The CTSI Research Ethics Consult Service provides investigators and other research personnel with expert consultation on ethical issues in the design and conduct of biomedical research. Research ethics consultation services are available for the following issues or others that may arise:
- Ethical factors in protocol design (clinical equipoise, randomization, placebo controls, blinding, inclusion / exclusion criteria, endpoints, stopping rules, etc.)
- Participant selection, recruitment, retention, withdrawal and follow-up
- Informed consent, refusal, and waivers of informed consent
- Therapeutic misconception
- Studies involving vulnerable populations
- Research in emergency settings
- Conflicts of interest
- Research participant privacy and confidentiality issues
- Barriers and motivations to participate in research protocols
- Research subject advocacy
- Special issues in genetics research
- Research integrity
- Research in cultures, communities, or groups
- Disclosure of results
- Disclosure and reporting of findings unrelated to study questions
Data and safety monitoring resources
Do you need a Data and Safety Monitoring Board (DSMB) for your research study? Here are a few resources to help you get started. Questions? Contact Bob Kolb.
- Data and Safety Monitoring Board Training Manual for Investigator-Initiated Studies (PDF). This manual provides information and training for Principal Investigators, DSMB members, IRB members, biostatisticians, and research staff on how to work effectively with DSMBs. The CTSA Collaborative Data and Safety Monitoring Board (DSMB) Workgroup, supported by NCATS, produced this resource after identifying a need to provide guidance, training and resources in DSMB practices for investigator-initiated research studies.
- FDA: Establishment and Operation of Clinical Trial Data Monitoring Committees Guidance for Clinical Trial Sponsors March 2006
The best time to ask for research ethics consultation is early in the conception of the project, rather than as an afterthought before submission of a grant or for IRB review. Of course, unexpected issues may arise at any point in the process in a protocol, and ethical issues may arise as a consequence of new information during its execution.
H. Robert Kolb