Informed consent form template for investigators conducting clinical research

Bulletin, Postgraduate Institute of Medical Education and Research, Chandigarh

Volumn 39, Issue 3, 2005, Pages 106-111

  Shafiq, N ^a   Sidhu, S ^a   Pandhi, P ^a   Malhotra, S ^a,b  

^a Department of Pharmacology ^*  (India)

^b POSTGRADUATE INSTITUTE OF MEDICAL EDUCATION AND RESEARCH   (India)

Author keywords

Autonomy; Clinical trial; Good clinical practice; Informed consent form

Indexed keywords

ORAL CONTRACEPTIVE AGENT;

CLINICAL RESEARCH; CLINICAL TRIAL; CONFIDENTIALITY; ELECTROCARDIOGRAM; GOOD CLINICAL PRACTICE; HUMAN; HUMAN IMMUNODEFICIENCY VIRUS; HUMAN RIGHTS; INFORMED CONSENT; MEDICAL DECISION MAKING; MEDICAL DOCUMENTATION; NUCLEAR MAGNETIC RESONANCE IMAGING; PREGNANCY; PROFESSIONAL PRACTICE; REVIEW; RISK FACTOR; SURGICAL TECHNIQUE;

EID: 33644833017     PISSN: 03022404     EISSN: None     Source Type: Journal    
DOI: None     Document Type: Review

References (10)

1. Beecher HK: Ethics and clinical research. N Engl J Med 1966; 274: 1354-1360
2. th ed, 1994; New York. Oxford University Press.
3. The Nuremberg Code (1949). In Ethics and Regulation of Clinical Research. Eds Levine R. New Haven. Yale University Press. 1986.
4. National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. The Belmont Report: Ethical Principles and Guidelines for the Protection of Human Subjects of Research U.S. Government Printing Office, Washington, DC, 1979.
5. Council for International Organizations of Medical Sciences. International Ethical Guidelines for Biomedical Research Involving Human Subjects CIOMS/WHO, Geneva, 1993.
6. World Medical Assembly, Declaration of Helsinki, revision (2000) www.wma.net. Accessed June 2, 2005.
7. Lyoyd J, Raven A: Handbook of clinical research. Churchill Livingstone. UK. Second Edition, 1994.
8. Grady C: Ethical principles in Clinical Research. In Principles and Practice of Clinical Research. Academic Press, New York, 2002, 15-26.
9. Herz D, Looman J, Lewis S: Informed consent: Is it a myth? Neurosurgery 1992; 30: 456-458.
10. Malhotra S: Practical nuances of conducting clinical trials in India. J & K Practitioner 2005; 12: 1-6.