Vulnerable Populations in Research

Vulnerable Populations in Research

T o be considered a vulnerable population, the targeted group must be the focus of the research. If the target is the general population, and one of these groups (except prisoners) will participate, they are not considered a "target" population.

Note: If prisoners are the targeted study population, the study must be reviewed via full board and a prisoner representative must be consulted by the IRB.

(See SOP 013: Research Involving Vulnerable Populations, SOP 014: Research Involving Children, and SOP 047: Research Involving Prisoners, for more guidance)

Diminished Capacity 

The PI should identify the intent to enroll vulnerable subjects in the proposed research in the initial submission and provide justification for their inclusion in the study. The justification must include a description of how mental capacity will be assessed. 

• If the research involves adults unable to consent, the IRB evaluates the proposed plan for consent of legally authorized representatives.
• The IRB evaluates and approves the proposed plan for the assent of participants. If mental capacity is over 7 years of age, an assent is needed with a guardian consent.
• Be aware that the IRB evaluates the research to determine the need for additional protections and consider the use of a data and safety monitoring board or data monitoring committee as appropriate. 
• The PI should provide appropriate safeguards to protect the subject’s rights and welfare, which may include the addition of an independent monitor. The independent monitor is a qualified individual not involved in the research study who will determine the subject’s capacity to provide voluntary informed consent.

An example of study that warrants independent monitoring:

• Those involving schizophrenic patients who will be exposed to placebo, and/or drug washout, and/or treatment with agents that are not approved by the Food and Drug Administration (FDA).

Examples of populations requiring independent monitoring:

• Individuals with schizophrenia, other psychotic disorders or conditions characterized by lack of reality testing (i.e., psychosis). 
• Populations not usually requiring independent monitoring would include those with substance use disorders. 

WVU Students and Employees (as participants)

WVU students and employees are considered a vulnerable population if the student is actively being taught by the a member of the research team or the employee reports to a member of the research team. The primary concern is perceived coercion. 

• If students are targeted as participants, be sure to include the language provided in the standard IRB approved consent template stating that participation is voluntary and their grades will not be affected.
• If employees are targeted as participants, be sure to include the language provided in the standard IRB approved consent template stating that participation is voluntary and their employment status will not be affected.

Suggestions to alleviate the concern of coercion:

• Ensure participation anonymous 
• Recruitment is done by a person who is not teaching the class or is not the supervisor.  The faculty or employer can recruit, however it must be clear that the class status,  grades or employee status will not be affected by non-participation or draw.  
• Conduct the research after grades have been provided.
• Other methods, such as having someone not involved with the study de-identify the data.

Research Involving Prisoners

• For detailed information regarding prisoners in research, please see the SOP 047: Research Involving Prisoners. 
• For National Institute of Justice-funded research (including Department of Justice): 
• A copy of all data must be de-identified and sent to the National Archive of Criminal Justice Data, including copies of the informed consent document, data collection instruments, surveys, or other relevant research materials.
• At least once per year, the researcher must provide the chief, Office of Research and Evaluation, with a report of the progress of the research.
• At least 12 working days before any report of findings is to be released, the researcher must distribute one copy of the report (including an abstract) to each of the following:
• Chairperson of the Bureau Research Review Board
• Regional Director
• Warden of each institution that provided data or assistance
• In any publication of results, the researcher must acknowledge the Bureau's participation in the research project.
• The researcher shall expressly disclaim approval or endorsement of the published material as an expression of the policies or views of the Bureau.
• Prior to submitting for publication the results of a research project conducted under this subpart, the researcher must provide two (2) copies of the material, for informational purposes only, to the Chief, Office of Research and Evaluation, Central Office, Bureau of Prisons.