Until about thirty years ago, the extent of disclosure about and consent-seeking for medical interventions was influenced by a beneficence model of professional behaviour. Informed consent shifted attention to a duty to respect the autonomy of patients. The new requirement arrived on the American scene in two separate contexts: for daily practice in 1957, and for clinical study in 1966. A confu...

OBJECTIVE To address the need to describe informed consent in pediatric settings and to identify barriers to parent understanding, this study assessed how aspects of clinician-parent communication during the informed consent conference (ICC) relate to parent understanding of informed consent and parent perception of the impact of the ICC on their anxiety and control. METHODS Parents of 127 ch...

What renders some mentally disordered patients incapable of informed consent to medical interventions? It is argued that a patient is incapable of giving informed consent owing to mental disorder, if a mental disorder prevents a patient from understanding what s/he consents to; if a mental disorder prevents a patient from choosing decisively; if a mental disorder prevents a patient from communi...

The therapeutic misconception has been seen as presenting an ethical problem because failure to distinguish the aims of research participation from those receiving ordinary treatment may seriously undermine the informed consent of research subjects. Hence, most theoretical and empirical work on the problems of the therapeutic misconception has been directed to evaluate whether, and to what degr...

National health care registries in the Nordic countries share many attributes, but different legal and ethical frameworks represent a challenge to promoting effective joint research. Internationally, there is a lack of knowledge about how ethical matters are considered in Nordic registry-based research, and a lack of knowledge about how Nordic ethics committees operate and what is needed to obt...

OBJECTIVE To explore the doctrine of informed consent and the development of capacity in adolescents with psychiatric problems to help clinicians better reflect on the relevant ethical issues. METHOD We discuss the relevant literature and explore the role of psychiatric impairment in adolescents' ability to consent. RESULTS In common law, there is no minimum age at which individuals are abl...

The reliance of subjects and researchers on the current regulatory scheme for human subject protection is misplaced. Investigators often assume that compliance with the requirements of the Common Rule, including Institutional Review Board approval of their research project, adequately fulfills the spirit of the federal regulation and protects them from liability for lack of adequate informed co...

The recruitment and counselling of sperm donors raise several ethical issues. The word 'donation' implies no payment and informed consent for donation is essential in respecting the autonomy of the giving party. This implies looking into the motivation of donors and, when accepted, information about the screening and its results. It is a sensitive issue, especially when pathology is uncovered i...

When obtaining samples from biobanks, resolving ethical and legal concerns is a time-consuming task where researchers need to balance the needs of privacy, trust and scientific progress. The Biobanking and Biomolecular Resources Research Infrastructure-Large Prospective Cohorts project has resolved numerous such issues through intense communication between involved researchers and experts in it...

This issue of the Journal of Empirical Research on Human Research Ethics highlights the ethical issues that arise when researchers conducting projects in low- and middle-income countries seek to share the data they produce. Although sharing data is considered a best practice, the barriers to doing so are considerable and there is a need for guidance and examples. To that end, the authors of thi...