March 27, 2003
To: |
IC Directors |
From: |
Acting Director, Executive
Secretariat |
Subject: |
IC Directors' Meeting Highlights
March 20, 2003 |
Decision Items
I. Human Subjects Enhancement Protection Program (HSEPP)
Dr. Tabak began the discussion by thanking the members of the HSEPP
committee, which was charged in February 2002 to propose options for
NIH programs and activities to address the long-term challenges associated
with improving human subjects protection in NIH-supported research.
After reviewing these challenges and noting that the committee had studied
the literature on this issue and conducted interviews with stakeholders,
Dr. Tabak presented the pros and cons that the committee had delineated
related to the three following options:
supporting studies that would provide data required to reach
informed decisions about human subjects protection in the future
creating a direct cost model in which applicants would include
the cost of an IRB review, using predetermined levels set by NIH
extending the HSEPP program for one more year
After the group's discussion, Dr. Zerhouni noted that the NSTC Committee
on Science (COS) is committed to reviewing the entire business model
but that this will be a long-term process. Stressing that human subjects
protection enhancement is an urgent issue, he summarized the group's
comments and directed that NIH should embark on studies to gather relevant
data and then develop a limited policy statement involving a direct
cost model addressing this specific patient-related area. NIH's activities
here could then feed back into the COS review. Option three, extending
the HSEPP program, was not approved. Dr. Zerhouni asked that Drs. Skirboll,
Seto, and Tabak lead the effort involving options 1 and 2.
Discussion Items
Il. Health Insurance Portability and Accountability Act (HIPAA)
Privacy Rule Update
Noting that April 14, 2003, is the main date for compliance with the
HIPAA Privacy Rule that was published August 14, 2002, Dr. Skirboll
stressed that NIH is working closely with the Office of the General
Counsel and the Office for Civil Rights in the preparation of clear,
cogent explanatory materials that will be available to guide NIH staff
and researchers in this area. She stressed that this NIH effort is educationalit
is not related to enforcement, which rests with the Office for Civil
Rights (for civil rights issues) and the Department of Justice (for
criminal issues).
Dr. Skirboll introduced Lora Kutkat of her staff, who spearheads the
NIH efforts.
Ms. Kutkat presented a summary of the Privacy Rule and ways that its
implementation may affect research and NIH activities, clarifying that
the Privacy Rule applies to
covered entity (including a health care provider who transmits
health information electronically for certain covered transactions).
protected health information (most identifiable health information
held by a covered entity).
Dr. Skirboll assured the group that NIH is working with HHS agencies
in formulating clear, standard language that NIH can pass on to its
grantees and that this effort is ongoing and materials will continue
to be prepared including fact sheets, FAQs, and legal interpretations.
Many questions that are frequently asked will be addressed by these
educational materials. She noted that OSP staff would be pleased to
do presentations at IC Council meetings and that the following Web sites
offer excellent resources: http://www.hhs.gov/ocr
and http://privacyruleandresearch.nih.gov.
Dr. Zerhouni praised the NIH educational effort and contribution to
the HHS-wide effort, noting that staff have done an excellent job of
distilling the essence of the Privacy Rule and its several hundred pages
of preamble and guidance. He requested that the resources also include
specific examples of real life scenarios that will guide researchers
in their everyday experiences.
III. Appropriations
Dr. Zerhouni announced that he had hoped that Senate Appropriations
Subcommittee staff members would be present to discuss the appropriations
process, but that Senate activities had intervened and they would be
unable to attend. The group then discussed the upcoming appropriations
hearings and how best to communicate the NIH message to the Congress.
IV. Information Items
Dr. Zerhouni encouraged attendees to bring issues and problems that
they feel should be addressed at future meetings to the attention of
the NIH Agenda-Setting Committee, which welcomes such input.
Dale Johnson
cc: OD Staff
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