IC Directors' Meeting Highlights

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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