ArticleThe American journal of bioethics : AJOB2023
IRBs and the Protection-Inclusion Dilemma: Finding a Balance.
Article in The American journal of bioethics : AJOB, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 29 papers.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
29 citing papers in PubMed, 70 citations in OpenAlex.
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- An Analysis of Institutional Review Board Policies for Enrollment of Adults with Impaired or Uncertain Decision-Making Capacity.Journal of empirical research on human research ethics : JERHRE · 2025Article
- Diversity in decentralized clinical trials: prioritizing inclusion of underrepresented groups.BMC medical ethics · 2025Review
- Article
- Fitting a square peg in a round hole? A mixed-methods study on research ethics and collaborative health and social care research involving 'vulnerable' groups.Health research policy and systems · 2025Article
- The Importance of Including Underserved Populations in Research.Pharmaceutical medicine · 2025Review
- Institutional community engagement leader perspectives on supporting ethical community-engaged research.Journal of clinical and translational science · 2025Article
- Developing a stakeholder-informed social responsibility model for translational science.PloS one · 2025Article
- Beyond the 5-year recovery mark: Perspectives of researchers with lived and living experience on public engagement and discourse.The International journal on drug policy · 2024Article
- Eliminating gender bias in biomedical research requires fair inclusion of pregnant women and gender diverse people.Communications medicine · 2024Review
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Authors and funding
5 authors at 3 institutions in 2 countries.
Funding
Abstract
Institutional review boards, tasked with facilitating ethical research, are often pulled in competing directions. In what we call the protection-inclusion dilemma, we acknowledge the tensions IRBs face in aiming to both protect potential research participants from harm and include under-represented populations in research. In this manuscript, we examine the history of protectionism that has dominated research ethics oversight in the United States, as well as two responses to such protectionism: inclusion initiatives and critiques of the term vulnerability. We look at what we know about IRB decision-making in relation to protecting and including "vulnerable" groups in research and examine the lack of regulatory guidance related to this dilemma, which encourages protection over inclusion within IRB practice. Finally, we offer recommendations related to how IRBs might strike a better balance between inclusion and protection in research ethics oversight.
Indexed as
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What OpenQuestion holds
Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.