Study design
Some standards of study design may be affected by the pandemic context
- Ethical decision making assumes that such judgements will be based on current scientific knowledge, that effectiveness of interventions is carefully assessed, and that transparency of the process is evident. CDC Ethics in Pandemic Flu
- Because the scientific basis for efficacy of particular interventions continues to be studied and models projecting the course of a pandemic are being investigated, sound scientific evidence for proposed interventions may not currently exist. The current knowledge basis should serve as a foundation for ethical guidelines and a commitment to ongoing scientific and ethical evaluation of interventions should be made. CDC Ethics in Pandemic Flu
- Consider and, where possible, address determinants of health that reside outside a person’s genetic endowment and personal behaviors, including the circumstances in which people grow, live, work, and age. These determinants might include individual resources, community resources, hazardous exposures, and opportunity structures. APHA Code of Ethics, 4.5.7.
- Exposing research participants to risk is ethically unacceptable if the study is not designed in a manner capable of providing valid results. WHO Ethics in an Outbreak
- In clinical trials, the appropriateness of features such as randomization, placebo controls, blinding or masking should be determined on a case-by-case basis, with attention to both the scientific validity of the data and the acceptability of the methodology from which participants will be drawn. WHO Ethics in an Outbreak
- In studies relying on qualitative methods, the potential benefits of using methodologies such as focus groups or of interviewing traumatized victims should be balanced against the risks and burdens to the individuals involved. WHO Ethics in an Outbreak
- Research on experimental treatments and preventative measures should seek to identify any sex- or gender-related differences in outcomes. WHO Ethics in an Outbreak
- Ensure that investigators use resources efficiently and effectively. APHA Code of Ethics, 4.2.3.
- Include impartial mechanisms for assessing the ethical appropriateness of public health policies and plans after they have been implemented, as well as mechanisms for adjusting such policies and plans to ensure continued adherence to ethical standards. APHA Code of Ethics, 4.5.10.
- When local researchers are available, they should be involved in the design, implementation, analysis, reporting and publication of outbreak-related research. WHO Ethics in an Outbreak
- Engaging with affected communities before, during, and after a study is essential to build and maintain trust. WHO Ethics in an Outbreak
- Collaborations should adhere to the requirements for fair research collaborations, such as those proposed by the WHO Council on Health Research for Development (COHRED). WHO Ethical Standards for Research During Public Health Emergencies
- Convene stakeholders throughout all phases of policy and intervention development, implementation, and evaluation. APHA Code of Ethics, 4.4.4.
- Participants should be treated with equal respect. They should be selected in such a way that minimizes risk, protects (but does not exclude) vulnerable populations, maximizes social value and collaborative partnerships, and does not jeopardize the scientific validity of the research. WHO Ethical Standards for Research During Public Health Emergencies
- Special care needs to be taken to protect the vulnerable while including them in the interventions and research. WHO Research Ethics in International Epidemic Response
- Groups considered to be ‘vulnerable’ should not be routinely excluded from research participation without a reasonable scientific and ethical justification. WHO Ethical Standards for Research During Public Health Emergencies
- Researchers should make efforts to ensure that studies do not disproportionately favour a particular sex or gender, and that women who are or might become pregnant are not inappropriately excluded from research participation. WHO Ethics in an Outbreak
- Ensure that communities understand that there is often no direct or immediate benefit to participants in studies conducted as part of epidemic response efforts. WHO Research Ethics in International Epidemic Response
- Prospective research participants must be able to weigh the risks and benefits of participation. WHO Ethical Standards for Research During Public Health Emergencies
- Researchers should inform potential participants about the circumstances under which their data or samples might be shared. WHO Ethical Standards for Research During Public Health Emergencies
- Prospective participants may be especially prone to the therapeutic misconception – that is, the mistaken view that the intervention is primarily designed to directly benefit the individual participants, as opposed to developing generalizable knowledge for the potential benefits of persons in the future. Efforts should be made to dispel the therapeutic misconception to the extent reasonably possible. WHO Ethics in an Outbreak
- In some situations, it may be necessary to develop rapid mechanisms for appointing proxy decision-makers, such as during outbreaks of diseases that affect cognitive abilities, or when an outbreak leaves a large number of children as orphans. WHO Ethics in an Outbreak
- When feasible and consistent with public health objectives, individuals should be asked to provide informed consent or be given the opportunity to opt out of the long-term storage of their specimens. WHO Ethics in an Outbreak
- Processes for obtaining informed consent, including the wording of documents and methods of obtaining and recording consent, should be developed in consultation with local communities. WHO Ethical Standards for Research During Public Health Emergencies
- Contact with participants in COVID-19 related research might thus be made through video or phone calls, with the registry of consent carried out through audiovisual means. PAHO Guidance and Strategies to Streamline Ethics Review and Oversight of COVID-19 Related Research