Frequently Asked Questions for Researchers
Q: What is the definition of clinical research vs. clinical trial?
A: Clinical Research- NIH defines clinical research as all research involving human participants. It does not include secondary studies using existing biological specimens or data collected without identifiers or data that are publicly available.
Clinical Trial- A clinical trial is a research study to assess the effectiveness of a new idea about treatment of a disease or condition. This idea could involve medication, or a device, or changes to participants’ behavior. Clinical trial participants are volunteers.
Q: What is an IRB?
A: Under FDA regulations, an IRB is an appropriately constituted group that has been formally designated to review and monitor biomedical research involving human subjects. In accordance with FDA regulations, an IRB has the authority to approve, require modifications in (to secure approval), or disapprove research. This group review serves an important role in the protection of the rights and welfare of human research subjects. The purpose of IRB review is to assure, both in advance and by periodic review, that appropriate steps are taken to protect the rights and welfare of humans participating as subjects in the research.
Q: What type of reviews does the IRB conduct?
- Initial IRB review for new protocols
- Change requests for amendments made to previous approved protocols
- Continuation Review of approval protocols
- Review of Unanticipated/Anticipated problems/Adverse Events/Deviations
- Study Closures
Q: What additional training is required by the IRB for the review of research studies?
A: All studies that are reviewed by the NCI-Central IRB (CIRB) or other central IRBs require Human Subject Protection and Good Clinical Practice training. Training documents should be submitted to regulatory coordinators.
Q: Who do I contact for any questions regarding IRB submission or Clinical Trial participant safety concerns?
Baptist Health Lexington IRB:
Regina Winner, MSN, APRN, PPCNP-BC Vice-Chairperson
Q: How do I find additional information regarding a specific research study?
A: You can reference clinicaltrials.gov for study specific statuses or you may contact the local research office.