FOOTNOTES
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Public Affairs Update

  • National Academies may study process of appointing government science & technology advisors . . . . The National Academy of Sciences’ (NAS) Committee on Science, Engineering and Public Policy (COSEPUP) met in February with other groups, including former White House science advisors and public health representatives, to discuss a perceived need by some in the science community to collect data on the process by which appointments are made to federal government science advisory panels. The suggestion that COSEPUP investigate this topic has emerged in a Washington abuzz with allegations that the Bush administration is unduly biasing advisory panels through a politically tainted selection process. (See February 2003 Footnotes page 3, "Bush administration appoints human subjects research advisory panel members".) Many in the scientific community have been concerned in recent months over the composition of a number of committees, including the Health and Human Services Secretary’s Advisory Committee on Human Research Protections (SACHRP). But systematic data on the process by which scientists and others are selected to advise the executive branch will be a key ingredient to the Academies’ effective formulation of guidelines on how best to ensure qualified, balanced advice, according to some COSEPUP members. If COSEPUP takes on the project, it could analyze the “federal government’s capacity to select highly qualified individuals for the top S&T-related advisory committees in the executive branch,” according to a draft charge. A review of legislation governing the provision of advice to the government, the Federal Advisory Committee Act of 1972 (FACA), might be included in its mission in order to examine whether FACA and related policies are “adequate to safeguard the independence of, and maintain an appropriate balance in, scientific and technical federal advisory committees.” It was suggested that the primary task of such a committee should be to address the question, “What are the risks of poor advice or advice that is colored by ideology?” COSEPUP mainly conducts studies on cross-cutting issues in S&T policy and was chartered by the Academies to serve the President’s Science Advisor, the Director of the National Science Foundation, the Chair of the National Science Board, and heads of other federal research and development departments and agencies, as well as chairs of relevant congressional committees. It also monitors developments in U.S. science and technology policy for the Academies.

  • Human subjects legislation . . . . Last spring, U.S. House of Representatives members Diana DeGette (D-CO) and James Greenwood (R-PA) introduced a bi-partisan bill (HR 4697) to address concerns about human subjects in medical experiments. Among other objectives, the bill, The Human Subjects Protection Act of 2002, would have extended Common Rule protections beyond the domain of federally funded research, set guidelines for and authorize resources for IRBs, and address informed consent. It also would provide new authority for the Department of Health and Human Services (HHS) and specifically to its Office of Human Research Protections (OHRP). The idea was to give OHRP the means to help prevent accidental deaths and injury such as occurred in medical experiments in recent years. The bill did not progress beyond committee last year but DeGette announced in February at the annual meeting of the American Association for the Advancement of Science that she would re-introduce the legislation. Of concern to some in the behavioral and social science communities is that the bill treats all human subjects similarly—regardless of level of risk—thus overburdening certain types of research. In its draft, the bill requires written consent of all human subjects, a complication for studies involving children and others unable to legally consent to participate in research. Social science organizations are monitoring this proposed legislation, ready to respond.

  • Medical/health researchers scramble to understand impact of federal government standards for electronic health information under HIPAA . . . . Health and Human Services Department (HHS) Secretary Tommy Thompson announced in February final security standards (i.e., the Privacy Rule) for protecting individually identifiable health information that is maintained or transmitted electronically (see www.hhs.gov/ocr/). He also announced modifications to a number of the electronic transactions and code sets adopted as national standards. Both final regulations are required as part of the administrative simplification provisions included in the Health Insurance Portability and Accountability Act of 1996 (HIPAA). According to Thompson, the “national standards required under HIPAA will make it easier and less costly for the health care industry to process health claims and handle other transactions while assuring patients that their information will remain secure and confidential.” Health insurers and certain health care providers and clearinghouses must establish procedures to protect the confidentiality, integrity, and availability of electronic health information by April 14. Researchers and IRBs now are scrambling to determine their roles relative to the Privacy Rule, and federal health research agencies are struggling to provide clear and timely guidance (e.g., see information provided by the National Institutes of Health (NIH) at www1.od.nih.gov/osp/ospp/hipaa/), but there is much to resolve. Related to this, NIH issued a statement affirming support for data sharing and stating that data sharing is “essential for expedited translation of research…to improve human health….” Starting with the October 1, 2003, receipt date, investigators submitting an NIH grant application seeking $500,000 or more in direct costs in any single year must include a data sharing plan or state why sharing is not possible. NIH encourages applicants to discuss their plan with their NIH program contact (see grants.nih.gov/grants/guide/notice-files/NOT-OD-02-004.html). The HHS security standards were published as a final rule in the February 20 Federal Register with an effective date of April 21, 2003. Most covered entities will have two years (until April 21, 2005) to comply. The Centers for Medicare and Medicaid Services (CMS) implements and enforces the security standards, transactions standards, and other HIPAA administrative simplification provisions, except for privacy standards, for which the HHS Office for Civil Rights has enforcement responsibility. NIH is not an enforcing agency. The complete text of both final rules is available at the CMS website (www.cms.hhs.gov/hipaa/hipaa2). See a summarizing fact sheet on HIPAA at www.hhs.gov/news/press/2002pres/hipaa.html.