During a research study, it may be necessary or desirable for subjects participating at one research site to transfer to another research site. This may be because the first site discontinues its research program, the subject permanently or temporarily moves out of the area, or other reasons.
Subject transfers do not require Board approval, but Schulman requires notification of subject transfers to help ensure that the subjects’ rights and welfare are protected. Both the transferring and receiving site should notify Schulman of subject transfers via the next Study Status Report Form.
At the original site, the subject and the sponsor or CRO should agree to the transfer, and the subject should sign an authorization to release protected health information to the new site.
At the new site, the subject should receive a site introduction letter from a research coordinator or the PI/QI and be presented with the new site’s current informed consent document(s) and HIPAA privacy authorization. If necessary, the new site may request Schulman’s approval to consent the subject via mail to ensure this process is completed in a timely manner. The transfer is not complete until the subject has signed the new site’s informed consent document(s).
If the original site submits a Final Report to close with Schulman, Schulman must obtain confirmation that the transferred subjects have been consented with the new site’s current informed consent prior to closing.
If compensation for participation differs at the new site, this should be discussed with the subject. The subject has the right to decline to continue participation at the site because of a difference in compensation, or for any other reason.
Contact Ongoing Review with any questions regarding this process.