Guidelines for special “vulnerable” populations

Definition: This term includes “those who are relatively (or absolutely) incapable of protecting their own interests” (as cited in DuBois, 2006). According to DuBois (2006), as based on the NBAC’s framework, vulnerability may exist in six potential ways: Cognitive/communicative vulnerability; institutional vulnerability; deferential vulnerability; medical vulnerability; economic vulnerability; and social vulnerability.

In essence, the knowledgeable and responsible IRB member becomes a representative for potentially vulnerable participants.

Foundational Ethical Principles (from the Code of Ethical Conduct of the APA):

  1. Nonmaleficience – Do no harm.
  2. Beneficience – Promote the well-being of participants.
  3. Justice – Equitable participant selection in instances where clear benefits are apparent.

Federal regulations require that special consideration be given to protecting the welfare of particularly vulnerable study participants. Participants including minors, pregnant women, adults with decisional impairment, prisoners, and the economically or socially disadvantaged are considered vulnerable research subjects, and projects involving such participants must undergo IRB review. Research with these populations requires implementation of special safeguards, particularly with respect to informed consent.

Children

According to federal regulations, "children" are persons who have not attained the legal age necessary to give informed consent to treatments or procedures involved in the research. In Michigan , individuals under the age of 18 are considered children for research purposes.

The IRB can approve research involving child participants if the proposed research fits into one of the following three categories (DuBois, 2006, p. 368):

  1. Research presenting “no greater than minimal risk” to children;
  2. Research involving an intervention or procedure presenting more than minimal risk to children that offers the ‘prospect of direct benefit’ or may ‘contribute to the …..well-being of the individual child’;
  3. Research involving an intervention or procedure that presents only a ‘minor increase over minimal risk’ yet does not offer any ‘prospect of direct benefit’ or ‘contribute to the well being’ of the child;

Special considerations:

1. Studies involving survey or interview procedures may not be reviewed at the exempt level when children are participants.

2. Observations of public behavior where the researcher is a participant in the activity may not be reviewed at the exempt level when children are participants.

3. Researchers working in educational and/or clinical/therapeutic settings must ensure that the participants know that the research is separate from any instruction or intervention and that no adverse consequences will come as a result of a decision to decline participation.

4. Where children are participants, the researcher must provide for obtaining both the consent of the child’s legal representative (parent or guardian) and the child’s assent (the child’s affirmative agreement to participate in the research). Only in very limited circumstances may the IRB waive the requirement for parental/guardian consent or child assent. When the IRB requires both the parent’s consent and the child’s assent in a research project, the researcher MUST obtain parental consent PRIOR to seeking the child’s assent or participation. The IRB requires participant assent and parental consent for all studies, unless a waiver with appropriate rationale is requested by the researcher and granted by the IRB.

5. Federal regulations also address research involving children who are wards of the state. Wards of the state may be participants in a research study only if the research is:

(1) related to their status as wards; or

(2) conducted in schools, camps, hospitals, institutions, or similar settings in which the majority of children involved as subjects are not wards

Where a study involves children who are wards of the state, the regulations require that the researcher appoint an advocate for each child who is a ward, in addition to any other individual acting on behalf of the child as guardian or in loco parent is. One individual may serve as advocate for more than one child. The advocate should be an individual who has the background and experience to act in, and agrees to act in, the best interests of the child for the duration of the child's participation in the research and who is not associated in any way (except in the role as advocate or member of the IRB) with the research, the researcher, or the guardian organization. Researchers should delineate in their application materials the study specific procedures addressing this requirement.

Prisoners

"Prisoner" is defined to include any individual involuntarily confined or detained in a penal institution. The term encompasses individuals sentenced to such an institution under a criminal or civil statute; detained in other facilities by virtue of statutes or commitment procedures which provide alternatives to criminal prosecution or incarceration in a penal institution; and/or detained pending arraignment, trial, or sentencing. Researchers must recognize that incarceration could affect a person's actual or perceived ability to make a genuinely voluntary and un-coerced decision whether or not to participate in a study. Hence, federal regulations provide safeguards for the protection of prisoners. It is suggested that any study that recruits prisoners must be reviewed at the Full Review level.

Four categories of research involving prisoners are permitted under the federal regulations:

  1. Study of the possible causes, effects, and processes of incarceration, and of criminal behavior, provided that the study presents no more than minimal risk and no more than inconvenience to the subjects,
  2. Study of prisons as institutional structures or of prisoners as incarcerated persons, provided that the study presents no more than minimal risk and no more than inconvenience to the subjects,
  3. Research on conditions particularly affecting prisoners as a class (for example, research on social and psychological problems such as alcoholism, drug addiction and sexual assaults, which present in a prison environment) provided that the study may proceed only after DHHS has consulted with appropriate experts including experts in penology medicine and ethics, and published notice, in the Federal Register, of its intent to approve such research, or,
  4. Research on practices, both innovative and accepted, which have the intent and reasonable probability of improving the health or well-being of the subject.

In reviewing the study, in addition to the usual criteria for approval, the CU-IRB must find the following:

  1. Any possible advantages accruing to the prisoner(s) through his/her participation in the study, when compared to the general living conditions, medical care, quality of food, amenities and opportunity for earnings in the prison, are not of such a magnitude that his/her ability to weigh the research risks against the value of such advantages in the limited choice environment of the prison is impaired,
  2. The risks involved in the research are commensurate with risks that would be accepted by non-prisoner volunteers,
  3. Procedures for participant selection within the prison are fair to all prisoners and immune from arbitrary intervention by prison authorities or prisoners. Unless the principal researcher provides to the CU-IRB justification in writing for following some other procedures, control participants must be selected randomly from the group of available prisoners who meet the characteristics needed for that particular research study,
  4. The informed consent information is presented in language understandable to the participant population,
  5. Adequate assurance exists that parole boards will not take into account a prisoner's participation in the research in making parole decisions, and each prisoner is clearly informed in advance that participation in the research will have no effect on his/her parole, and
  6. Where the CU-IRB finds there may be a need for follow-up examination or care of participants after their participation ends, adequate provision has been made for such examination or care, taking into account the varying lengths of individual prisoners' sentences, and for informing participants of this fact.

If the study was not initially approved to recruit prisoners, then the researcher may not enroll a prisoner should such a person present as a possible participant. The rules also apply for a subject who at a later date becomes a prisoner, because it is unlikely that the CU-IRB review of the research study contemplated the constraints imposed by incarceration. Therefore, if a researcher determines that a subject has become a prisoner at some later date after enrollment, and the study involves additional research interventions or interactions with that subject, the subject must either be dropped from follow-up, or the researcher must submit a modification request prior to further interaction with the prisoner subject(s).

Of particular concern is the research participation of prisoners who are also minors. Involvement of such individuals in research necessitates close scrutiny, as they may be particularly vulnerable.

Persons with diminished decisional capacity (decisional impairment)

Individuals in a wide variety of situations may have diminished capacity to make sound and well-reasoned decisions, including giving consent to participate in a study. For example, impairment may occur at times of great stress and may make a potential participant more vulnerable to real or perceived coercion. Diminished capacity can be temporary or permanent, and is not limited to individuals with neurological, psychiatric, or substance abuse problems. Conversely, individuals with neurological, psychiatric, or substance abuse problems should not be presumed to have diminished capacity to consent. Participants with diminished capacity are considered vulnerable and therefore researchers need to employ additional protections.

Considerations include:

  1. People with insufficient capacity to consent should not be used as research participants when research could be conducted with decisionally capable participants;
  2. Research studies must include a thorough justification of the research design used, including a description of procedures designed to minimize risks to subjects;
  3. Express preference should be given for research that has specific potential benefits for participants;
  4. Studies designed to provoke symptoms, withdraw subjects rapidly from therapies, use placebo controls, or otherwise to expose participants to risks that may be inappropriate are subject to heightened scrutiny;
  5. No person who has the capacity to consent may be enrolled in a study without his or her informed consent;
  6. When potential participants are capable of making informed decisions about participation, they may accept or decline participation without involvement of third parties;
  7. Any potential or actual subject’s objection to enrollment or continued participation in a research study must be heeded in all circumstances;
  8. A researcher, acting with a level of care and sensitivity that will avoid the possibility or appearance of coercion, may approach people who previously objected to ascertain whether they have changed their minds;
  9. For research studies that present greater than minimal risk, the CU-IRB may require that an independent, qualified professional assess the potential subject’s capacity to consent. The study should describe who will conduct the assessment and the nature of the assessment. The CU-IRB may permit researchers to use less formal procedures to assess potential subjects’ capacity if there are good reasons for doing so;
  10. A person who has been determined to lack the capacity to consent to participate in a research study must be notified of that determination before permission may be sought from his/her legally authorized representative to enroll that person in the study. If permission is given to enroll the person in the study, s/he must then be notified. Should the person object to participating, this objection must be heeded;
  11. Persons determined to lack the capacity to consent should not be enrolled in a study which is not likely to result in direct benefit to them, unless the study presents no more than minimal risk, and;
  12. For research studies involving subjects who have fluctuating or limited decision-making capacity or prospective incapacity, researchers should establish and maintain ongoing communication with involved caregivers, consistent with the subjects’ autonomy and with medical confidentiality.

Particularly with vulnerable populations, researchers must continue to conceptualize and treat consent as an ongoing process.

Women and Minority Populations

All research involving human subjects should be designed and conducted to include members of both genders and of minority groups, unless a clear and compelling rationale and justification establishes that such inclusion is inappropriate with respect to the health of the subjects or the purpose of the research. Cost is not an acceptable reason for exclusion except when such a study would duplicate data from other sources. Studies should employ a design with gender, racial and/or age representations appropriate to the known incidence/prevalence of the disease or condition being studied. If subjects of a certain gender, race or age group are to be excluded, such exclusion must be clearly explained and justified by the researcher.

For example, if inclusion of women is impossible or inappropriate with respect to the purpose of the research, the health of the subjects, or other reasons, or if there is a disproportionate representation of one gender in the only study population available, these reasons for excluding women or men, or for not including either gender in numbers appropriate to the incidence/prevalence of the disease, must be well explained and justified by the researcher.

It is not expected that every minority group and subpopulation will be included in each study. However, broad representation and diversity are the goals, even if multiple sites are needed to accomplish it. The National Institutes of Health, (NIH), has identified the minimum racial descriptors as

  1. American Indian or Alaskan Native: A person having origins in any of the original peoples of North America, and who maintain cultural identification through tribal affiliation or community recognition,
  2. Asian or Pacific Islander: A person having origins in any of the original peoples of the Far East, Southeast Asia, the Indian subcontinent or the Pacific Islands and Samoa,
  3. Black, not of Hispanic origin: A person having origins in any of the black racial groups of Africa , and
  4. Hispanic: A person of Mexican, Puerto Rican, Cuban, Central or South American or other Spanish culture or origin regardless of race.

Each minority group may contain subpopulations which are delimited by geographic origins, national origins and/or cultural differences. The minority group or subpopulation to which an individual belongs is determined by self-reporting.

Special considerations are needed in cases of research involving pregnant women. Of particular importance is clear assessment of potential risk for both mother and unborn child.

College Students

Consistent with an overall concern that no research participant should be coerced, researchers should take particular precautions to avoid the unintentional coercion that may occur when a potential research participant is also a student. Further, to avoid potential conflicts and harm that can arise with multiple relationships, researchers should be cautious about using their own students as research participants.

Researchers who wish to use their own students should be able to provide a good scientific reason, rather than convenience, for selecting those students as research participants. In instances where researchers use their own students in their research, the CU-IRB generally requires that someone other than the researcher/instructor obtain informed consent and collect the data. When this is not possible, the CU-IRB will consider other methods for obtaining consent and collecting data that would not reveal to the researcher/instructor whether or not a student participated in the research project until after final grades have been determined. The students should be informed of what these procedures are in the informed consent document.

Researchers may propose to give extra credit to students who participate in a research project only when alternative means of obtaining equivalent extra credit with equivalent effort are made available to students who do not wish to volunteer as research subjects. The researcher should make sure that students are not being coerced into participating. For example, if volunteering for a survey takes 30 minutes and the student's output is not evaluated for its quality to determine whether extra credit is given, the alternative should involve 30 minutes of effort and the output should not be evaluated (beyond assurance that a good faith effort was made). The informed consent document should make clear the consequences of withdrawing from a study prior to completion (e.g., dispensation of extra credit). In general, the researcher should give the extra credit even if the subject withdraws, unless the student withdraws immediately or there is clear evidence of bad faith on the part of the student.

There may be circumstances when a researcher wants to use required class assignments (e.g., journal entries or evaluations) in his or her research. The course syllabus should clearly state that the assignments are required for the course, but that at the end of the semester, the researcher/instructor will ask the student for permission to use the assignments for research purposes. It should be clear that participation will not affect a student's grade. The students should understand procedures to be used to ensure that the researcher/instructor does not know who has consented until after final grades have been determined (e.g., department secretary keeps informed consent documents until after the course grades have been handed in).

Students in public schools

Educational research is highly valuable and requires the participation of many parties including students, school systems, teachers, communities, administrators, and parents. Special consideration must be given to protecting the best interest of children (see section on Children reviewed above).

At times, a “passive consent” approach will be utilized wherein parents are informed that research may be taking place in their child’s school. In such case, parents must be notified and given the opportunity to choose not to have their child participate.

School-based researchers must be sure to provide appropriate and attractive options for those who choose not to participate. Non-participants must be assured that the decision to decline participation will not result in adverse impact on grades, evaluations, and overall treatment within the school setting.

FERPA requires that written parental permission be attained before reviewing students written educational records. Schools may disclose, without consent, information that is considered “directory” information which includes name, address, telephone number, date and place of birth, honors and awards, and dates of attendance. Schools must inform parents of the potential release of this directory information and give reasonable time and opportunity for parents to decline disclosure. Research in private schools that do not receive federal funding are not subject to FERPA provisions.

Researchers conducting school-based research must make efforts to reduce any “educational harm” that may arise if too much instructional time and effort is diverted to research efforts.