From: "Vasgird, Daniel" <Daniel_Vasgird@rfcuny.org>

To: "'coi@osaspe.dhhs.gov'" <coi@osaspe.dhhs.gov>

Date: Tue, Sep 26, 2000 1:29 PM

Subject: COI Comments

I will be brief:

I attended the COI cnference in August and spoke with Dr. Nightingale and

also Dr. Puglisi at OHRP about my strong belief that the existing IRB's

should be integral to the process of determining whether COI exists as well

as the process of informing subjects. The reasons are :

The IRB's already have the focal and primary role as advocate for research

subjects. Informed consent, risk/benefit analysis and equity maintenance are

at their core of responsibilities and this is the essence (or should be) of

COI determination and revelation also. It has taken 20+ years to get the

system in place. IRB's are quite simply about as objective an entity as one

can hope for in the present market‑driven global climate. They need to be

pivotal.

This being said I also agree with Dr. Shalala, Dr. Koski and Dr. Sugarman

(Duke), all of whom recently said that IRB's are presently stretched to the

limit (and beyond for some) and require much more in terms of resources (PS

and OTPS). I do not agree with those who say COI evaluation would require

skills and responsibilities that should not involve the IRB's. The IRB

system needs to be enhanced and expanded, not limited in terms of purview.

Ultimately human subjects protection is what any COI process should be

about. In my experience it is the single existing entity that can come close

to making objective determinations.

Thank you.

Daniel R. Vasgird, PhD

Office of Research Conduct

Research Foundation of CUNY

30 West Broadway, 11th Floor

New York, NY 10007

Ph: 212‑4178485

Fax: 212‑4178479

email: Daniel_Vasgird@rfcuny.org