Authored by Andrea Pescina Liberale & Jamison V. Kovach, University of Houston
In a series of articles, we will present the newest in research administration from the Journal of Research Administration. Read the full JRA here.
Research activities, such as clinical trials for example, involve enrolling human subjects as volunteers to participate in research studies (Gabriele, 2000). Given that a substantial portion of research is sponsored by the federal government through money collected from U.S. taxpayers, investigators and research institutions have a responsibility to ensure research funding is not used in ways that harm or unnecessarily risk harming subjects participating in research studies. Given the volume of regulations, guidelines, etc. regarding research involving human subjects at the federal, state, and local levels, however, it can often be challenging to maintain compliance (Steinert, 2002). This research investigates how to reduce the time to review and render approval/ denial decisions for research protocols that involve human subjects.
To ensure the ethical conduct of research involving human subjects, institutions that receive federal funding for research are required to establish an institutional review board (IRB). The intent of the IRB is to protect the ethical rights and welfare of human subjects from research risks through the initial and continuing review of research protocols, adverse events, amendments, and other issues. The policies and procedures used to guide this process within each institution assists investigators with maintaining compliance with federal regulations (Steinert, 2002). That is, the modifications to research protocols, consent forms, recruitment materials, etc. often requestedby IRB committees are meant to balance the risks and benefits of a proposed research protocol (Gabriele, 2003; Gearhart, 2010).
Read the full article here.
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