Healthy Skepticism Library item: 2448

Warning: This library includes all items relevant to health product marketing that we are aware of regardless of quality. Often we do not agree with all or part of the contents.

Publication type: Journal Article

Isidor JM, Kaltman SP.
Fast track to disaster? Considerations raised by the current recruitment techniques for clinical research subjects
J Biolaw Bus 2002; 5:(3):46-7
http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=pubmed&dopt=Abstract&list_uids=12816118

Abstract:

Efforts to obtain Food and Drug Administration (FDA) approval of new drugs on a “fast track” are not without hazards for physicians and other providers involved in conducting clinical research. Increasingly, research sponsors have implemented competitive subject recruitment techniques that encourage investigators and their staffs to move studies along rapidly, but may also raise concerns about subject safety. The purpose of this article is to examine competitive recruitment practices and to examine the ethical and legal issues related to obtaining information consent for clinical research within this current framework.

Keywords:
Clinical Trials*/ethics Coercion Competitive Behavior Drug Industry Human Experimentation*/ethics Humans Informed Consent/ethics Liability, Legal Research Personnel/legislation & jurisprudence Research Subjects/supply & distribution* Research Support/economics United States analysis United States FDA Food and Drug Administration clinical trials drug company sponsored research relationship between researchers, academic institutions and industry conflict-of-interest safety of participants informed consent ETHICAL ISSUES IN PROMOTION: ETHICS OF TRIALS REGULATIONS, CODES, GUIDELINES: DIRECT GOVERNMENT REGULATION SPONSORSHIP: RESEARCH