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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.

Forthcoming events

Will the next pandemic be caused by H5N1 influenza?

Monday, 02 June 2025, 1pm to 2pm @ Richard Doll Lecture Theatre

The world is currently experiencing a panzootic of H5N1 influenza. Wild birds have carried the virus across all continents and an unprecedented number of mammalian species have been infected including humans. What will it take for this virus to go pandemic, and does the introduction of the virus into dairy herds in USA bring that one step closer? Wendy will discuss the current knowledge on host range barriers that protect us from more frequent zoonoses and pandemic from bird flu, and show how we can use this scientific knowledge to risk assess the current situation.

Better treatment for tuberculosis

Monday, 09 June 2025, 1pm to 2pm @ BDI/OxPop Building LG seminar rooms

Resolving the genetic basis of type 2 diabetes in 125 000 Mexicans

Tuesday, 10 June 2025, 1pm to 2pm @ Richard Doll Lecture Theatre

The burden of drug resistant infections, the GRAM project

Monday, 16 June 2025, 1pm to 2pm @ BDI/OxPop Building LG seminar rooms