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August 9, 2006


To: IC Directors
From: Director, Executive Secretariat
Subject: IC Directors' Meeting Highlights — July 27, 2006

Discussion Items

I. Follow-up — Title 42 Policy

Dr. Tabak provided an overview of the chronology of the development of the extramural/OD Title 42 model. This model provides a workable methodology for categorizing the majority of non-intramural positions. There are six categories of positions that fit into the Title 42 model:

  • Scientific executives — Title 42 (f)
  • Science policy leader or science programs leader — Title 5 or Title 42 (f)
  • Science policy analyst or science program analyst — Title 5
  • Health science program or review officers — Title 5
  • Senior scientific officer — Title 42 (f)
  • Program coordinators and specialists — Title 5

He went on to describe each one of these categories in detail.

Both the OER and an established Extramural/OD Title 42 (f) Committee (EFTC) will have oversight responsibilities. Recommended membership to the EFTC, to be approved by the SC, includes:

  • Deputy Director, NIH – Chair
  • Deputy Director of Extramural Research – Co-Vice Chair
  • 2 IC Directors – One as Co-Vice Chair
  • 2 Extramural Program Directors
  • 2 Deputy Directors
  • OD Policy/Program Representative

There is a proposed plan for moving current T 42 employees to this new model.

Dr. Tabak further explained the HHS “exhaustion” requirement noting that other mechanisms must be exhausted before Title 42 is used. Both categorical exceptions and individual exceptions must be approved. The current exceptions are “top 5,” senior investigators, and “direct report” scientific program heads. The EFTC must agree that exhaustion requirements have been met before Title 42 search is initiated and Title 42 can be used only for positions identified in the Model as appropriately filled under Title 42. Dr. Tabak concluded by reviewing the requirements for Title 42 positions for non-citizen doctoral scientists.

II. NIH Patient Travel Policy

Dr. Gallin began by explaining the need to establish a fair policy for the reimbursement of patient travel. He shared the guiding principle that NIH will make every effort to assure fairness in reimbursing clinical research protocol participants for travel and subsistence. This will include taking into account the scientific needs of the studies and the financial and/or medical needs of the individual participants.

The proposed policy states that the reimbursement for each protocol:

  • Establishes its own protocol-specific reimbursement rate that will be approved by the IRB.
  • Inludes travel, meals, and lodging.
  • Ranges from zero to the government rate.
  • Based on objective factors that include the practices for similar NIH protocols, the rarity of the disease, and the benefits/burdens placed on the subject/family.

Participants will be informed of the protocol reimbursement rate during enrollment and a social worker will assess whether any supplemental reimbursement is needed for valid financial/medical reasons.

The reviewing bodies that were consulted in developing this new policy included the NIH Steering Committee, the NIH Medical Executive Committee (MEC), the Intramural Working Group (IWG), and the CC Bioethics Department.

Stakeholder feedback was integrated into the final policy. The target date for the implementation of this new policy is October 1, 2006. Dr. Gallin concluded by sharing implementation strategies that include:

  • A review of new protocols and an annual review of existing protocols.
  • IC costs will be monitored and tracked and will include a 6 month evaluation.
  • Quarterly report to ICs and the IWG.
  • IWG/MEC annually review/approve implementation procedures at all intramural sites.
  • Clinical Center to maintain database of reimbursement levels for comparative purposes.

The IC Directors recommended approval of this policy.

III. Other Informational Items

Dr. Hodes reported on the Trans-NIH Roadmap/OPASI Consultation meetings noting benefits that included support for the Roadmap process. He commended the work of the chairs for providing a forum for advocacy. Follow up sessions will identify topics, subject to vote, and the meeting outcomes will be compiled in a summary report and presented at the September retreat.

Dr. Zerhouni also reflected on the benefits of the process for consulting independent samples versus a two-day meeting of the full scientific community. He noted several themes that have emerged that represent continuing needs:

  • A call for more data density including tools leading to increased understanding at the molecular level and for disease-specific entities: animal models, RNA coding, single cell molecular analysis, and proteins in modification states.
  • Less centralization and a need to innovate both in training and peer review. The message to grantees is that “the roadmap is a sandbox for experiments.”
  • Issues related to translational research, including considerations of training programs and dissemination.


IV. OIG/NIH Interactions: Mr. Levinson, Inspector General

Mr. Levinson provided historical background and an overview of the mission, jurisdiction, and scope of responsibilities of the HHS Office of the Inspector General. The powers of the Inspector General were authorized by Congress in 1978 in response to the Watergate scandal, contract scandals, and concerns about Medicare fraud issues.

Its functions include both audit and criminal investigations, however, OIG powers are limited since enforcement decisions rest with Agency leadership and are shared with the Department of Justice. Within HHS, there are 800 auditors and accountants, 400 criminal investigators, and 125 analysts in the Office of Evaluations and Assessment. They respond to:

  • Vulnerabilities in Programs.
  • GAO requests.
  • Issues of fraud, waste, and abuse (Medicare and Medicaid fraud issues dominate these resources).

An annual Work Plan identifies potential areas of vulnerability. Mr. Levinson noted the key message is that a constructive and effective partnership with the OIG provides Agencies with the ability to self correct. By maintaining a strong reputation, external scrutiny is avoided.

Questions from the audience addressed the clarification and interpretation of rules and the implications for Federal agencies of the Sarbanes Oxley Act. Mr. Levinson noted that the “sentinel effect” of the act was to motivate internal accounting control.

Ann Brewer
cc: OD Senior Staff

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