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Volumn 5, Issue 4, 2003, Pages 309-313

The impact of escalating regulatory requirements on the conduct of clinical research

Author keywords

Clinical research; Regulatory issues

Indexed keywords

ADOPTIVE IMMUNOTHERAPY; CLINICAL RESEARCH; CLINICAL TRIAL; FINANCIAL MANAGEMENT; FOOD AND DRUG ADMINISTRATION; HEALTH CARE POLICY; INFORMED CONSENT; MEDICAL AUDIT; MEDICAL ETHICS; ORGANIZATION AND MANAGEMENT; PRACTICE GUIDELINE; PROTECTION; QUALITY CONTROL; REVIEW; RISK BENEFIT ANALYSIS; VOLUNTEER;

EID: 0142063069     PISSN: 14653249     EISSN: None     Source Type: Journal    
DOI: 10.1080/14653240310002225     Document Type: Review
Times cited : (9)

References (12)
  • 1
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    • visited 25th May 2003
    • Belmont report: Ethical principles and guidelines for the protection of human subjects of research. http://ohrp.osophs.dhhs.gov/humansubjects/guidance/belmont.htm visited 25th May 2003.
  • 2
    • 84879115616 scopus 로고    scopus 로고
    • visited 25th May 2003
    • World Medical Association Declaration of Helsinki http://www.cirp.org/library/ethics/helsinki visited 25th May 2003.
  • 3
    • 0142063141 scopus 로고    scopus 로고
    • Jesse's intent
    • In; Amdur RJ, Bankert EA, editors; Sudbury, MA: Jones and Bartlett
    • Gelsinger, Paul. Jesse's intent. In; Amdur RJ, Bankert EA, editors. Institutional Review Board: Management and Function Sudbury, MA: Jones and Bartlett, 2001: xv-xxiv.
    • (2001) Institutional Review Board: Management and Function
    • Gelsinger, P.1
  • 4
    • 0042708464 scopus 로고    scopus 로고
    • Expanding disclosure of conflict of interests: The views of the stakeholders. IRB
    • Brody B, Anderson C, McCrary SV et al. Expanding disclosure of conflict of interests: The views of the stakeholders. IRB. Ethics Hum Res 2003;25:1-8.
    • (2003) Ethics Hum Res , vol.25 , pp. 1-8
    • Brody, B.1    Anderson, C.2    McCrary, S.V.3
  • 5
    • 0028835789 scopus 로고
    • Institutional conflict of interest
    • Emanuel EJ, Steiner D. Institutional conflict of interest. N Engl J Med 1995;332:262-7.
    • (1995) N Engl J Med , vol.332 , pp. 262-267
    • Emanuel, E.J.1    Steiner, D.2
  • 6
    • 0034682384 scopus 로고    scopus 로고
    • Is academic medicine for sale?
    • Angell M. Is academic medicine for sale? N Engl J Med 2000;342:1516-8.
    • (2000) N Engl J Med , vol.342 , pp. 1516-1518
    • Angell, M.1
  • 7
    • 0034571605 scopus 로고    scopus 로고
    • Dealing with conflicts of interest in biomedical research: IRB oversight as the next best solution to the abolitionist approach
    • Goldner JA. Dealing with conflicts of interest in biomedical research: IRB oversight as the next best solution to the abolitionist approach. J Law Med Ethics 2000;28:379-404.
    • (2000) J Law Med Ethics , vol.28 , pp. 379-404
    • Goldner, J.A.1
  • 9
    • 0031261128 scopus 로고    scopus 로고
    • IRB review of adverse events in investigational drug studies
    • Prentice ED, Gordon BG. IRB review of adverse events in investigational drug studies. IRB: Rev Human Subj Res 1997;19:1.
    • (1997) IRB: Rev Human Subj Res , vol.19 , pp. 1
    • Prentice, E.D.1    Gordon, B.G.2
  • 10
    • 84879073015 scopus 로고    scopus 로고
    • (OEI-01-97-00193); visited 25th May 2003
    • Department of Health and Human Services, Office of the Inspector General. Institutional Review Boards: A Time for Reform. (OEI-01-97-00193) http://oig.hhs.gov/oei/reports/oei-01-97-00193.pdf visited 25th May 2003.
    • Institutional Review Boards: A Time for Reform
  • 11
    • 84879090938 scopus 로고    scopus 로고
    • Scientific research: Continued vigilance critical to protecting human subjects (GAO/HEHS-96-72)
    • visited 25th May 2003
    • United States General Accounting Office. Scientific research: Continued vigilance critical to protecting human subjects (GAO/HEHS-96-72) http://www.gao.gov/archive/1996/he96072.pdf visited 25th May 2003.
  • 12
    • 0034334228 scopus 로고    scopus 로고
    • The IRB is not a data and safety monitoring board
    • Bankert, E, Amdur, R. The IRB is not a data and safety monitoring board. IRB: Rev Hum Subj Res 2000;22:9-11.
    • (2000) IRB: Rev Hum Subj Res , vol.22 , pp. 9-11
    • Bankert, E.1    Amdur, R.2


* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.