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Amendment of the...
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EDITORIAL
Year : 2020  |  Volume : 66  |  Issue : 3  |  Page : 119-122

Ethics committees: Actions during pandemic and lockdown situations


Department of Pediatrics, Surya Hospitals, Mumbai, Maharashtra, India

Date of Submission29-Apr-2020
Date of Decision06-May-2020
Date of Acceptance20-May-2020
Date of Web Publication25-Jun-2020

Correspondence Address:
S B Bavdekar
Department of Pediatrics, Surya Hospitals, Mumbai, Maharashtra
India
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Source of Support: None, Conflict of Interest: None


DOI: 10.4103/jpgm.JPGM_431_20

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How to cite this article:
Bavdekar S B. Ethics committees: Actions during pandemic and lockdown situations. J Postgrad Med 2020;66:119-22

How to cite this URL:
Bavdekar S B. Ethics committees: Actions during pandemic and lockdown situations. J Postgrad Med [serial online] 2020 [cited 2020 Aug 12];66:119-22. Available from: http://www.jpgmonline.com/text.asp?2020/66/3/119/287695




The COVID19 epidemic and the subsequent lockdown[1] 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 Challenges Top


The Ethics Committees (ECs) in India have varying capabilities and are in different stages of evolution.[2] 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.
Table 1: Challenges faced by the ethics committees

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 :: Amendment of the Sops Top


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.
Table 2: Elements to be included in SOP related to conduct of virtual meetings[3],[4],[5]

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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:[6],[7]

  • Suspension or slowing down of enrollment of participants, as prospective participants may not be able to follow up at designated times and trying to do so might expose them to undue risks
  • Extension of duration of a research project, as enrollment rate may slow down during the lockdown period
  • Reducing the number of visits and/or substituting personal visits with telephone or video visits, to ensure adequate safety monitoring while minimizing the risk of exposure during travel for a follow-up visit
  • Transferring the participants at the site to investigational sites which are outside the risk zones
  • Informing the participants about other sites near to their residence that they can access in the event of a medical emergency or to obtain investigational drug supplies
  • Directly supplying the investigational and other drugs, as the participant may be unable to visit the trial site for obtaining these
  • Advising participants to discontinue study medication for safety concerns, when it is not possible for the participant to visit the trial site for scheduled visits
  • Closure of sites when it is just not possible to continue participation at all. Conversely, the EC may allow activation of a site that has not been initiated so far, to substitute for the closed sites. This may be required when the site is not in the hot-spot region
  • Non-initiation of an approved research study.


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:

  • Relax administrative requirements: The EC could initiate the review process even though certain complementary documents (e.g., copies of investigator CVs, or Good Clinical Practice Training Certificates) are not submitted. The EC may direct the investigator to submit these prior to initiation of the study. The EC may issue an “in-principle” or “provisional” approval, while certain requirements are being fulfilled
  • Expedite the review process:[8] The usual timelines can be shortened for emergency-related research. For example, the EC should dispatch research project documents within 24 hours of receipt, ensure that members submit their comments within the next 48–72 h and that meetings are held within the next 24 h. The ECs can co-opt external experts from the related disciplines, so that their assessments are available for consideration at the virtual meetings. For example, in the current COVID19 epidemic, specialists from the disciplines of infectious diseases, Virology, Immunology and/or, intensive care can be co-opted. The ECs can also have services of experts in bio-safety and microbiology to guide in the review of projects that entail collection, storage, and transport of bio-hazardous samples. If young experts are busy working, the EC can draw on the expertise of retired professions in these areas
  • Coordination with other ECs: Many drug trials will be planned at multiple centers in a given city or state. In such a situation, the facility of a lead EC reviewing the project can be utilized. This will help avoid duplications and delays.


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.



 
 :: References Top

1.
Government of India. Ministry of Home Affairs. Order dated 24 March 2020. Available from: https://www.mha.gov.in/sites/default/files/MHAorder%20copy_0.pdf. [Last accessed on 2020 May 07].  Back to cited text no. 1
    
2.
Thatte UM, Bavdekar SB. Clinical research in India: Great expectations? J Postgrad Med 2008;54:318-23.  Back to cited text no. 2
[PUBMED]  [Full text]  
3.
Institutional Review Board. University of Utah. Board Member Guidance Series. Virtual IRB Meetings. Version C1620. Available from: https://irb.utah.edu/_resources/documents/pdf/bmgs-virtual_irb_meetings-version_c1620.pdf. [Last accessed on 2020 Apr 28].  Back to cited text no. 3
    
4.
Office of the Institutional Review Board. Standard Operating Procedures. IRB Meeting Conduct. Available from: https://irb.unm.edu/sites/default/files/103.7%20IRB%20Meeting%20Conduct.pdf. [Last accessed on 2020 Apr 28].  Back to cited text no. 4
    
5.
ADVARRA. Impact of COVID-19 outbreak on ongoing research and protocols under Advarra IRB review. Available from: https://www.advarra.com/about-advarra/news/impact-of-coronavirus-outbreak-on-protocols-under-advarra-irb-review/. [Last accessed on 2020 Apr 28].  Back to cited text no. 5
    
6.
Guidance on the Management of Clinical Trials during the COVID-19 (Coronavirus) pandemic. Version 2 (27/3/2020). Available from: https://ec.europa.eu/health/sites/health/files/files/eudralex/vol-10/guidanceclinicaltrials_covid19_en.pdf. [Last accessed on 2020 Apr 28].  Back to cited text no. 6
    
7.
US Food and Drug Administration. FDA Guidance on Conduct of Clinical Trials of Medical Products during COVID-19 Pandemic. Guidance for Industry, Investigators, and Institutional Review Boards. March 2020 Updated 16 April 2020. Available from: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/fda-guidance-conduct-clinical-trials-medical-products-during-covid-19-public-health-emergency. [Last accessed on 2020 Apr 28].  Back to cited text no. 7
    
8.
UNESCO International Bioethics Committee (IBC), UNESCO World Commission on the Ethics of Scientific Knowledge and Technology (COMEST). Statement on COVID-19: Ethical considerations from a global perspective. Available from: https://unesdoc.unesco.org/ark:/48223/pf0000373115/PDF/373115eng.pdf.multi. [Last accessed on 2020 Apr 29].  Back to cited text no. 8
    



 
 
    Tables

  [Table 1], [Table 2]



 

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