Preparing your RSRB (IRB) Submission
How to submit to the RSRB (IRB)
The Research Subjects Review Board (RSRB) conducts Institutional Review Board (IRB) reviews via Click IRB. This includes submissions that will be reviewed by an external Reviewing IRB (review OHSP Guidelines for when University of Rochester is the Relying IRB).
Click IRB is a module within the Integrated Online Research Administration (IORA) system. To access the Click IRB system, you must complete Human Subject Protection (HSP) training. All individuals engaged in human subject research must complete this training. Approximately 24–48 hours following course completion, all internal faculty, staff and students will receive access to Click IRB.
Preparing your RSRB (IRB) submission
Required Materials
All RSRB (IRB) submissions must include a study protocol:
- Investigators writing their own protocol should use a RSRB protocol template. Doing so will help ensure the protocol addresses all necessary elements. Templates also include guidance for completing each section.
- Investigators given protocols (e.g., by a sponsor) should use the protocol provided. Note, however, that a site-specific protocol addendum may be required (review our FAQ for more information).
As applicable, RSRB (IRB) submissions must also include:
- All recruitment materials intended to be seen or heard by potential subjects (e.g., recruitment flyers);
- All consent documents and/or scripts that will be used to facilitate the informed consent process (reference RSRB consent form templates);
- All study measures that will be completed by subjects and/or include questions that will be asked to subjects (e.g., questionnaires, assessments, interview scripts, subject diaries);
- Data collection sheets (or list of variables) for all records reviews;
- A completed Data Security Assessment Form for all research involving data that is collected, transmitted or stored electronically;
- Details related to drugs, devices and/or biologics that are under study;
- All team members engaged in research conduct; and
- Information about study funding, research locations, and conflicts of interest.
Keys to facilitating the RSRB (IRB) review process
Key #1: Study protocol
The protocol is the primary mechanism for communicating why and how the research will be conducted. Do not leave content open to interpretation; content should be clear and detailed. IRBs cannot approve research when it is unclear how:
- The research will be conducted;
- Subjects will be protected; and
- Regulatory/institutional requirements will be met.
Key #2: Consistency
Consistency within a study protocol is critical for providing the IRB (as well as your study staff) a clear picture of how the research will be conducted. It is equally important to ensure consistency among all supporting documents included within the IRB submission. Mismatched content within and among documents does not allow the IRB to validate that the criteria for IRB approval will be met.
RSRB (IRB) submission FAQs
No. It is a common mistake to assume that the grant and the study protocol are one in the same when they’re not. Grants typically have page limitations and only provide a summary of the intervention/procedures. Thus, grants are not detailed enough to act as the study protocol.
If you’re acting as an enrolling site on multi-site research, you may be asked to submit a site-specific protocol addendum. The purpose of this addendum is to clarify the University’s role in the research and/or how study procedures will be conducted locally (e.g., local recruitment methods). RSRB protocol templates can be used as a guide for drafting addendums, as long as sections that do not need clarification are removed. Addendums should only include new or clarifying information. Do not repeat content provided in the primary protocol.
Submissions are scheduled for review on a first come, first serve basis; standard submission deadlines are not set. IRB Coordinators work diligently to schedule review items in a timely manner. However, several extraneous factors may affect the timing of board review (e.g., the quality of the submission, the number of other review items already scheduled for any one meeting, and board member time constraints). If you know in advance you will be submitting a timely review item (e.g., a Just-in-Time application), please notify your IRB Coordinator as early in the process as possible.
Submit a proposal to the IRB for review as a concept study.
‘Just-in-Time’ (JIT) refers to a specific award procedure utilized by the National Institutes of Health (NIH), and some foundations. The JIT process allows some elements of a grant submission (e.g. IRB approval) to be submitted later in the application process, thereby allowing the Investigator to initially focus on the science of a specific submission. Once an initial submission has been reviewed by the NIH, those receiving scores in a fundable range will receive notice from NIH requesting the submission of additional materials. At that time, the initial application for approval of the research should be submitted to the reviewing IRB with documentation pertaining to the initiation of the JIT process.
For further clarification, the ’Just-in-Time’ process applies only to grants that have been:
- Submitted to NIH;
- Received a fundable score; and
- Received notification form NIH to initiate the JIT process.
Investigators unsure of whether this process applies to their grant submission should contact their Program Director at the NIH.
RSRB fees are charged for some types of review, depending on funding. For additional information, see the RSRB Fee Structure.