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Experience of the selected Ethics Committee of Pune city regarding the review of COVID-19 protocols during the pandemic


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

Date of Submission03-Jan-2022
Date of Acceptance05-Feb-2022
Date of Web Publication02-Nov-2022

Correspondence Address:
Sonopant G Joshi,
4th Floor, Symbiosis College of Nursing, Symbiosis International (Deemed University), Pune, Maharashtra
India
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Source of Support: None, Conflict of Interest: None

DOI: 10.4103/picr.picr_2_22



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 [Epub ahead of print] [cited 2022 Dec 9]. Available from: http://www.picronline.org/preprintarticle.asp?id=360436


   Introduction Top


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,[1] and compelled them to adopt new administrative and functional modalities.[2] In addition, the Indian Council of Medical Research (ICMR) released special guidelines for ethical review of research studies during the pandemic.[3] This study aimed at exploring the functioning and experiences of a selected EC from India during the pandemic.


   Methods Top


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.


   Results Top


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.


   Discussion Top


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,”[4] 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.[5]

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.

Acknowledgement

The researchers thank all those who directly or indirectly supported the study.

Financial support and sponsorship

Nil.

Conflicts of interest

There are no conflicts of interest.

 
   References Top

1.
Hsu NS, Hendriks S, Ramos KM, Grady C. Ethical considerations of COVID-19-related adjustments to clinical research. Nat Med 2021;27:191-3.  Back to cited text no. 1
    
2.
Tuttle KR. Impact of the COVID-19 pandemic on clinical research. Nat Rev Nephrol 2020;16:562-4.  Back to cited text no. 2
    
3.
Mathur R. National Ethical Guidelines for Ethics Committees Reviewing Biomedical and Health Research during COVID-19 Pandemic. New Delhi (IN): ICMR National Centre for Disease Informatics & Research, Bengaluru; 2020. Available from: https://www.icmr.gov.in/pdf/covid/techdoc/EC_Guidance_COVID19_06052020.pdf. [Last accessed on 2020 Aug 12].  Back to cited text no. 3
    
4.
Brandt AM. Racism and research: The case of the Tuskegee syphilis study. Hast Cent Rep 1978;8:21-9.  Back to cited text no. 4
    
5.
Faust A, Sierawska A, Krüger K, Wisgalla A, Hasford J, Strech D. Challenges and proposed solutions in making clinical research on COVID-19 ethical: A status quo analysis across German research ethics committees. BMC Med Ethics 2021;22:96.  Back to cited text no. 5
    




 

 
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