Keeping in mind that I am not a HIPAA expert, I offer this up for your
consideration...I'm sorry it is a bit long.

When a health care activity is performed within the research study itself -
for example, a clinical trial or other clinical intervention study - any
individual clinical record information that is generated within that
research is PHI that is subject to all the HIPAA regulations that apply to
PHI that becomes part of the health care treatment, payment and operations
records of the health care provider. Information gathered during the
clinical trial is also usually entered into the medical record.  Plus, as
Mr. Schoen mentioned, the sponsor has to have access to the medical record
anyway in order to gather information about the adverse event and also to
verify the data from the trial. It is likely that your institution/IRB has
already required an authorization to be signed in addition to the informed
consent form prior to participation in the trial. Information submitted to a
sponsor for a clinical trial is almost never de-identified data - which
would not require an authorization.

Additionally, HIPAA has a clause that allows for sponsor access to the
patient information for monitoring the "safety, effectiveness and quality"
of an FDA regulated product.  This covers adverse event treatment. This is
from hipaaadvisory.com
(http://www.hipaadvisory.com/regs/finalprivacymod/fda.htm):

"Section 164.512(b)(1)(iii), as modified, permits covered entities to
disclose protected health information, without authorization, to a person
subject to the jurisdiction of the FDA with respect to an FDA-regulated
product or activity for which that person has responsibility, for the
purpose of activities related to the quality, safety, or effectiveness of
such FDA-regulated product or activity. Such purposes include, but are not
limited to, the following activities and purposes listed in subparagraphs
(A) through (D): (1) To collect or report adverse events (or similar
activities regarding food or dietary supplements), product defects or
problems (including problems with the use or labeling of a product), or
biological product deviations, (2) to track FDA-regulated products, (3) to
enable product recalls, repairs, or replacement, or for look-back (including
locating and notifying persons who have received products that have been
withdrawn, recalled, or are the subject of look-back), and (4) to conduct
post-marketing surveillance."

Our attorneys have advised against payment to the PI for compensation for
treatment since their opinion is that it limits treatment to that particular
institution when, ethically, the subject should be allowed treatment at the
facility of their choice.

Hope this helps,

Tammi Jaynes RN CCRC
Project Manager
Office of Clinical Trials
University of North Carolina
919-843-2333 (office)
919-843-2399 (fax)
919-216-4385 (pager)

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