May
17, 2001
To: |
IC Directors |
From: |
Director, Executive Secretariat |
Subject: |
IC Directors' Meeting Highlights—April
26, 2001 |
I. Declaration of Helsinki and Implications
for Clinical Trial Design
Dr. Greg Koski, Director of the DHHS
Office for Human Research Protections, distributed copies of three documents:
- The statement he delivered last month in
Pretoria, South Africa, at the conference, The Revised Declaration
of Helsinki: Interpreting and Implementing Ethical Principles in Biomedical
Research.
- The current World Medical Association Declaration
of Helsinki, as amended in October 2000.
- An editorial by Juhana Idanpaan-Heikkila,
Secretary General of the Council for International Organizations of
Medical Sciences (CIOMS), on "Ethical principles for the guidance
of physicians in medical research the Declaration of Helsinki."
Dr. Kirschstein noted that NIH will provide input
on the Declaration of Helsinki at the upcoming World Medical Association
(WMA) meeting in Geneva, Switzerland. Dr. Koski traced the history of
this issue since the most recent revisions were proposed. HHS convened
a working group, in which NIH was involved, to consider the revisions.
This group developed a position paper and presented it to a White House
group that is working across Federal agencies and departments. There wasn't
enough time to issue a Federal rule before the Pretoria meeting, so HHS
issued its position paper as a formal HHS statement. Dr. Koski thanked
Drs. Skirboll and Seto and Ms. Kawazoe for their assistance in this area.
He noted that there was overwhelming agreement with the HHS position among
the 45 nations represented at the Pretoria meeting. Dr. Koski suggested
that we should tell our investigators and grantees not to change any policies
at this time; he is working with Dr. Baldwin on a short statement that
will guide IRBs. Meanwhile, he is continuing to work toward a government-wide
statement.
Dr. Keusch noted that the Declaration of Helsinki
is intended to be a broad, overarching document and should not be confused
with other detailed documents. The FIC has been asked to support CIOMS,
which it will not do until CIOMS obtains input from the developing world
on this issue; CIOMS is in the process of doing that. The group agreed
that the phrase, "...treatment is impractical or unaffordable," which
appears on page 2, paragraph 4, of the HHS paper should be modified
to say, "...treatment is not accessible."
Dr. Kirschstein asked Dr. Baldwin and her staff
to work with Dr. Koski immediately following the meeting to condense
Dr. Koski's statement into a one-page document. She noted that this
is the first time the WMA has solicited input from NIH.
II. Loan Repayment
NIH staff have met with both House and Senate
staffers on the financial management of the new loan repayment programs.
In response to questions, NIH staff explained that the programs will be
administered centrally with review in the ICs. As a result of these meetings,
Dr. Kirschstein asked Dr. Lenfant to reassemble the group of IC Directors
who had recommended how to handle the loan repayment programs. There was
a general consensus that we should consult with outside groups as part
of this process. Dr. Kirschstein would initially like to pursue the loan
repayment programs as a pilot.
III. Information Items
Dr. Alexander had surgery last Wednesday
to correct a detached retina.
The Secretary signed the Federal Register notice
establishing the NIBIB, and Dr. Kirschstein announced that Dr. Dean
will become its Acting Director. Congress appropriated $40.2 million
of new money for NIBIB; a task force of IC Directors is still working
to identify existing programs that should be moved to NIBIB.
Dr. Kirschstein announced that she has appointed
Dr. Barry Kramer as Associate Director for Disease Prevention. He will
also retain his position as head of OMAR.
The OS has asked NIH for a list of any briefings
we want to give the Secretary between now and June 1. Dr. Kirschstein
asked IC Directors to send her any topics the Secretary needs to know
about.
Dr. Kirschstein reminded the group that next week's
IC Directors' meeting will be the third session of the intramural retreat,
and will be for principals only. The group will make decisions about
Building 10 and then discuss intramural priorities.
Dr. Olden announced that NIEHS is hosting the Student
National Medical Association (SNMA) health fair this weekend. One focus
of the fair will be health disparities. He thanked Drs. Maddox and Fauci
for participating.
A few years ago Dr. Baldwin was ready to announce
that NIH is proposing to retain patent rights for discoveries made at
foreign institutions. This Guide Announcement was drafted some time
ago, but has not yet been issued. The announcement would clarify that
NIH would retain the patent rights to discoveries made under NIH grants
awarded to foreign institutions but would grant back to the awardee
institution the right to use the patent in its own country. This policy
cannot be retroactive but can be effective immediately. No concerns
were voiced, but Dr. Baldwin is checking to confirm other agency policies.
Dr. Ehrenfeld noted that CSR is managing the bond
campaign this year. The kickoff is planned for mid-May.
Karen Pelham O'Steen
cc: OD Staff
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