Research Involving Vulnerable Populations

 

IMPORTANT ANNOUNCEMENT regarding research with minors involving online surveys:

The MTSU IRB is currently reviewing requests to administer online surveys to minors only through the full committee review.  Also, please be advised that the IRB is currently reviewing a policy procedure in compliance with Children's Online Privacy Protection Act (COPPA - 1998). Approvals to allow such interventions are granted only on a case-by-case manner.  Importantly, requests to waive parental consent for studies conducted through online means are not entertained under any circumstances.  

 

Definition

Individuals whose willingness to volunteer in a study may be unduly influenced by the expectation, whether justified or not, of benefits associated with the participation

 

Examples

  • Groups with a hierarchical structure
  • Patients with incurable disease or persons in nursing homes
  • Ethnic minority groups
  • Homeless individuals, nomads and refugees
  • Minors and those incapable of giving consent

 

Categories and Examples of Vulnerability

  • Cognitive and Communicative vulnerability:
    • Children, adolescents, patients suffering from mental retardation or dementia
    • Educational deficits, unfamiliarity with language, stressful emergency conditions, and etc.
  • Juridical or Institutional vulnerability:
    • Person who is under official authority who may have their own benefits
  • Deferential vulnerability:
    • Influence of other people in the subjects’ life (relatives, friends, etc.)
  • Medical vulnerability:
    • Prospective patients with severe medical condition
  • Social vulnerability:
    • individuals belonging to undervalued social groups (sex workers)
  • Economic vulnerability:
    • subjects with low economic background
  • Infrastructural vulnerability:
    • patient tempted to enroll in trials offering resources or facilities

 

The Researchers' Committment

  • When a study includes vulnerable subjects, additional care must be taken to protect their rights
  • It is the responsibility of the investigator and his/her investigative team to ensure that the vulnerable subjects are not exploited in the name of research
  • The study design team must be aware of the special requirements needed for the vulnerable population and they should develop their study protocol appropriately
  • A clear strategy for obtaining informed consent and a concerted goal to protect the subjects’ confidentiality must be part of the research plan and not merely a compliance paperwork

 

The Institution's Committment

  • Studies involving vulnerability must be reviewed by an ethics committee, the IRB in this case
  • Written standard operation procedures must be maintained
  • Requirements must be established for all studies regardless of whether they involve vulnerable subjects
  • Assign IRB members with appropriate expertise to serve as primary reviewers
  • Make the IRB determinations and recommendations in convened full committee meetings when needed
  • Require the researchers to justify the reason to use vulnerable populations
  • Impose mandatory measures to ensure participant rights and confidentiality are protected
  • The MTSU ORC and the IRB have the shared responsibility to ensure the research activities conducted or sponsored by the University are carried out in ethical manner as described in this training

Click here to watch an OHRP video on Questions on Research with Vulnerable Populations - 28:12 min

 

Mandatory Requirements for IRB Approval

  • Approval for research involving vulnerable population is permissible only through either expedited or full committee review. No exemption will be granted.
  • No informed consent waiver will be granted although waiver for signature will be granted if a case is made by the PI that such a signature waiver is required to protect the participants
  • In addition to the above, all other documents required for a general IRB approval must also be provided
  • The PI and the research team must be adequately trained through the CITI program's appropriate vulnerability module
  • Depending on the study and the participants, additional qualifications must be met by the research team in order to involve vulnerable population

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