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.
Presentation
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
This page was last reviewed on
March 3, 2010
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