Article Sidebar

Submitted
May 10, 2021
Published
May 10, 2021
Download
PDF
Statistic
Read Counter : 81 Download : 40

Main Article Content

Abstract

BACKGROUND


Before starting any research study, a review and approval by Institutional Ethics Committee and Institutional Review Board has become mandatory. The ultimate goal of research is to safeguard the public health or population and thus every human has the right to understand the nature besides the risks and benefits of research. Only after approval, a study can be carried out keeping in view any modifications required to meet the regulatory requirements. Both thesis and independent research projects need permission of the IEC & the IRB to safeguard the dignity, rights, safety and well being of all actual and potential research participants. The committee also examines compliance with all regulatory requirements, applicable guidelines and laws.


OBJECTIVE


To have an insight into the research pattern for 2 years in a tertiary care teaching hospital this study was undertaken.


MATERIALS & METHODS


The present retrospective, observational study was conducted in the Deptt. of Pharmacology, Govt. Medical College, Jammu after taking permission from  Institutional Ethics Committee. IEC record of year 2014 and 2015 was assessed and compared.


Different patterns of various research proposals both thesis and independent research proposals was assessed. A tertiary care hospital of north india, IEC GMC jmu is registered with the DCGI. An attempt was made to strictly follow the confidentiality while making analysis.


RESULTS


A total of 244 research projects were submitted and got approval from IEC. 116 research projects were submitted in 2014 out of which 85 (73.2%) were thesis projects and 31 (26.7%) were independent research projects. 128 research projects were submitted in 2015 out of which 88 (68.7%) were thesis research projects and 40 (31.2%) were independent research projects.Most thesis proposals fell in category B or B/C whereas most independent proposals fell in category B/C or C.


CONCLUSION


A similar trend was followed in both the years but a rising trend was seen among the independent research projects. It may be because of the new accredition policy and research rider by Medical Council of India

Keywords

Institutional Ethics Committee Institutional Review Board Research

Article Details

How to Cite
Palvi Kudyar, Roshi, Vishal R. Tandon, & Brij Mohan Gupta. (2021). Comparative analysis of distribution patterns of research protocol: a retrospective, observational study. International Journal of Research in Pharmacology & Pharmacotherapeutics, 7(4), 347-353. https://doi.org/10.61096/ijrpp.v7.iss4.2018.347-353
Download Citation
Endnote/Zotero/Mendeley (RIS)
BibTeX

References

  1. [1]. Hippocratic Oath. Ethical Code. [cited: 2018]. Available
  2. from: http://www.britannica.com/topic/Hippocratic-oath
  3. [2]. The Nuremberg Code.Nuremberg Military Tribunal.JAMA. 276(20), 1996, 1691
  4. [3]. WMA Declaration of Helsinki. Ethical Principles for Medical Research Involving Human Subjects. [cited: 2018]. Available from: http://www.wma.net/en/30publications/10policies/b3/
  5. [4]. Schedule Y. Drug and Cosmetic Rule. Government of India.1945. [cited 18]. Available
  6. from:http://www.rgcb.res.in/wp-content/uploads/2014/07/Schedule-Y.pdf
  7. [5]. International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals. ICH Harmonised Tripartite Guideline: Guideline for Good Clinical Practice E6(R1), 1996.
  8. [6]. Das NK, Sil A. Evolution of Ethics in Clinical Research and Ethics Committee. Indian J Dermatol.62(4), 2017, 373-379
  9. [7]. Standard Operating Procedure Institutional Ethics Committee, GMC Jammu Version – 1.0, dated: 25-June-2013.[cited:2018] Available from: http://gmcjammu.nic.in/SOP%20IEC.pdf
  10. [8]. Kaur R, Christopher AF, Gupta V, Bansal P. A cross-sectional study: Need of equal respect for all professionals in the Institutional Ethics Committees' composition. PerspectClin Res.8(2), 2017, 85-89
  11. [9]. National Ethical guidelines for biomedical & health research involving human participants. ICMR 2017 Available from: https://www.icmr.nic.in/sites/default/files/guidelines/ICMR_Ethical_Guidelines_2017.pdf
  12. [10]. Schedule Y, The Drugs and Cosmetics Rules, 1945 (as amended upto 2005) New Delhi: CDSCO; 2005. Central Drugs Standard Control Organization
  13. [11]. Kulkarni R, Suraiya U. Accreditation of ethics committees in India: experience of an ethics committee. Indian J Medical Ethics12(4), 2015, 241-245
  14. [12]. KUYARE, Mukta S; TAUR, Santosh R; THATTE, Urmila M. Establishing institutional ethics committees: challenges and solutions–a review of the literature. Indian J Medical Ethics11(3), 2016, 181
  15. [13]. Levine RJ. Ethics and Regulation of Clinical Research. New Haven, Connecticut: Yale University Press; 1988
  16. [14]. Thatte UM. Do all projects require ethics committee clearance? J Postgrad Med48(2), 2002, 91.
  17. [15]. Kotsis SV, Chung KC. Institutional review boards: what's old? What's new? What needs to change?. PlastReconstr Surg.133(2), 2014, 439-45
  18. [16]. Wise P, Drury M. Pharmaceutical trials in general practice: the first 100 protocols. An audit by the clinical research ethics committee of the Royal College of General Practitioners. BMJ 313(7067), 1996, 1245-8.