Getting Started with Human Subject Research
Are you new to human subject research at the University, or could use a refresher on the process? The guidance on this page can be a great resource as you’re getting started.
Review a step-by-step process for starting human subject research
Human Research Protection Program (UR-HRPP)
The University of Rochester’s Human Research Protection Program (UR-HRPP) ensures that individuals involved with human research understand and apply their obligations to protect the rights, dignity, welfare, and privacy of research subjects. The UR-HRPP is a coordinated effort among several University departments and committees. Based on the nature of a research proposal, multiple UR-HRPP review processes may be required in order to initiate a study.
Downloadable guide
Acronyms and abbreviations
UR-HRPP? RSRB? IRB? HSP? There are a lot of acronyms and abbreviations used in research. Our Abbreviations page covers a lot of them, and there’s also a downloadable version for you to print and keep on-hand.
Steps for getting started
Below, you’ll find key steps for initiating most types of human subject research at the University of Rochester. You can also view a schematic version of this flowchart.
Step one: Validate study feasibility
After you’ve generated an idea, it’s critical to think through whether the research is feasible to conduct. If it is not feasible to meet study objectives, the research should not be conducted.
- Is the research relevant?
- Is there scientific merit?
- Is the study designed to answer the question at hand?
- Do you have adequate time, resources, population, and funding to accomplish the aims of the research?
- Per University of Rochester Policy, all research involving billable clinical services (e.g., clinical procedures, items or tests) are required to conduct a Coverage Analysis to mitigate the risk of billing errors and identify budget deficits. Trials with a planned deficit require Departmental/Division Sign-Off and the identification of an unrestricted account to absorb the deficit at trial close-out. Services are available through the Clinical and Translational Science Institute’s (CTSI) Office of Clinical Research (OCR) to assist in feasibility assessment and pre-award finance planning.
Step two: Verify the proposal involves ‘human subject research’
To be considered ‘human subject research’, the proposal must meet the definition of ‘research’ and ‘human subject’. All proposals involving ‘research’ and ‘human subjects’ (per federal definition), require Institutional Review Board Approval (IRB).
Proposals that do not meet the definition of ‘human subject research’ do not require review by an IRB. However, when unsure, when documentation is required for the funding agency or publisher, or the Investigator just would like documentation, proposals may still be submitted through Click IRB for formal review and determination of not human subject research.
Review when you need RSRB (IRB) approval
Note: If the research involves funding and/or requires contract/agreement review, reference our additional guidance below.
Step three: PI eligibility, training, and conflicts of interest
Per University policy, PIs must hold full-time faculty positions or full-time positions enjoying similar rights and privileges. Part-time clinical faculty in the School of Medicine & Dentistry and the School of Nursing having the rank of Assistant Professor or above may also be PI. Exceptions are made for students (including undergraduate, graduate, and medical students, as well as residents and fellows) conducting not human subject research or research deemed exempt.
Per OHSP Policy, all individuals engaged in the conduct of human subject research must complete basic human subject protection training through the Collaborative Institutional Training Initiate (CITI).
One to two days following course completion, internal (University of Rochester) faculty, staff and students will be provided access to the Click IRB module in the IORA system.
Any new or revised financial interests related to the submission must be reported (applicable to all study team members). The resulting Conflict of Interest (COI) Management Plan or Transparency Checklist must be included in the IRB submission.
Step four: Prepare and submit your IRB application
All human subject research must be submitted to the Research Subjects Review Board (RSRB), the University of Rochester’s Institutional Review Board (IRB), via the Click IRB review module in the Integrated Online Research Administration (IORA) system.
This includes studies where the RSRB will act as the Reviewing IRB (i.e., the IRB designated to review and approve the research), as well as studies that will be reviewed by an External IRB (administrative institutional review is required prior to submission to the External IRB).
Step five: Department, ancillary, and IRB reviews are conducted
There are several different reviews that will be conducted as part of the process.
Upon submission, per OHSP Policy, the RSRB will direct all submissions to the PI’s department (primary appointment) for scientific and resource review and approval. Note:
- Additional procedures may be required as part of this review process, based on department-specific procedures/practices.
- Further review processes will not proceed until departmental approval has occurred.
Following departmental approval, the proposal will be assigned to an IRB Coordinator to facilitate review. For a summary of how RSRB review is carried out, reference our RSRB (IRB) Review Process page.
Note: Based on Ancillary review requirements, proposals may be withheld from RSRB review until applicable Ancillary Committee approval has been granted.
Following departmental approval, the RSRB will direct submissions to applicable Ancillary Committees or review and approval. Ancillary Committee review will then be conducted per the committee’s standard operating procedures. The timing of review, in relation to RSRB review (i.e., before, concurrent with, or after RSRB review), is dependent on committee requirements.
If the RSRB is relying on an External IRB to review and approval the research, submit the proposal to the External IRB for review and approval (per the External IRB’s standard operating procedures) following RSRB confirmation of reliance. Once the study is approved by the External IRB, documentation of the approval should be uploaded into the Click IRB system.
Research involving grants, agreements, and contracts
All grant submissions, agreements (including but not limited to non-disclosure agreements, clinical trial agreements, sponsored research agreements, data use agreements, data transfer agreements and material transfer agreements) and contracts must be reviewed by the Office of Research and Project Administration (ORPA).
After you’ve validated study feasibility, initiate funding proposals and/or contract/agreement reviews via submission in the IORA system.
Note:
- Grant submissions:
- Proposals involving multi-site research must identify the IRB acting as the Reviewing IRB for all sites (as applicable). Review OHSP Policy 504: IRB Reliance and Cooperative Research for additional information.
- Proposals should not be submitted for IRB review until they receive a ‘fundable’ score.
- Agreement/contract reviews can occur concurrently with steps two through five above.
- PI-Initiated research that is externally funded may require an additional Institutional Risk Assessment if/when full indemnification is not offered/made available in the clinical trial agreement.
All research involving billable clinical services are required to have their budget and study calendar in OnCore, the University’s Clinical Trial Management System (CTMS).
Services are available through OCR to assist in this process. To access OnCore, complete their request access form and designated training.
Once the study budget and calendar have been built in OnCore, review and sign-off is required by the Research Compliance Office (a division of ORPA), prior to contract/agreement execution.
Once a proposal has been funded and/or an agreement/contract has been executed, ORPA will process the award in IORA and assign a GR5 number (a Finacial Activity Object [FAO]). A copy of the award notice and/or executed agreement/contract will be documented in the IORA system.
If the research involves a billable clinical service, the study must be finalized and activated in OnCore following contract/agreement execution and IRB approval. OnCore activation results in the creation of a study record in eRecord if the study has billing risk.
Step six: Initiate study conduct
Studies cannot be initiated until all of the applicable activities identified above have been completed/approved.
Important points to keep in mind once research studies begin:
- The PI has full and final responsibility for the conduct of the approved research. Review OHSP Policy 901: Investigator Responsibilities for a summary of responsibilities, as well as the associated summary sheets for research deemed exempt, non-FDA regulated, and FDA-regulated research. For collaborative research, additional responsibilities are summarized in OHSP Policy 504: IRB Reliance and Collaborative Research.
- All research must be conducted in accordance with the IRB-approved protocol (and all supporting documents). All revisions to the research must be submitted to the Reviewing IRB for review and approval prior to implementation. IRB approval must be maintained throughout the conduct of the research. If a study is assigned an expiration date, a continuing review (progress report) must be submitted and approved to continue conducting the research. If IRB approval lapses (i.e., the approval expiration date passes before the study is re-approved), all research activities must cease until re-approval is obtained.
- All participating sites engaged in multi-site research, where the RSRB is the Reviewing IRB, must be submitted and approved prior to study implementation at the participating site (participating sites are submitted following RSRB approval of the overall study, under the umbrella of the overall study). Review OHSP’s Guideline and Flowcharts When University of Rochester is the Reviewing IRB for additional information.
- Post-Approval Consultations are available free-of-charge through the OHSP Division of Quality Improvement to aid study teams in achieving research compliance.
- All administrative requests, financial requests or programmatic changes related to a grant or agreement must be communicated via the designated ORPA liaison.
- All new or revised COI Management Plans or Transparency Checklists that are put into place during the conduct of a research study must be submitted to the RSRB for continued review.