Resolution of “Unacceptable” human subjects protections (also called human subjects concerns) involves an interaction between the PI and the Program Official. PIs may need to work with the Program Official to resolve human subjects concerns. Documentation of the final resolution of human subjects concerns must be signed by an Institutional Official and provided to the Program Official for approval.
Although the phrases "passive consent" and "active consent" have become a part of custom and practice in certain fields of research, neither term appears in the HHS regulations, Federal policy, or Federal guidance documents, and therefore, they cannot replace Federal requirements. The HHS regulations (46.116) state the general requirements for informed consent:
Prospectively obtained, legally effective informed consent of the subject or the subject's legally authorized representative
Consent shall be sought only under circumstances that:
provide the prospective subject or the representative sufficient opportunity to consider whether or not to participate; and
minimize the possibility of coercion or undue influence.
Information that is given to the subject or the representative during the consent process shall be in language understandable to the subject or the representative.
Informed consent, whether oral or written, may not include any exculpatory language through which the subject or the representative is made to waive or appear to waive any of the subject's legal rights, or releases or appears to the investigator, the sponsor, the institution or its agents from liability for negligence.
A waiver of some or all of the elements of informed consent described in 46.116(c) and (d) may be justified by addressing each element of either (c) or (d) in the Human Subjects section of the application. (c): (1) the research or demonstration project is to be conducted by or subject to the approval of state or local government officials and is designed to study, evaluate, or otherwise examine:
(i) Public benefit or service programs; (ii) Procedures for obtaining benefits or services under those programs; (iii) Possible changes in or alternatives to those programs or procedures; or (iv) Possible changes in methods or levels of payment for benefits or services under those programs; and (2) the research could not practicably be carried out without the waiver or alteration OR (d): (1) the research involves no more than minimal risk to the subjects (2) the waiver or alteration will not adversely affect the rights and welfare of the subjects (3) the research could not practicably be carried out without the waiver or alteration; and (4) whenever appropriate, the subjects will be provided with additional pertinent information after participation.
Informed consent documents may provide all of the information required in the Human Subjects section of the application. If the Scientific Review Group raised human subjects concerns because the Human Subjects section was inadequate, an informed consent document may be accepted as a response to concerns in lieu of a revised Human Subjects section.
At this point, OER suggests that investigators who propose studies that may result in incidental findings describe their plans for addressing incidental findings in the Human Subjects section of their applications as follows:
how observed incidental findings will be handled by research staff, and
how plans for handling incidental findings will be presented to potential participants during the informed consent process.