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