Types of IRB Submissions
Prior to Submitting to the IRB
Prior to drafting and submitting your protocol to the IRB, please review the following questions:
- Does your research require IRB oversight?
Confirm that the proposed protocol is human subjects research and needs IRB review. The IRB highly recommends investigators do not make the not human subjects research (NHSR) determination without first consulting the IRB.
- Are you eligible to serve as Principal Investigator (PI) at Rice University?
Per Rice University Policy 301, the PI status is a “privilege granted to faculty members who hold an academic appointment in the tenure-track or research ranks under Policy 201 ‘Faculty Appointments, Promotions, and Tenure,’ (or an equivalent appointment under any successor policy). Instructional or special rank appointments do not have PI/PD Eligibility status.”
When exceptions to be a PI are requested, the academic/administrative unit leader should make the request before the proposal is submitted for review, as approval rests with the Vice Provost for Research. The appropriate mechanism is the PI Eligibility Form.
- Have you reviewed your protocol and associated materials against the Rice guidance?
Please review the below guidance when drafting your protocol to ensure compliance. Relevant guidance may include:
- Does your research require review from any other committees or groups?
Depending on the type of research, your protocol may require additional review from other committees or groups, such as:
- Environmental Health & 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.
- Institutional Biosafety Committee
The Institutional Biosafety Committee (IBC) is responsible for reviewing projects that involve, but are not limited to, synthetic and recombinant DNA, pathogens and other potentially infectious material (including tissue or samples derived from humans), and transgenic animals. The IBC also provides oversight to the intramural community in matters pertaining to the control of biohazards associated with the use of microbiological agents and their vectors. The IBC also represents the interests of the community with respect to public health and protection of the environment.
- Conflicts of Interest Committee
Per Rice University Policy 216, individuals engaged in scholarship and research activities or applying for federal, state, or local grants at Rice University have ethical and legal responsibilities to disclose certain activities to the university, and to avoid creating Conflicts of Interest (COI) or the appearance of a COI.
- Office of Technology Transfer
The Office of Technology Transfer (OTT) at Rice University assists the faculty, staff, and students in commercializing technology created and developed at Rice. This office also assists with facilitating the exchange of materials (e.g., data, specimens) between institutions.
The types of materials transferred under MTAs may include anything from software to cell lines, cultures, plasmids, nucleotides, proteins, bacteria, pharmaceuticals, chemicals, and other proprietary physical materials and transgenic animals.
Whenever a member of the faculty wishes to provide materials to a third party (whether from a non-profit or for-profit institution), the sending scientist should complete our Outgoing Submittal Form and attach a copy of the MTA for our review, negotiation and signature.
Submitting a Protocol in Cayuse IRB
You must complete a protocol application in Cayuse IRB (aka Cayuse Human Ethics). In addition to completing the application, you will need to submit all relevant protocol materials. This may include the consent form(s), recruitment materials, survey/questionnaire/interview documents, device user manual/picture, executed reliance agreements, etc. as applicable.
Poorly written or incomplete submissions will result in longer review times.
When to Submit in Cayuse IRB
Exempt, Non-Exempt (Expedited), and Closure Requests will be reviewed on a rolling basis. Exceptions for review timeline may be made for time sensitive research, such as senior theses. However, turnaround times remain dependent on the volume of submissions at any given time, submission quality and completeness, ongoing IRB projects, and staffing.
For full board studies, submissions will receive an initial review by the IRB Compliance Administrator. The initial review may result in requests for additional information or changes before the protocol can be reviewed at a scheduled IRB meeting.
- Cayuse IRB uses a smart form application which uses the responses of the applicant to develop the protocol.
- Provide the information required in the application sections of the protocol.
- Always download the most current version of the IRB templates/forms from the IRB website.
- Avoid the use of jargon, define acronyms at first use, and provide context for uncommon procedures to help the IRB members quickly understand what the research involves and assess risk.
- Proofread the entire application, checking for clarity, completeness, and consistency throughout.
- 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.
- Write the consent forms using the provided Rice University templates.
- Write the consent forms in second person (“You” statements).
- In general, consent forms should use simple 6-8th-grade-level language. If appropriate, the language level can be adapted to your target study population.
- Microsoft Word includes a tool to check the readability of your document. If your title includes scientific terms, you may want to exclude that text in your readability check.
- Define all medical and technical terms and acronyms.
- Proofread the consent form for errors. The IRB will not always be able to catch all errors on the researcher’s behalf.
- Ensure all necessary documents have been attached to the protocol for review.
- Use easy to interpret file names so IRB reviewers can quickly discern the contents of your attached documents.
- Consider the use of dates in the file name of documents that may be subject to review (e.g., informed consent documents, recruitment documents, surveys, etc.)
- Proofread the attachments and ensure they are consistent with the protocol application.
What Modifications Need IRB Approval?
All changes or updates to your protocol, even minor ones, must receive IRB approval before you implement them. Modifications to an existing protocol must conform to the aims/objectives of the originally approved submission. Significant changes to the protocol’s research plan, such as the hypothesis, aim/objectives, and protocol design/intervention, may require the submission of a new protocol.
Implementing protocol changes without IRB approval is a violation of federal regulations and University policies.
Exceptions to this procedure include:
- Per 45 CFR 46.108(a)(3)(iii), 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 the subjects.
In such cases, investigators must report this action to the IRB with 10 business days using the Incident Report in Cayuse IRB.
- Provide a complete description of the proposed modifications in the Modification Description section, and make the appropriate updates to the protocol application and attached documents.
- If changes are made to study procedures, ensure the consent form, recruitment materials, etc. have been updated as appropriate.
For example, if you are making changes to the compensation scheme, you will need to update all other materials that reference compensation, such as the consent form and recruitment documents. When changing these documents, it is helpful to add a revision date to the document and/or the file name.
- Remove outdated forms, especially if they are not in use. Previously approved documents will be archived in the system as a part of previously approved submissions. It is unnecessary to maintain these documents for historical purposes.
o For example, if you are now using version 2 of the study consent form, you can remove version 1 from the protocol application as it is no longer in use.
If your research will continue beyond the approval expiration date, you should submit a continuing review request at least eight weeks before the protocol is set to expire.
- Exempt protocols do not require continuing review unless otherwise stated in the initial approval letter.
- Under the revised Common Rule, continuing review is longer always required for protocols reviewed on an Expedited basis. However, Rice IRB policy is that protocols reviewed on an Expedited basis are subject to a 5 year Continuing Review cycle.
- Protocols reviewed on a Full Board basis require continuing review on at least an annual basis and may require review more frequently.
If Rice is serving as the IRB of Record for multi-institutional research, ensure you are including all site information when you complete the Annual Review Form.
If something does not go according to plan, 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. It should be noted that Incident reports are intended as an official communication to the IRB; filing an Incident report with the IRB does not automatically indicate that disciplinary action will be taken.