The Ethical Problems of the Open Label Extension Study
| Autor: | Kenneth C. Micetich |
|---|---|
| Rok vydání: | 1996 |
| Předmět: |
Health (social science)
Scrutiny Relation (database) Research Subjects education Disclosure Risk Assessment Placebos Double-Blind Method Research participant Ethics Medical Risks and benefits Randomized Controlled Trials as Topic Cross-Over Studies Actuarial science Patient Selection Health Policy Extension study Beneficence Institutional review board Therapeutic Human Experimentation humanities Issues ethics and legal aspects Research Design Personal Autonomy Patient Compliance Assumption of risk Business Patient Participation Open label Ethics Committees Research |
| Zdroj: | Cambridge Quarterly of Healthcare Ethics. 5:410-414 |
| ISSN: | 1469-2147 0963-1801 |
| DOI: | 10.1017/s0963180100007210 |
| Popis: | The institutional review board (IRB) Is charged with assessing the risks and benefits of research projects Involving human subjects. Ethical considerations and federal regulations require that an IRB, in part, must find that the potential risks of participation are proportional to the potential benefits (If any) and to the Importance of the knowledge that may be learned before the IRB can approve the voluntary assumption of risk by a research participant. Adequate assessment of the risks and benefits requires careful scrutiny of the study design In relation to the study objectives. |
| Databáze: | OpenAIRE |
| Externí odkaz: |
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