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 providing advice to scientists and physician-investigators.
To identify workable solutions to ethical challenges in clinical and translational research, program staff support three main activities:
- Providing specialized ethics consultative services to investigators, study teams and clinicians across all stages of the translational research process
- Developing ethics training programs, courses and Continuing Medical Education (CME) activities to promote greater understanding of ethical principles governing the conduct of translational research among Mayo Clinic scientists, clinicians and research staff
- Examining 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 program is its research consultation service, called the Clinical and Translational Research Ethics Consultation (ClinTREC) service. ClinTREC staff assist new and established scientists and clinical investigators at all stages of research, from protocol development through the publication of research results. Working with researchers, ClinTREC staff develop recommendations based on existing institutional policies, national standards, ethical principles and scholarship.
The ClinTREC service is available free-of-charge to basic, clinical and translational researchers in any position — graduate student or medical student, postdoctoral or clinical fellow, consultant or research staff (for example, study coordinator, nursing staff or research technician).
Scientists and clinical investigators can seek ClinTREC assistance 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 ClinTREC staff can help researchers incorporate best practices into their research designs at the earliest stages, potentially avoiding delays in obtaining research approvals or initiating subject recruitment.
ClinTREC staff members work collaboratively with the Mayo Clinic Research Subject Advocate, Mayo Clinic Institutional Review Board (IRB) and Mayo Clinic Research Compliance Unit to assist investigators in navigating the regulatory process.
Although ClinTREC staff are available to assist on any ethical issues of concern, scientists and clinical investigators are encouraged to work with ClinTREC staff on issues related to improving informed consent procedures, developing biorepositories and returning research findings to study volunteers. Investigators are also encouraged to work with ClinTREC staff on research protocols dealing with socially sensitive issues — for example, human embryonic stem cells or race and genetics.
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 variations 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?"