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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

Online Introduction to Immunisation Training - 20 April 2021

Tuesday, 20 April 2021, 9.30am 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.

IIC 2021 - The Virtual Edition. Hot Topics In Infection And Immunity In Children

Friday, 02 July 2021

IIC - The ESPID-Oxford Course is a residential training course covering topics in paediatric infection for paediatric infectious diseases trainees and trainers, and for all those who manage children with infections. This will be the 18th edition of the course. After having to cancel last year's IIC, the Organising Committee have decided to hold IIC 2021 as a one-day, intensive virtual event.

Virtual Immunisation Update Training – 13 July 2021

Tuesday, 13 July 2021, 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 – 14 July 2021

Wednesday, 14 July 2021, 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.**