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Vulnerable Groups – Quality System for Health Research

In health research, special ethical considerations must be made when the project involves vulnerable groups. Vulnerable groups may include individuals who, due to age, illness, disability, or social circumstances, may have reduced ability to safeguard their own interests.

Helseikon

Examples of vulnerable groups include:

  • Children and adolescents
  • Individuals with cognitive impairments
  • People with mental health challenges
  • Elderly individuals with reduced functional capacity
  • Individuals in dependent relationships (e.g., patients, students, inmates)
  • People in crisis situations or with limited access to healthcare or legal protection

Ethical considerations when researching vulnerable groups:

  • Consent: Ensure that participants are capable of giving informed consent. If not, consent must be obtained from a legal representative, and the participant’s own wishes must still be respected.
  • Recruitment: Recruitment must be done in a way that avoids coercion or undue influence.
  • Information: Information must be adapted to the target group’s level of understanding.
  • Risk assessment: The project must assess whether participation may cause harm or discomfort, and how this will be prevented or mitigated.
  • Follow-up: There must be a plan for follow-up and support for participants during and after the study.

Responsibility:
The project manager is responsible for ensuring that vulnerable participants are treated with respect and care, and that the project complies with ethical guidelines and legal requirements.

Resources:

  • National Research Ethics Guidelines
  • REK (Regional Committees for Medical and Health Research Ethics)
  • Sikt – Data Protection Services
  • USN’s Research Ethics Support: forskningsetikk@usn.no

Questions about the Quality Assurance System for Health Research?

The Department of Research, Innovation, and Library Services manages the Quality Assurance System for Health Research at USN. The quality assurance system is reviewed and updated as needed. If you have suggestions for improvements or notice that content is missing, feel free to report it to forskningsetikk@usn.no. We will reply to your email.