Consent in health research with incapacitated adults in a time of pandemic: The National Health Research Ethics Council needs to urgently reassess its guidelines

Abstract

In most instances, health research involves patients who are capable of giving informed consent, a statutory and ethical requirement. A smaller subset of patients lacking this capacity owing to their condition present an ethical problem, particularly because both the Bill of Rights of the Constitution of South Africa, and the National Health Act, require adult participant consent, without exception. Local research ethics guidelines, as a way of facilitating such research, suggest the use of a strategy combining proxy and delayed consent. Under conditions of a pandemic, research involving possibly large numbers of critically ill, incapacitated adults is likely. However, with lockdown restrictions, proxy decision-makers will not be available much of the time. Currently, local guidelines do not address the problem of what ought to be done in situations where incapacitated research participants die before being able to provide delayed consent for use of their research data. Under such circumstances, retention and use of such data is ethically justifiable based on the resultant public health benefits. The National Health Research Ethics Council needs to urgently reassess its consent guidelines in this respect.