• How can my institution and I resolve a designation of “Unacceptable” Protection of Human Subjects shown on the Summary Statement?
• Why can't I use a “passive” process for obtaining consent?
• When is it appropriate to consider a waiver of some or all of the required elements of informed consent?
• When is it appropriate to consider a waiver of documented informed consent?
• How much information about Informed Consent do I need to submit to the NIH?
• If investigators can anticipate that their proposed studies could reveal incidental findings that may have potential clinical significance, how should they address the possibility of incidental findings in their applications?

How can my institution and I resolve a designation of “Unacceptable” Protection of Human Subjects shown on the Summary Statement?

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.

Why can't I use a “passive” process for obtaining consent?

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.

When is it appropriate to consider a waiver of some or all of the required elements of 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

(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.

When is it appropriate to consider a waiver of documented informed consent?

It is appropriate to consider a waiver of the requirement for documented informed consent if an investigator can provide justification for:

• The only record linking the subject and the research would be the consent document and
• The principal risk would be potential harm resulting from a breach of confidentiality;

OR

• The research presents no more than minimal risk of harm to subjects and involves no procedures for which written consent is normally required outside of the research context.

46.117(c)

How much information about Informed Consent do I need to submit to the NIH?

The PHS 398 Instructions specify that the recruitment procedure and informed consent process be described in the Research Plan in the application.

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 (see question here), an informed consent document may be accepted as a response to concerns in lieu of a revised Human Subjects section.

If investigators can anticipate that their proposed studies could reveal incidental findings that may have potential clinical significance, how should they address the possibility of incidental findings in their applications?

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:

• A study involving fractionation of normal human blood suggests a potential infection;
• A baseline study of mental status indicates a psychiatric condition;
• A screening protocol for an exercise intervention identifies a cardiac insufficiency;
• A brain imaging study of depressed individuals reveals a potential structural abnormality (From Nature, Vol. 433. January, 2005, p. 185.).

No NIH policies/guidance specifically address incidental findings, however, NINDS, NIDA, NIBIB, NIMH, NIA and Stanford University sponsored a recent meeting on “Detection and Disclosure of Incidental Finding in Neuroimaging Research.” (http://www.ninds.nih.gov/news_and_events/proceedings/ifexecsummary.htm)

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:

1. how observed incidental findings will be handled by research staff, and
2. how plans for handling incidental findings will be presented to potential participants during the informed consent process.