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|NIH Staff FAQs|
Last Revised: February 11, 2010
||Related NIH Staff FAQs|
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:
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.
It is appropriate to consider a waiver of the requirement for documented informed consent if an investigator can provide justification for:
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.
Incidental findings are apparent medical abnormalities that may have clinical implications and are observed in the course of research studies but are unrelated to the topic under study.
Examples might include: