Ethical Considerations

Ethical Support we provide:

• Research Subject Advocate
• Ethical guidance for protocol, research planning and consent development
• Training and Educational Opportunities

Request support for ethical considerations from a regulatory perspective by contacting the CTSI-Regulatory Team.

What is a research subject advocate (RSA)?

A research subject advocate is independent of the research team who acts on behalf of a research participant. 

An RSA can:

• Address concerns regarding a subject’s experience in a research protocol, and can direct any questions, complaints or ideas for improvement of research practices.
• Be present during the process of consent for high-risk studies, as advised by the Senate Advisory Committee for Human Research Protection.
• Provide a research participant perspective while planning study protocols.

What Ethical Considerations should be Addressed During Research Planning and Protocol Development

Researchers should approach ethical considerations from a multi-pronged approach and should base their ethical considerations off the Belmont Report, respect for persons, beneficence and justice.

Researchers should consider ethical standards when developing their recruitment plan, identifying their target population, determining inclusion/exclusion criteria, obtaining informed consent, protecting subject confidentiality, identifying risk of harm and evaluating the risk/benefit ratio, and communication of the study results. Research should be based on scientific validity and social and clinical value. 

Human subject research is required to undergo an independent review by an independent ethics committee, such as the Institutional Review Board (IRB).