Department:

UAMS Human Research Advisory Committee

Policy Number:

15.3

Section:

Consent

Effective Date:

July 31, 2002

Revision Date:

October 11, 2002

Subject:   Waiver of Consent

A waiver may be considered by the HRAC. Decisions to waive informed consent or documentation of informed consent should be clearly documented in the HRAC's minutes (see HRAC policy 6.3).

The HRAC may approve a waiver of some or all of the consent requirements provided that:

1.   The research involves no more than minimal risk to subjects (see HRAC policy 16).

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 they have participated in the study [38 CFR16.116(d)]

Under the Federal Policy (but not FDA regulations), if the research is designed to evaluate or demonstrate possible changes in (or alternatives to) provision of benefits or services provided for under federal, state, or local programs, an HRAC may approve alteration or waiver of the consent requirements [38CFR16.116(c)]. If the research could not practicably be carried out without the waiver or alteration of the consent requirements, the HRAC may approve such a waiver.

In making decisions regarding record reviews and plans for contacting individuals thus identified, HRACs should consider the importance of the research, the extent to which privacy will be invaded, the sensitivity of the information to which the investigators will have access, plans for further contact of the subjects, and the feasibility of obtaining consent from all prospective subjects.

The HRAC may waive the consent requirement if:

1.   They are satisfied that the information contained in the files is not particularly sensitive

2.   The investigator has devised procedures to protect the confidentiality of the information to be collected

3.   The study could not practicably be carried out if consent were required.

Behavioral scientists sometimes need to observe the behavior of people who either are not aware that they are being observed or who are unaware that their behavior is being recorded for research purposes. Because subjects might behave differently if they knew they were being observed, researchers may request that the consent requirements be waived (if subjects must be unaware of their involvement, they will not have the opportunity to consent or refuse to participate in the research).

Although consent requirements can be waived if the HRAC determines that the knowledge to be gained is important, this decision can easily be influenced by the extent to which HRAC members approve of either the subject matter or what they expect may be the findings of the research. HRAC members should guard against the inclination to approve or disapprove research based upon their personal feelings about the possible outcome of a research proposal. Drawing the line between judgments about the social or scientific value of a particular study and personal attitudes towards the subject matter of that study is admittedly difficult. HRAC members should try to distinguish between qualms they may have about the subject matter (e.g., homosexuality or drug abuse) and qualms they may have about the research methods (e.g., covert observation, staged events, and so forth).