ArticleThe American journal of bioethics : AJOB2021
Informed Consent: What Must Be Disclosed and What Must Be Understood?
Article in The American journal of bioethics : AJOB, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 30 papers.
What it found
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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.
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Who cites it
30 citing papers in PubMed.
- Randomized study of two different consent procedures on recall: a study within a digital alcohol intervention trial.Trials · 2024Trial
- Artificial Intelligence-Generated Synthetic Data in Healthcare: A False Promise for Underserved Populations?Bioethics · 2026Article
- Article
- Critical care nurses' perspectives on moral distress: a qualitative study in a public sector tertiary care setting.BMC nursing · 2026Article
- A Pilot Study to Explore Length and Readability Characteristics of Subject Information Sheets/Informed Consent Forms of Clinical Trial Applications in the EU.Clinical and translational science · 2026Article
- Reconceptualizing Informed Consent as the Objective Activity of Real Person.Journal of bioethical inquiry · 2026Article
- Barriers and facilitators to participant recruitment and retention among black adults in a mobile health intervention to control hypertension (MI-BP): A mixed methods study.Journal of clinical and translational science · 2026Article
- LuminaConsent: AI-driven standardization and quality enhancement of urological informed consent documentation.Northern clinics of Istanbul · 2026Article
- Protocol to Assess the Knowledge, Attitude, and Practices of Midwives in the Implementation of Maternal Healthcare Guidelines in a Selected District, Limpopo Province, South Africa.Nursing reports (Pavia, Italy) · 2025Article
- Critical Care Physicians' Perspectives on Nudging in Communication.JAMA network open · 2025Article
- The Ethics of Set and Setting in Psychedelic Psychotherapy.Neuroethics · 2025Article
- Cisnormative Language and Erasure of Trans* and Genderqueer Student Representation in Biology Education Research.CBE life sciences education · 2025Article
- Consideration and Disclosure of Group Risks in Genomics and Other Data-Centric Research: Does the Common Rule Need Revision?The American journal of bioethics : AJOB · 2025Article
- Article
- Emerging Ethical Challenges in Manufacturing of Cell-Based Medicines.Advances in experimental medicine and biology · 2025Review
- Informed proxy consent for ancient DNA research.Communications biology · 2024Article
- Article
- Ethical framework for FACILITATE: a foundation for the return of clinical trial data to participants.Frontiers in medicine · 2024Article
- Oral Squamous Cell Carcinoma: Features and Medico-Legal Implications of Diagnostic Omission.Case reports in dentistry · 2024Article
- The Normative Power of Consent and Limits on Research Risks.Ethical theory and moral practice : an international forum · 2024Article
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Authors and funding
2 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
Over the last few decades, multiple studies have examined the understanding of participants in clinical research. They show variable and often poor understanding of key elements of disclosure, such as expected risks and the experimental nature of treatments. Did the participants in these studies give valid consent? According to the standard view of informed consent they did not. The standard view holds that the recipient of consent has a duty to disclose certain information to the profferer of consent because valid consent requires that information to be understood. The contents of the understanding and disclosure requirements are therefore conceptually linked. In this paper, we argue that the standard view is mistaken. The disclosure and understanding requirements have distinct grounds tied to two different ways in which a token of consent can be rendered invalid. Analysis of these grounds allows us to derive the contents of the two requirements. It also implies that it is sometimes permissible to enroll willing participants who have not understood everything that they ought to be told about their clinical trials.
Indexed as
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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.