You learn that one of the subjects from your study will be admitted to prison next week. You assert that it is in the best interest of the subject to remain in the study while incarcerated. However, the study was not approved by the IRB in accordance with the requirements for research involving prisoners under Subpart C. What is the best course of action?
A. Stop all research activities with the subject immediately.
B. Notify OHRP and request an exception.
C. Withdraw the subject from the study and delete the collected data.
D. Notify the IRB promptly and allow the subject to remain in the study while the IRB makes the determinations required by the regulations.

Respuesta :

The most appropriate course of action in the given scenario would be:

D). Notify the IRB promptly and allow the subject to remain in the study while the IRB makes the determinations required by the regulations.

  • The most effective and appropriate action plan on knowing that one of the subjects associated with your study which is not approved is to be imprisoned by next week would be to inform the IRB.
  • This informing process would assist in permitting you to accomplish your research and keep the subject for the study until it gets over.
  • This is necessary because IRB would require to make decisions as per the laws and regulations or else there may be undesired consequences on your study as well.

Thus, option D is the correct answer.

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