Clinical Research Ethics Consultation Service

The goal of the Clinical Research Ethics Consultation Service is to provide investigators and trainees with research collaboration, education, and consultation on questions that address ethical issues in the design and conduct of translational and clinical research, as well as to heighten awareness and promote a dialogue and a culture of research integrity while furthering the mission of the UR CTSI. The intent is to consider and involve clinical research ethic up stream in the process of research planning and design and when appropriate involve clinical research ethics personnel as consultants and eventually collaborators. However, consultation may be requested during any phase of a study from conceptualization, planning, implementation, analysis, and reporting. The topics of potential coverage are broad and include, but are not limited, to the following:

  1. Clinical trial design (e.g., sham surgery, choice of outcome measures, "me too" studies, underpowered studies)
  2. Informed consent (e.g., impaired decision-making, subject understanding, high-risk interventions, disclosure of conflict of interest)
  3. Faculty/institutional conflicts of interest (e.g., does a conflict of interest exist and if so what are the options for management?)
  4. Clinical trial monitoring/adverse event reporting (e.g., incidental findings, ethical issues with data safety monitoring boards)
  5. Research in vulnerable populations (i.e., drug users, seriously ill, prisoners)
  6. Genetic information/biorepositories (e.g., communicating study-acquired genetic information to affected non-participants)

 

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NIH Funding Acknowledgement ** Important ** All publications resulting from the utilization of CTSI resources are required to credit the CTSI grant by including the NIH FUNDING ACKNOWLEDGEMENT and must comply with the NIH Public Access Policy.