People who may be especially susceptible to coercion or undue influence are considered vulnerable subject populations. Additional protections are required for research involving vulnerable subject populations in part due to the history of research-related exploitation among these groups. These include:
- Children/minors.
- Cognitively impaired individuals.
- Pregnant subjects/fetuses, neonates, placental/fetal materials.
- Prisoners (this does NOT include individuals on probation or parole, unless detained in a treatment center).
- Subjects whose primary language is not English.
- Undocumented immigrants.
- Individuals who are illiterate.
- Individuals diagnosed with significant mental illness or physical disability.
- Students or employees of a study investigator.
- Individuals with substance addiction.
- Individuals with low socio-economic status, to the extent that they might be coerced into taking risks by payment of a significant economic benefit to take part in the study.
IRB considerations about vulnerable subjects
- If a research project will involve prisoners or children, federal law and university policy impose additional requirements.
- The IRB will ensure that the investigator provides appropriate additional safeguards to protect subject wellbeing. Investigators will be asked to give justification for selecting vulnerable subject groups.
- As much as possible, to preserve the subjects’ privacy and autonomy the initial contact with vulnerable individuals should be made by or through people who have no connection with the research.
- If the subjects are not literate and the consent presentation is verbal, investigators should ensure all requirements for obtaining documented consent are followed.
- Under certain circumstances, a witness may need to be present when vulnerable subjects document their consent.
Contact ORCA at orca@ucsc.edu with any questions about research studies with vulnerable groups and allow extra time for review of these studies.
Research involving children or adolescents
Federal regulations permit the IRB to approve the following categories of research involving children or minors:
- Research that involves no more than minimal risk to children, if adequate provisions are made for soliciting the assent of the children and the permission of their parents or guardians.
- Research that involves more than minimal risk if:
- the research offers the prospect of direct benefit for the individual subject;
- the risk is justified by the anticipated benefit; and
- the relation of the anticipated benefit to the risk is at least as favorable to the subjects as that presented by available alternative approaches.
- Research that involves more than minimal risk to children if:
- the risk represents a minor increase over minimal risk;
- the intervention or procedure presents experiences to subjects that are reasonably proportionate with those inherent in their actual or expected medical, dental, psychological, social or educational situations; and
- the research is likely to yield generalizable knowledge about the subjects’ disorder or condition which is of vital importance for the understanding or amelioration (improvement) of the subjects’ disorder or condition.
- Research that the IRB believes does not meet the previous categories, but finds that the research presents a reasonable opportunity to further the understanding, prevention, or alleviation of a serious problem affecting the health or welfare of children, must be reviewed by HHS.
Guidance for working with children
To provide additional protection for investigators and underage human subjects, the UCSC IRB encourages investigators who will be working with children in a one-to-one situation to use procedures that reduce the potential and perceived risk to the child and the investigator. These procedures should be fully described in the study submission. Possible protective measures an investigator might use include:
- Having a third party present, or a trusted adult within sight or earshot.
- Recording interviews on video.
- Conducting meetings or interviews in a location that offers the possibility of passive surveillance by a third party, like a public place or in a room with a large window through which the encounter can be discreetly observed.
If an investigator cannot include any protective methods in the research, the investigator should provide a justification why the research could not be carried out with protective measures in place.
Reporting of child abuse or neglect
The California Child Abuse & Neglect Reporting Law (CANRA) requires certain individuals to report suspected child abuse or neglect.
Under CANRA, legally mandated reporters include:
- Clergy members (i.e., a priest, minister, rabbi, religious practitioner, or similar functionary of a church, temple, or recognized denomination or organization).
- Any custodian of records of a clergy member.
- Child care providers (e.g., an administrator of a public or private day camp; an administrator or employee of public or private youth center, recreation program, or organization; a licensee, administrator, or employee of licensed community care or child day care facility; an employee of a child care institution (foster parents, group home personnel, personnel of residential care facilities)).
- Educators (e.g., teachers; instructional aides; teacher’s aides or assistants employed by any public or private school; classified employees of any public school; administrative officers or supervisors of child welfare and attendance, or certificated pupil personnel employees of any public or private school; any employee of a County Office of Education or the State Department of Education whose duties require direct contact and supervision of children; Head Start Program teachers).
- Law enforcement (i.e., any employee of any police department, county sheriff’s department, county probation department, or county welfare department; peace officers; firefighters (except for volunteer firefighters); and animal control officers or humane society officers).
- Medical professionals (e.g., nurses, paramedics, EMT’s, physicians, dentists, chiropractors, alternative health practitioners, physical therapists).
- Mental health professionals (e.g., clinical social workers, trainees and interns; marriage, family and child counselors, trainees and interns; school counselors; psychologists, psychological assistants, and interns; alcohol and drug counselors).
- Commercial film and photographic print processors.
A complete list of mandated reporters is provided in the California Penal Code (PC) section 11165.7.
Investigators are not specifically identified as mandated reporters under CANRA or under UCSC IRB policy. If an investigator is a mandated reporter in another role (e.g. physician or teacher), this reporting requirement carries over to research activities and would need to be made clear. Clarifications should occur both in the IRB submission (in the “Subject Identification” section) as well as to subjects during the informed consent process.
Research involving people with limited decision-making capacity
The decisional capacity of potential research subjects should be evaluated if there is reason to believe that they may not be capable of making voluntary and informed decisions about research participation. Whenever possible, investigators should attempt to obtain informed consent directly from the research subject, but if a subject’s decisional capacity is limited surrogate consent may be warranted. See Informed Consent for more information.
Capacity assessments
Capacity assessments are needed for research involving subjects who may not possess full decision-making capacity, unless the investigator can justify why such assessments would be unnecessary for a particular group. Based on risk to subjects, the IRB reviewer will determine whether this assessment is required.
There are a variety of methods that can be used to assess capacity. In some cases, standardized cognitive assessments may be warranted; in other cases, less formal procedures may be used, such as having the individual recall and summarize their understanding of the study, including risks and benefits. Methods include repetitive teaching, audiovisual presentations, follow-up questions to assess subject understanding, audio/video-recording of consent interviews, or involvement and/or concurrent consent of a trusted family member or friend in the disclosure and decision-making process.
In general, the capacity assessor should be an investigator or consultant familiar with dementias or cognitive impairment and qualified to assess and monitor subjects’ capacity and consent on an ongoing basis. The IRB will consider the qualifications of the proposed individual(s) and whether they are sufficiently independent of the research team and/or institution.
For more information, see Decision Making Capacity Guidelines.
Research involving pregnant subjects
For research that specifically aims to recruit pregnant subjects, regulations require the following:
- Any risk is the least possible for achieving the objectives of the research.
- Each individual providing consent is fully informed regarding the reasonably foreseeable impact of the research on the fetus or neonate.
Research that specifically includes pregnant subjects is not common at UC Santa Cruz. Reach out to orca@ucsc.edu for guidance on requirements of this subject population.
For more information, see Additional Protections for Pregnant Women, Human Fetuses and Neonates Involved in Research.
Research involving fetuses or fetal tissue
The University of California is compliant with California state law that permits research using human embryonic stem cells if that research is reviewed and approved by a federally registered IRB.
Research conducted by UC Santa Cruz investigators that is funded by federal agencies other than the Department of Veterans Affairs (VA) must comply with provisions of the NIH Revitalization Act of 1993 (Public Law 103-43) with respect to use of fetal tissue. The VA prohibits research involving a fetus, in-utero or ex-utero (including human fetal tissue) or in vitro fertilization by VA investigators.
Research involving prisoners
Additional provisions apply to any research with incarcerated individuals as subjects. If the study is aimed at a broader subject population and prisoners are only incidentally involved, the research would not be considered to involve prisoners.
Research involving prisoners cannot be exempt from IRB review.
If an adolescent (e.g., age 13-18) is detained in a juvenile detention facility, they are considered a prisoner. In addition to the regulations involving prisoners, the regulations involving minors would also apply.
If a subject becomes a prisoner after enrollment in research
When a previously enrolled research subject becomes a prisoner and the relevant research study did NOT indicate that prisoners would be enrolled as subjects, the PI should promptly notify the IRB of this event. All research interactions and collection of identifiable information must cease until the requirements at HHS regulations at 45 CFR 46, subpart C have been satisfied with respect to the relevant study.
Research involving subjects whose primary language is not English
The PI is responsible for ensuring subjects are provided with an opportunity to ask questions in their primary language. The PI is also responsible for ensuring non-English speaking subjects are provided with accurate translations, in the subject’s primary language, of the consent documents and other study materials used (e.g., questionnaires, recruitment materials, etc.).
Research involving subjects who are undocumented immigrants
Justification is required for research that will ask subjects about documentation status. The submission must also include a description of how the rights and welfare of this vulnerable subject population will be protected. If the research is related to the subject’s documentation status, investigators will need to complete required training.
Research involving UC Santa Cruz students
Students in subordinate relationships (like that between student and instructor, or employee and supervisor) are considered vulnerable subjects because of the risk of real or perceived coercion. The voluntary nature of their participation could be skewed by their relationship with the investigator. Student participation in research must not be mandatory and the investigator must provide a reasonable academic alternative for students not wishing to participate.
If the study will collect or use identifiable student educational records (GPA, SAT test scores, etc.), investigators will need to complete required FERPA training and comply with all applicable FERPA regulations.