Informed Consent Guidance

Informed Consent is a process in which researchers provide information to potential participants regarding the details of a research study prior to their enrollment in the study. Obtaining an informed consent involves:

The potential participant in a research study must participate willingly, having been adequately informed about the research. If the potential participant in a research study is part of a vulnerable population (i.e. pregnant women, cognitively impaired individuals, illiterate, children, or prisoners) special protections are required.

Special safeguards for Vulnerable Population

Special considerations must be in place to protect the rights and welfare of potential participants likely to be vulnerable to coercion or undue influence. The safeguards employed for vulnerable subjects include, among many other strategies, assessing the decision-making capacity of potential subjects, securing the involvement of a legally authorized representative, requiring parental permission from a parent/ legally authorized representative and in some studies from both parent, in addition to the child’s assent, and ensuring that incentives are not coercive.

The Informed Consent Document

The informed consent document is one aspect of the informed consent process, however it is very important. The Informed consent must

Please refer to the checklist below as a guide while you are preparing your informed consent document. To assist the investigators in preparing the informed consent document, the IRB has generated an Informed Consent Template that address the elements noted below.

Basic elements are required (Per regulations) for all informed Consent forms

Additional elements as appropriate