Under what condition is it recommended to inform the subject's primary physician about participation?

• A. It must be done in all cases without subject consent.
• B. It should be done regardless of whether the subject agrees to inform the primary physician.
• C. It should be done only if the subject consents to inform the primary physician.
• D. It is recommended that the investigator inform the subject's primary physician about the subject's participation if the subject has a primary physician and agrees to the primary physician being informed.

Answer: (D)

Sharing information with the subject’s primary physician supports coordinated medical care and safety, but only when the subject has a primary physician and agrees to share that information. If consent is given, the physician can review the subject’s other treatments and conditions, watch for potential interactions, and manage any adverse events in the context of routine care. This respects the subject’s autonomy and privacy by avoiding disclosure without consent. If there is no primary physician or the subject does not consent to inform, disclosure isn’t appropriate. Therefore, informing the primary physician is recommended only when the subject has a primary physician and agrees to being informed.