Table III.

Ethical issues for consideration during outbreaks/epidemics

Topic	Details
Social value	Public health relevance, importance of using unapproved interventions to save lives, prevent spread of infection in care of outbreaks or epidemics
Scientific design and conduct	Use of unapproved interventions after thorough scientific consultation for trial (placebo/intervention). Clear inclusion exclusion criteria
Benefit risk assessment	Benefit and risks assessed at both individual and population level. Supportive care, adequate monitoring/follow up, management of adverse events, etc.
Selection of study population/recruitment of participants	Fair selection of participants following defined methodology removing the possibility of any bias or discrimination of particular group or individual
Protection of privacy and confidentiality	Identifying information of confirmed cases to be reported to public health authorities but protected from unauthorized access to media or others
Community consideration	Efforts be made to engage with communities to communicate, discuss sensitivities involved. Release timely, accurate updates to remove panic
Qualification and site facilities	Site well equipped to deal with outbreaks/appropriate facility for isolation and quarantine. Investigators and health workers trained/qualified to understand ways of infection control
Informed consent process	Prior approvals with dummy protocol/informed consent forms. EC may be requested to allow oral consent/waiver of consent depending on situation, efforts be made to simplify informed consent in local language
Collaboration	Urgent need to join hands to make collective efforts for infection control. Adequate safeguards needed and sharing data, sample storing for future use, biobanking, etc., and fast-track systems to facilitate collaboration
Governance mechanism	Well informed, responsive governance mechanism involving all stakeholders who can work towards a common goal of outbreak control and guide research

Source: Ref. 5