Protecting Human Subjects of Research

Over many years the Federal government has constructed a system for peer and community review of research involving human subjects, in order to assure objective assessments of the risks and benefits of the research to the subjects and the larger scientific enterprise. The notion of “risk” includes both the probability of an adverse event and the harm that would occur to a subject with such an adverse event. The application of these procedures began with biomedical research but was also applied to social and behavioral sciences. These procedures are implemented through Institutional Review Boards (IRBs).

As several National Academy of Sciences panels have noted, both the probability of harm and the nature of harm to individual subjects vary between the biomedical fields and others. Hence, the application of human subjects’ protections needs to take into account those differences. Over the past several years these differences have increasingly been recognized by research universities. For example, at Georgetown we have a separate IRB devoted to social and behavioral research.

We want to continuously improve our performance as a research university, and this includes improving human subject protection review procedures. To improve on services, we commissioned an external review of the social and behavioral research IRB was conducted by several members of AAHRPP (Association for Accreditation Human Research Protection Programs), as they are responsible for assuring the highest standards in protection of human subjects. The review team met with the IRB (faculty committee that reviews applications), the IRB staff, the Director of Regulatory Affairs, Dean of Research, Vice Provost for Research, the Provost, and faculty members from Main Campus, the Law Center and the Medical Center.

We’ve received the report and had meetings to discuss how we can implement some of the recommendations:

• To reduce the burden on investigators completing IRB packages, a new software platform will be introduced within the next year.

• We will eliminate the requirement that chairs or unit heads on Main Campus approve an IRB application before it is submitted to the IRB.

• To expedite IRB review of protocols, the IRB staff themselves will determine whether an application is non-human subject research, exempt from review, or eligible for expedited review. These steps allow the IRB members to focus on more important matters.

• Beyond what is required by federal regulations, scientific review will not take place on the social and behavioral IRB. Further, it is assumed that grant funding and peer-review in the publication process are sufficient scientific review. Undergraduate students must gain input from their mentor(s) to meet the standards of rigorous research.

• To reduce delays, the IRB will process applications during the summer.

Finally, we learned from our benchmarking that we should encourage more Main Campus faculty active in research to serve a term as IRB members. Such membership will assure that the IRB can execute effective peer review processes intended in the regulations.

Our hope in making these changes is that rigorous human subject protection review can also be expeditious, and that the efforts of the IRB members are disproportionately focused on higher-risk research.

We congratulate all those providing input and evaluative comments to this review process and thank the IRB staff and members who will execute these innovations.