IRB Policies and Procedures

Section 6: Procedures for Research with Vulnerable Populations

6.0 Protected Populations in Research

The IRB has a special obligation to protect the rights and welfare of subjects who are particularly vulnerable including all those who cannot give informed and legal consent themselves. Three classes of subjects, (a) fetuses, pregnant women, and human in vitro fertilization; (b) prisoners, and (c) children are singled out in federal regulations for additional protective measures.

6.1 Inclusion of Fetuses, Pregnant Women, and Human In Vitro Fertilization

Any research activity that may involve more than minimal risk to a fetus is covered by 45 CFR 46 Subpart B. This includes research that may pose minimal or low risk for subjects themselves, but might present risks if subjects were pregnant or become pregnant during the course of the study. In such cases, screening for pregnancy and exclusion of pregnant subjects is advised. Researchers who are doing research that is directed toward fetuses, pregnant women, or in vitro fertilization should be familiar with the requirements of 45 CFR 46 Subpart B.

6.2 Inclusion of Children in Research

All research with children receives special scrutiny. Children are defined (45 CFR 46.402) as “persons who have not attained the legal age for consent to treatments or procedures involved in the research, under the applicable law of the jurisdiction in which the research will be conducted.” In Texas, the legal age for consent is 18. All research for which consent is required must also, where possible, obtain the assent of the child subject. Most often, assent is obtained with the use of a child “assent form” which is a version of the consent form in language appropriate for the child’s ability to understand the elements of consent. Expedited proposals with children as subjects (except those enrolled as regular students at Texas Tech University) will be reviewed by two reviewers which may result in a somewhat longer time to process the proposal.

6.3 Inclusion of Prisoners in Research

Any research activity that involves prisoners as subjects must undergo Full Board review subject to 45 CFR 46 Subpart C.

The regulations require the IRB to provide additional safeguards because incarceration per se could affect the ability of prisoners to make truly voluntary and un-coerced decisions about whether to participate in research. It is required that at least one member of the IRB be a prisoner or prisoner representative in order to approve prisoner research. The Texas Tech University IRB has one member who serves on the board at meetings to represent interest in prisoner research. In order to approve research on prisoners, the board must make specific findings in Appendix O.

Researchers contemplating research in jails and prisons should consult the OHRP guidance at http://www.hhs.gov/ohrp/policy/index.html#prisoners.

6.4 Inclusion of People with Limited Competence

Under some circumstances it is possible to conduct research with subjects who may not be competent to fully consent to research. In such cases, the consent must be signed by a legally authorized representative, if there is one, and generally an assent must be agreed to by the subject. When no legally authorized representative exists and the competence of the subject might be in doubt, the subject’s signature on a consent form should be validated by someone believed to be able to speak on behalf of the subject. That person (a) should be a close relative or family member or a friend of long standing, if possible, and (b) must also sign a declaration stating that s/he knows the subject well enough to be able to express the subject’s wishes.