Healthy Skepticism Library item: 3473
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
Weiss GB, Winslade WJ.
Is post-marketing drug follow-up research or advertising?
IRB 1987 Jul-Aug; 9:(4):10-1
Abstract:
The authors raise a number of questions about postmarketing studies sponsored by drug companies: 1) Do drug monitoring studies involving nonacademically affiliated physicians require IRB approval? 2) What sort of consent from patients is necessary for this form of study-none, oral or written? 3) Should the patient be informed that monetary benefit flows to the physician from the drug company for conducting the study? 4) What are the legal consequences of physician participatioin in these studies in the event of adverse reactions?
Keywords:
*analysis/United States/postmarketing research/doctors/Institutional Research Board/IRB/drug company sponsored research/bioethics/ reimbursement to doctors/ETHICAL ISSUES IN PROMOTION: PAYMENTS IN STUDIES/PROMOTION DISGUISED: POSTMARKETING RESEARCH/REGULATION, CODES, GUIDELINES: ACADEMIC INSTITUTIONS/SPONSORSHIP: RESEARCH
Advertising
Conflict of Interest
Disclosure
Drug Industry*
Drug Toxicity
Ethics Committees
Ethics Committees, Clinical
Ethics Committees, Research
Fees and Charges
Financial Support*
Human Experimentation*
Humans
Informed Consent
Jurisprudence
Patient Care
Patients*
Pharmaceutical Preparations*
Physicians*
Research
Research Personnel
Research Subjects
Scientific Misconduct
Therapeutic Human Experimentation
