50thAnniversary

Chapter 3 – Protected Populations

The federal government has specific regulations for research that involves a subject or subjects who belong to any one of the four groups known as protected populations:

  • children
  • persons with mental illnesses or developmental disabilities
  • prisoners
  • pregnant women, fetuses, and neonates (newborns)

Researchers intending to involve subjects who are members of a protected population in a study are required to abide by the applicable guidelines in “Protected Populations.”

Because most of the studies supported by Union Institute & University are social, artistic, or behavioral (rather than research that might pose physical harm), this chapter focuses on federal guidelines for social science / behavioral research involving protected populations. If a proposed study is in the natural or medical sciences, the researcher should thoroughly review Office of Human Research Protections / Department of Health and Human Services guidelines as well as guidelines on ethical practice specific to the researcher’s discipline or field.

3.A. Children

Children are considered to be protected because their youth may make full understanding of the risks and benefits of a study impossible, making them unable to make a truly informed decision. They are also vulnerable to coercion and undue influence. Recognizing that regulations may vary from state to state and country to country, the IRB defines a child as any individual under the age of 18. If a study will occur in an area where different legal definitions exist, the researcher should incorporate this information into the proposal if he or she is seeking a waiver of requirements for this protected population.

If the subjects of a study will be children, the researcher is expected to respect each child as an autonomous being. Consequently, the researcher must secure the assent of each child as well as the consent of the child’s parents / guardians or legal representatives. If a child cannot read, the consent process will need to be adapted to provide the information orally. Documentation of the child’s assent and the consent of parents or guardians must follow the guidelines for informed consent.

Each class of subjects that one might consider to be incompetent, such as young children, should be considered on their own terms. “Respect” requires giving them the opportunity to choose whether to participate to the extent they are able to make a decision.

Researchers are not required to obtain a child’s assent if the child is incapable of providing it. Each individual child’s ability to assent must be determined. In other words, researchers cannot assume that all children below a certain age are unable to assent. Even a very young child may be capable of understanding what is proposed and thus can agree or decline to participate. In rare instances, a child’s assent may not be required if the intervention or procedure is likely to benefit the well-being of the child directly and is available only in the context of the research. This situation occurs most frequently in biomedical research.

In determining whether children are capable of assenting, the IRB will 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.

When interacting with children, use language the child can understand and present concepts in a way the child can grasp. Researchers should also take care that the child does not feel pressured by the researcher as an adult (authority figure) or by the child’s parent, guardian, or legal representative—other authority figures.

In studies that involve more than minimal risk, obtain consent from both parents, if possible. (See “Studies with Children—More than Minimal Risk.”) For minimal risk studies, consent from one parent is sufficient. Consent from one parent is also permitted if a parent is deceased, unknown, incompetent, or not reasonably available, or if one parent has legal responsibility for the care and custody of the child. In the absence of a parent or parents able to give consent, consent may be given by a child’s legal guardian or legal representative.

Children who are wards of the state or of any agency, institution, or other entity may participate in research only if the study (1) is related to the children’s status as wards, or (2) will be conducted in schools, camps, hospitals, institutions, or similar settings in which the majority of children involved as subjects are not wards (that is, the fact that an individual subject is a ward is incidental). In these situations, researchers must provide for the appointment of an advocate for each child who is a ward. The advocate is in addition to the child’s guardian or legal representative, and he or she must have the background and experience necessary to act in the best interests of the child for the duration of the child’s participation in the research. An individual may serve as advocate for more than one child; the advocate may not be associated in any way with the proposed research, the researcher(s), or the child’s guardian organization. (See 45CFR46, Subpart D.)

3.B. Studies with Children—More than Minimal Risk

Research that involves no more than minimal risk to children may be approved only if the IRB determines that adequate provisions are made for soliciting the assent of the children and the permission of their parents, guardians, or legal representative, according to 45 CFR 46.408 (See “Informed Consent with Children.”)

In studies with children that involve more than minimal risk, researchers should obtain consent from the parent, guardian, or legal representative before obtaining assent from the child, unless the requirement for obtaining parental, guardian, or legal representative permission can be waived.

When research is conducted under the following two conditions, permission should be obtained from both parents, unless one parent is deceased, unknown, incompetent, not reasonably available (e.g., lives in another state or country, or is incarcerated), or when only one parent has legal responsibility for the custody and care of the child. (See “Informed Consent with Children” and “Children” under “Protected Populations.”)

Union Institute & University’s IRB will approve studies that can reasonably be expected to pose more than minimal risk to children only if one of the following two conditions applies:

  • The study has a reasonable prospect of direct benefit to individual subjects. In such cases, the relationship of anticipated benefit to possible risk must be at least as favorable to the subject as benefits presented by available alternative approaches.
  • The study has no prospect of direct benefit to individual subjects, but the potential risk is only slightly greater than minimal. In such cases, the intervention or procedure will be comparable to what might be encountered in actual psychological, social, educational, or medical situations. If subjects will not benefit directly, the study must be reasonably likely to yield generalizable knowledge about the subjects’ disorder or condition that is of vital importance for understanding or ameliorating it.

3.C. Persons with Mental Illnesses or Developmental Disabilities

Persons who have a mental illness or a developmental disability are particularly vulnerable subjects because their illness or disability is likely to hinder their ability to make informed, voluntary decisions. Their circumstances may also increase the likelihood of harm. This possibility is particularly true with behavioral research that involves persons with certain types of mental illnesses.

In studies that will involve subjects who have mental illnesses or developmental disabilities, researchers should obtain and follow specific guidelines designed for these subject groups by the American Psychological Association (APA).

The informed consent process for studies involving persons with mental illnesses or developmental disabilities should be carefully designed to fit the level of the subjects’ ability to comprehend and voluntarily give consent. In some situations, the researcher will need the consent of a subject’s legal guardian or legal representative. In every instance, a patient advocate is required. The advocate must have the background and experience necessary to act in the best interests of the subject for the duration of her or his participation in the research. An individual may serve as advocate for more than one subject. The advocate may not be associated in any way with the proposed research, the researcher(s), or the subject’s guardian organization (if applicable).

3.D. Prisoners

Because of their incarcerated status, prisoners (or someone who becomes a prisoner during the course of a study) are under special constraints that may affect their ability to make voluntary (not coerced) decisions about participating as research subjects. Studies involving prisoners may not present more than minimal risk. Prisoners may be asked to participate as subjects only in certain types of studies. Prisoners may participate in studies of the following:

  • Possible causes, effects, or processes of incarceration and/or of criminal behavior
  • Prisons as institutional structures
  • Prisoners as incarcerated persons
  • Conditions particularly affecting prisoners as a class
  • Practices—innovative or accepted—that have the intent and reasonable probability of directly improving the health or well-being of the individual subject

The IRB may approve research involving prisoners if any possible advantages for the prisoner through her/his participation, when compared to the general living conditions, medical care, quality of food, amenities, and opportunity for earnings in the prison, are not of such magnitude that the prisoner’s ability to weigh the risks of the research against the value of such advantages in the limited choice environment of the prison is impaired. In order words, the advantages of receiving special treatment should not lead to a prisoner consenting even if the research is not in his/her best interest.

If a research study participant becomes a prisoner during the course of a study, the researcher must notify the IRB immediately. The IRB will review the research proposal again to determine whether the subject should remain in the study, whether the IRB has sufficient representation for evaluating a study involving a prisoner, and whether appropriate protections are provided for the prisoner.

3.E. Students Used as Research Participants

When faculty or student researchers plan research projects involving students enrolled in classes taught by the researcher, the researcher must assure that participation is voluntary, that students are fully informed of the purpose of the study, and that an informed consent process is included. Coercion—unintentional or otherwise—is not acceptable. Researchers must provide a good scientific reason, rather than convenience, for conducting research with their own students as participants. The research should be relevant to the class subject matter, and participation in the study should be a part of the learning experience for the students.

Researchers presenting good reasons for involving their own students in their research studies, should ask someone else to obtain informed consent and collect the data—distribute and pick up surveys and questionnaires or other instruments. If another person is not available to assist with the research, the researcher should devise other methods for obtaining informed consent and collecting data. These methods should include details about how the researcher will not be able to determine which students participated until final grades are determined. These procedures should be presented in the informed consent form.

Acceptable recruitment methods include posting notices about the study in several locations within the school, distributing flyers to the general student population or to a specific student group, or using both posters and flyers. If personal discussions about a study occur, someone other than the researcher should conduct them. Any student who feels coerced to participate in a research project should contact the IRB.

Extra Credit and Alternative Activities
A researcher may give students extra credit for participating in a research study if students who do not participate are given an alternative activity so that they are also able to earn extra credit. Participation in alternative activities must also be free of coercion. The option to withdraw at any time without consequences, such as grades, should be included in the informed consent form. If a student withdraws from the research study, extra credit should still be given.

Other Considerations
If student records are used as a basis for research, all personally identifying information must be removed from the records. School districts and/or individual school policies may dictate how researchers may obtain database and other student records for research purposes. Researchers must obtain approval to conduct their research in their school and/or school system. Researchers planning to use student participants are required to take the “Students in Research” optional module of the CITI Course in the Protection of Human Research Subjects.

3.F. Pregnant Women, Neonates, and/or Fetuses

Pregnant women, neonates (newborns), and/or fetuses are protected by federal regulations as subjects of studies that pose a potential risk to the physical well-being of the woman, the neonate, and/or the fetus. Such projects must be consistent with the federal guidelines established by the OHRP. (See 45CFR46.204 and 45CFR46.205.)

For studies that do not pose physical risk to subjects, such as many social and behavioral science research projects, pregnant women are not considered to be protected. As an example, a study that compares some behavioral characteristic of women with children and women who have no children would not usually require special protections for any pregnant women who might be study participants.

3.G. Elderly Persons and Persons with Physical Illnesses or Impairments

The federal government does not require special protections for elderly persons or persons with physical illnesses or impairments because age and/or physical limitations do not mean that an individual is incapable of making an informed decision about participation in a study.

Studies involving elderly persons or physically ill or physically impaired individuals do, however, require researchers to be aware of and sensitive to the potential for additional risk related to a subject’s physical limitations or differences.

When working with these subjects, researchers may also need to adapt their informed consent process to meet subjects’ special circumstances. If, for example, a study includes elderly persons, the researcher should be prepared for the likelihood that a subject will have hearing difficulties or a visual impairment. (See “Informed Consent in Special Circumstances.”)