The Food and Drug Administration has numerous regulations and guidance documents for investigators in their responsibilities for conducting FDA regulated research; investigators should have a thorough understanding of their role and responsibilities and how it relates to the protection of research participants. Research professionals are continuously challenged by the evolving regulatory landscape and the increased risk associated with the complexity of research protocols.
The CTSC can provide investigators with awareness of regulatory requirements and acceptable standards for the conduct of clinical trials and the protection of human subjects. We can help investigators understand the function of the FDA and Investigator responsibilities for those holding Investigational New Drug (IND) applications or Investigational Device Exemptions (IDE) or those investigators conducting research under and IND or IDE.
Clinical Investigators: View the September 2013 IND guidelines that have been recently been posted on the FDA/CDER website: [Investigational New Drug Applications (INDs) — Determining Whether Human Research Studies Can Be Conducted Without an IND].
IRB approval, IRB exemption or a “non-human subjects” research determination made by the IRB is required prior to the CTSA providing services for research involving human subjects, data and/or specimens.
The CTSC supports high quality, reproducible research across the spectrum of clinical and translational sciences by identifying efficient and cost effective ways in which to promote adherence to regulatory requirements and overall responsible conduct of research by:
- Harmonizing cross institutional policies and infrastructure to improve the quality of human subject protections and promote a clear culture of responsibility among CTSC investigators.
- Streamlining regulatory review process to promote research collaboration, which will facilitate translation of scientific ideas to clinical practice.
- Providing innovative educational opportunities in Regulatory Sciences to complement and extend existing CTSC Regulatory offerings to all members of the translational workforce.
All CTSC partner institutions have robust research compliance programs and offices, and offer a full range of training on compliance topics such as:
- The Scientist as a Responsible Member of Society
- Conflict of Interest Disclosures
- Safe Laboratory Practices
- Human Subjects Protection
- Mentor/Mentee Responsibilities
- IND/IDE processes
- Collaborative Team Research
- Peer Review
- Responsible Conduct of Research
- Data Acquisition, Management
- Research Misconduct
- Responsible Authorship & Publication
Case Western Reserve University's Continuing Research Education Credit (CREC) Program provides investigators documented training in the protection of human subjects in research. The program is available to human subjects researchers at University Hospitals Cleveland Medical Center, The MetroHealth System, Case Western Reserve University, Louis Stokes Cleveland VA Medical Center, and The Cleveland Clinic. The Collaborative Institutional Training Initiative (CITI) is a training service to which the University subscribes. CITI provides comprehensive online educational programs in multiple areas including the protection of human subjects in research.
The NIH requires Responsible Conduct of Research (RCR) training at all CTSA institutions. Responsible Conduct of Research Guide to read an article about RCR training within the CTSA network entitled: "Instruction in the Responsible Conduct of Research: An Inventory of Programs and Materials within CTSAs."
SMART IRB is a platform designed to ease common challenges and burdens associated with initiating multisite research and provide a roadmap for institutions to implement the NIH Single IRB Review policy. Through a flexible master IRB reliance agreement, standard operating procedures, and complementary tools and resources, SMART IRB supports and encourages collaboration and harmonization across the nation.
For online help, such as SOP manuals, policies and FAQs visit the SMART IRB website.