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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

Influenza Vaccination Update Training

Wednesday, 18 September 2019, 9am to 1pm

Influenza vaccination update training covering the childhood and adult national programmes. A summary update will be included on pneumococcal (adult), shingles and pertussis in pregnancy vaccination.

Influenza Vaccination Update Training

Tuesday, 24 September 2019, 9am to 1pm @ Oxford Science Park, Magdalen Centre 1 Robert Robinson Avenue, Oxford OX4 4GA

Influenza vaccination update training covering the childhood and adult national programmes. A summary update will be included on pneumococcal (adult), shingles and pertussis in pregnancy vaccination.

Thames Valley & Wessex Paediatric Infectious Diseases Course

Monday, 30 September 2019, 10am to 4.45pm @ 34 Broad Street Oxford OX1 3BD

This one-day course is for consultants, trainees, specialist nurses and all those who care for children with infections.

Immunisation Update Training

Tuesday, 08 October 2019, 9am to 1pm

Immunisation update training for General Practice Nurses and other registered healthcare practitioners who administer/advise about immunisations within the Thames Valley. A free half-day Immunisation update training for General Practice Nurses and other registered healthcare practitioners who administer/advise about immunisations in the Thames Valley.

Immunisation Update Training

Wednesday, 09 October 2019, 9am to 1pm

Immunisation update training for General Practice Nurses and other registered healthcare practitioners who administer/advise about immunisations within the Thames Valley. A free half-day Immunisation update training for General Practice Nurses and other registered healthcare practitioners who administer/advise about immunisations in the Thames Valley.

Introduction to Immunisations

Monday, 02 December 2019 to Tuesday, 03 December 2019, 9am - 4pm

A free 2-day Training Event for general practice nurses and health professionals new to immunisation practice who administer / promote / advise about vaccines in the Thames Valley. Funding for this event is from NHS England through Health Education England.