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NEWS AND SPECIAL REPORTS |
Senior Director, Pharmacia Corporation, Washington, DC, USA marguerite.d.baxter{at}pharmacia.com
CLINICAL RESEARCH ENHANCEMENT ACT PASSES
One success of the 106th Congress is the enactment of the Clinical Research Enhancement Act. The legislation addresses a number of initiatives to strengthen clinical research and the preparation of the next generation of clinical scientists. Broadly the legislation authorizes the expansion of clinical research efforts at the National Institutes of Health (NIH). It authorizes increased financial and programmatic resources for clinical research and improvement of the peer review mechanisms for clinical research. The legislation also expands loan repayment options for clinical researchers. The four new enhancement awards created by the enactment of the legislation are highlighted below:
ASSOCIATION OF AMERICAN MEDICAL COLLEGES ESTABLISHES A TASK FORCE ON CLINICAL RESEARCH
The Association of American Medical Colleges (AAMC) has established a Task Force, composed of representatives from the Council of Deans, the Council of Teaching Hospitals and Health Systems and the Council of Academic Societies, to assess clinical research and identify methods for member organizations to strengthen initiatives in clinical research. The Task Force has been requested to provide a report within 12 months on the following issues:
FEDERAL POLICY ON RESEARCH MISCONDUCT
On December 6, 2000, the Office of Science and Technology Policy issued its final regulation in the Federal Register with regard to research misconduct. Federal agencies have one year to implement the new definition of research misconduct in their misconduct regulations. The procedural aspects of the policy are modeled after existing rules in the Public Health Service, and include aspects relative to inquiry, investigation and adjudication. The rule specifies that research misconduct "does not include honest error or differences of opinion" but does include fabrication, falsification or plagiarism. Fabrication is defined as making up data and recording or reporting them. Falsification is established as manipulating research materials or processes, or changing or omitting data in such a way that the research is not accurately represented. Plagiarism is the use of another person's words, results or ideas without providing the appropriate credit.
DEPARTMENT OF HEALTH AND HUMAN SERVICES ESTABLISHES ADVISORY COMMITTEE ON HUMAN RESEARCH PROTECTIONS
Even though the Clinton Administration is winding down, its commitment to increase the oversight and protection of human subjects in research is not diminished. On December 14, 2000 Secretary Shalala announced the establishment of the new National Human Research Protections Advisory Committee. The Committee, which will hold its first meeting on December 20, will serve as the DHHS's principal advisory group on issues relative to human subjects protection. Further, it is expected that the advisory committee will serve to reinforce the responsibility of research institutions to oversee clinical researchers and institutional review boards. The 12-person advisory panel of non-governmental representatives will be augmented by the designation of 17 ex-officio members from federal institutions.
NIH ESTABLISHES THE NIH GENE TRANSFER SAFETY ASSESSMENT BOARD AS PART OF THE NIH RECOMBINANT DNA ADVISORY COMMITTEE (RAC
The federal oversight of gene therapy research continues to evolve in follow-up to the study-related death of a young research participant over a year ago. During the week of December 9, the NIH published several proposed changes to the NIH guidelines for the oversight of gene therapy research. In a major step, the NIH guidelines will adopt the same standard and timeline for the reporting of serious adverse events occurring in human gene transfer research. In addition, the guideline establishes an assessment board to review and provide analysis of serious adverse events involving human gene transfer research. NIH will now require only the expedited reporting of serious adverse events that are unexpected or possibly caused by the gene therapy as opposed to reporting all serious adverse events as previously required. The discrepant reporting requirement between the NIH and the Food and Drug Administration (FDA) was one of the issues raised at Congressional hearings before the Senate Health, Education, Labor and Pensions (HELP) Committee last year during its investigation of federal oversight of gene therapy. This change in NIH policy brings into conformance NIH and FDA adverse event reporting requirements.
The NIH Gene Transfer Safety Assessment Board will be comprised of government and non-government experts and will include liaison representation from the FDA. The 15-member panel will meet quarterly. The function of the Assessment Board will include: "A) Reviewing serious adverse event reports, annual reports, and other relevant safety information and assessing toxicity and safety data across all gene transfer trials and analyzing the data for trends; B) identifying significant trends or single events; C) developing information that will enhance the development, design, and conduct of human gene transfer clinical trials, and D) reporting aggregated data to the RAC to enhance review of new protocols and to enhance public understanding and awareness of the safety of human gene transfer research studies...."
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