Per Rice Policy 326, determination of whether your research project requires IRB oversight has to be made by the IRB, not by the investigator overseeing the project.

If you will obtain:

1. data about the subjects of the research through intervention or interaction with them;
2. identifiable private information about the subjects of the research
3. the informed consent of human subjects for the research

You are engaged in research and your project does require IRB oversight.

Additionally the US FDA mandates IRB oversight can be triggered by the following criteria: 1) The involvement of one or more human research participants, 2) the study or analysis of a test article, and 3) either plans to submit data to the FDA for supporting licensure of the test article or the test article in question is a new drug or an investigative medical device.

Rice University faculty appointed to any rank (i.e., assistant, associate, full) of any professor title (including research and teaching) automatically qualify for PI status.

Anyone at Rice that does not have “professor” in their title does not automatically qualify for PI status.

For non-funded research, complete the PI Eligibility form here: https://rice.app.box.com/file/1809982931527?s=15eq8h93khpac2zpr4ro2jzc43y8mupi

You must obtain IRB approval before you begin any research activities involving human subjects. Starting without approval is a compliance violation and could lead to serious institutional or federal consequences.

a. All personnel involved in human subjects research must complete CITI Human Subjects Training.

b. Register for CITI: https://www.citiprogram.org

1. Choose: Social & Behavioral Research Investigators or Biomedical Research Investigators, depending on your study type.
2. Training must be completed before submitting your protocol in Cayuse IRB.

a. Rice University uses Cayuse IRB for all submissions.

b. Visit Cayuse IRB Portal

c. Complete all required fields, upload documents, and include your training certificates.

Need help? Email irb@rice.edu or call 713-348-4820 for guidance.

a. Review times vary:

1. Exempt: ~ 5 business days
2. Expedited: ~ 7 business days
3. Full Board: ~1 month or more, depending on board schedule

b. Incomplete or unclear submissions may cause delays. Responding quickly and accurately to revision requests helps speed up review times.

c. Please be mindful that there are periods where Rice IRB experiences uncharacteristic high volume. This can cause reviews to be a few days longer than normal before you hear back regarding your submission. We will prioritize submissions as they come in.

An IRB Administrator will review your submission for completeness and route it for the appropriate level of review. You’ll receive emails throughout the process with status updates or requests for revisions.

You’ll receive an email from Cayuse detailing requested changes or clarifications. Review comments carefully and reach out to irb@rice.edu if anything is unclear.

Log into Cayuse IRB, make the requested edits directly in your protocol or documents, and resubmit. Be sure to include a response to reviewer comments if requested.

No. You may not begin recruiting, collecting data, or interacting with participants until you have received the official IRB approval letter./p>

Log in to Cayuse IRB to view real-time status. You may also email irb@rice.edu for an update.

If your study is high risk or does not meet Exempt/Expedited criteria, it will be placed on the next Full Board agenda. Submission deadlines and meeting dates can be found here https://research.rice.edu/integrity/irb/meeting-deadline-calendar

a. Exempt and Expedited protocols: No longer require continuing review. However, Rice IRB has implemented a 3-year administrative check-in for status updates.

b. Full Board protocols: Valid for 1 year; require annual Continuing Review.

a. Exempt: Most changes do not require resubmission unless they increase risk, affect eligibility, or involve a change in PI.

b. Non-Exempt: Any changes must be submitted as a Modification in Cayuse and approved before implementation.

Unsure if your changes affect Exempt status? Contact irb@rice.edu or refer to the decision tool here.

Submit a Study Closure Form in Cayuse when:

This helps ensure accurate records and compliance with federal regulations.

1. All research activities are complete.
2. No further interaction or data analysis with identifiers is occurring.

Report unanticipated problems, serious adverse events, or breaches of confidentiality within 5 business days via Cayuse IRB. These must be reviewed for participant safety and compliance.

Yes—if the data is identifiable or was collected for another research purpose, you likely need IRB approval. De-identified or public datasets may qualify for Exempt review. Email irb@rice.edu to confirm.

Activities that are being performed in classrooms for the purposes of teaching students may or may not require IRB oversight. Instructors have been authorized to make this determination on their own. Rice IRB Staff have developed a new guidance form to help them with this process, it can be found here.

1. Yes—if they involve human subjects and are intended to contribute to generalizable knowledge.
2. Yes — When research could be used for future analysis or as a thesis or dissertation foundation, students must have obtained IRB oversight for the initial study.
3. For class projects not intended for public dissemination, IRB approval may not be needed, but best practices (e.g., including a syllabus disclaimer) are encouraged.

Contact irb@rice.edu for help.

This is a serious violation of Rice policy and federal law. Consequences can include:

1. Retraction of your data
2. Ineligibility for future research
3. Institutional sanctions
4. Inability to publish or present your findings

Always obtain IRB approval before starting your project.