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Freedom of Information Act Office

IC Directors' Meeting Highlights

June 2, 2003

To: IC Directors
From: Director, Executive Secretariat
Subject: IC Directors Meeting Highlights—May 15, 2003

Decision Item

I. Update on Human Subjects Research Enhancement Program (HSREP)

Dr. Tabak, representing the working group (WG) in this area, summarized the decisions made at the March 20, 2003, IC Director's Meeting on the issue as follows:

  • to support studies to provide data to reach informed decisions about costs associated with Human Subjects Protection (HSP);
  • to create a direct cost model, using predetermined levels set by NIH, in which applicants would include the cost of an Institutional Review Board (IRB) review; and
  • to not extend the Human Subjects Research Enhancement Program.

Subsequently, it became clear to the WG that developing a direct cost model presented several challenges. Specifically, OMB circular 21 precludes an item's being allocated to a direct cost pool that has also been allocated to an indirect cost pool. Thus, an institution that includes the costs of IRBs in its facilities and administration (F&A) rate would have to participate in a lengthy process to re-negotiate the F&A rate to exclude IRB costs if it wished to use a direct cost method. This would apply even if the institution is over the 26-percent administrative cap. Also, because circular 21 requires institutions to treat all Federal protocols consistently, other Federal agencies would need to be informed if NIH pursues a direct cost modeling plan.

Because of this situation, the WG now recommends that NIH extend the HSREP for one final year and encourage participating institutions to partner with smaller institutions. During this time, the WG will work to develop mid-term and long-term plans to guide institutions in addressing the burden of IRB costs.

After discussion Dr. Zerhouni characterized the consensus as follows:

  • to continue for one final year the HSREP program and encourage partnering with smaller institutions;
  • to state a clear NIH policy in accordance with circular 21 that no costs associated with the review of human research protocols by an IRB may be charged as direct costs for NIH- funded research involving human participants, unless such costs are not included in the institution's F&A rate; and
  • to continue to explore alternative mid- and long-term solutions on how institutions effectively address increased compliance costs associated with human subjects protection.

Dr. Tabak said he would broaden the membership of the working group and added that the WG will inform staff of other HHS agencies.

Discussion Items

II. IC Directors' Reviews

Dr. Kington summarized the process for reviewing IC Directors every five years. These reviews will resume this summer.

III. Other Information Items

Dr. Kington reminded everyone to encourage employees to complete the HHS employee survey that was recently distributed.

He then updated the group on the activities of the Administrative Resources Advisory Committee (ARAC), which he chairs. He announced that the eight working groups (human resources, information technology, budget, finance, grants, EEO, facilities, and acquisitions) are drafting recommendations regarding how these activities can be more efficiently organized at NIH, including a first assessment of performance bench marks. Both he and Dr. Zerhouni stressed that this ARAC effort is an opportunity to ensure that we seek changes where they will improve how we do business while maintaining our high standards in meeting the scientific objectives of NIH.

[Tom Gill for ]
Dale Johnson
cc: OD Staff

This page last reviewed on July 20, 2011

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