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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

Department of Paediatrics Away Day 2019

Wednesday, 26 June 2019, 9am to 4pm

We cordially invite all Paediatrics staff and students to attend the Departmental Away Day, held on Wednesday 26th of June at St Catherine's College, Manor Rd, OX13UJ Oxford.

Hot Topics In Infection And Immunity In Children 2019

Monday, 01 July 2019 to Wednesday, 03 July 2019

Hot Topics In Infection And Immunity In Children - 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.

Introduction to Immunisations

Monday, 15 July 2019 to Tuesday, 16 July 2019, 9am - 4pm @ Bracknell Open Learning Centre - Bracknell Open Learning Centre, Rectory Lane, Bracknell RG12 7GR

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.

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.