Question

Which one of the following federal agencies has issued guidance stating that research subjects should be informed that the agency may review the subjects' individual medical records?

1) National Institutes of Health (NIH)
2) Centers for Disease Control and Prevention (CDC)
3) Food and Drug Administration (FDA)
4) Department of Health and Human Services (HHS)

Answer 1

The Department of Health and Human Services (HHS) has issued guidance stating that research subjects should be informed that the agency may review their individual medical records.

Step-by-step explanation:

The Department of Health and Human Services (HHS) has issued guidance stating that research subjects should be informed that the agency may review the subjects' individual medical records. The federal agency that has issued guidance stating that research subjects should be informed that the agency may review the subjects' individual medical records is the Food and Drug Administration (FDA). The FDA is responsible for protecting public health by regulating and supervising products such as pharmaceutical drugs, vaccines, and medical devices. Part of their regulatory activities includes overseeing clinical trials to ensure the protection of participants and adherence to ethical standards, which includes informing research subjects about possible review of their personal medical records.