LAUSR

Conducting a research study is usually a complex enterprise requiring a number of steps, starting with the initial idea and formulation of a research question, followed by the literature review, writing up the protocol, and then conducting the study. One of these steps is obtaining approval from the institutional review board (IRB) or a formal statement that the research is exempt from IRB oversight. (Other names used for institutional review bodies are, for example, ethics committee, independent ethic committee, ethical review board, research ethics board, human subjects committee, or human studies committee.) The IRB review has two critical goals: ensuring the adequate protection of volunteers in human studies (“do no harm”) and enabling a scientific process by which new knowledge may be rigorously acquired, bringing potential benefit to the public and society broadly (“help others”). A third goal, added by some, is protection of the institution from litigation. In our role as editors for Academic Psychiatry, we often field questions regarding the necessity of IRB approval for papers based on projects involving educational data or educational cases. We have learned that many of our colleagues are unaware of the need for prospective IRB approval or formal exemption for education-related studies, and we have seen that many more of our colleagues view the process of seeking approval from an IRB as burdensome, time-consuming, or intimidating. In this editorial, we wish to reaffirm the importance of prospective IRB review, leading to approval or formal exemption for projects conducted by our authors, before submitting manuscripts to Academic Psychiatry. Toward this objective, we further wish to emphasize a less well-appreciated function of the IRB approval process, namely, to serve as a pedagogical resource for investigators, especially for those who are new to the conduct of human studies and research in general. We will discuss the critical functions of IRBs and how the IRB application processes can promote learning, particularly regarding clarity of writing, formulating research questions, and the ethical imperatives of research.