Research Practitioner articles from November 2002

Research Practitioner archives from November 2002

From the editors.(human medical experimentation)(Editorial)
November 1, 2002... The ethics of human experimentation once again are the focus of intense scrutiny. The participation of children in clinical research studies and the use of people in biological and chemical weapons research are 2 lively topics of...

Judge strikes down pediatric rule. (In the News).
November 1, 2002... Last month, a federal judge struck down the Food and Drug Administration's (FDA) Pediatric Rule, which required drug companies to test new products in children so that adequate information about safety and dosage in children could be included...

OHRP director resigns, plans to return to Harvard. (In the News).(Greg Koski, Office for Human Research Protections)
November 1, 2002... Greg Koski, MD, PhD, the first director of the Office for Human Research Protections (OHRP), has resigned after 2 years of service. In a letter to Department of Health and Human Services Secretary Tommy Thompson, Koski stated that he would...

Stem cell research and cloning: the state of the science.
November 1, 2002... Although stem cell research has the potential to cure human diseases, the field is young and is filled with ethical questions. On the one hand, stem cell research has extraordinarily high potential, but on the other hand, it involves...

A HIPAA primer for research practitioners.(Health Insurance Portability and Accountability Act of 1996)
November 1, 2002... Today, a number of factors compromise the confidentiality of health information. In order to address the erosion of privacy, Congress included a section in the Health Insurance Portability and Accountability Act of 1996 (HIPAA) authorizing...

Continuing education.
November 1, 2002... Instructions Continuing Nursing Education 1. Read the articles: Stem cell research and cloning: The state of the science and A HIPAA primer for research practitioners. 2. Using the enclosed Scantron sheet, complete according to...

Bridging the clinical trial recruitment leap. (Issues In Clinical Trials Management).
November 1, 2002... Difficulty recruiting subjects into clinical trials of investigational drugs is a long-standing challenge that has slowed the drug development process. Pharmaceutical sponsors seek innovation in the trial recruitment process so that clinical...

OHRP/FDA collaborate on smallpox vaccine clinical trials in children. (Regulatory Update).(Office for Human Research Protections)
November 1, 2002... The Office for Human Research Protections (OHRP) and the Food and Drug Administration (FDA) are soliciting public review and comment on a proposed research protocol submitted by Harbor-UCLA Medical Center titled, "A Multicenter, Randomized...

FDA issues guidance development plans. (Regulatory Update).(Brief Article)
November 1, 2002... FDA's Center for Drug Evaluation and Research (CDER) has issued its annual list of planned guidance documents to be developed in fiscal year 2003. As a refresher on the purpose of guidance documents, recall that regulations often can be quite...

Waiver of certain human subject protections for research on prisoners. (Regulatory Update).
November 1, 2002... The Department of Health and Human Services (HHS) has proposed waiving the applicability of certain human subject protections [see 45 CFR 46.305(a)(1) and 46.306(a)(2)] for certain research conducted or supported by HHS. These are...

A rose by any other name? (Regulatory Update).(Secretary's Advisory Committee on Genetics, Health, and Society)(Brief Article)
November 1, 2002... HHS recently abolished the Secretary's Advisory Committee on Genetic Testing. It then announced in the October 23, 2002, Federal Register, the establishment of the Secretary's Advisory Committee on Genetics, Health, and Society. The function...

FDA warning letters. (Regulatory Update).(compliance requirements in clinical research)
November 1, 2002... Several recent FDA warning letters continue to point out failures of compliance in the conduct of clinical research and also a pattern of failing either to have appropriate standard operating procedures or to comply with one's own procedures....