Freedom of Information Act Office
IC Directors' Meeting Highlights
June 19, 2006
|From:||Director, Executive Secretariat|
|Subject:||IC Directors Meeting Highlights—May 25, 2006|
I. Human Subjects (HS) Research and Peer Review Outcomes at CSR
Dr. Martin presented an analysis and discussion of CSR peer review outcomes for R01 HS research. For the purposes of this analysis, HS research applications designated Exemption 4 were considered non HS. He then proposed and discussed three issues affecting data on peer review outcomes:
- the impact of human subject concerns;
- the impact of HS versus non-HS applications, new applicants versus established PIs, and revisions; and
- the impact of the rate of Type 2 submissions and other activities.
After presenting CSR data and observations based on the CSR data, Dr. Martin concluded that nearly all the differences in peer review outcomes for HS versus non-HS applications at CSR can be accounted for by —
- poor outcomes on applications with human subject concerns (code 40s and 50s) and
- different submission rates for the different subgroups (new versus established PIs and initial versus revised submissions).
Dr. Martin listed several questions that remain unanswered:
- Why are funded HS applicants more likely to stop applying for NIH-funded research after the initial RO1 award than funded non-HS applicants?
- Are they dropping out of research or just out of NIH-funded research?
- And finally, to what extent does the difference in submission rates affect the reported difference in peer review outcomes?
Dr. Martin pointed out that the following issues remain:
- How can we get the message out about CSR peer review outcomes for HS applicants?
- What can the NIH do to improve applicants’ responses to HS requirements?
- Why are Type 2 HS submission rates so low?
- Why are funded new HS PIs not applying for grants at the same rate as funded non-HS PIs?
- What is the impact on the human subject research enterprise at the NIH and what can we do about it?
He thanked Mr. Dumas, Ms. Lindquist, and Dr. Kotchen, of CSR, and OER staff for their efforts towards this presentation.
In the ensuing discussion, the point was raised that we need to consider HS applications that are reviewed by ICs as well in order to round out the global NIH picture on this issue. Dr. Zerhouni concluded by noting that the CSR information presented was an excellent way to corner the issues regarding RO1 HS applications.
II. Transformation of the Commissioned Corps (Corps)—Part 2
Dr. Wyatt updated the group on the Corps transformation activities that have taken place since ADM John O. Agwunobi, ASH, visited on April 13, 2006. These include the NIH request for all ICs to designate their mission critical officers and the Office Force Readiness and Development request for Corps officers to select from the following response teams for deployment:
- Tier 1 — Rapid Deployment Force (RDF) teams available to deploy in 12 hours.
- Tier 2 — Applied Public Health Teams (APHTs) and Mental Health Teams (MHTs), available to deploy in 36 hours.
- Tier 3 — all other officers, available to deploy in 72 hours.
On May 5, 2006, the Secretary sent a memorandum to the Heads of Operating and Staff Divisions announcing this tiered response system and directing that all active duty officers except those designated as mission critical should indicate their availability for one of these tiers. The Secretary announced that civilian personnel are requested to respond as well and asked for the support of the Agency Heads and Division supervisors in identifying and releasing responders. Dr. Wyatt noted that 22.8 percent of NIH Officers have signed up for Tier 1 and Tier 2 teams and 26 percent have been designated mission critical. Sixty-six percent are basic ready.
Dr. Wyatt summarized the Secretary’s expectation for the Corps transformation as articulated by the ASH at his previous visit:
- Growth of the Corps to 10 percent over its present size.
- All officers must meet basic readiness requirements and be considered deployable.
- Creation of 4 functional groups: clinical, applied public health, mental health, and research — in addition to professional categories to improve meeting public health and readiness needs.
- One third of the officers in these groups (except research) should be ready at any given time to respond to a crisis like Hurricane Katrina.
- Increasing use of the Corps to fill isolated, hardship, and hard to fill positions.
- DHHS Agency clinical positions would be fillable by Corps officers only.
- Two contiguous weeks of basic officer training for all new officers within 6 months of being called to active duty.
- Officers in research — including those designated as mission critical — would be deployed for only the most serious threats.
He then summarized the observations and recommendations the group made to the ASH at the April 13 meeting, including the concern that requiring Corps only clinical positions would negatively affect NIH operations.
Dr. Wyatt recognized and thanked the NIH Officers who are working on the Transformation Working Groups, mentioned that Dr. Zerhouni will be meeting with the Secretary on transformation issues, and noted that the ASH will return to present to the group on June 8.
The group again discussed the Corps transformation and how it will affect the NIH in its unique status as a research-oriented institution, pointing out the impact of the proposed changes on Clinical Center operations as well as IC operations and budget. Dr. Zerhouni advised the group that the NIH needs to be ready to recruit when the call comes for an increase in Corps members and urged that Directors review any remaining requests of officers to be on the three deployable teams.
cc: OD Senior Staff