Research without Consent

Introduction:

Why do healthcare facilities include language like this within forms of general consent to treatment? Jane Hartsock argues that this language is problematic for patients and clinicians and, in today’s ethical and legal milieu, it is meaningless. Using her experience as an attorney, Jane provides the legal perspective of how and when clinicians must obtain informed consent according to the Common Rule. She talks about consent in light of interventionary relationships between clinician and patient/participant and speaks briefly about biospecimen research. The questions raised during the discussion delve into: types of information that needs to be removed from electronic health records (EHR) to protect subject identity, issues raised in identification based on genetics, consent as an ethical process and not just a legal form, as well as other topics.