Ethics review board obligations
Ethics review processes need to be adapted to the urgency and unique circumstances of a pandemic
- The committee should be diverse in terms of gender and include health professionals with knowledge about COVID-19, methodologists, ethicists and community representatives. PAHO Guidance and Strategies to Streamline Ethics Review and Oversight of COVID-19 Related Research
- Members should be knowledgeable about ethics of research with human subjects, including on ethical aspects of research during emergencies. PAHO Guidance and Strategies to Streamline Ethics Review and Oversight of COVID-19 Related Research
- Members must be available to conduct a rapid review of protocols. To achieve this, committee members who can meet the time and expertise requirements should be preidentified before they are assigned protocols. PAHO Guidance and Strategies to Streamline Ethics Review and Oversight of COVID-19 Related Research
- It is essential to pre-identify a certain number of members who will share the major burden of review. These members would require specialized training (or equivalent experience) in reviewing research in outbreaks so that they are able to rapidly review research proposals without compromising ethical considerations. WHO Guidance for Research Ethics Committees for Rapid Review of Research During Public Health Emergencies
- It is possible that committee members will not be available to conduct rapid reviews because of their duties related to pandemic response. In such cases, consultants may be called upon to serve as ad hoc committee members, with voice and vote. PAHO Guidance and Strategies to Streamline Ethics Review and Oversight of COVID-19 Related Research
- Subject experts (technical) and people with strong knowledge of ethics (both in country and abroad) willing to serve as ad hoc or co-opted members during outbreaks should be identified and contacted in advance, as there is a likelihood of receiving multiple projects that need to be reviewed in a short time. WHO Guidance for Research Ethics Committees for Rapid Review of Research During Public Health Emergencies
- Countries’ capacity to engage in local research ethics review may be limited during outbreaks because of time constraints, lack of expertise, diversion of resources to outbreak response efforts, or pressure from public health authorities that undermines reviewers’ independence. International and nongovernmental organizations should assist local research ethics committees to overcome these challenges. WHO Ethics in an Outbreak
- Support mechanisms to ensure coordination between the reviews of the ethics review committee and the activities of regulatory authorities, such as the health authority responsible for regulating clinical trials. Ideally, the actions of the ethics review committees and regulatory authorities should occur simultaneously. PAHO Guidance and Strategies to Streamline Ethics Review and Oversight of COVID-19 Related Research
- Independent ethics review should proceed collaboratively between one local and one international review body, with at least one being well-versed in research ethics. WHO Ethical Standards for Research During Public Health Emergencies
- It is important to note that more than one committee reviewing protocols on COVID-19 during the emergency may result in practical difficulties, particularly in the case of multicenter studies. Therefore, it is crucial that all COVID-19 ethics review committees, regardless of structure, have mechanisms in place to effectively coordinate and communicate between themselves and with health authorities in order to avoid duplication of efforts or the loss of valuable time. PAHO Guidance and Strategies to Streamline Ethics Review and Oversight of COVID-19 Related Research
- While some crucial emergency public health research should still undergo full REC (research ethics committee) review because of significant risks to individuals or populations under study, a fast-track review approach should generally be adopted. WHO Research Ethics in International Epidemic Response
- To prepare for the review of emergency research, research ethics committees should agree on a process for rapid review. WHO Guidance for Research Ethics Committees for Rapid Review of Research During Public Health Emergencies
- Review should not be expedient to the point of dropping or narrowing ethical principles. WHO Research Ethics in International Epidemic Response
- Those responsible for approving research protocols should ensure that clinical trials are not initiated unless there is a reasonable scientific basis to believe that the experimental intervention is likely to be safe and efficacious, and that the risks have been minimized to the extent reasonably possible. WHO Ethics in an Outbreak
- Create a pre-emergency repository of study protocols or protocol parts, perhaps relying on a “Wikipedia-style” model which stores and articulates “best practices” in research design. WHO Research Ethics in International Epidemic Response
- “Rolling” or contemporaneous review for protocols or parts of protocols could help speed the process. WHO Research Ethics in International Epidemic Response
- Retrospective review could be combined with an accountability infrastructure for non-compliant or substandard research ethics conduct. WHO Research Ethics in International Epidemic Response
- Maintaining online systems for the review of research protocols (such as ProEthos) facilitates the work of the committee and decreases considerably the amount of time required for the submission of documentation and information. PAHO Guidance and Strategies to Streamline Ethics Review and Oversight of COVID-19 Related Research
- To avoid putting committee members at risk or affecting patient care and the operation of health care delivery centers, ethics monitoring can be carried out through reports submitted by researchers at established deadlines, submitted remotely, and/or deferred. PAHO Guidance and Strategies to Streamline Ethics Review and Oversight of COVID-19 Related Research
- All communications should be documented and archived. WHO Guidance for Research Ethics Committees for Rapid Review of Research During Public Health Emergencies
- Thoughtful preparation and attention to process will not provide guidance in all specific circumstances. The practice of attending to fair process may provide support for local decision makers addressing unanticipated questions. CDC Ethics in Pandemic Flu