The Institutional Review Board (IRB) conducts review and approval of research that involves human participants. IRB protocols are submitted through the Cayuse IRB submission system. The Office of Research Integrity encourages all researchers without previous experience with the Cayuse IRB system to contact an IRB Administrator to receive guidance on using the system and obtaining a user account.
Prior to developing an IRB protocol, it is worth ensuring that your research project requires IRB oversight. The only appropriate method for making this determination is by contacting an IRB Administrator to discuss your project, as Rice Policy 326 prohibits investigators from making this determination on their own.
If the IRB determines a project does not meet the regulatory requirements for IRB oversight, a Determination Letter will be provided to the investigator which states IRB approval is not required (i.e., that the project is "Not Human Subjects Research", or NHSR). Otherwise, the investigator will need to submit a protocol application in Cayuse IRB for review and approval.
If an investigator has incorrectly determined that their research does not require IRB oversight, the IRB will not be able to retroactively grant IRB review. Additionally, conducting human subject research without an approved protocol violates both Rice Policy and federal regulations. In this event, an Incident Report must be filed, and Rice may be required to report the situation to cognizant agencies.
Although Rice Policy 326 dictates that this determination can only be made by the IRB or an IRB Administrator, we find it helpful for investigators to know the general rules that trigger IRB oversight.
OHRP Regulated Oversight: -- Generally known as "The (Revised) Common Rule", regulations from the OHRP are located at 45 CFR 46, and dictate that activity requires IRB oversight if it is "a systematic investigation, including research development, testing, and evaluation, designed to develop or contribute to generalizable knowledge" and if an investigator either "obtains information or biospecimens through intervention or interaction with living individuals, and uses, studies, or analyzes the information or biospecimens", or "obtains, uses, studies, analyzes, or generates identifiable private information or identifiable biospecimens" about living individuals.
FDA Regulated Oversight: -- Regulations from the FDA are located at 21 CFR 50, 21 CFR 56, and additional locations, and generally dictate that activity requires IRB oversight if it, A) involves one or more human research participants, B) involves the study of one or more test articles that are under investigation, and C) either information will be submitted to the FDA to support licensure of the test article or the test article is an investigative new drug or an investigative medical device. However, IRB regulations for FDA oversight tend to be considerably more complicated than The Common Rule, so the IRB strongly encourages investigators to reach out early if they believe that their study may trigger FDA oversight to ensure a timely review process.
As a general rule, IRB oversight of FDA projects is slightly slower than projects receiving oversight under the regulations of The Common Rule. Additionally, please anticipate that most FDA projects will receive Full Board Review at both their Initial Review and subsequent Modifications and Continuing Reviews.
Training for Research with Human Participants
You should complete human subjects research training at the earliest stages of planning your research. Understanding and implementing foundational principles of human subjects research, such as informed consent and potential risks in data collection/storage, will help you design a sound protocol.
All personnel on IRB protocols (including principal investigators, postdoctoral fellows, graduate or undergraduate students, non-Rice research project members, and community participants with access to data) are required to complete training courses prior to approval of the protocol. This involves an appropriate training course for your research protocol. Additional training guidance can be found here or you can contact an IRB Administrator at irb@rice.edu for guidance on appropriate training.
All IRB training at Rice uses the Collaborative Institutional Training Initiative (CITI) system. Rice University has arranged for Single Sign On (SSO) access to CITI, which allows you to use your Rice NetID and Password to log in to the system. New user accounts can be requested here.
After completion of the training modules, you may print your completion report through the "Print" link on the learner’s menu or save the certificate as a PDF. The PI on the protocol should keep a copy of research personnel training for their records, but training reports for Rice personnel do not need to be uploaded to the IRB protocol or provided to IRB Administrators; training will be verified independently at the time of protocol review. Training certificates for non-Rice personnel must be attached to IRB protocols, as this cannot be independently verified by IRB Administrative staff during review.
Registration on the Cayuse IRB System
All IRB submissions at Rice University use the Cayuse IRB system, which can be accessed here.
All Rice personnel who will be listed on an IRB protocol will need to have an account in the Cayuse IRB system. New user accounts can be requested by faculty here.
Many useful forms and guidance documents are available here. Rice's Human Research Protection Program Handbook can be downloaded here.
Create an outline and an expected research period for your protocol. This is for your use in identifying important details, and will not need to be submitted.
Address any potentially controversial or ethical issues upfront (e.g., incomplete disclosure or deception). These procedures may be allowable, but the IRB does expect sound reasoning and justification for approval.
Avoid the use of jargon in your protocol and especially in the Informed Consent and Recruitment materials.
Please define acronyms at first use and provide context for uncommon procedures to help the IRB members quickly understand what the research involves so that they can assess the risks.
Develop and assemble the tools that you will use for your study. This includes any surveys, interview questions, plans for data storage and management, etc.
Develop recruitment materials for participants, and refer to the Recruitment Guidance information when drafting recruitment materials.
International research, including remote work, is subject to research under both US and international rules. We strongly recommend familiarizing yourself with international regulations at an early stage of your research. Some international guidance can be obtained from the US Department of Health and Human Service's Office of Human Research Protections. The IRB recommends enlisting a local collaborator who can help you address international site requirements and identifying site contacts for obtaining ethics reviews and permissions to conduct research at that international site. Additional guidance on international research is also available.
Develop a data storage plan with appropriate security measures. Please consult with Rice’s Office of Information Technology and Office of Technology Transfer for any specific questions you may have regarding the requirements for securing and handling research data. Please note that Rice IRB and OIT policies do not allow confidential information (such as private, identifiable information) to be stored on computers owned by students, as the Office of Information Technology cannot ensure security of data on these systems.
Consult with the IRB about protocol-specific processes and questions, including research that involves investigative drugs or devices, course-based or community-based research, multi-site research, and projects involving participants that are pregnant, prisoners, or minors.
Please note that commencement of research activities should not begin until IRB approval has been granted.
Cayuse IRB uses a smart form application, which means that the form will populate additional fields and pages as appropriate based on the information provided by the investigator.
Complete the protocol application, being sure to use the current forms provided on the IRB website. If you’re ever in doubt about which form to use, please contact an IRB Compliance Administrator
Until each section of the IRB protocol has been completed, the system will not allow the form to be submitted. Pay close attention to fields and attachments that are required, as these may be the reason that the "Submit" option has not yet become active. Once all required fields are filled, a check mark will appear for that section in the left-hand bar.
Remember that your IRB protocol should represent, clearly and concisely, the entirety of your research program to the IRB. If the IRB cannot understand your research process, they cannot evaluate the potential benefit or risk, which means that it cannot be effectively reviewed and it cannot be approved.
Upload all required documents, including informed consent forms, surveys, interview questions, recruitment materials, permissions from external sites, human subjects research training certifications for external researchers, reliance agreements, etc.
Proofread all materials for accuracy and consistency. The presence of errors or inconsistencies decreases clarity and can delay approval of your research protocol.
IRB protocols are reviewed on an ongoing basis. Protocols that meet criteria for an Exempt or Expedited status have a typical turnaround of 2-3 weeks. (Please note that Expedited status is a regulatory classification, and does not indicate a more rapid review; protocols are reviewed on an Expedited basis per regulatory allowance and not by investigator request.) Protocols that must be reviewed at a convened meeting of the IRB are typically scheduled for the next appropriate IRB meeting, which happens monthly during academic year and on an ad hoc basis during the summer. Please note that turn‐around time is dependent on the completeness of the application submitted and the PI’s responsiveness to questions and requests from the reviewers. A calendar for scheduled convened meetings of the IRB can be found here.
Although the IRB may be able to meet short deadlines to accommodate funding or course-related issues, this can not be guaranteed. Complete, well-written protocols (i.e., those that include all required documents and that address all scientific and research ethics issues and hence do not require requests for additional information or clarification) will be reviewed more quickly.
Exempt and Expedited Protocols are typically reviewed by an IRB Compliance Administrator within a week. If additional clarification or information is needed, the protocol will be returned. Otherwise, the IRB Administrator will forward the protocol to the IRB for review. Exempt and Expedited protocols are reviewed by a member of the IRB that is designated by the IRB Chair. Typically, this review happens within 5 business days. Once this review is complete, a Determination Letter will be provided to the investigator that indicates the terms of approval and any period for continuing review or that will specify any changes required by the reviewer.
Full Board Protocols are also reviewed by an IRB Compliance Administrator, typically within a week. If additional clarification or information is needed, the protocol will be returned to the investigator. Otherwise, the IRB Administrator will add the protocol to the agenda for the next appropriate IRB meeting. To ensure scheduling, the protocol must be complete and ready for review prior to the listed meeting submission deadline (see IRB Meeting & Deadline Calendar). IRB members will be assigned to serve as primary and secondary reviewers based on their expertise, but all IRB members will provide feedback during the meeting.
During the IRB meeting, the board considers federal and state regulations, university policies, and best practices, along with the underlying principles of The Belmont Report to evaluate the benefit, the risks, and the potential outcomes of the research. The IRB will then vote on the protocol. Determination Letters will typically be provided within 1 week of the IRB meeting. The Determination Letter may indicate approval, along with conditions of continuing review, or it may indicate changes required to receive approval, in which case the protocol will be returned. Once any revisions requested have been made, an additional Determination Letter with approval conditions and continuing review information will be provided. If significant problems are noted in the first review, a second full-board review by the full convened IRB may be required.
All review timelines are approximate. Review times may be slower during times of high submission volume, staff vacation, and official university closures. All material submitted to the IRB (emails, responses to requests for additional information, initial studies, modifications, continuing reviews, etc) is reviewed in the order received.
Note: No research activities may begin until you have received approval from the IRB.
Emergency Changes to IRB Protocols -- Per federal regulations, investigators may implement changes to approved research prior to IRB review and approval ONLY if the changes are necessary to eliminate apparent immediate hazards to research participants. If this becomes necessary, investigators must report this action to the IRB within 10 business days using the Incident Report in Cayuse IRB and should halt any further use of the protocol until the IRB has reviewed the Incident.
Modification of Protocols Exempt from IRB Oversight Changes to Exempt protocols no longer require pre-approval, so modifications to these protocols, for either personnel or research procedures, are generally not required. The exception to this is if the modification will result in a change of the protocol to a non-Exempt status. Guidance for the types of changes that might trigger non-Exempt status can be found here.
Modification of non-Exempt (i.e., Expedited or Full Board) Protocols -- Before implementing any change(s), a Modification must be submitted in Cayuse IRB and be reviewed and approved. Typically, reviews take place at the same level of oversight as the initial approval (e.g., Modifications of protocols receiving Expedited review will also receive Expedited review).
If the Modification changes the recruitment, informed consent, or other study documents, please remove the outdated documents that will no longer be used. Old versions will be archived in Cayuse IRB and will be available if needed, but removing the outdated versions simplifies review and prevents confusion on the part of researchers.
Written IRB approval of all change(s) is required before they can be implemented.
Incident Report -- If something does not go according to plan, or research is performed in a way that is inconsistent with the IRB protocol, a report must be filed with the IRB as soon as possible. Incident reports may also be used to report non-compliance events, such as failure to comply with applicable federal, state, and local regulations. Guidance about how promptly these events must be reported can be found here.
Continuing Review Application -- Protocols that receive Expedited Review generally have a 5-year approval period. Protocols subject to Full Board Review require review on an annual basis (unless a more frequent review period is specified by the IRB in a Determination Letter). If you anticipate that your research will continue beyond these approval periods, you should submit a continuing review request at least 6-8 weeks before the expiration date to allow time for the IRB Administrators to ensure that the protocol is complete and ready for review. Continuing Review requires submission of a Continuing Review Form.
Closeout Report -- IRB practices dictate that protocols should remain open for as long as research is ongoing (including recruitment, informed consent, data collection, data analysis, and publication). If you feel that your project is complete and you are done with data analysis, please contact an IRB Administrator to discuss how to appropriately manage the data that you have collected. When appropriate, you should submit an IRB Closure Request in Cayuse IRB to indicate that the protocol is no longer active.
Approval by the IRB is a necessary step in the performance of certain research projects, but some research programs may also require approval from other committees or groups, as described below.
Environmental Health and Safety -- Environmental Health & Safety (EH&S) provides support to the Rice Community in the areas of chemical and biological safety, fire safety, office and laboratory safety. Investigators are responsible for consulting with EH&S prior to beginning research with biological specimens.
The Institutional Biosafety Committee -- The Institutional Biosafety Committee (IBC) is responsible for reviewing projects that involve, but are not limited to, synthetic and recombinant nucleic acids, biohazardous materials (including tissue or samples derived from humans), and transgenic animals. The IBC also represents the interests of the community with respect to public health and protection of the environment. If you have questions or concerns related to the IBC, you can contact the IBC Compliance Administrator or call 713-348-7349.
The Office of Technology Transfer -- The Office of Technology Transfer (OTT) assists the faculty, staff, and students of Rice University in commercializing technology created and developed at Rice. The OTT also assists with facilitating the exchange of materials (e.g., data, specimens) between institutions, typically via use of material transfer or data use agreements (MTAs and DUAs).
Conflicts of Interest Committee -- The Conflicts of Interest Committee assists Rice University investigators in the evaluation of real, potential, or perceived conflicts of interest generated by their research and other activities and helps to develop and approve conflict management plans to mitigate these concerns. Importantly, no area of scholarship is exempt from real, potential, or perceived COI, so the IRB strongly encourages any researcher with questions to contact a Conflicts of Interest Compliance Administrator for guidance.
