Review of biomedical and health research proposals can be fast-tracked in an emergency situation, such as the COVID-19 pandemic, while ensuring strict monitoring of the conduct of research, the Indian Council of Medical Research (ICMR) has said.
In its recently released 'Guidelines for Ethics Committees Reviewing Biomedical and Health Research during COVID-19 pandemic', the apex health research body said review of multi-centre research in India can be carried out by one main designated ethics panel for fast-track decision making.
"Common review is generally carried out for research involving low or minimal risk, survey or multi-centric studies using anonymised samples or data or those that are public health research studies determined to have low or minimal risk.
"However, in an emergency situation like the current one, for all types of research including high-risk studies or those involving vulnerable population can be taken up for fast-track common review while ensuring strict monitoring and oversight by registered local ethics committees," the guidelines stated.
Research during emergencies can be reviewed in an expedited manner on a case-by-case basis depending on the urgency and need. If an expedited review is done, full ethical review can follow whenever next possible, it said.
The role of ethics committees is very important in reviewing protocols prepared for such emergency situations, the document highlighted.
Responsiveness to the situation includes the use of expedited or fast-track processes but ensuring robust ethics review, as well as for monitoring the conduct of research.
During this pandemic and restricted environment of research, even non-coronavirus health research needs to be ongoing, the document said.
"There are provisions in the guidelines to facilitate them. It is expected that this guideline will be useful not only for ethics committees but for all stakeholders in research, including researchers, sponsors and even the public at large to inform them about the ethical conduct and review of research for ensuring participant safety and right at all time," it said.
According to the guidelines, research participants who suffer direct physical, psychological, social, legal or economic harm as a result of participating in the study are entitled to free healthcare and referrals as needed. However, for research-related Serious Adverse Events (SAE), appropriate financial compensation and insurance coverage should be provided as per norms, it said.
"For expediting the process, electronic documents may be accepted for review and timelines shortened for accelerated procedures and virtual or tele/video conferences should be attempted to ensure social distancing as face-to-face meetings may not be suitable."
"Withholding information in public health emergencies may be a threat to national security, and therefore the right balance must be maintained to protect individual privacy and confidentiality, and relevant disclosure to public health authorities," the guidelines stated while adding that steps should be taken to protect participants of researchers from possible stigma or discrimination.
Participants should not be made to pay for any expenses incurred beyond routine clinical care and wherever possible may be given a reasonable amount to cover incidental expenses.
"Ethics committee will have to ensure that all COVID-19 related research (all clinical trials as well as biomedical and health research) be registered on Clinical Trial Registry of India (CTRI) and seek approvals as per relevant guidelines and applicable regulations," the ICMR document stated.