”Theirs was not to make reply, Theirs was not to reason why.”
Keywords:Institutional Review Board, Research Approval Process
Background: In 1974, the United States passed the Research Act, which required creating and implementing guidelines for conducting research on humans and animals. In 1978, universities and hospitals created Institutional Review Boards for reviewing and approving research protocols in the United States.
Objectives: This article will define and explain the components of a research protocol, research team member roles and responsibilities, pre-protocol submission training requirements, and provide suggestions for improving how researchers obtain research approval.
Lessons Learned: The author failed to provide all the required information before collecting Informed Consent to prospective participants for four different study protocols.
Conclusions: Obtaining research approval is necessary for most study designs. It is a complex and frequently tedious process, but obtaining approval gives research studies greater credibility.
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