Consent Waivers and Exceptions in Research

Introduction:

In January 2020, Jane Hartsock, JD, MA, gave a presentation entitled, "Research without Consent." Why do healthcare facilities include such impenetrable language on general consent forms? 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, Hartsock offers the legal perspective of how and when clinicians must obtain informed consent, according to the Common Rule. She discusses consent in light of interventionary relationships between clinician and patient/participant and speaks briefly about biospecimen research. Topics include: 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; and others.