THRIV Research Ethics Consultation Service (T-RECS)

THRIV Research Ethics Consultation Service (T-RECS) provides consultation on ethical issues that arise anywhere along the translational spectrum of research, including during the development, conduct, analysis, reporting or commercialization of research.

T-RECS is available to the UVA research community and to the THRIV research community, including research participants and community partners.  We offer support and education by providing a forum for in-depth conversation and analysis of ethical issues in clinical and translational research.

T-RECS is provided by the UVA SOM Center for Biomedical Ethics and Humanities (CBEH) together with THRIV.

How Researchers Use This Service

Investigators can use this service during study development, prior to grant or IRB submission, and to consider perceived ethical issues that are anticipated to be complex such as when a placebo-controlled trial is justified. Investigators and IRBs can ask for consultations for issues where regulatory guidance is not clear or is still evolving.

Sometimes, consultations relate to a particular research participant. For example, a research coordinator requested a consultation when the child of a study investigator expressed interest in enrolling in the parent’s research study.

In some cases, researchers seek our advice when someone familiar with the research has suggested that a particular plan of action is “unethical.” Our service has been able to help the requestor decide how to respond to the concern.

Examples of Potential Consultation Questions:

Study Development
What if informed consent is not practical for my study?
When is a placebo-control ethically appropriate?

Study Implementation
Can I withdraw a participant against his/her wishes?
What must I do if my participants need medical care or other help?

Study Analysis
Should I tell participants about their research findings?
What if a participant requests his or her data be withdrawn?

Community Engagement
How should I negotiate disagreements with community stakeholders?
How should I share the research data with the community?

This list is not all-inclusive, but it is intended to offer suggested ways to use the service.

The focus of a T-RECS consultation is not regulatory compliance—which is the purview of other entities—but novel or complex ethical issues for which regulatory requirements or ethical norms are not clear or readily resolved. Such advice will be advisory only and non-binding; requestors retain responsibility for their decisions regarding actions taken or not taken. The consultations generally are confidential, and the details are not discussed with others without the requestor’s permission unless disclosure is required by law.

T-RECS complements but does not supersede the work of other entities at any of the THRIV institutions that are involved in the supervision of research, such as the respective Institutional Review Boards (IRB), the Institutional Animal Care and Use Committees (IACUC), Clinical Trials Offices, or the Offices of the Vice Provost for Research (VPR), etc. Consult requests regarding questions of law, regulation, or institutional policy will generally result in a recommendation that the requestor contact the appropriate institutional organization for an authoritative response.

For more information:

Call Sandra Burks at 434.924.9061
Email her at sgb2c@virginia.edu

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