lWaiver will
not adversely affect rights and welfare of subjects
lInformation
provided to subjects as appropriate after participation
l
Also – the regulations allow
for the waiver of written consent when:
1)The only record linking the subject and the research would be the
consent document and the principal risk is breach of confidentiality.Each subject must be asked whether he/she
wants documentation linking the subject with the research.
2) The research presents no more than minimal risk of harm and involves
no procedures for which written consent is normally required outside the
research context.
