National CTSA Consortium

Accelerating Discoveries Toward Better Health

Visit CTSACentral.org for information about the national CTSA program.

The National Center for Advancing Translational Sciences funds the CTSA program.

Approval, Guidance and Policy

Find guidance for regulatory processes.

Approvals

Secure approval to initiate your project plan.

For support identifying required approvals for your project plan, consider generating a Customized Action Plan.

The Research Subjects Review Board (RSRB) reviews research that is conducted or supported by the University of Rochester to determine that the rights and welfare of the human subjects are adequately protected. Human Subject Research Protocols are submitted using the RSRB Online Submission System (ROSS).
- Information about additional required approvals is found on Page 19 of the RSRB Investigator Guidance.
University Committee on Animal Resources (UCAR) requires that you complete training before you can work with animals in the laboratory and/or gain access to the Vivarium. Animal Use Protocols must be submitted online using Topaz Enterprise.

Regulatory Guidance

Guidance to assist with your project plan.

ClinicalTrials.gov - Assistance with mandated study registration and result reporting
FDA-regulated processes - Clinical research with drugs and devices, and pre-clinical studies
HIPAA Research Activities Forms and Guidance
RSRB Guidance for Human Subject Research - Guidance for IRB-related requirements, including the extensive RSRB Investigator Guidance

Policies

RSRB - Policies Governing Human Subject Research - Including:
- Departmental Scientific Review
HIPAA Policy Manual - Including:
- Use or Disclosure of PHI for Research Activities
- Electronic Transfer of Protected Health Information via Facsimile and Electronic Mail
Office of Research Project and Administration (ORPA) - Regulations and Policies - Including:
- Clinical Research Billing
- Clinical Research Policies, Procedures, Forms, Templates and Practice Aids
Payments to Research Subjects for Incentives/Participation - Read the FAQ
University Policies and Guidance, including specific policies for faculty, as well as general policies for staff, employees and faculty.

NIH Funding Acknowledgement ** Important ** All publications resulting from the utilization of CTSI resources are required to credit the CTSI grant by including the NIH FUNDING ACKNOWLEDGEMENT and must comply with the NIH Public Access Policy.