Freedom of Information Act Office
IC Directors' Meeting Highlights
March 27, 2003
|From:||Director, Executive Secretariat|
|Subject:||IC Directors Meeting Highlights—March 20, 2003|
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.
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
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.
cc: OD Staff