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VOLUME 5 , ISSUE 2 ( May-August (2018), 2018 ) > List of Articles


Informed Consent Process in the New Millennium

Ranabir Pal, Swapan K Paul

Citation Information : Pal R, Paul SK. Informed Consent Process in the New Millennium. Bengal Physician Journal 2018; 5 (2):22-24.

DOI: 10.5005/jp-journals-10070-5208

License: NA

Published Online: 01-04-2018

Copyright Statement:  NA


In this new millennium, the clinical trial is inseparably linked with an upgrade of health care by generating invaluable data in preventive, promotive and curative health. Globally research experts have concerns regarding ensuring financial and other compensations along with optimum health benefits for research participants in clinical trials in the emerging market economy. A significant number of human healthy volunteers (participants) take part in researches in both developed and developing countries. Participants are frequently unaware that the informed consent process is mandatory for investigators, funders and participants and their free will must be documented. There are sparse published medical works of literature that attempted to assess the extent to which all the norms of the informed consent process are followed in Indian settings in this area to the best of our knowledge. We need to conduct researches on the preparedness of the clinical trials participants towards their awareness of the criticality of the informed consent process and their motives for participation. This narrative review enlightened the facts that very patient, extensive and careful transparent narration and dissemination of the information can only ensure truly informed and autonomous decision improving the validity of the study.

  1. Informed consent in clinical trials: Perceptions and experiences of a sample of South African researchers. Health SA Gesondheid (Online). 2009;14(1): 81-87.
  2. Investigating the informed consent process, therapeutic misconception and motivations of Egyptian research participants: a qualitative pilot study. Eastern Mediterranean Health Journal [Internet]. World Health Organization Regional Office for the Eastern Mediterranean (WHO/EMRO); 2015 Mar 1;21(3):155-163.
  3. Principles of recruitment and retention in clinical trials. Int J Nurs Pract. 2003;9(6):338-346.
  4. Benefits to research subjects in international trials: do they reduce exploitation or increase undue inducement? Dev World Bioeth. 2008;8(3):178-191.
  5. Does informed consent to research require comprehension? Lancet. 2003;362(9400):2016-2018.
  6. An overview of challenges and dire need of clinical trials. Calicut Med J 2007;5(3):e2.
  7. The promise and pitfalls of clinical trials overseas. Science 2008;322(5899):214-21.
  8. Methods used to maintain a high level of participant involvement in a clinical trial. J Epidemiol Community Health 2001; 5(5):348-351.
  9. Attitudes, understanding, and concerns regarding medical research amongst Egyptians: a qualitative pilot study. BMC Med Ethics. 2007;8:9.
  10. Indian study of women with cervical lesions called unethical. Br Med J 1997;314(7087):1065.
  11. Cultural barriers, ‘competence’ and informed consent in population-based surveys. Indian J Med Ethics 2003;11:2.
  12. The therapeutic misconception: informed consent in psychiatric research. Int J Law Psychiatry. 1982; 5(3–4):319-29.
  13. Therapeutic misconception in clinical research: frequency and risk factors. IRB. 2004;26(2):1-8.
  14. Informed consent – why are its goals imperfectly realized? N Engl J Med. 1980;302(16):896-900.
  15. Informed consent: study of quality of information given to participants in a clinical trial. BMJ. 1991; 303(6803):610-613.
  16. Attitudes of dental patients towards participation in research. East Mediterr Health J. 2014; 20(2):90-98.
  17. Profile and role of the members of ethics committees in hospitals and research organisations in Pune, India. Indian J Med Ethics. 2009;6:78-84.
  18. Public attitudes toward participation in cancer clinical trials. J Clin Oncol. 2003; 21(5):830-835.
  19. Assessing the awareness of and willingness to participate in cancer clinical trials among immigrant Latinos. J Community Health. 2012; 37(2):335-343.
  20. Critical Research in developing countries recent moral arguments. Cad Saude Publica 2002;18(5):1455-1461.
  21. A model designed to enhance informed consent: Experiences from the HIV prevention trials network. Am J Public Health 2005; 95(3):412-419.
  22. Optimizing the HIV/AIDS informed consent process in India. BMC Medicine 2004;2:28.
  23. Barriers to informed consent. Semin Oncol Nurs 1999;15(2):89-95.
  24. Longer consent forms for clinical trials compromise patient understanding: so why are they lengthening? J Clin Oncol 2007;25:e13-e14.
  25. What makes clinical research ethical?. Jama. 2000 May 24;283(20):2701-2711.
  26. The Association of the British Pharmaceuticals Industry. 2012 edition. [online] Available at
  27. The use of an educational video during informed consent in an HIV clinical trial in Haiti. JAIDS Journal of Acquired Immune Deficiency Syndromes. 2006 Aug 15;42(5):588-591.
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