Special Population Requirements

Special/Vulnerable Populations

Who qualifies as a special/vulnerable population and what documents are needed in addition to the IRB proposal?

Children

Explanation: Anyone under the age of 18 will need additional consent documents in order to participate in the research.

Studies may include, but are not limited to, the following:

  • Asking children to evaluate their peers or family
  • Asking parents/guardians/teachers to report on the behavior of children
  • Mandatory reporting of abuse
  • Asking children for information about behavior unknown to parents / illegal behavior
  • Children who are not under their parents’ care (wards of the state, foster children, etc.)
  • Children with compromised mental/communicative capacities

DOCUMENTATION

ASKING CHILDREN TO EVALUATE THEIR PEERS OR FAMILY

  • Some studies are interested in peer social interactions, resulting in a need to have identified children evaluate other identified children, for example to correlate what one says about oneself to others’ views of them. This creates some difficulty, however, because the named classmates are participants in the research, as the regulations define human subject as a person “about whom an investigator obtains identifiable private information.” The consequence is that researchers will need to get parental consent and child assent both for children who are evaluating others and those classmates who are being evaluated.
  • If the evaluation of others is intended only to inform you about the views of the respondents, then there may be no need to obtain/maintain identifiers for the classmates. If that’s the case, the procedures to keep any information about those who are being evaluated anonymous should be made clear in the protocol and consent forms.
  • See Special Populations: Classrooms and Students in this section for more information about classroom studies, as well as Classroom and School-based Research elsewhere on the IRB website.
  • When researchers wish to ask children about their family environment or the behaviors that they witness from their family members, the family members are similarly participants in the study. In such cases, there may be significant risks to the family members if information about financial status, emotional well-being, illegal behaviors or other sensitive topics were disclosed. Their consent must be sought, or the researcher needs to explain why their consent should be waived.

ASKING PARENTS / GUARDIANS / TEACHERS TO REPORT ON THE BEHAVIOR OF CHILDREN

  • As when children are asked to report on the behavior of peers and parents (see above), assent may be needed from the true subjects of the study, in this case, the children, when parents are being asked to report about their child’s behavior. This requirement is particularly important when the child can be identified, and the topics are sensitive ones. The IRB will consider the particular circumstances to determine if assent is needed in all such third-party interviews.

MANDATORY REPORTING OF ABUSE

  • If the researcher or their staff obtains credible evidence that a child being evaluated for research purposes shows signs of abuse, it is mandated by state law that the researcher must report that information to the New York Statewide Central Register of Child Abuse and Maltreatment (sometimes referred to as the State Central Register or SCR). Research that, because of the topics explored (for example, parental discipline) or because of the population to be studied.

Classrooms and Students

Explanation: The college classroom is the site of many research activities, both when students are being trained in the research procedures and methods in the behavioral and social sciences, and when investigators are interested in research questions where students are the appropriate population.

Studies may include, but are not limited to, the following:

  • Class projects
  • Consenting minors (including college students who are younger than 18)
  • Observing student behavior in a classroom setting
  • Having students fill out surveys in a classroom setting
  • Offering extra credit as compensation for participation
  • Accessing academic records
  • Students taken out of the classroom setting for testing
  • Evaluating educational programs/tools
  • Classroom observation
  • Wanting to test students in a class where a researcher is teacher/supervisor/teacher’s aide, etc
  • Use of classroom materials that have already been collected for non-research purposes
  • Use of Banner ID for identifiers with students at SUNY Brockport

DOCUMENTATION

Illegal Behavior

Explanation: Any research that is gathering data on participants who are engaging in illegal behavior puts those participants at risk of being discovered and perpetrator and facing legal repercussions. Even though the researchers do not condone any illegal behavior, it is the researchers’ and IRB’s responsibility to determine how to study this population to offer them and/or society some benefit, while protecting these participants from the risk of negative repercussions of participation in research.

Studies may include, but are not limited to, the following:

  • Underage drinking
  • Underage smoking
  • Sexual behavior (due to the age of the participants involved)

DOCUMENTATION

Please note: Signatures on the consent forms can be waived in order to protect the participant’s anonymity.

Inclusion of Women and Minorities in Study Populations

Explanation: NIH has specific recommendations concerning the proper representation of women and minorities in research studies including:

Studies may include, but are not limited to, the following:

  • Special emphasis should be placed on the need for inclusion of minorities and women in studies of diseases, disorders, and conditions which disproportionately affect them
  • If one minority is excluded or is inadequately represented in this research a clear & compelling rationale for exclusion or inadequate representation should be provided
  • Composition of study population must be described in terms of gender and racial/ethnic group, together with a rationale for its choice
  • Gender and racial/ethnic issues should be addressed when developing a research protocol and sample size appropriate for the scientific objectives of the study
  • Protocols must employ a study design with gender and/or minority representation appropriate to the scientific objectives of the research
  • Whenever there are scientific reasons to anticipate differences between men and women, and racial/ethnic groups you should include an evaluation of these gender and minority group differences in the proposed study
  • If adequate inclusion of one gender and/or minorities is impossible or inappropriate with respect to the purpose of the research because of the health of the subjects or if they are the only study population available the rationale for the study population must be well explained and justified

Non-English-Speaking Populations and International Research Projects

Explanation: A wide range of protocols involve potential participants whose primary language is not English, or who do not speak English at all.

Studies may include, but are not limited to, the following:

  • Non-English Speaking Populations
  • Illiterate populations
  • Review of research activities by other countries and communities
  • Cultural considerations in research

DOCUMENTATION

Please note: In cases where the participant is illiterate a verbal consent can be acquired

Prisoners

Explanation: In the past, prisoners were sometimes seen as a convenient population for conducting all kinds of research where their ability to refuse to participate was compromised. The regulations are intended to afford these individuals additional protections because of this potential and historical vulnerability.

A prisoner is defined as: An(y) individual involuntarily confined or detained in a penal institution. The term is intended to encompass individuals sentenced to such an institution under a criminal or civil statute, individuals detained in other facilities by virtue of statutes or commitment procedures which provide alternatives to criminal prosecution or incarceration in a penal institution, and individuals detained pending arraignment, trial, or sentencing.

Studies are limited to the following:

  • “A study of possible causes, effects, and processes of incarceration, and of criminal behavior”
  • “Study of prisons as institutional structures or of prisoners as incarcerated persons”
  • “Research on conditions particularly affecting prisoners as a class (for example vaccine trial and other research on hepatitis which is much more prevalent in prisons than elsewhere; and research on social and psychological problems such as alcoholism, drug addiction, and sexual assaults)” or
  • “Research on practices, both innovative and accepted, which have the intent and reasonable probability of improving the health or well-being of the subject”

DOCUMENTATION

You can find all of the forms associated with the IRB here.

Compromised Cognitive and/or Communication Capacity

Explanation: Two crucial issues when a researcher wishes to collect data from cognitively challenged participants are

  1. Legal consent and
  2. Communication about the research with the participant.

Please note: Safety may also be a concern that the IRB would take into consideration