Research with Children and Prisoners
Guidance for research with children and prisoners
In accordance with the policies set forth in 45 CFR 46.111(7)(b), when some or all of the subjects (such as children, prisoners, pregnant women, persons with disabilities, or other potentially vulnerable subjects) are likely to be vulnerable to coercion or undue influence, additional safeguards must be in place in the study to protect the rights and welfare of these subjects. The UW-Madison's Human Research Protections Program has developed general guidance for investigators on conducting research with vulnerable populations. In addition, the Health Sciences IRBs shall be looking for the following additional details in protocols involving children and prisoners.
Children (persons under 18 years of age) can be included as subjects in research only if there is no greater than minimal risk to the children, and the IRB finds that adequate provisions are made for soliciting the assent of the children and the consent of their parents or guardians. Assent means a child's agreement to participate in research. Mere failure to object should not, absent affirmative agreement, be construed as assent.
- The IRB shall determine that adequate provisions are made for soliciting the assent of the children, when in the judgment of the IRB the children are capable of providing assent. In determining whether children are capable of assenting, the IRB shall take into account the ages, maturity, and psychological state of the children involved. This judgment may be made for all children to be involved in research under a particular protocol, or for each child, as the IRB deems appropriate. If the IRB determines that the capability of some or all of the children is so limited that they cannot reasonably be consulted or that the intervention or procedure involved in the research holds out a prospect of direct benefit that is important to the health or well-being of the children and is available only in the context of the research, the assent of the children is not a necessary condition for proceeding with the research. Even where the IRB determines that the subjects are capable of assenting, the IRB may still waive the assent requirement under circumstances in which consent may be waived in accord with the general informed consent guidelines.
- The consent form must indicate that either the child may withdraw or the parent may withdraw the child from the research at any time. Research involving preschool age children must indicate when the research will be conducted (e.g., during the month of October) and the duration of the activities(s).
- Exemptions for research involving children - research using children as subjects, when the research only involves tests, may be exempt. However, research that includes survey or interview procedures or observations of public behavior is exempt only if the investigator does not participate in the observed activities.
A prisoner is defined as any individual involuntarily confined or detained in a penal institution. When reviewing protocols involving prisoners, at least one member of the IRB must be a prisoner or a prisoner representative; however, a majority of the IRB shall have no association with the prison(s) involved.
The IRB will approve research only if it finds that: 1) the risks involved in the research are commensurate with risks that would be accepted by non-prisoner volunteers; 2) procedures for selection of subjects are fair to all prisoners and immune from arbitrary intervention by prison authorities; 3) the information is presented in language that is understandable to the subject population; 4) adequate assurance exists that parole boards will not take into account a prisoner’s participation in the research, and 5) adequate provisions are provided if there is a need for follow-up examinations or care after the end of their participation.
- Research involving prisoners is never exempt from review; either expedited or full IRB review is necessary.
- Biomedical or behavioral research may involve prisoners as subjects, only if the research falls into one of the following categories:
- the proposed research involves solely the following: (i) study of the possible causes, effects, and processes of incarceration and criminal behavior, provided that the study presents no more than minimal risk; or (ii) study of prisons as institutional structures or of prisoners as incarcerated persons, provided that the study presents no more than minimal risk and does not compromise the prisoners' condition (legal or otherwise).
- research on conditions particularly affecting prisoners as a class (e.g., research on social and psychological problems such as alcoholism, drug addiction, sexual assaults) provided that the study may proceed only after the IRB has consulted with appropriate experts; or
- research on practices, both innovative and accepted, that have the intent and reasonable probability of improving the health or well-being of the subjects.