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Year : 2021  |  Volume : 14  |  Issue : 6  |  Page : 668-673

Completeness of informed consent documents in synopsis of postgraduate medical students of a medical college of Western Maharashtra

1 Resident, Dept of Community Medicine, AFMC, Pune, Maharashtra, India
2 Faculty, ACMS, New Delhi, India
3 Prof and HoD, Dept of Community Medicine, AFMC, Pune, Maharashtra, India
4 Associate Professor, Dept of Community Medicine, AFMC, Pune, Maharashtra, India

Correspondence Address:
Arun Kumar Yadav
Department of Community Medicine, Armed Forces Medical College, Pune - 411 040, Maharashtra
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Source of Support: None, Conflict of Interest: None

DOI: 10.4103/mjdrdypu.mjdrdypu_292_20

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Introduction: Research is a key requirement and is an integral part of postgraduate (PG) studies. In biomedical and health research involving human participants, obtaining voluntary informed consent is a must requirement for researchers' respect for individual autonomy as well as safeguard of participants against abuses and exploitations. The Indian Council of Medical Research (ICMR) has come out with the Revised National Ethical Guidelines for Biomedical and Health Research Involving Human Participants – 2017 giving essential and additional elements of an informed consent document (ICD). Materials and Methods: The study was a descriptive study done over a period of 12 weeks. A sample of 155 PG students were selected, who had submitted their synopsis in medical research unit of a medical college of Western Maharashtra. ICDs were scrutinized and evaluated with a checklist given by the ICMR guidelines 2017 and analyzed using SPSS version 20. Results: Of 155 students, 131 (91.6%) were males as compared to 24 (15.48%) females, and 43 (27.7%) belonged to clinical specialty as compared to 112 (78.3%) from para and nonclinical. Of 155 students, 143 (92.3%) had attached informed consent forms (ICFs) as compared to 12 (7.7%) who had not attached in their synopsis. In ICFs among 143 students, 59 (41.1%) students used English and local language (Marathi) and 84 (58.7%) used only English language. Conclusion: PG students have appropriately prepared ICFs; however, there are some discrepancies in some of the elements. There is a requirement of sensitizing PG students through regular training programs to reduce discrepancies in ICDs.

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