Clinical and Translational Research Ethics Consultation (ClinTREC)

The goal of the CCaTS Clinical and Translational Research Ethics Program is to promote ethical conduct in research. Faculty and staff in the program pursue this goal by helping scientists and clinician-investigators identify practical solutions to ethical challenges.

The program staff supports three main activities:

  • Providing specialized ethics consultation services to clinical investigators, scientists, research staff and specialists in regulatory affairs across all stages of the translational research process.
  • Coordinating educational activities related to the responsible conduct of clinical and translational research.
  • Conducting research examining the ethical and social values that influence how patients and the communities served by Mayo Clinic view the potential benefits and risks of clinical research.

An integral component of the research ethics program is the Clinical and Translational Research Ethics Consultation (ClinTREC) service. The ClinTREC staff is available to assist researchers in managing ethical issues at all stages of research, from protocol development through the publication of research results. This includes but is not limited to questions about ethics in:

  • Research involving human participants.
  • Research using animals.
  • Peer review.
  • Authorship.
  • Mentorship.
  • Publications.
  • Conflicts of interest.
  • External collaborations.
  • Research misconduct.

Working with biomedical and clinical researchers, the ClinTREC staff develops recommendations based on existing institutional policies, national standards, ethical principles and scholarship.

The ClinTREC service is available free of charge to clinical and translational researchers in any position — graduate student or medical student, postdoctoral or clinical fellow, consultant or research staff (including study coordinators, nursing staff, research technicians and administrative staff).

Scientists and clinical investigators can seek help at any stage of the research process, though investigators who think there may be complex ethical, social or policy issues related to their research are encouraged to make contact early in the research design process. Ongoing communication with the ClinTREC staff can help researchers incorporate best practices into their research designs, potentially avoiding delays in obtaining research approvals or initiating subject recruitment.

Although ClinTREC staff members are available to assist on any ethical issues of concern, scientists and clinical investigators are especially encouraged to work with the ClinTREC staff on research protocols that may raise potentially sensitive issues. Examples include:

  • Research involving human embryonic stem cells.
  • Storage of clinical samples for future research.
  • Human gene or genome editing.
  • Animal-human chimera or hybrid research.
  • Research involving vulnerable populations.
  • Research topics related to race or ethnicity.
  • Genetic research.
  • Research on stigmatizing diseases.

ClinTREC staff members work collaboratively with the Mayo Clinic Institutional Review Board (IRB), Research Subject Advocate, Conflict of Interest Review Board, Institutional Animal Care and Use Committee, and Office of Responsible Conduct of Research to help investigators in managing regulatory requirements and assuring ethical conduct of research.

Examples: Situations where investigators may find it helpful to involve the ClinTREC service

  • "I am the principal investigator for a clinical trial and would like to recruit subjects for this study from my practice. What precautions need to be taken to address potential conflicts of interest?"
  • "What are the potential ethical issues associated with putting a human neuronal stem cell into the brain of a developing mouse embryo?"
  • "I have completed a study looking at genetic variants associated with coronary artery disease. These variants are not routinely evaluated by cardiologists but may impact the health of volunteers in my study. Should I share these findings with my research subjects and, if so, what's the best way to contact them?"

Consultants

Contact

To learn more or request a research ethics consultation, email researchethicsconsult@mayo.edu.