Research Practitioner articles from January 2003

Research Practitioner archives from January 2003

From the editors.(risk reduction)(Editorial)
January 1, 2003... The issues of risk and of risk reduction in clinical research are high-lighted in this issue of Research Practitioner. In his article on the placebo effect, Dr. O'Mathuna reviews aspects of the application of placebos in clinical studies and...

Cigarettes, nicotine, and the U.S. Food and Drug Administration.
January 1, 2003... The attitudes of scientists, government administrators, and Congress on the issue of tobacco regulation by the U.S. Food and Drug Administration (FDA) have changed dramatically since the first Surgeon General's report on smoking and health in...

New findings and old myths about the placebo effect.
January 1, 2003... Attempts to understand the mysteries of placebos and the placebo effect hove increased greatly in recent years. Some medical researchers view placebos as invaluable tools that allow them to learn about the efficacy of drugs and therapies,...

Accreditation comes of age: a status report from AAHRPP. (Issues In Human Subject Research).(Association for the Accreditation of Human Research Protection Programs)
January 1, 2003... The Association for the Accreditation of Human Research Protection Programs (AAHRPP) operates on the premise that voluntary accreditation of organizations within the research community, along with oversight by an accrediting body, is one of...

Protecting research volunteers: NCQA's human research protection accreditation programs: National Committee for Quality Assurance. (Issues In Human Subject Research).
January 1, 2003... Although assumption of certain risks certainly is part of human clinical research, minimizing those risks is desirable. The volume and complexity of research conducted today are beyond the scope of what the current Institutional Review...

JCAHO, NCQA form partnership to review quality of human research protection programs. (In the News).(Joint Commission on Accreditation of Healthcare Organizations)(National Committee for Quality Assurance)
January 1, 2003... The Joint Commission on Accreditation of Healthcare Organizations (JCAHO) and the National Committee for Quality Assurance (NCQA) have joined forces to create a new voluntary accreditation mechanism for human research protection programs. The...

11 named to new Secretary's Advisory Committee on Human Research Protection. (In the News).
January 1, 2003... Health and Human Services (HHS) Secretary Tommy G. Thompson named 11 experts on January 3 to serve on the Secretary's Advisory Committee on Human Research Protection (SACHRP), which will be chaired by Ernest Prentice, associate dean for...

FDA action against former AHA president. (In the News).(David Faxon, American Heart Association)
January 1, 2003... In December, the British Medical Journal (BMJ) reported that Dr. David Faxon, former American Heart Association (AHA) president, had signed a consent agreement with the Food and Drug Administration (FDA) limiting his clinical research. The...

HHS' regulatory agenda for 2003. (Regulatory Update).(Department of Heath and Human Services)
January 1, 2003... The Regulatory Flexibility Act of 1980 and Executive Order 12866 require federal agencies to publish a semiannual inventory of all rulemakings (advance notice of proposed rulemaking [ANPR], a notice of proposed rulemaking [NPRM], or a final...

New Privacy Board established to address HIPAA `waiver of consent'. (Regulatory Update).(Health Insurance Portability and Accountability Act of 1996)(Brief Article)
January 1, 2003... Wellesley, MA--January 6, 2003--New England Institutional Review Board (NEIRB), a subsidiary of Thomson Health Care, announces the formation of The Privacy Board to review requests for use of private health information under HIPAA Privacy...

User fees strike medical devices. (Regulatory Update).
January 1, 2003... For many years, the medical device industry strongly resisted the implementation of a user fee system on its products by FDA. Such a system would be analogous to that implemented by FDA on the pharmaceutical industry via the Prescription Drug...

FDA establishes Office of Combination Products. (Regulatory Update).
January 1, 2003... The FDA established a new office to manage the processing of complex drug-device, drug-biologic, and device-biologic combination products that are becoming more frequent in health care. The new Office of Combination Products (OCP) will be...

FDA approved Prozac for pediatric use to treat depression and OCD. (Regulatory Update).(obsessive compulsive disorder)(Brief Article)
January 1, 2003... The FDA has approved new uses for the antidepressant Prozac (fluoxetine) to treat children and adolescents ages 7 to 17 for depression (major depressive disorder) and obsessive compulsive disorder (OCD). This is the first approval of one of...

Conference on institutional biosafety committees. (Regulatory Update).
January 1, 2003... A February 20-22, 2003, conference in Institutional Biosafety Committees (IBC) is being co-sponsored by the NIH Office of Biotechnology Activities (OBA), the NIH Office of Laboratory Animal Welfare, the American Biological Safety Association,...

FDA warning letters. (Regulatory Update).(proper management of research documentation and reports)
January 1, 2003... Two recent FDA warning letters are summarized in this issue. These letters are intended to help readers understand the nature of FDA violations, so that strategies to prevent such violations at their own institutions can be developed. The...