Prisoners are classified as a vulnerable population per CFR 46 Subpart C. A question an IRB sometimes faces is exactly who are prisoners? While the answer seems clear, some grey areas do exist with this vulnerable population.

The prisoner definition per §46.303 states, “…any individual involuntarily confined or detained in a penal institution.” Based upon this definition an individual being held in a prison or jail is a prisoner. However, what about individuals on a work release program or staying in a halfway house as part of their reintegration back into society; should we consider those individuals ‘prisoners’ when they are the study population?

Individuals on a work release status that requires them to return to the facility at night are prisoners since they are still considered detained. Individuals residing in a halfway house require a more in-depth understanding of the release conditions to the halfway house to determine a ‘prisoner’ status.

The full definition per §46.303 specifies that individuals being detained in other facilities that, “…provide alternatives to criminal prosecution or incarceration in a penal institution…” meet the criterion of being prisoners. Therefore, if failure to return to the halfway house at night or leaving without permission would result in the individual being returned to an incarceration facility, the answer is yes, they are prisoners. However, if the individual can leave the halfway house without penalty, technically they should not be considered a prisoner for research purposes.

It is important to note that individuals serving sentences under some form of community corrections (probation/parole) are not considered prisoners under the CFR definitions, however similar special considerations such as the risk of coercion need to be considered. These will be discussed in future articles.

Author: Ron Wallace, PhD

The IRB may grant a waiver of informed consent in certain instances. (Not to be confused with a waiver of consent documentation, where consent other than written consent is obtained, please see our article Waiver of Documentation of Consent if you would like more information). A full waiver of consent completely waives the requirement to obtain informed consent. However, in order for a full waiver of informed consent to be granted there are certain criteria that must be met. In this article we will discuss the specific criteria, along with examples of when a waiver of informed consent may be granted.

 

For a waiver of informed consent to be granted the following criteria must be met;

• The research involves no more than minimal risk.
• The research could not be carried out practicably without the waiver.
• The waiver will not adversely affect the rights and welfare of the subjects.
• When appropriate, the subjects will be provided with additional information about their participation.

 

Below are examples of when a waiver of consent may be granted, pending the above is met;

• Retrospective chart reviews
• Studies of existing pathology specimens
• Public observation studies

 

If you have questions regarding your study and if a waiver of consent may apply, you can refer to the CFRs at § 46.116.f. If you would like to talk through things please feel free to reach out to the Solutions IRB administrative team, at reviews@solutionsirb.com or 1-855-226-4472.

By: Cora Crawford