When some or all research participants are children, prisoners, pregnant women, persons with disabilities, or others who are likely to be vulnerable to coercion or undue influence, the federal Common Rule (45 CFR 46) requires that the project include additional safeguards to protect the rights and welfare of these participants. Each research protocol involving a vulnerable population must describe these additional protections. An investigator should allow extra time for review of protocols involving vulnerable populations because the reviews are often more complicated. FDA regulations (21 CFR 50) also require special protections for children involved in clinical research.
The federal Common Rule and FDA regulations restrict situations in which children, as that term is defined by state law, can participate in research. In Wisconsin, generally, a child is considered to be anyone under 18 years of age, but in some instances children younger that 18 may consent to research. See, Applying State Law in Human Subjects Research, for additional information.
Investigators should review Subpart D of 45 CFR 46 and Subpart D of 21 CFR 50 to insure that the proposed research follows federal rules for research involving children.
Most commonly, children participate in research only if there is no greater than minimal risk to them and the IRB finds adequate provisions are made for soliciting the consent of the parents or guardians of children and the assent of the children. If the child is 11 years old or older, the written assent of the child must be obtained. The consent form should always indicate, regardless of the age of the child, that either the parent or the child may withdraw the child from participation in the research at any time. The assent form should be written in language appropriate to the age level of the child involved.
See, UW-Madison guidance on Assent by Children.
Note: The exemption from IRB review for research involving survey and interview procedures or observations of public behavior (45 CFR 46.101(b)(2)) does not apply to research with children, except for research involving observation of public behavior when the investigator does not participate in the activities being observed.
A prisoner is defined by federal rule as any individual involuntarily confined or detained in a penal institution. This definition includes individuals detained in other facilities by virtue of statutes or commitment procedures that provide alternatives to criminal prosecution or incarceration in a penal institution as well as individuals being held prior to arraignment, trial, or sentencing.
Additional time is required to schedule an IRB meeting when prisoner research is involved. In most cases, protocols involving prisoners must be reviewed by the full IRB; they cannot receive an expedited review. When reviewing research involving prisoners, at least one IRB member must be a prisoner representative, and a majority of the IRB members must have no association with the prison(s) involved in the research. Only the HS IRB and the SBS IRB review federally funded prisoner research. The MR IRB may review non-federally funded research involving prisoners. The ED IRB does not review prisoner research, regardless of funding.
Note: Federally funded research involving prisoners as subjects must conform to Subpart C of the federal rules (45 CFR 46). Investigators should review this subpart to insure that the proposed research is allowable under federal rules. The exemptions from IRB review listed in 45 CFR 46.101(b) do not apply to research involving prisoners.
Research involving individuals receiving protective services, voluntarily or involuntarily, because of aging, chronic mental illness, developmental disabilities or like incapacities or receiving inpatient or outpatient treatment for mental illness, development disabilities or substance and alcohol dependency in Wisconsin must comply with the special conditions imposed by Wisconsin law. Written permission for the conduct of the research at an inpatient or outpatient treatment facility must be obtained from the appropriate officials at that facility. The research may also need to be approved by the Department of Health and Family Services (DHFS). For additional information, consult with your IRB office or the UW-Madison Office of Administrative Legal Services at 608-263-7400. See, also, Applying State Law in Human Subjects Research and Research with Adults Lacking Consent Capacity.
Research involving individuals who are voluntarily or involuntarily residing in an institution, such as a nursing home or residential psychiatric institution, because of physical or mental conditions should take into account that the characteristics of the institutional setting may create circumstances that could compromise the voluntary nature of participation in research. Ethical principles suggest that persons who are institutionalized, particularly if disabled, should not be chosen for studies that bear no relation to their situation just because it would be convenient for the researcher. Nevertheless, investigators should not assume that all institutionalized individuals are incapable of competent and voluntary consent and should describe in the protocol the process that will be used to assess each individual’s capacity to give voluntary, informed consent. For additional information, consult with your IRB office or the UW-Madison Office of Administrative Legal Services at 608-263-7400. See, also Research with Adults Lacking Consent Capacity.
Investigators conducting research involving individuals with impaired decision making capacity should describe in the protocol any necessary additional safeguards that will be provided to protect these individuals from coercion or undue influence. Impaired decision-making capacity means the inability to receive and evaluate information effectively or to communicate decisions to such an extent that the individual lacks the capacity to manage his or her research participation decisions.
Individuals with impaired decision-making capacity may include adults and emancipated minors who have a psychiatric disorder (e.g., psychosis, neurosis, personality or behavior disorders), an organic impairment (e.g., dementia), or a developmental disorder (e.g., mental retardation) that affects cognitive or emotional functions to the extent that capacity for judgment and reasoning is significantly diminished. Individuals may also have impaired decision making capacity when they are under the influence of or dependent on drugs or alcohol, suffering from degenerative diseases affecting the brain, are unconscious, in a coma, confused, in pain, suffering from a terminal illness or emotional trauma or have severely disabling physical handicaps.
It is important to keep in mind that not all persons with the above conditions will lack decision making capacity. An assessment of a participant’s capacity must be made by the investigator. An investigator should include in the protocol a description of the method that will be used to assess the decision making capacity of potential participants. Investigators should be prepared to assess decision making capacity of participants on an ongoing basis in situations where a participant’s physical or mental status may change during the course of the research.
Investigators should also describe the procedures they will follow in obtaining consent from the incapacitated individual or his or her legally authorized representative. Investigators may rely on a valid, previously executed advance directive and/or research power of attorney or an appropriate legally authorized representative to consent to participation in research on behalf of individuals who lack the capacity to consent. In the case of institutionalized individuals with impaired decision making capacity, investigators must also satisfy state law requirements.
For additional information, consult with your IRB office or the UW-Madison Office of Administrative Legal Services at 608-263-7400. See, also, Applying State Law in Human Subjects Research and Research with Adults Lacking Consent Capacity.
Investigators conducting research involving pregnant women, human fetuses, and neonates should review Subpart B of the federal rules (45 CFR 46), which includes additional required protections.
Research involving viable neonates must also comply with both Subpart A and Subpart D of 45 CFR 46.