Year : 2023 | Volume
: 14 | Issue : 1 | Page : 43--44
Experience of the selected Ethics Committee of Pune city regarding the review of COVID-19 protocols during the pandemic
Sonopant G Joshi1, Abhijeet Ashok Safai2, Samir Sumant Barve3,
1 Department of Community Health, Symbiosis College of Nursing, Symbiosis International (Deemed University), Pune, India
2 Associate Data Analyst - Actu-Real, Pune, India
3 Symbiosis Community Outreach Programme and Extension, Symbiosis Medical College for Women, Symbiosis International (Deemed University), Pune, Maharashtra, India
Dr. Sonopant G Joshi
4th Floor, Symbiosis College of Nursing, Symbiosis International (Deemed University), Pune, Maharashtra
|How to cite this article:|
Joshi SG, Safai AA, Barve SS. Experience of the selected Ethics Committee of Pune city regarding the review of COVID-19 protocols during the pandemic.Perspect Clin Res 2023;14:43-44
|How to cite this URL:|
Joshi SG, Safai AA, Barve SS. Experience of the selected Ethics Committee of Pune city regarding the review of COVID-19 protocols during the pandemic. Perspect Clin Res [serial online] 2023 [cited 2023 Mar 28 ];14:43-44
Available from: http://www.picronline.org/text.asp?2023/14/1/43/360436
A sudden upsurge in COVID-19 research during the pandemic in 2020 brought a tremendous workload over Ethics Committees (ECs). Altered lifestyles and changes in research-related approaches due to the pandemic posed a completely different scenario to ECs, and compelled them to adopt new administrative and functional modalities. In addition, the Indian Council of Medical Research (ICMR) released special guidelines for ethical review of research studies during the pandemic. This study aimed at exploring the functioning and experiences of a selected EC from India during the pandemic.
This is a descriptive secondary data analysis entailing functioning of the EC during April 1, 2020–March 31, 2021. An EC working at the central place of Pune city was selected. Out of the total of 131 protocols received during the time period, only COVID-19-related protocols (n = 60) were selected for the analysis. The protocols covered various topics such as COVID-19 vaccinations, drug development, investigations, and epidemiological studies. In addition, minutes of all the EC review meetings conducted during the period were analyzed. This study was approved by an Institutional Ethics Committee.
Changes in functioning style of the Ethics Committees
The EC reviewed the protocols by online mode using video conferencing. The documents were accepted on E-mail as soft copies for initial scrutiny by the secretariat department. Any deficiency or missing documents were communicated through E-mail to the principal investigator within the time frame. Any complicated protocols were circulated to the Chairperson of EC on E-mail for the expert opinion. The dates for online meeting were fixed as per the convenience of all the EC members, and the documents were circulated on E-mail at least 2 weeks prior to the scheduled meeting. The protocols were categorized for review in full committee review, expedited review, and exemption.
Analysis of the research protocols reviewed
From April to August 2020, we received maximum COVID-19-related protocols. Twenty-eight (47%) protocols were reviewed in full committee online meetings. Two online meetings were conducted exclusively for serious adverse events causality assessment. Twenty-six (43%) suitable protocols were prioritized to give expedited reviews at beginning of the study period. Six (10%) protocols could not be reviewed due to submission in inappropriate formats and technical deficiencies, or self-withdrawal by the researchers.
Fourteen (23%) studies were related to repurposed drugs, proprietary drugs, and alternative medicines such as proprietary Ayurvedic formulations for COVID-19. Other (n = 46, 77%) were nondrug-related studies. Observational studies (n = 44, 73%) were comparatively more than interventional studies (n = 16, 27%). The interventional studies included repurposed use of drugs, vaccines, noninvasive devices, and exercise techniques. Six (37.5%) of the interventional studies were related to the proprietary Ayurvedic drugs or formulations.
We observed a large pool of COVID-19 proposals, especially at beginning of the study period, and the researchers were keen to undertake these studies in fast-track mode. The committee has to change its modalities to online meetings and consideration of expedited approvals to suitable proposals. With reference to the learnings from “Tuskegee Syphilis study,” this EC categorized observational studies as those having high risk, and meticulously reviewed all the proposals. Around one-third of protocols amongst interventional studies were related to the proprietary Ayurvedic drugs and preparations. This indicated a large consumption of alternative medicines for COVID-19 care. Similar to a study from Germany, this EC also faced challenges to review protocols within a short time.
This study documented the information which could be useful to compare the functionality of other ECs. Documentation and knowledge sharing about experiences of various ECs during the COVID-19 pandemic are needed to design appropriate strategies in managing ethics-related issues if similar situations arise in future.
The researchers thank all those who directly or indirectly supported the study.
Financial support and sponsorship
Conflicts of interest
There are no conflicts of interest.
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