QUALITATIVE ANALYSIS OF RESEARCH PROTOCOLS PRESENTED TO THE INSTITUTIONAL ETHICS COMMITTEE IN A TEACHING INSTITUTION: A RE-SEARCH ON RESEARCH.

  • Divya Stephy John Government Kilpauk Medical College, Chennai, Tamilnadu, India-600010.

Abstract

Introduction: Increase in research aptitude among students has resulted in a rise in the protocol numbers that get submitted to the Institutional Ethics Committee (IEC) for the purpose of recognition in dissertation, publications and forum presentations. Approval of research protocols by the IEC is considered the first barrier for most student researchers. Lack of solid concepts regarding dynamics involved in research seems to have resulted in unwarranted fear among students to pursue research. The current analysis attempts to identify areas of lacunae by retrospective reflection on the protocols submitted to the IEC in a teaching institution. Methodology: Retrospective Qualitative Analysis of 102 Protocols submitted by postgraduate medical students between January, 2013 to August, 2013 to the IEC were assessed by the following parameters: - Scientific and technical soundness of protocols, Ethical considerations and risk minimization strategies employed, Adequacy of documentation and scrutiny of  Informed consent process, Temporal relationship between submission of protocols  and commencement of  the research procedures.  Results: 79.41% of  protocols were approved by the IEC. 95% of protocols were in proper format and adequate documentation.90% of the protocols were submitted for approval prior to the commencement of study.  20.59% of the submitted protocols were denied approval on the first hearing by the IEC. Discussion: We infer that majority of the postgraduate students are aware about the existence of guidelines in clinical research. The most common errors leading to non approval of research protocols are due to misjudgement regarding technical feasibility in available infrastructure, non comprehensive review of literature, non-addressal of ethical guidelines/risk minimisation strategies towards participants and inadequate documentation.

 

 

Keywords: Biomedical Research, Institutional Ethics Committee, Qualitative Research

Downloads

Download data is not yet available.

Author Biography

Divya Stephy John, Government Kilpauk Medical College, Chennai, Tamilnadu, India-600010.
Department of Pharmacology

References

1. M. F. Ashley Montagu, M.D. Primitive Medicine. . N Engl J Med. 1946 July 11; 235:43-49DOI: 10.1056/NEJM194607112350203.

2. Richard Eisenberg, Carl Faingold. Knowledge Objectives in Medical Pharmacology. Aspet [Internet]. 2012. Available from: https://www.aspet.org/uploadedfiles/divisions_and_chapters/aspet_divisions/pharmacology_education/content/educational_assets/knowledge%20objectives%202012%20edition%20final.pdf.

3. Peter M Dunn. Perinatal lessons from the past: James Lind (1716-94) of Edinburgh and the treatment of scurvy. Arch Dis Child Fetal Neonatal Ed 1997;76:1 F64-F65 doi:10.1136/fn.76.1.F64

4. Indian Council of Medical Research. Handbook on Ethical guidelines for Biomedical research on Human participants.Oct, 2006.21p.

5. University of Aberdeen. Ethics and Research – the theoretical basis [Internet]. Available from: https://www.abdn.ac.uk/clsm/documents/EricM_CERB.pdf.

6. Sukhlecha A. Research publications: Should they be mandatory for promotions of medical teachers? J Pharmacol Pharmacother. 2011;2:221–4. [PMC free article] [PubMed]

7. CIOMS International ethical guidelines for biomedical research involving human subjects. Available from: www.cioms.ch/publications/layout_guide2002.pdf

8. Jadhav M, Bhatt A. Ethics in clinical research in India: A survey of clinical research professionals’ perceptions. Perspect Clin Res. 2013 Jan– Mar; 4:4–8.

9. Soumil Patwardhan, Nithya Gogtay, Urmila Thatte, C S pramesh. Quality and completeness of data documentation in an investigator-initiated trial versus an industry-sponsored trial. Indian Journal of Medical Ethics Vol XI No 1 January-March 2014;19-24
Statistics
171 Views | 253 Downloads
How to Cite
1.
John D. QUALITATIVE ANALYSIS OF RESEARCH PROTOCOLS PRESENTED TO THE INSTITUTIONAL ETHICS COMMITTEE IN A TEACHING INSTITUTION: A RE-SEARCH ON RESEARCH. JDDT [Internet]. 14Mar.2015 [cited 22Sep.2021];5(2):69-2. Available from: https://jddtonline.info/index.php/jddt/article/view/1067