IRB Protocol Submission and Review
The Institutional Review Board (IRB) conducts review and approval of research that involves human participants. A protocol is considered Human Subjects Research if it meets the below definitions:
According to 45 CFR 46, a human subject is "a living individual about whom an investigator (whether professional or student) conducting research:
- Obtains information or biospecimens through intervention or interaction with the individual, and uses, studies, or analyzes the information or biospecimens; or
- Intervention includes both physical procedures by which information or biospecimens are gathered (e.g., venipuncture) and manipulations of the subject or the subject's environment that are performed for research purposes.
- Interaction includes communication or interpersonal contact between investigator and subject.
- Obtains, uses, studies, analyzes, or generates identifiable private information or identifiable biospecimens."
Research means a systematic investigation, including research development, testing, and evaluation, designed to develop or contribute to generalizable knowledge.
Additional guidance may be reviewed at Levels of IRB Review.
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.
Principal Investigators and research personnel are required to complete the Collaborative Institutional Training Initiative (CITI) Human Subjects Research training course(s) prior to approval of their protocol:
- If you conduct studies that obtain data through intervention or interaction with a living individual or their identifiable private information; or
- If you are an IRB committee member. You will need to complete the "IRB Committee Members" course.
Documentation of this training can be uploaded as a pdf in the training section in the IRB protocol in Cayuse IRB, or verified by the Compliance Administrator at the time of the review of the protocol. When you complete all of the required modules successfully, you may print your completion report through the "Print" link on the learner’s menu. The PI on the protocol should keep a copy of research personnel training for their records.
Additional CITI training guidance can be found here.
- Create an outline and timeframe for your protocol. (See below for a link to timelines, so you can realistically anticipate when you might initiate your protocol.)
- Establish a method to recruit participants, and refer to the Recruitment Guidance webpage when drafting recruitment materials.
- Develop all necessary tools, such as consent documents, survey or interview questions, debriefing form, etc. Consent form and debriefing templates can be found here.
- International research, including remote work, will be subject to US and international regulations. It is begin research on your regulatory requirements early. 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.
- Develop a data storage plan with appropriate security measures. Please consult with Rice’s Information Security Office for any specific questions you may have regarding the requirements for securing and handling research data.
- Consult with the IRB about processes and other protocol-specific questions, including protocol form choice (Exempt or non-Exempt (expedited/full board)).
- Review guidance on the different review categories, types of submissions, and the IRB review timelines.
- Read the IRB Application Tips and Suggestions page.
- Choose and complete the appropriate protocol application (Exempt or non-Exempt (expedited/full board)). The application type is selected when completing the “Exemption Screen” in the Cayuse IRB protocol application:
- Selecting “YES” to this question will populate the application with the non-Exempt (expedited/full board) sections.
- Selecting “NO” will populate the application with the Exempt application sections.
- Always use current forms provided on the IRB website. If you’re ever in doubt about which form to use, please contact the IRB Compliance Administrator at email@example.com.
- Assemble all required documents, such as consent form, interview questions, recruitment scripts, permissions from external sites, human subjects research training certification, etc.
- Proofread all materials for accuracy and errors to maximize clarity and present yourself as a professional researcher to your participants.
All timelines are approximate. Review times may be slower during times of high volume of submissions, staff vacation, and official University breaks. All IRB submissions are reviewed in the order received (initial studies, modifications, continuing reviews, and responses to comments). The IRB may be able to accommodate funding or course related deadlines with advanced notice. A complete, well-written protocol should address all scientific and research ethics issues so that the IRB does not need to request clarifications or seek additional information.
- Exempt and Expedited Protocols are processed by the IRB Compliance Administrator in approximately 10 business days. The IRB Compliance Administrator will provide an initial review of the completeness and determine the appropriate type of review. Submissions may be returned to the investigator for changes. The review type may be reassessed at any time during the review process. Once you respond to the Compliance Administrator’s comments, and the protocol meets conditions for approval, the protocol will then be sent to the IRB Chair for final review and approval. If the Chair does not require additional changes in their review, the IRB Compliance Administrator will then issue a formal approval letter.
- Full Board Protocols must be submitted by the listed meeting submission deadline (see IRB Meeting & Deadline Calendar). Depending on their area of expertise, certain IRB members will serve as primary and secondary reviewers, but all IRB members will provide feedback during the scheduled IRB meeting. During the IRB meeting, the board considers protocols within the scope of federal and state regulations, university policies, and best practices. You will receive the board's feedback 3-4 business days after the meeting. Once you have completed any revision requests, the IRB office will issue an approval letter in Cayuse IRB. The IRB will not send a protocol to the scheduled IRB meeting if significant information is not provided (e.g., study procedures are not explained in detail or risks related to study procedures are not provided). When a protocol is reviewed at the scheduled meeting, a protocol may require a second full-board review and revision process.
Note: No research activities may begin until you have received approval from the IRB.
Once your exempt, expedited, or full board protocol has been approved by the IRB, you are responsible for the following post-approval actions, as applicable:
- Modification -- Before implementing any change(s) in your approved protocol activities, you must submit a Modification and receive written IRB approval for the change(s).
- Incident Report -- If something does not go according to plan in a way that places participants at risk or causes undue concern, you must report these circumstances to the IRB as soon as possible. Incident reports may also be used to report non-compliance, such as failure to comply with applicable federal, state, and local regulations.
- Continuing Review Application -- If your research will continue beyond the approval expiration date, you should submit a continuing review request at least six weeks before the protocol is set to expire.
- Exempt protocols do not require continuing review unless otherwise stated.
- Under the revised Common Rule, continuing review is longer required for Expedited protocols. Note that some Expedited protocols may still require continuing review if they have not yet been transitioned to the new rule.
- Full Board protocols require continuing review.
- Closeout Report -- You should submit an IRB closeout report when your protocol is complete, so that we do not maintain open records for your protocol.
Request a Classroom or Lab Presentation
The Human Research Protection Program provides educational resources and training opportunities for those involved in human subjects’ research. Faculty can arrange for class or lab presentations to discuss ethics, the history of human subjects’ research and/or application process. To schedule a presentation, please contact the IRB Compliance Administrator at firstname.lastname@example.org.