Ethics committee meetings – Online or face to face?

Abstract

Ethics committee meetings are held periodically, with all members being physically present in the meeting room. During the COVID-19 pandemic, and the lockdown, a number of committees have resorted to the use of videoconferencing. Online meetings have significant advantages over physical or face-to-face meetings, though the guidelines and regulations imply that online meetings should not be the norm. Considering the advantages of online meetings in terms of saving time and costs, can the regulations and guidelines be tweaked to allow them even after the lockdown is over?

INTRODUCTION

Every crisis is a teacher! Even COVID-19 has taught us many things. By staying strictly at home, it has given a chance for nature to recuperate. It has also taught us that a large part of traveling we did, within and out of the city, was really not essential. The big lesson being that technology can substitute travel.

The lockdown has made some research-related functions difficult, and stakeholders are worried about compliance during this period. The National Ethical Guidelines for Biomedical and Health Research Involving Human Participants (Indian Council of Medical Research [ICMR] 2017) has a full section on “Research During Humanitarian Emergencies and Disasters,” which allows a number of research-related activities to be conducted with minimal violation of the lockdown. Ethics committee (EC) meetings too can be conducted via videoconferences.[1]

The ICMR has also released National Guidelines for ECs Reviewing Biomedical and Health Research during the COVID-19 pandemic. Inter alia, this permits the initiation of multicentric studies after approval by one main designated EC for fast-track decision-making.[2]

We conducted our first EC meeting via videoconference using Skype this month. Unfortunately, the software was not very useful for group meeting, and the video and audio quality was poor. Subsequently, we used a licensed version of Zoom, but there are concerns of privacy and confidentiality of data exchanged on this platform.[3]

However, there are alternate videoconference apps, which can be used. This raised an interesting possibility, whether even after the lockdown is lifted, can EC meetings be held using videoconference, instead of the face-to-face physical meetings?

Ethics committees

ECs were first included in the Declaration of Helsinki at the Tokyo meeting of the World Medical Association. Over the last 45 years, the roles and responsibilities of ECs have undergone a sea change. Currently, ECs operate under the National Ethical Guidelines for Biomedical and Health Research Involving Human Participants, 2017, of the ICMR.[1] This document does not specify that EC meeting must be held physically (as opposed to virtually), in so many words, but implies so:

4.9.16 All members of the EC (including the Chairperson and the Member Secretary) present in the room have the right to vote/express their decision and should exercise this right.

However, the same guideline does give adequate leeway to the EC in times of national emergencies and disasters, to which a whole section is devoted. Section 12.5.3 states that:

• Measures such as virtual or tele-conferences should be attempted when face-to face meetings are not possible

• In situations where members of local ECs are unavailable due to the emergency, the ethics review may be conducted by any other recognized EC within India for initiating the study, until the local EC is able to convene its meeting.

Therefore, it is clear that physical or face-to-face meeting is an acceptable mode, without any regulation mandating it. The ICMR guidelines, however, clarify that videoconferencing is only permissible under conditions, such as the present.

During the current COVID-19 pandemic and the resultant lockdown, many ECs have resorted to videoconferences using Zoom, Skype, Cisco, WebEx, etc., Overall, our experience is very good, for most software (except Skype) with clear audio and video, as well as screen share options. Thus, it comes to the mind that why should we not continue this mode of EC meetings even after this lockdown is over?

We have discussed this idea with our more knowledgeable colleagues, and they have put forward the following concerns:

1. All EC members may not be net savvy and might find it difficult to use this technology. Competencies of EC members have been brought into question repeatedly, and their familiarity with technology is a serious concern [4]

2. Members of some ECs are not proficient enough and inappropriate functioning has been identified as a leading challenge in the work ECs.[5] The need for improving EC functioning has been voiced by many [6,7]

3. EC review is an important function, and it should be given due importance by physical meetings.

Though many of our members are not net savvy, they are learning. During the lockdown, we see many senior citizens have started using their mobile phones to access news, order groceries, etc., Necessity has forced them to learn to handle new technology, they will learn videoconferencing too.

The need to improve EC competence and functioning is unanimously felt. The Central Drugs Standard Control Organisation (CDSCO) registration and the National Accreditation Board for Hospital (NABH) accreditation was a step in this direction.

No doubt the work of the ECs is very important, however a large amount of equally important work is done online today, and a brief list is given below:

1. Almost all financial transactions are done online, including payment of salaries, fees, taxes, and bills

2. Evidence in civil and criminal cases can be given online, and even prisoners appear via videoconferencing before the courts

3. Registration of ECs, and training of members, is being done online, as are many transactions with the CDSCO

4. Recently, the Prime Minister held a meeting with many chief ministers via videoconference.

It would not be out of place to enumerate the advantages of videoconferencing over physical meetings of ECs. These would lead to:

1. Saving the time and expense of concerned members, and the organization

2. Saving fuel by preventing traveling, saving the problems of parking, which exist in all city hospitals

3. Allowing members who are pressed for time, to attend the meetings.

This is not to say that EC members will never visit the hospital, they will do so for audits, assessments, NABH visits, etc., Permitting videoconferencing would mean that they will make 5–6 visits annually rather than the 15–16 visits. We agree that the overall saving may not be a great amount, but we would have made a beginning. However, it may not be out of place to mention that elsewhere, virtual EC meetings are permitted and the University of Utah has an standard operating procedure on holding virtual institutional review board meetings.[8]

Presently, the regulators and the ICMR do not allow videoconferencing for EC meetings, so lets us continue with physical meetings while requesting the authorities to change the rules to allow virtual meetings.

Financial support and sponsorship

Nil.

Conflicts of interest

There are no conflicts of interest.