University of Rochester
The purpose of the University’s Human Research Protection Program (UR-HRPP) is to ensure that individuals involved with human subject research understand and apply their obligations to protect the rights, dignity, welfare and privacy of research subjects at the University of Rochester (and its affiliates) by adhering to the highest ethical standards and by complying with applicable federal and state regulations, as well as institutional policies.
The President of the University, with concurrence of the Board of Trustees, has appointed the University’s Institutional Official (IO) with the responsibility to oversee the implementation and maintenance of the UR-HRPP. At the University of Rochester, the IO role is delegated to the Vice President for Research. Daily administration of the UR-HRPP is charged to the Office for Human Subject Protection (OHSP).
To meet the needs of the UR-HRPP, the IO and OHSP coordinate efforts and collaborate with several other departments and institutional committees that provide a variety of oversight, support, and educational opportunities for investigators, study coordinators and research staff conducting human subject research. This includes, but is not limited to:
As a result of the UR-HRPP’s collaborative efforts, and the commitment of the University of Rochester research community at-large, the UR-HRPP has maintained accreditation through the Association for the Accreditation of Human Research Protection Programs (AAHRPP) since 2007.
Navigating the ethical, regulatory, and institutional standards and requirements within the UR-HRPP can be complicated. Below is a summary of basic ‘need-to-know’ information for conducting human subject research at the University, with corresponding resources.
All human subject research requires Departmental and Institutional Review Board (IRB) review. Reference our Getting Started with Human Subject Research page for more information.
All study team members engaged in the conduct of human subject research are minimally required to complete and maintain Human Subject Protection (HSP) training. Further training may be required based on the nature of the research; reference our UR-HRPP Training Requirements page for more details.
With the exception of research confirmed to be not human subject research or determined to be exempt, Principal Investigators (PIs) must meet University PI eligibility requirements.
All research-related contracts, grants and agreements are administered by the Office of Research & Project Administration (ORPA).
Only ORPA representatives are permitted to execute (sign) contracts and communicate post-award administrative requests (e.g., project period extensions, budget modifications, programmatic changes) to funding sponsors on behalf of the University. This includes:
All clinical research (i.e., research involving a test article [drug, device, or biologic] or clinical procedure) must comply with the Clinical Research Billing Policy, ensuring that clinical procedures, items or tests that are experimental are budgeted for (and subsequently will be billed for) appropriately. To facilitate this, all research involving billable clinical services must conduct a Coverage Analysis during the study development process. Following IRB approval and throughout research conduct, these studies must be entered to and tracked via the OnCore Clinical Trial Management System.
All faculty and research staff with the ability to influence the design, conduct and reporting of research are required to report annually all external financial interests for review. New or revised financial interests should be reported within 30 days of discovery or acquisition.
In the event a financial conflict of interest is identified, the Dean will take action to eliminate, reduce, or manage the conflict through a Conflict of Interest Management Plan; these plans must be followed.
Investigators with funding through Public Health Service are also required to complete conflict of interest training every 4 years, and report reimbursed or sponsored travel related to their institutional responsibilities.
All research utilizing protected health information (PHI) conducted under the University of Rochester Medical Center (URMC) & Affiliates covered entity or with study team members that are part of the URMC & Affiliates covered entity must with comply the Health Insurance Portability and Accountability Act (HIPAA) and URMC HIPAA Policies and Procedures.
All human subject research that involves collecting, transmitting or storing electronic data are required to complete the University’s Human Subject Research Electronic Data Security Assessment Form. The form must be included with all IRB submissions and the research may be subject to further review by Data Security. For additional information, see the Guideline for Human Subject Research Data Security Requirements.
All research that is potentially subject to the European Union’s General Data Protection Regulations (GDPR) and/or China’s Personal Information Protection Law (PIPL) must undergo review by the Privacy Office and Counsel.
Additional review and approval by applicable UR-HRPP Ancillary Committees is required for human subject research involving specific types of subject populations, procedures or research services.
This review ensures:
All data and/or biospecimen shared outside of the institution require the execution of clinical trial agreement, data use or material transfer agreement via ORPA, regardless of the identifiability of the data/biospecimens. This is includes identifiable, coded, de-identified, anonymized, and/or anonymous data/biospecimens.
All research meeting the definition of an ‘applicable clinical trial’ must meet ClinicalTrials.gov registration and reporting requirements in accordance with funding, Food & Drug Administration, and the Office of Clinical Research’s Policy 001 Public Disclosure of Clinical Trial Information.