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In June 1998, Icos and many medical centers asked the FDA to waive consent requirements in situations where the patient was at high risk of dying and relatives could not be reached.
A number of studies have suggested that members of the public are more willing to waive consent when they understand the issues involved in carrying out such studies.
This wide variation in approach and agree rates raises important challenges for research ethics boards and data protection authorities in determining when to waive consent requirements, when to press for increased quality control, when to permit local adaptation of the consent process, and when to permit alternatives to individual express consent.
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For legal and ethical reasons, waived consent is "an area where universities are concerned that they not make a mistake," Dr. Cheung explained.
The IRB waived consent for the study.
The research ethics board of Sainte-Justine Hospital approved waived consent for this study.
While some medical ethicists opposed waiving consent, the FDA approved the proposal in August 1998 for five medical centers.
This has lead to a number of publications on community consultation on the specific issue of waived consent.
Research ethics boards at each site waived consent for enrolment in this strictly observational study (Ottawa - Ottawa Health Science Network Research Ethics Board (OHSN-REB)).
Can surrogate consent be a fair and ethical solution, or can we ask for waived consent and, if so, under what circumstances?
Study approval and waived consent were authorized by the local ethics committee (Comitè Ètic d'Investigació Clínica, Fundació Parc Taulí; Reference CEIC 2014637).
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