David,
The FDA has issued new regulations effective 2/2/99, so your question is very timely.  The FDA policy is much broader than the PHS and seeks to disclose interests, rather than correct them.

The FDA requires disclosure if:  compensation to the Investigator is higher for a favorable outcome than for an unfavorable outcome, compensation in the form of an equity interest or tied to sales of the product; significant equity interest in the sponsor, including ownership interest, stock options, etc, that exceeds $50,000 during the time the study is conducted and for one year after; proprietary interest in the product, including a patent, trademark, copyright or licensing agreement; significant payments to the Investigator to support activities of the Investigator with a value of more than $25,000, excluding the costs of conducting clinical studies, during the time of the study and for one year following completion.

According to the guidelines, your Investigator would only need to disclose his stock ownership if it exceeds 50k.  It is actually the organization submitting a marketing application to the FDA, that is required to disclose this information to the FDA.  Of course, your institution may have more stringent requirements.

The final regs were issued in the Federal Register on 2/2/98, volume 63, number 21, the title is Financial Disclosure by Clinical Investigators.  I have a slightly worn copy that I could easily fax to you, if you don't mind the occasional bit of underlining.

Colleen

Colleen Corcoran
Clinical Research Administrator
Research Foundation for Mental Hygiene, Inc.
(518) 474-5663
(518) 474-6995 fax

>>> "David R. Fielder" <xxxxxx@COOPER.CPMC.ORG> 01/25 8:01 PM >>>
Is it OK for an MD to conduct a clinical trial (drug or device) as the PI
and own shares in the sponsor company, as long as there is prior disclosure
and evaluation/review of that relationship?  I have been under the
impression that this is something to be avoided almost at "all costs", but
am being told not necessarily so.  It may be that it's all a judgement call
based on significance to company direction, % of shares owned, multi-site
trial etc.  For example (may be a worst case), what if the PI was also the
CEO of the sponsoring corporation?  This latter example gets into
self-funding of research, another interesting area I expect.

 Would appreciate any specific references/regulations available.

 Thanks, David
===================================================================
Mr. David R. Fielder                    tel: 415.561.1600
Vice President, Research                fax: 415.561.1753
California Pacific Medical Center   email: xxxxxx@cooper.cpmc.org
Research Institute                 website: http://www.cpmc.org
2340 Clay Street,  5th Floor
San Francisco, CA 94115

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