Clinical Research Ethics

The mission of the Clinical Research Ethics Group is to create and maintain an institutional culture and ethos supportive of ethical research.

In order to fulfill this mission, the Clinical Research Ethics Group will achieve the following specific aims:

  • Promote an enhanced and integrated clinical research ethics educational program across all UT Health Science Center schools and partnering institutions with a goal of increasing understanding of and commitment to the ethical conduct of research.
  • Provide consultation on ethical considerations in the design of clinical and translational studies as they are being developed and implemented.
  • Promote and conduct research on ethical issues in clinical and translational research.
  • Serve as an advocate for the target community by: 1) facilitating cross-cultural adaptation of research instruments and approaches and 2) providing feedback to other groups within the CTSA on ethical considerations and strategies for implementation of community consultation.

Services Provided and Associated Costs

At the present time, the primary service provided is consultation on ethical considerations in designing and implementing IIMS clinical and translational research projects. This consultation is provided in conjunction with the Design and Biostatistics Group. Service requests and customer communications will occur through the IIMS SPOC. This service is provided at no cost to the IIMS K-12 trainees. Charge-back fees for other IIMS investigators will be incorporated into the charge-back structure for parallel services provided by the Design and Biostatistics Group.

Future services will include: 1) access to one or more on-line research ethics courses that complement the CITI course required of all researchers and 2) cross-cultural adaptation of English research instruments for use with Mexican American subjects who speak only Spanish or almost exclusively Spanish. On-line research ethics courses will be developed over the next 2-3 years. These will be available at no charge to IIMS-affiliated investigators and institutions. A fee structure for non-IIMS-affiliated investigators will be established and will differentiate between those seeking academic credit and those seeking a certificate of completion only.

Cross-cultural adaptation of English research instruments will begin in year 2 with a goal of completing cross-cultural adaptation of one instrument in years 2 to 5. Instruments to be cross-culturally adapted will be determined on the basis of use by IIMS investigators, i.e., frequent use that precludes inclusion of Spanish-only speakers in research for which they would otherwise be eligible. A fee will be charged for any other cross-cultural adaptations of research instruments. The size of the fee will be determined on the basis of the person-hours required to complete the adaptation.

Please contact us (562-IIMS or IIMS/CTSA@uthscsa.edu ) with any questions or for additional information.