Research Practitioner articles from July 2004

Research Practitioner archives from July 2004

From the editors.(scientific community-ethical aspects)(Editorial)
July 1, 2004... In this issue of Research Practitioner, Parascandola and O'Mathuna provide 2 very different perspectives on the relative roles of science, politics, and religion in discussing public policy issues raised or potentially solved by science and...

A U.S. clinical trials registry?(In the News)
July 1, 2004... Renewed efforts are in the works to bring to fruition a longtime goal of many clinical researchers--establishment of a U.S. registry for clinical trials. Proponents of registries have argued that some trials are never published because they...

"Human Dosing Studies" and the EPA.(In the News)
July 1, 2004... Earlier this year, the Institute of Medicine (IOM) released a new report urging the Environmental Protection Agency (EPA) to impose "stringent" scientific and ethical standards on studies of toxic chemicals that use human subjects. The...

Politics and science.
July 1, 2004... Concerns about the influence of politics on science have existed for many years. Over the past 50 years, national leaders and policy makers hove become increasingly dependent upon scientific experts to inform decision-making and resolve...

Beyond Therapy: the report of the President's Council on Bioethics.
July 1, 2004... In October 2003, The President's Council on Bioethics published Beyond Therapy: Biotechnology and the Pursuit of Happiness. The report is not the typical scientifically technical or policy-oriented report. It does not summarize the scientific...

Continuing education.(examination-questions and mailing addresses)
July 1, 2004... Instructions Continuing Nursing Education 1. Read the articles: Politics and science and Beyond Therapy: The report of the President's Council on Bioethics. 2. Using the enclosed Scantron sheet, complete according to directions....

Common problems with informed consent in clinical trials.(Issues In Research Management)
July 1, 2004... Informed consent plays a critical role in the protection of human subjects in clinical trials. Despite the increased attention focused on human protection issues, problems with informed consent frequently are encountered. This paper examines...

Emotion and logic in the informed consent process.(Issues In Research Management)
July 1, 2004... The ability of prospective subjects to make informed choices regarding clinical trial participation depends on their decision-making and risk analysis skills. Although informed consent requires a rational choice, recent psychological research...

FDA cancels meeting on 21 CFR Part 11 concerns.(Regulatory Update)(Food and Drug Administration not to reschedule it's conference)(Brief Article)
July 1, 2004... Due to the death of former President Ronald Reagan, the federal government was closed on the date scheduled for the public meeting to discuss various topics concerning FDA's regulations on electronic records and electronic signatures in 21...

FDA guidance on handling and retention of BA and BE testing samples.(Regulatory Update)(Food and Drug Administration)(bioequivalence studies to follow new rules)(Brief Article)
July 1, 2004... In the May 26, 2004, Federal Register, the Food and Drug Administration (FDA) announced the availability of a guidance for industry titled Handling and Retention of BA and BE Testing Samples. The guidance provides recommendations for study...

FDA guidance documents for industry on medical imaging drug and biological products.(Regulatory Update)(Food and Drug Administration)(Brief Article)
July 1, 2004... In the May 5, 2004, Federal Register, FDA announced the availability of 3 guidance documents for industry on Developing Medical Imaging Drug and Biological Products. These documents are intended to assist developers of medical imaging drug...

FDA seeks comments on possible barriers to the availability of medical devices intended to treat or diagnose diseases and conditions that affect children.(Regulatory Update)(Food and Drug Administration)
July 1, 2004... In the June 21, 2004, Federal Register, FDA's Center for Devices and Radiological Health (CDRH) issued a request for comments concerning the possible barriers to the availability of medical devices intended to treat or diagnose diseases and...

FDA issues final guidance on the premarket assessment of pediatric medical devices.(Regulatory Update)
July 1, 2004... In the May 14, 2004, Federal Register, FDA announced the availability of the guidance titled Premarket Assessment of Pediatric Medical Devices. This guidance presents FDA's current thinking on the type of safety and effectiveness information...

FDA issues draft guidance documents on premarketing risk assessment, development and use of risk minimization action plans, and good pharmacovigilance practices and pharmacoepidemiologic assessment.(Regulatory Update)(Food and Drug Administration)
July 1, 2004... In the May 5, 2004, Federal Register, FDA announced the availability of 3 draft guidance documents titled Premarketing Risk Assessment, Development, and Use of Risk Minimization Action Plans, and Good Pharmacovigilance Practices and...

FDA issues proposed rule on human subject protection for foreign clinical studies not conducted under an investigational new drug application.(Regulatory Update)
July 1, 2004... In the June 10, 2004, Federal Register, FDA issued a Proposed Rule in which it proposes to revise its regulations on its acceptance of foreign clinical studies not conducted under an investigational new drug application (IND) as support for...

FDA posts Q&A guidance on ICH E5; Ethnic Factors in the Acceptability of Foreign Clinical Data.(Regulatory Update)(International Conference on Harmonization )(Brief Article)
July 1, 2004... This ICH guidance was endorsed by ICH in February 1998 and issued as a guidance document by FDA in June 1998. The guidance is intended to facilitate the registration of drugs and biologics among ICH regions by recommending a framework for...

HHS guidance released on financial relationships and interests in research involving human subjects.(Regulatory Update)(Health and Human Services)
July 1, 2004... In the May 12, 2004, Federal Register, the Department of Health and Human Services (HHS) announced a final guidance document for Institutional Review Boards (IRB), investigators, research institutions, and other interested parties, titled...

NIH issues guidance on informed consent for gene transfer research.(Regulatory Update)(National Institutes of Health)(Brief Article)
July 1, 2004... The National Institutes of Health's Office of Biotechnology Activities (OBA) has issued guidance on how to develop an informed consent document in language that will be understandable to potential gene transfer research participants and their...