From: Eisenstadt, Anita R. [aeisenst@nsf.gov]
Sent: Wednesday, May 14, 2003 9:51 AM
To: Drew, Glen (OS)
Cc: Eisenstadt, Anita R.; Fritsch, Robin C.; Rubin, Philip E.; Plattner,
Stuart
Subject: NSF Comments on HHS Draft Guidance on Financial Conflicts -
Docke t No. 02N-0475

Glen - 

The National Science Foundation (NSF) is submitting comments on the HHS
Draft "Financial Relationships and Interests in Research Involving Human
Subjects:  Guidance of Human Subject Protection." ("Guidance"). (Docket
Number 02N-0475).  

In the past, NSF and HHS worked together to coordinate their investigator
conflict of interest policies.  It was our understanding that NSF was
participating in a working group chaired by Stuart Nightingale to develop
Guidelines/Points to Consider concerning financial interests in research
involving human subjects.  NSF was surprised and disappointed that HHS
published the Draft Guidance in the Federal Register without providing NSF
or the other agencies that are members of the Human Subjects Research
Subgroup (HSRS) with an opportunity to review or comment on the Guidance.
This precluded coordination among our agencies in developing the Guidance.

In Section I.D of the Guidance, "Basis for this Document", HHS cites to
several sections of the Common Rule for the Protection of Human Subjects (45
CFR Part 46) as the basis for issuing the Guidance.  NSF is also a signatory
to the Common Rule.  We question whether these provisions of the Common Rule
provide authority to regulate investigator and institutional conflicts of
interests.  By interpreting the Common Rule in this manner, it may create
the impression that other agencies that are signatories to the Common Rule
must also regulate financial conflicts of interest for their grantees
conduct research involving human subjects.  We do not believe that this is
the case.

We have some suggested edits to the text of the Guidance.  In Sections II.A
and II.C.4, the Guidance includes both potential and actual conflicts of
interest.  Because the term "potential" is too open-ended and speculative,
we recommend deleting the word "potential."  

The preamble states that the Guidance applies to research funded by HHS or
regulated by FDA.  However, there is inconsistency in the text about the
scope of the Guidance.  We therefore recommend adding language to Sections
II.C.1 and II.C.4 that clarifies that it only applies to HHS funded
research.

In addition, Section I.A, "Purpose" states that the Guidance provides
"requirements."  The word "requirements" connotes a legal regulatory
obligation and is inconsistent with Guidance.  The word "requirements'
should be deleted.

We hope these comments are helpful.

Robin Fritsch				Anita Eisenstadt
Alternate DAEO			Assistant General Counsel
National Science Foundation		National Science Foundation