Background Several jurisdictions, including Singapore, Australia, New Zealand and most recently Ireland, have a public interest or public good criterion for granting waivers of consent in biomedical research using secondary health data or tissue. However, the concept of the public interest is not well defined in this context, which creates difficulties for institutions, institutional review boards and regulators trying to implement the criterion. Main text This paper clarifies how the public interest criterion can be defensibly deployed. We first explain the (...) ethical basis for requiring waivers to only be granted to studies meeting the public interest criterion, then explore how further criteria may be set to determine the extent to which a given study can legitimately claim to be in the public interest. We propose an approach that does not attempt to measure magnitude of benefit directly, but rather takes into account metrics that are more straightforward to apply. To ensure consistent and justifiable interpretation, research institutions and IRBs should also incorporate procedural features such as transparency and public engagement in determining which studies satisfy the public interest requirement. Conclusion The requirement of public interest for consent waivers in secondary biomedical research should be guided by well-defined criteria for systematic evaluation. Such a criteria and its application need to be periodically subject to intra-committee and intra-institution review, reflection, deliberation and amendment. (shrink)

BackgroundInstitutional review boards (IRBs) have been criticised for delays in approvals for research proposals due to inadequate or inexperienced IRB staff. Artificial intelligence (AI), particularly large language models (LLMs), has significant potential to assist IRB members in a prompt and efficient reviewing process.MethodsFour LLMs were evaluated on whether they could identify potential ethical issues in seven validated case studies. The LLMs were prompted with queries related to the proposed eligibility criteria of the study participants, vulnerability issues, information to be disclosed (...) in the informed consent document (ICD), risk–benefit assessment and justification of the use of a placebo. Another query was issued to the LLMs to generate ICDs for these case scenarios.ResultsAll four LLMs were able to provide answers to the queries related to all seven cases. In general, the responses were homogeneous with respect to most elements. LLMs performed suboptimally in identifying the suitability of the placebo arm, risk mitigation strategies and potential risks to study participants in certain case studies with a single prompt. However, multiple prompts led to better outputs in all of these domains. Each of the LLMs included all of the fundamental elements of the ICD for all case scenarios. Use of jargon, understatement of benefits and failure to state potential risks were the key observations in the AI-generated ICD.ConclusionIt is likely that LLMs can enhance the identification of potential ethical issues in clinical research, and they can be used as an adjunct tool to prescreen research proposals and enhance the efficiency of an IRB. (shrink)

Epidemiological studies usually do not pose high risk to participants. At the same time they provide valuable knowledge and improve public and individual health. In many countries, studies involving human subjects are subject to ethics review. Research shows that the process of obtaining ethical approval from institutional research boards or research ethics committees is sometimes costly, time-consuming and seriously delays important research projects. In this article we consider arguments against and in favor of ethics review of epidemiological studies. On the (...) one hand, it seems that minimal risk epidemiological studies should not be a subject to ethics review, since any delay of an important study has its death toll and health costs. In this perspective, the calculus of costs and benefits supports rejecting the whole existing approach. Nevertheless, we argue that institutional research boards or ethics research committees protect research participants from wrongs and up till now are the best tools of social and political control over the research enterprise. (shrink)