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 a