Ethics committees: Actions during pandemic and lockdown situationsSB Bavdekar
Department of Pediatrics, Surya Hospitals, Mumbai, Maharashtra, India
The COVID19 epidemic and the subsequent lockdown were unprecedented and unforeseen. Individuals and institutions were not ready to handle such a situation and have had to make several adjustments. Institutional Ethics Committees were also affected and are still adjusting to and coping with the challenges that have emerged.
The Ethics Committees (ECs) in India have varying capabilities and are in different stages of evolution. Some ECs have already digitized the submission and review processes. In contrast, there are ECs that are still following the age-old processes using paper documents for submission, review, collation of members' comments, and decision making. Many ECs use a combination of digitized and conventional processes. For example, they advise researchers to submit proposals as paper- and electronic copies. The electronic versions are sent to members through email for review and their comments are obtained through emails. The paper copies are only kept for record in the EC office. The ECs were affected to a variable extent by the circumstances created by the epidemic and the subsequent lockdown. The ones using digital processing had lesser difficulties in carrying out their essential functions.
The main issues or difficulties faced by the Ethics Committees are listed in [Table 1]. Many ECs did not have any standard operating procedures (SOPs) for dealing with the situation of pandemic combined with prolonged period of lockdown. Although ECs had defined processes for amending SOPs, how could they amend the SOPs that required members to meet in person, discuss and debate? In-person meetings were not feasible and virtual/online meetings were not even mentioned in the SOP. The lockdown made it difficult for the office staff to attend EC office on a regular basis and the documents could not be physically transported to the external members' offices/residences. Many internal members and EC office-bearers faced difficulties reaching the institution or were busy managing increased volumes of clinical work, including emergencies. Therefore, ECs dependent on the paper-based system had to suddenly adjust to the new paradigm of using electronic processes for submission and review. The ECs also found it difficult to convene meetings of their subcommittees (e.g., Serious Adverse Event Committee, i.e., SAE committee) for urgent review and decision. Absenteeism among the EC office staff interfered with the EC's functions. Filing reports for fulfilling regulatory requirements was delayed, too. In addition, routine and for-cause monitoring of research projects could not be undertaken. Maintaining communication channels with the investigators also proved to be challenging. Many investigators were working from home or the research project staff was not available at the research site. Investigators of ongoing projects faced challenges in enrolling new participants, scheduling the follow-up visits, and procuring supplies of investigational and other drugs. They required guidance and support at a time when the EC office itself was working with skeletal staff. The ECs were required to find quick fixes for the challenges faced. They did so through ad hoc decisions. The ECs need to devise a plan so that they can continue to discharge their responsibilities in an effective and efficient manner, even during emergency situations.
In the absence of an SOP to deal with emergency situations and lockdowns, the ECs actions were hampered and they became prisoners of their own SOPs. The ECs will have to amend SOPs so that they allow greater flexibility in their working during a pandemic-cum-lockdown situation. While formulating the amendments, the following issues may have to be looked into:
Decision-making process and authorities
Under usual circumstances, decisions are taken on the basis of discussions held during full-board meetings. However, this is not possible in emergency situations. Although decisions regarding approval of research projects will have to be taken at the full-board meetings, other decisions pertaining to choosing non-COVID research projects for review, changing timelines, etc. can be delegated to the Member-Secretary or a subset of EC. And it must be understood that these decisions will require to be altered, as the situation changes (state of the pandemic, easing of travel restriction, attendance of support staff in the EC, etc.). In such situations, personnel aware of the ground realities are best placed to make the necessary changes.
Limiting the submission of new research projects
It is obligatory upon the ECs to review projects related to the emergency, even while working in a challenging atmosphere. Hence, it is logical for ECs to allow submission of research projects only pertaining to the emergency (e.g., COID19-related projects, in the current situation). This seems appropriate as EC would be expected to expedite the review of several emergency-related research projects and as investigators of projects not related to the emergency may not be able to initiate them in the current situation. However, the EC may have to also continue to take up research projects related to dissertations and those with a request for funding with predefined timelines.
Relaxation of certain timelines
The EC's SOPs describe various timelines for different processes and actions; for example, timeline for EC to acknowledge receipt of a communication from an investigator or timeline for the investigator to reply to EC's letter seeking clarifications. The EC may consider the relaxation of these timelines without compromising on regulatory requirements and without adversely affecting participant safety. This is required as the support staff at the EC office and research staff assisting investigators may find it difficult to attend office every day and as the investigators might be busy attending to the emergency-related work.
Suspension/postponement of certain activities
EC may suspend routine site monitoring visits to ensure that clinician-investigators can continue to carry their emergency-related clinical work. This would also mean that members and staff of the EC do not have to visit clinical areas and face an increased risk of exposure to infection. The projects could be monitored, as far as possible, entirely through review of reports received from the investigator. Due to the postponement or suspension of a few activities, the EC staff and office-bearers will be able to provide more time to the emergency-related research projects.
Convening meetings using virtual/online platforms
Irrespective of the degree to which ECs had evolved in using electronic processes, hardly any EC had provisions for convening virtual meetings. Thus, when the lockdown was enforced, ECs found themselves ill-equipped to deal with the situation. SOPs should be suitably amended so that decisions can be taken through virtual meetings [Table 2]. The ECs need to decide whether the virtual meetings should be limited to unusual or extraordinary circumstances or should they be conducted frequently, if not routinely. Given the current situation of COVID-19, wherein waves of epidemic are expected to occur, ECs will have to be prepared for conducting virtual meetings more frequently, at least for the next 6–12 months. The in-person or physical meetings allow visualization of non-verbal and interpersonal cues and enhance interaction. Hence, conduct of virtual meetings on a routine basis may not be a preferred option. The ECs may spell out their policy whether allowing a member, who cannot be present for an in-person meeting, can attend it using electronic means. The ECs should also allow its subcommittees (e.g., SAE subcommittee) to conduct meetings through online platforms.
Guidance to Researchers regarding ongoing projects
Investigators with ongoing research projects and sponsors of those projects are responsible for taking appropriate actions to safeguard participants' health and well-being in a constantly changing and challenging situation. However, bogged down by their clinical duties during the emergency situation, they may require EC's guidance. The EC, through a general circular, can advise them to consider undertaking protocol amendments for ensuring participant safety without compromising the study integrity:,
In emergency situations, the EC should have an SOP to consider requests for protocol amendments, expeditiously.
Promotion of research related to the pandemic
The pandemic, especially caused by a novel organism, offers unique opportunities for research regarding: identifying preventive strategies (including vaccines), defining high-risk populations, determining efficacy of different therapeutic options, and identifying prognostic factors, among others. In fact, ECs have a moral duty to encourage and expedite such research. Although the EC should carry out risk-benefit analysis, ensure the safety and well-being of the research participants, and maintain data integrity, it should also find ways to encourage and accelerate the emergency-related research. Some of the measures that can accelerate processes, such as, digital submissions, use of internet-based communication system, holding virtual meetings, deferring nonessential work, etc. have already been discussed. Other measures that could also help include:
The ECs were hardly ready for working in these trying circumstances. However, they progressively got adjusted to the situation. Appropriate amendments in SOPs will arm the ECs with flexibility in working, which is extremely important. It will help them to be agile in responding. It will ensure that they are able to play their role in emergency-related research without compromising on the safety of the participants.
[Table 1], [Table 2]