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)

Adolescence, defined in the US as 11–21 years of age, is a critical period for prevention, as it marks the onset of risk behaviors. Minor (<18 years) self-consent and inclusion in biomedical resear...

Given the primary mandate for institutional review boards (IRBs) to protect potential participants from harm, the egregious history of research abuses, and the fact that there is no mention of incl...

First, the authors should be congratulated for bringing our attention to this important issue. They have made important observations about what may be holding us back in efforts to make progress in...

In this paper, we examine the case of psychedelic medicine for Alzheimer’s disease and related dementias (AD/ADRD). These “mind-altering” drugs are not currently offered as treatments to persons with AD/ADRD, though there is growing interest in their use to treat underlying causes and associated psychiatric symptoms. We present a research agenda for examining the ethics of psychedelic medicine and research involving persons living with AD/ADRD, and offer preliminary analyses of six ethical issues: the impact of psychedelics on autonomy and consent; (...) the impact of “ego dissolution” on persons experiencing a pathology of self; how psychedelics might impact caregiving; the potential exploitation of patient desperation; institutional review boards’ orientation to psychedelic research; and methods to mitigate inequity. These ethical issues are magnified for AD/ADRD but bear broader relevance to psychedelic medicine and research in other clinical populations. (shrink)

Friesen et al. (2023) article explores tensions within institutional review boards (IRBs) when they aim both to protect participants from harm and to include under-represented populations in clinic...

In “IRBs and the Protection-Inclusion Dilemma: Finding a Balance,” Dr. Phoebe Friesen and her collaborators (2023) provide a compelling framework that helps Institutional Review Boards (IRBs) think...

The ethics review of qualitative health research poses various challenges that are due to a mismatch between the current practice of ethics review and the nature of qualitative methodology. The process of obtaining ethics approval for a study by a research ethics committee before the start of a research study has been described as “procedural ethics” and the identification and handling of ethical issues by researchers during the research process as “ethics in practice.” While some authors dispute and other authors (...) defend the use of procedural ethics in relation to qualitative health research, there is general agreement that it needs to be supplemented with ethics in practice. This article aims to provide an illustration of research ethics in practice by reflecting on the ways in which we identified and addressed ethical and methodological issues that arose in the context of an interview study with mental health service users and relatives. We describe the challenges we faced and the solutions we found in relation to the potential vulnerability of research participants, the voluntariness of consent, the increase of participant access and the heterogeneity of the sample, the protection of privacy and internal confidentiality, and the consideration of personal and contextual factors. (shrink)

In “IRBs and The Protection Inclusion Dilemma: Finding a Balance,” Friesen et al. (2023) argue that IRBs ought to attend more, and better, to the need for the inclusion of under-researched populati...

Research ethics committees (RECs) have a crucial role in protecting children in research. However, studies on REC members’ perspectives on paediatric research are scarce. We conducted a qualitative study to explore Swedish scientific REC members’ perspectives on ethical aspects in applications involving children with severe health conditions. The REC members considered promoting participation, protecting children and regulatory adherence to be central aspects. The results underscored the importance of not neglecting ill children’s rights to adapted information and participation. REC members supported (...) a contextual and holistic approach to vulnerability and risk, which considers the child’s and parents’ psychological wellbeing and the child’s integrity, both short and long term. The ethical complexity of paediatric research requires continuous ethical competence development within RECs. (shrink)

We are grateful to Friesen and colleagues for drawing attention to the tension between the protection of populations that may experience vulnerability with their inclusion in research (Friesen et a...

In their target article, Friesen et al. (2023) offer recommendations primarily aimed at IRBs for reaching a better balance in the ongoing challenge of the protection-inclusion dilemma. The authors...

The COVID-19 pandemic’s disproportionate harm to racialized communities and increased public attention to the deaths of Black people at the hands of police (Elijah McClain, Breonna Taylor, George F...

In their article, Friesen et al. (2023) discuss two challenging roles the IRBs are playing: protecting research participants from research-related risks and promoting inclusion of diverse populatio...

I agree fully that a “clearer picture of how vulnerability might manifest and how it can be accommodated, ideally without resorting to mere exclusion from research, is needed” (Friesen et al. 2023,...

IRBs often face dueling values in research: their historically grounded mission to protect research participants from harm conflicts with more recent attention to the importance of including underr...

Friesen et al. (2023) describe barriers to research in patient populations that have been historically labeled as vulnerable and, as a result, are under-represented in research due to the Instituti...

In articulating the protection-inclusion dilemma, Friesen et al. (2023) identify an important issue facing institutional review boards (IRBs) and elucidate historical factors contributing to its de...

Pregnant people are often listed among groups that have been excluded from research on the basis of perceived vulnerability, to the detriment of the entire class. Lack of research among pregnant pe...