Ethox and WEH Seminar: What gives them the right? Legal privilege and waivers of consent for research
Jon Merz, Department of Medical Ethics and Health Policy, Perelman School of Medicine, University of Pennsylvania
Thursday, 20 September 2018, 11am to 12.30pm
Seminar Room 0, Big Data Institute, University of Oxford Old Road Campus, OX3 7FZ
ABSTRACT
Waivers of informed consent for research participation are permitted in the United States under the Common Rule, the Health Insurance Portability and Accountability Act regulations, and the FDA's Exception from Informed Consent (EFIC) rule for emergency research. We assess the novel question regarding what legal right researchers have to carry out research procedures on or about another person, be it experimental medical intervention, psychological or social manipulation, or invasion of privacy, without the permission of their subjects. Our analysis frames waivers of consent as a species of presumed consent, and we address the underlying empirical question of whether it is reasonable to believe that subjects from whom no consent is sought would in fact agree, if asked. A scoping review of what is known about participation and refusal rates in US-based research suggests that a large minority, on average, do not agree to take part in research. Refusal rates vary widely. This suggests that, while researchers may assert the social utility of their studies are high enough to justify waivers, there is reason to suspect that many who would be enrolled under a waiver of consent would not want to be enrolled. We conclude that waivers should be rare, and that IRBs and researchers must explicitly address study acceptability in the community at large and the target population of their proposed research.
VIEW Previous Richard Doll seminars IN Public health and epidemiology
Professor Sir Richard Doll
Forthcoming events
The epidemiology of periportal fibrosis in the context of intestinal schistosomiasis
Monday, 09 October 2023, 1pm to 2pm @ BDI/OxPop Building seminar rooms
Defeating Meningitis by 2023 Global Roadmap
Monday, 16 October 2023, 1pm to 2pm @ BDI/OxPop Building seminar room 1
Population structure, admixture and ancestry variation across China Kadoorie Biobank and Utility of imaging-based body fat composition in predicting traits and cardio-metabolic diseases
Wednesday, 18 October 2023, 12pm to 1pm @ BDI/OxPop Building LG seminar room 0
OxPop Festival of Global Health - The Cancer Conflict
Thursday, 19 October 2023, 5pm to 8pm @ Richard Doll Lecture Theatre, Richard Doll Building, Roosevelt Drive, Oxford, OX3 7LF
Cancer Treatments: trust and information
Chronic infections and risk of NCDs in Chinese adults
Monday, 30 October 2023, 1pm to 2pm @ BBDI/OxPop Building seminar rooms
Metabolomics and diabetes in CKB and UKB
Thursday, 02 November 2023, 12pm to 1pm @ BDI/OxPop Building LG seminar room 0