinking an eye. Where will these funds come from? We need to work with funders to make sure that this happens.

We also need to foster dialog in our community about the role and scope of IRB oversight. Researchers need to be confident that sound research designs that follow standard subject-protection guidelines will be approved without undue delay. Institutions need to be confident that they can establish IRBs whose members reflect the expertise for reviewing proposals from today's interdisciplinary research teams. Doing this may require structures and procedures not previously considered. This might include hiring consultants to provide specialized expertise; it might include forming specialized IRBs across university consortia.

A greater level of cooperation

How do we move to an IRB system that serves investigators and research participants well? Some have argued that institutional human participant research programs should be accredited in much the same way that laboratory animal facilities are accredited. This is not a simple matter given the number of IRBs in operation--more than 4,000 in the United States. Discussions are currently under way to develop an institutional accreditation system that would be self-supporting through the generation of fees paid by accredited programs. APA is involved indirectly in these discussions through its membership in the Consortium of Social Science Associations, which was invited to participate in these early discussions and will represent the concerns of all behavioral and social scientists as this plan moves forward.

One thing is clear. IRBs are faced with enormous challenges and they are not going to miraculously disappear as some may hope. Fostering greater cooperation between IRBs and psychological scientists is an essential first step in making the system work well for all concerned.