Research Practitioner articles from May 2003

Research Practitioner archives from May 2003

From the editors.(Health Insurance Portability and Accountability Act of 1996)(Editorial)
May 1, 2003... HIPAA is here. The compliance date for the Health Information Portability and Accountability Act of 1996 came and went. After months of hand wringing and confusion, the Privacy Rule is a reality--or is it? In good American tradition,...

Conflict of interest guidelines for federal advisory groups. (In the news).
May 1, 2003... Conflict of interest guidelines for federal advisory groups A group of environmental and public health experts are urging the Office of Government Ethics (OGE) to establish uniform guidelines on financial conflicts of interest for federal...

Uncertain future for European clinical trial registry. (In the News).
May 1, 2003... European scientific organizations are calling for an international registry of clinical trials. The European Science Foundation (ESF), an umbrella organization representing 76 scientific bodies, warns that a recent European Commission...

Gene therapy research: the vexing vectors and enhanced federal oversight.
May 1, 2003... Gene therapy represents one of the most nascent and experimental approaches in the application of genetics to medicine. However, before its potential usefulness can be realized, certain technical problems common to all methods of gene...

Translational research: turning pure science into clinical strategies.
May 1, 2003... Broadly defined, translational research includes any research that is done with the aim of bringing laboratory findings to the clinic, and includes almost any biomedical research project. In April 2003, the Journal of the American Medical...

HIPAA--up close and personal. (Issues in Research Management).(Health Insurance Portability and Accountability Act of 1996)
May 1, 2003... April 14, 2003, the compliance deadline for the Privacy Rule provisions of the Health Insurance Portability and Accountability Act of 1996 (HIPAA) has come and gone, and the sky is still above our beads. Now what? This article discusses...

Regulatory: FDA proposes new rules to improve drug and biological safety reporting. (Current Considerations).
May 1, 2003... The Food and Drug Administration (FDA) announced in a March 14, 2003, Federal Register notice its intent to revise pre-and post-marketing safety reporting for human drug and biological products. The proposed rule, titled "Safety Reporting...

Office for Civil Rights clarifies issue on IRB review of HIPAA authorizations. (Regulatory Update).(Institutional Review Boards)(Health Insurance Portability and Accountability Act of 1996)
May 1, 2003... In an April 25, 2003, letter to the International Pharmaceutical Privacy Consortium, the Director of the federal Department of Health and Human Services' (HHS) Office for Civil Rights (OCR) clarified that under the Privacy Rule, which came...

FDA seeks consumer representatives for its advisory committees and panels. (Regulatory Update).(Brief Article)
May 1, 2003... FDA has numerous Advisory Committees (for drug and biologic products) and Advisory Panels (for medical devices) that need voting or non-voting consumer representatives. The committees and panels in need include: * Center for...

FDA drug/biologic consolidation completed. (Regulatory Update).(Brief Article)
May 1, 2003... The final phase of the FDA consolidation of certain biologic products into its Center for Drug Evaluation and Research (CDER) was completed in March 2003. The transfer of review and approval of the targeted biologic products will be...

FDA annual guidance agenda lists many research documents for update. (Regulatory Update).(Brief Article)
May 1, 2003... The April 4, 2003, Federal Register included FDA's annual guidance agenda, in which the agency lists the guidance documents it plans to issue or update in the coming year. Many clinical research documents are listed in that agenda. This...

Public comment on proposed research solicited. (Regulatory Update).(Alcohol, Sleep and Circadian Rhythms in Young Humans, Study 2--Effects of Evening Ingestion of Alcohol on Sleep, Circadian Phase, and Performance as a Function of Parental History of Alcohol Abuse/Dependence)
May 1, 2003... OHRP is soliciting public review and comment on a proposed research protocol titled, "Alcohol, Sleep and Circadian Rhythms in Young Humans, Study 2--Effects of Evening Ingestion of Alcohol on Sleep, Circadian Phase, and Performance as a...

FDA guidance on xenotransplantation addresses clinical research issues. (Regulatory Update).
May 1, 2003... FDA issued a final guidance in April 2003 on "Source Animal, Product, Preclinical and Clinical Issues Concerning the Use of Xenotransplantation Products in Humans." This document provides guidance on the production, testing, and...

FDA posts warning letter issued to Dr. Alkis Togias. (Regulatory Update).(Johns Hopkins Asthma and Allergy Center)(Brief Article)
May 1, 2003... The widely publicized June 2001, case involving the death of Ellen Roche, a healthy research volunteer participating in a study at the Johns Hopkins Asthma and Allergy Center, resulted in several inspections conducted by FDA and OHRP,...

Recent FDA IRB warning letter. (Regulatory Update).(Institutional Review Board, Huntsville Hospital, Alabama)
May 1, 2003... FDA issued an April 11, 2003, Warning Letter to Mr. L. Joe Austin, Chief Executive Officer of the Huntsville Hospital Institutional Review Board in Huntsville, Alabama. The Warning Letter included the following findings from an inspection...