|Ahead of print publication
Functioning of Institutional Ethics Committees During the COVID-19 pandemic: An opinion survey
Shatavisa Mukherjee1, Shambo Samrat Samajdar1, Rohan Tripathi2, Santanu Kumar Tripathi1
1 Department of Clinical and Experimental Pharmacology, School of Tropical Medicine, Kolkata, West Bengal, India
2 Inovocare Healthsoft Solutions Pvt. Ltd., Kolkata, West Bengal, India
|Date of Submission||27-May-2021|
|Date of Decision||25-Jun-2021|
|Date of Acceptance||28-Jun-2021|
|Date of Web Publication||11-Jan-2022|
Department of Clinical and Experimental Pharmacology, School of Tropical Medicine, Kolkata - 700 073, West Bengal
Source of Support: None, Conflict of Interest: None
|How to cite this URL:|
Mukherjee S, Samajdar SS, Tripathi R, Tripathi SK. Functioning of Institutional Ethics Committees During the COVID-19 pandemic: An opinion survey. Perspect Clin Res [Epub ahead of print] [cited 2022 Jul 7]. Available from: https://www.picronline.org/preprintarticle.asp?id=335577
| Introduction|| |
The COVID-19 pandemic had challenged every sphere of humankind, with research conduct being no exception. With a broad acceptance of essentiality of research for newer modalities to combat the pandemic, institutional ethics committees (IECs) needed to rapidly review related researches on a priority basis without compromising the scientific validity and ethical requisites keeping in mind protection of research participant's rights, safety, and well-being. However, the increase of pandemic and unforeseen lockdowns challenged the IEC functioning. To ensure ethical and unhindered expedited research during the outbreak, review bodies across the nation embraced digitized system for the conduct of IEC reviews. However, despite IECs' decadal upgradation to digitalize its processes, enforcement of lockdown rules found all IECs inept in dealing the situation with hardly any IEC having laid down provisions for convening virtual review meetings. With in-person meetings not being feasible, it was the need of the hour for all IECs to opt for online meetings to ensure smooth IEC functioning during this difficult time. However, transition from conventional to digitized mode of conduct was faced with some obvious challenges. In this background, we deemed it worthwhile to understand the ethics committee members' perspectives regarding functioning of IECs during this pandemic.
| Methods|| |
An online survey-based observational study was conducted among ethics committee members pan India, who were connected through telephone/WhatsApp/email and requested to answer the survey questions. A survey questionnaire was developed and validated. Questions were based on attitude and perception of different ethics committee members regarding boon and bane of virtual ethics review meetings. The study commenced after obtaining due approval from IEC. Responses were duly analyzed using standard statistical software.
| Results|| |
This online survey included various ethics committee members pan India, where responses were recorded 74% from eastern region, 11% from southern, and 15% from western India. With various members (as per role in IEC) as respondents, maximum responses were recorded from basic medical scientists (30.43%), followed by clinician and lay person (15.22%), member secretary (10.87%), social scientist (8.7%), social worker (6.52%), chairperson (6.52%), legal expert (4.35%), and basic scientist (2.17%). While 89% of respondents revealed having virtual mode for conduct of IEC meetings, only 72% of them had a standard operating procedure (SOP) laid down for the same. Over 52% of respondents believed that virtual meetings can substitute physical ones. Nearly 23.9% of respondents stated difficulty in playing their respective role in virtual meetings, whereas 54.3% of respondents found it “not so difficult.” Data privacy and confidentiality are a prime issue when electronic mode is in use. In an attempt to know whether ethics committee members were convinced in terms of data privacy and confidentiality during virtual meeting, 80% of respondents believed that data confidentiality is adequately assured in virtual meeting mode. However, 20% of respondents believed that the very purpose of ethics oversight and assurance of participants' interest is likely to be compromised in this virtual meeting paradigm. Only 9% of respondents stated that IEC meetings were not recorded in their setup. While minimal resource usage and time saving hailed this virtual mode of IEC meeting conduct, issues such as internet disruption and technology literacy proved to be major constraints at the user end.
| Discussion|| |
Today, India is battling the devastating second wave of COVID-19 with many states under reimposed lockdown rules. To ensure smooth conduct of scientific research in this ongoing emergency situation, it is crucial to empower the IECs with training and sensitization program regarding online meeting conduct, which was the main essence of this study. However, being an opinion survey in design, the study embraces limitations such as unconscientious responses and few responders' difficulty in understanding and interpretation of questionnaire items.
ICMR bioethics unit in its support to foster smooth EC functioning nationwide has developed guidance document for IECs reviewing biomedical and health research in the COVID-19 pandemic. The said guideline has also formulated SOP template to briefly describe the IEC conduct in accordance with social distancing norms during the COVID-19 outbreak. It is expected that all IECs develop their own SOP in line with this and adhere to it ensuring smooth IEC functioning and unhindered research conduct nationwide.
Financial support and sponsorship
Conflicts of interest
There are no conflicts of interest.
| References|| |
Ghooi RB. Ethics committee meetings-Online or face to face? Perspect Clin Res 2020;11:121-3. [Full text]
Thangaraju P, Jindal A. Prerequisite of doing clinical trial with drugs in COVID-19 patients: Situational experience. Perspect Clin Res 2020;11:135. [Full text]