There are three ways I saw this done:
1. Specific language about tissue and other subject specimen in the informed consent form in your trial(s),
2. After the study is complete, if there is a potential adverse event, using the HIPAA exception for FDA-related matters to obtain info, perhaps using a material transfer agreement from the academic medical center, or
3. Consent directly from the patient, if you are able to get it, typically by asking a principal investigator to pass along the request to the study subject(s)
Roger
------------------------------
Roger Cepeda, JD, MBA, RAC
MedTech Law LLC
roger@medtech.lawMobile: 847-421-8361
------------------------------
Original Message:
Sent: 28-Nov-2022 12:41
From: Anonymous Member
Subject: HIPAA and Biospecimens
This message was posted by a user wishing to remain anonymous
I'm looking for a lawyer who specializes in HIPAA and use of biospecimens retained from pivotal clinical studies. Just sending out a general query in the forum if anyone has recommendations.
Thanks.