Question

When conducting an industry-sponsored trial at a VHA facility, the researcher must comply with the adverse event reporting requirements of all of the following except the _________.

1) Institutional Review Board (IRB)
2) Food and Drug Administration (FDA)
3) Office for Human Research Protections (OHRP)
4) Veterans Health Administration (VHA)

Answer 1

In an industry-sponsored trial at a VHA facility, the researcher must comply with the adverse event reporting requirements of the IRB, FDA, and VHA, but not with the OHRP.

Step-by-step explanation:

When conducting an industry-sponsored trial at a VHA facility, the researcher must comply with the adverse event reporting requirements of several oversight bodies, but not with the Office for Human Research Protections (OHRP), as this agency does not directly involve itself in the oversight of such trials at VHA facilities. Researchers are instead required to adhere to the guidelines and reporting requirements of the Institutional Review Board (IRB), Food and Drug Administration (FDA), and the Veterans Health Administration (VHA). These requirements are in place to ensure that human subjects are protected during clinical trials and include obtaining informed consent, minimizing risks relative to benefits, and reporting any adverse events to the relevant regulatory bodies.