700-15-Targeting Vulnerable Populations in Research
| Title: |
Targeting Vulnerable Populations in Research |
| Owner: |
IRB |
| Last Update/Revised: |
05/01/2024 |
Policy: The inclusion of certain groups of participants who may be vulnerable to undue influence or coercion may require additional protections. Examples of vulnerable populations include the economically disadvantaged, racial and ethnic minorities, the uninsured, the elderly, the homeless, those with human immunodeficiency virus (HIV), and those with other chronic health conditions, including mental illness. Note that research on some populations is prohibited at USU (for example, children, pregnant women, and prisons; see 700-14: Research Activities Not Permitted at USU). When the research involving vulnerable populations is reviewed, the IRB applies any additional federal regulations as applicable. The IRB will also evaluate whether additional safeguards have been included in the study to protect the rights and welfare of participants who may be vulnerable to undue influence.
The IRB requires at least one or more individuals who are knowledgeable about or have experience in working with these participants to be part of the review process (whether as a member of the board or an ad hoc consultant).
New study submissions, amendments, and continuing review applications involving vulnerable populations may be reviewed by the convened board or by expedited review, as appropriate.
The IRB reviews research involving vulnerable populations according to applicable requirements and guidelines and makes determinations using the IRB Reviewer Checklist.
Purpose: The purpose of this policy is to describe additional protections that may be required when a vulnerable population is used in research.
Procedures: If a vulnerable population is targeted in the proposed research, an appropriate member or ad hoc consultant will evaluate the research proposal to ensure that precautions are taken to protect the participants.
Scope: This policy applies to research targeted at vulnerable populations.
Documents and Forms:
None