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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

NDPH Special Seminar - Could cigarette smoking really protect against a few types of cancer?

Monday, 21 October 2019, 1pm to 2pm @ CEU meeting room, 3rd Floor, Richard Doll Building, Old Road Campus, OX3 7LF

Richard Doll Seminar - Chronic kidney disease of unknown cause: the epidemic you’ve never heard of

Tuesday, 22 October 2019, 1pm to 2pm @ Seminar rooms, BDI, Old Road Campus, OX3 7LF

UVBO Seminar - Nutrient timing and human health

Thursday, 24 October 2019, 1pm to 2pm @ School of Anthropology, 61 Banbury Road, OX2 6PE

NPEU Seminar - title TBC

Monday, 28 October 2019, 2pm to 3pm @ Seminar room 0, BDI, Old Road Campus, OX3 7LF

Richard Doll Seminar - Prostate cancer screening and treatment: what is the trial evidence and linked epidemiology?

Tuesday, 29 October 2019, 1pm to 2pm @ Seminar rooms, BDI, Old Road Campus, OX3 7LF

Health Services Research Unit Methods Group – Clinical Outcome Assessments: Content validity and meaningful change

Tuesday, 05 November 2019, 10.30am to 11.30am @ L1 Meeting room, Richard Doll Building, Old Road Campus, OX3 7LF