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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.

Oxford Talks

Forthcoming events

Virtual Influenza Update Training

Wednesday, 22 September 2021, 10am to 12.30pm

This training is for general practice nurses and other health professionals who as part of their role already administer and promote / advise about influenza vaccines. The training will cover the theory of the influenza programme. ** Please note the local logistics of delivering the 2021/22 influenza programme will NOT be addressed **

Online Introduction to Immunisation Training - 6 October 2021

Wednesday, 06 October 2021, 9.15am to 3pm

This training is for general practice nurses and other health professionals who are new to the role of administering and promoting and / or advising about vaccines.

Virtual Immunisation Update Training – 25 January 2022

Tuesday, 25 January 2022, 9.30am to 12.30pm

A free immunisation update training for General Practice Nurses and other registered healthcare practitioners who administer/advise about immunisations within the BOB and Frimley ICS. **This is an online training and will be delivered using Microsoft Teams.**

Virtual Immunisation Update Training – 26 January 2022

Wednesday, 26 January 2022, 9.30am to 12.30pm

A free immunisation update training for General Practice Nurses and other registered healthcare practitioners who administer/advise about immunisations within the BOB and Frimley ICS. **This is an online training and will be delivered using Microsoft Teams.**

Oxford Vaccine Group 17th Immunisation Seminar

Thursday, 17 March 2022, 9am to 4pm

Save the date!