This section of the Investigator Manual discusses the inclusion of participants with impaired decision-making, prisoners, children, pregnant women and neonates, and other special populations.
Participants with Impaired Decision-Making
If your research includes cognitively impaired adults, or adults with potentially absent, diminished or fluctuating capacity to consent, review the HRP 417-CHECKLIST-Cognitively Impaired Adults to see the categories of research in which those with impaired decision-making may be involved. Use this checklist to ensure you are providing sufficient justification in your protocol or application for enrollment of these individuals. See also HRP 013-SOP-Legally Authorized Representatives, Children and Guardians, and HRP 090-SOP-Informed Consent.
Your protocol or application should specify the validated assessment tool that will be used for assessing capacity to consent to research and a copy should be provided with your application. If a standard assessment tool will not be used the IRB may require documentation to determine whether the tool is appropriate in the context of the study and population.
For studies involving non-English speaking participants, your protocol or application must describe how the assessment will conducted. The assessment tool does not need to be translated unless the assessor will assess the participant’s capacity to consent by speaking in the participant’s language. For studies where the assessment will be conducted in English but will include the involvement of an interpreter, the assessment tool does not need to be translated.
Your protocol or application should be explicit regarding the use of a legally authorized representative if one may potentially be utilized to consent on behalf of a participating adult.
As a matter of subjects’ protection, assent should be obtained from incompetent or incapacitated adults for research participation to the extent they are able to provide assent. Even where a legally authorized representative has consented to the research participation, an incompetent or incapacitated adult should, except in rare cases, not be included over their objection (known as dissent). The IRB will consider instances in which superseding considerations may affect this guidance.
Review HRP 415-CHECKLIST-Prisoners to ensure that you provide sufficient information in your protocol or application to justify enrollment of prisoners in your study.
Following IRB review and approval of DHHS-supported research involving prisoners, the IRB will provide a certification letter to the Office of Human Research Protections (OHRP) as required in 45CFR46.306.
Once the research has commenced, similar considerations apply when a participant becomes a prisoner at any time during the conduct of the study, regardless of study funding. In this event:
- Report this to the IRB as a reportable event; and
- Review HRP 415-CHECKLIST-Prisoners to ensure you have provided sufficient information.
If your research involves children under the age of 18, review the HRP 416-CHECKLIST-Children to ensure that you provide sufficient information in your protocol or application to justify enrollment of children. Consider whether parental permission and assent should be obtained (refer to HRP 416 for guidance) and incorporate this information in your protocol or application. For information on state law implications for enrolling children, see HRP 013-SOP-Legally Authorized Representatives, Children, and Guardians.
It possible that a child will reach the age of majority during the course of the study. The Office for Human Research Protections (OHRP) notes that informed consent should be viewed as an ongoing process throughout the duration of a research project. When a child who was enrolled in research with parental or guardian permission subsequently reaches the legal age of consent to the procedures involved in ongoing research, the subject’s participation in the research is no longer regulated by the requirements of 45 CFR part 46.408 regarding parental or guardian permission and subject assent. Unless requirements for obtaining informed consent can be waived, minors who were initially enrolled with parental/guardian permission and then reach the age of majority must provide legally effective consent if the project continues to meet the definition of research involving human subjects. This includes interacting or intervening with the subject or having access to private identifiable information.
Pregnancy testing of children who may participate in research requires special consideration. Such testing could be performed either to confirm eligibility for the study or as part of routine safety monitoring, such as before the administration of a study drug. Researchers must consider how results of such tests will be handled when they involve children and to whom they will be disclosed. This plan must be clearly outlined in the IRB materials as well as in any consent and assent documents.
Under Wisconsin law, certain health care providers must report to law enforcement or child protective services if they have reason to suspect that a child seen by them in the course of professional duties has been abused.
Reportable child abuse does not include consensual sexual activity by an individual 16 years of age or older. Additionally, health care providers who provide health care services to a child and individuals who obtain information about a child who is receiving health care services from a health care provider are not required to report, unless the following is suspected:
- The sexual intercourse or sexual contact occurred or is likely to occur with a caregiver.
- The child suffered or suffers from a mental illness or mental deficiency that rendered or renders the child temporarily or permanently incapable of understanding or evaluating the consequences of his or her actions.
- The child, because of his or her age or immaturity, was or is incapable of understanding the nature or consequences of sexual intercourse or sexual contact.
- The child was unconscious at the time of the act or for any other reason was physically unable to communicate unwillingness to engage in sexual intercourse or sexual contact.
- That another participant in the sexual contact or sexual intercourse was or is exploiting the child.
“Health care services” includes pregnancy testing, as well as family planning services, obstetrical health care or screening, and diagnosis and treatment for a sexually transmitted infection.
If in the course of clinical research a minor has a positive pregnancy test and there is a reasonable suspicion of abuse, the Principal Investigator or a member of the research team should report to law enforcement or child protective services. Nothing in the law requires reporting to a child’s parents/guardians. Researchers should use their judgment in determining whether parents/guardians should be notified of the test results and/or notified of a report to law enforcement or child protective services.
An executive order issued by the governor in 2012 makes all UW employees mandatory reporters of child abuse. For questions pertaining to Wisconsin’s mandatory reporting statute and the executive order, please contact the UW-Madison Office of Legal Affairs at 608-263-7400.
For guidance on assent, the Assent Process and Documentation section.
Pregnant Persons and/or Neonates
If you plan to include pregnant persons and/or neonates in your study, additional regulatory requirements may apply. For details on requirements for studies involving pregnant persons and/or neonates, refer to HRP 412-CHECKLIST-Pregnant Persons, HRP 413-CHECKLIST-Non-Viable Neonates, and HRP 414-CHECKLIST-Neonates of Uncertain Viability.
In Wisconsin, the reporting of pregnant persons who habitually abuse drugs or alcohol to a severe degree is permissive but NOT mandatory. Pregnant persons seeking help for drug or alcohol abuse generally do not meet reporting criteria. For studies with a Certificate of Confidentiality (CoC), the CoC protects information about drug or alcohol use from disclosure. In this case, reporting may not occur without explicit consent of the participant. It is advised that researchers not combine the consent to report with the research consent form, especially for potentially therapeutic studies. Rather, if it is determined in a specific case that a report should be made, it is recommended that consent is obtained through a separate form obtained at the time of a proposed report. No reporting may occur if the pregnant person refuses consent. Contact UW legal counsel for assistance.
Other Special Populations
In addition to the populations listed above, other groups of individuals may be considered vulnerable and require additional protections and rationale be in place to involve these groups in your study. Examples of vulnerable populations include non-English speakers, students, employees of the researcher(s)/those with a status relationship with the researcher(s), and active-duty military members. Examples of additional protections that may be required include having someone outside the study team observe the informed consent process, exclusion of the population if not required to achieve study objectives, and independent assessment to address consent capacity.
Please note, generally, enrolling subjects who are in a status relationship with the researcher(s) is discouraged. It raises special ethical concerns such as a recruitment and consent process that is not free from undue influence. Additionally, enrollment of individuals already known to the research team may heighten the potential for loss of confidentiality for those subjects.
However, if enrolling subjects with a status relationship with the researcher(s), such as family members, students, and employees, is unavoidable, the status relationship should be declared in the IRB application and justification for the inclusion of these subjects provided. The IRB will consider, on a case-by-case basis, the following factors in support of potential exceptions to the general prohibition on enrollment of subjects with potential status relationships with the researcher(s):
- The research presents minimal risk to subjects.
- If the potential subjects are students or employees, participation in the research represents a potential educational opportunity for those individuals.
- The recruitment of these subjects involves only indirect methods (i.e., potential subjects are not recruited on a personal basis). These subjects are recruited through the posting of IRB-approved flyers/ads or through IRB-approved communications sent out to a larger group (e.g., mass mailings through email or letters).
- The consent process will not be conducted by someone with whom the potential subject has a status relationship.
- If the research is conducted within the classroom setting, the instructor is blinded to the identity of participants. For example, a third party who is not in a status relationship with the students could receive data directly from the participants and strip the data of identifiers before providing the information to the researcher who is in a status relationship with the students.
If the IRB agrees that subjects in a status relationship with the research team may be enrolled in a research study, the IRB generally would require the consent form to clarify that participation in the research study or refusal to do so will not affect the individual’s employment or status as a student (e.g., grades or class standing) at the university.
Other individual exceptions for studies where there may be therapeutic benefit but greater than minimal risk may be considered by the IRB. The IRB acknowledges that patients have an inherent status relationship with their health care providers and manage these relationships differently.
Under Wisconsin state law, special provisions apply to individuals receiving protective services (voluntary or involuntary) or inpatient or outpatient treatment for mental illness, developmental disabilities or drug or alcohol dependency in Wisconsin must comply with the special conditions imposed by Wisconsin law.
- Protective services: Persons who receive protective services have the right not to be subjected to experimental research without the express and informed consent of the patient and the patient’s guardian and after consultation with independent specialists and the patient’s legal counsel. More than minimal risk research involving this population must be approved by the IRB and the Wisconsin Department of Health Services before study activities can begin.
- Mental health treatment, et al: Persons receiving treatment for mental illness, developmental disabilities, and alcoholism or drug dependency have the right not to be subjected to experimental research without the express and informed consent of the patient and the patient’s guardian (if any) and after consultation with independent specialists and the patient’s legal counsel. More than minimal risk research involving this population must be approved by the IRB and the Wisconsin Department of Health Services before study activities can begin.
For a full list of vulnerable populations and protective measures, see HRP 334 – WORKSHEET-Vulnerable Populations. For assistance with Wisconsin Department of Health Services review, contact the Reliance and Navigation Team (RELIANT; firstname.lastname@example.org).