Institutional Review Board (IRB)

When do I need to submit to IRB?

You need to submit to IRB if your study fits the definition of research, involves human subjects, and includes interaction/intervention with human subjects or provides you with access to personally identifiable private information.

• Research is defined as a systematic investigation that may include research development, testing and evaluation, designed to develop or contribute to generalizable knowledge.

• Generalizable Knowledge might include information presented to a broader audience or published with the intent of drawing scientific conclusions or increasing the body of scientific knowledge.

• Human subjects are defined as living individuals that a researcher collects personally identifiable private information and/or data through interaction with the subjects.

• Interaction and intervention include any interpersonal contact with the subjects and intervening with them or their environment through the use of procedures or manipulations.

How do I submit a study for IRB review?

Before anything, make sure that you have completed the IRB Human Subjects Research Training.

1. Log into Cayuse IRB. If you have not yet made an account, request access here.

2. From the DASHBOARD, click on the New Study button.

3. In the Study Details screen, enter the name of the study and click on the Check Mark button.

4. Click on the New Submission button and then the Initial button.

5. In the Submission Details screen, click on the Edit button.

6. Complete each section, ensuring there is a green check mark opposite the corresponding section. The check mark indicates that all the required fields have been answered. Save your work as you proceed through the actions. You may begin a study, save your work, and then return to the form later to complete it.

7. When the initial submission has been completed, click on the Complete Submission button.

8. Finally, click on the Confirm button to complete the initial submission.

9. Once certified, the submission is forwarded to the HRPP for pre-screening. The submission may be forwarded to the IRB Reviewer or sent back to the PI requesting changes.

10. The IRB Reviewer may return the submission back to the PI for revisions or approve the study.

11. The researchers are kept informed at each stage of the process and receive updated emails regarding the status of the study as it progresses.

Additional Information

Types of Proposals

If a project constitutes human subjects research according to the definitions above, there are three types of proposals. Investigators should use the descriptions that follow to determine which category of review is appropriate and check with the HRPP Manager, the IRB Chair, or a member of the IRB if questions remain.

Exempt Category

Research in the Exempt category includes research that involves minimal risk and fits certain precisely defined categories such as survey research in which responses are anonymous. The principles of The Belmont Report must still be observed in research in the exempt category.

Expedited Category

Expedited proposals involve minimal risk and fit within one of nine precisely defined categories such as research with surveys or interviews.

Research projects involving no more than minimal risk are suited for the expedited category. Projects with children or other vulnerable populations must be approved by two expediting reviewers (45 CFR 46, Subparts B-D). Projects that are not suitable for the exempt category or those that raise other than routine ethical issues will, at the discretion of the reviewer, be referred to the Full Board for review. Communication regarding the review will be contained in Cayuse IRB. The PI and primary contact will receive notification by email when a decision has been made by a reviewer in Cayuse IRB. Investigators will be notified of the final outcome of each review by an electronic letter of approval, a copy of which will be contained in the Cayuse IRB system. Expedited proposal review categories are in Appendix D, 63 FR 60364, November 9, 1998.

Full Board Proposals

Research projects involving human subjects that do not qualify for either exempt or expedited categories of review must be reviewed and approved by the full IRB at a convened meeting. The IRB meets on the last Tuesday of the following months during the academic year: September, October, November, February, March and April. A Full Board proposal must be submitted at least three weeks before the scheduled meeting. Please check the HRPP website for accurate monthly details.

After a full discussion of a full board proposal, the IRB may take one of the following actions by majority vote:

Approve: The IRB can approve the project as submitted without any changes for no more than 12 months. Projects that involve significant risks can be approved for less than 12 months at the discretion of the IRB. The decision to require a period of approval of less than 12 months is determined in the course of discussion of the proposal and is part of the motion to approve the project. Any specific findings required by 45 CFR 46 such as those needed for approval of research with prisoners (45 CFR 46.305-306), or for waivers of signed consent (45 CFR 46.117) should be documented in the minutes. Motions to approve a proposal may include a finding that the research involves no more than minimal risk, thus making the project potentially eligible for expedited continuing review.

Minor Revisions Required: The IRB may approve a project contingent upon specific, minor modifications by the Principal Investigator. When the revised proposal with the changes incorporated is received in Cayuse IRB, it will be routed to the chair or a member designated in the minutes (usually the primary reviewer) who will compare the modifications received with the actions requested by the IRB. If the modifications are in compliance with the IRB directives, the chair or the primary reviewer will approve the project for the period of time specified by the IRB. Note: although the approval is not effective and the project may not go forward until the modifications are approved, the period of approval is a maximum of 12 months from the date of the convened meeting.

Defer Pending Resubmission: If the IRB deems that the proposal requires substantial revisions, or if unanswered questions remain, the IRB will require the investigator to resubmit the proposal and attachments with all of the changes required and all of the questions resolved. A revised version of the proposal with the incorporated changes will be reconsidered at the next board meeting following resubmission.

Disapprove: The IRB may disapprove a research project if it has determined that the human subjects are at a greater risk than the benefits to be accrued. This action is taken only after all negotiations with the investigator have failed to result in a resolution of the pertinent ethical issues. Notification will include the reasons for the disapproval. Upon disapproval, the Principal Investigator can submit a revised proposal to the IRB. Federal regulations specify that the administration of the university cannot approve a project which the IRB has disapproved.

Review Categories

Letter and spirit both matter. The IRB cannot approve a proposal that is not consistent with the criteria set forth in 45 CFR 46 or the interpretations of 45 CFR 46 issued by OHRP (see Guidance Documents at http://www.hhs.gov/ohrp/policy/). At the same time, every project is reviewed with consideration of the more general ethical principles of respect for persons, beneficence, and justice described in The Belmont Report. The integrity and good will of investigators is assumed, but the IRB is required not only to ensure the protection of human subjects but also to document that their rights and welfare have been protected. In reviewing proposals, the IRB must determine that each one satisfies the following standards:

Risks to subjects. Risks to subjects are minimized by the use of procedures that are consistent with sound research and that do not unnecessarily expose the subjects to physical, psychological, social, economic, or other risks. In the case of research involving diagnosis or treatment, risk is minimized by the use of procedures already in use for diagnostic and treatment purposes whenever appropriate.

Risks vs. benefits. Risks to the subject are reasonable in relation to anticipated benefits, if any, to subjects, and to the importance of the knowledge that may reasonably be expected to result. In order to assess the importance of the knowledge resulting from the research, the IRB must be satisfied with the soundness of the rationale and the research design. The board's concern about the scientific validity of research is in direct proportion to the risk involved. In evaluating risks and benefits, the IRB considers only those risks and benefits that may result from the research (as distinguished from the risks and benefits of therapies or services that subjects would receive even if they did not participate in the research). The IRB does not consider the long-range effects of applying the knowledge gained in the research as among those research risks or benefits that fall within its responsibility. When students are offered course credit for participation, there must be non-research alternatives for earning the same credit for the similar time and effort.

Subject selection. The selection of subjects must be equitable. In making this assessment, the IRB takes into account the purposes of the research, the setting in which the research will be conducted, and the population from which the subjects will be recruited.

Other considerations. The IRB may also consider the acceptability of the research project in terms of other applicable standards of professional conduct and special vulnerabilities of the subjects.

Appeals of IRB Decisions

In virtually all instances, investigators work with the IRB to reach agreement on the best ways to meet human subjects requirements while conducting research. In cases where the investigator and committee reach an impasse, a decision by the IRB to disapprove a project is final. Federal regulations prohibit the university from approving a project which the IRB has disapproved.

Continuing Review, Annual Progress Reports, and Termination of Projects

Texas Tech University's assurance of compliance with the federal government requires at least annual review by the IRB of all expedited and full review studies involving human subjects research. As part of continuing review, the IRB has regulatory authority to observe, or have observed, the consent process and the research itself and to audit records such as consent forms at any time. When the approval for a project nears expiration, the investigator should complete the Renewal submission in Cayuse IRB. The procedures below apply depending on the level of initial review. Except for Exempt category projects, the investigator will be informed by an emailed letter of the outcome of continuing review.

Exempt research. Exempt research is not subject to continuing review. Any modifications that (a) change the research in a substantial way, (b) might change the basis for exemption, or (c) might introduce any additional risk to subjects should be reported to the IRB for review before they are implemented.

Timing of review. When a proposal is approved or renewed by either expedited or full review, approval normally extends to the last day of the month preceding the anniversary of the approval. The anniversary is determined by the date of final approval (initial or continuing) by an expediting reviewer or the date of the convened full IRB meeting at which approval (including contingent approval) occurs, not the date of final approval of required changes. When continuing review is required for a period of less than a year, the expiration date is determined in a similar manner.

Approximately 30 days prior to the expiration of the approval, the HRPP staff will send an email through the Cayuse system to the Principal Investigator noting the date of expiration and the need to complete a Renewal submission. The Renewal requires a report on the status of the project, descriptions of all adverse events affecting the rights or welfare of human subjects, and any changes contemplated in the research protocol and/or informed consent/assent forms. A complete clean proposal may be required every three years if the initial proposal has been amended within the three years.

Expedited continuing review/Renewal. Projects initially approved by expedited review will normally undergo expedited continuing review/renewal unless changes to the research are contemplated that might move it out of the expedited category. Because 10 working days should be allowed for processing a proposal and due to the volume of expedited reviews, prompt completion of the Renewal submission is important to ensure that the approval of a project does not lapse. Expediting reviewers will be assigned the renewal, and will have access to the original proposal including the current consent form, any subsequent modifications, and access to the complete file on each project. Criteria are the same as for initial review, but continuing expedited review of research involving children requires review by only one expediting reviewer. At the discretion of the reviewer, independent verification that no material changes have occurred since the previous IRB review may be required.

Full Board continuing review/renewal. Projects initially approved by the Full Board will normally not undergo Full Board continuing review unless the progress report identifies additional risks. Prompt completion of the Renewal in Cayuse IRB is important to ensure that the approval of a project does not lapse.

For continuing review/renewal conducted by the Full Board, a primary reviewer will be designated. When deemed appropriate, protocols requesting Full Board review are distributed to all IRB members and include the Renewal, current consent forms, prior modifications and the original proposal. The primary reviewer will be provided with the Renewal, the original proposal, any subsequent modifications, and access to the complete file on each project. Criteria are the same as for initial review. At its discretion, the board may require independent verification that no material changes have occurred since the previous IRB review.

Termination. All Principal Investigators must maintain an active IRB-approved protocol until the project is complete. Once data have been rendered non-identifiable, they no longer constitute identifiable private information and further data analysis does not require continuing approval.

If the HRPP does not receive the request for a renewal by the due date noted on the form, IRB approval automatically expires and a letter of termination is sent to the Principal Investigator. By not completing the Renewal or otherwise notifying the IRB that the project has been terminated, the investigator certifies that during the preceding period of approval there were no changes to the protocol or consent form and no adverse events. Projects that continue without IRB approval or projects initiated without IRB approval are out of compliance with federal regulations and with Texas Tech University policy. In such cases a report of non-compliance will be filed with the Vice President for Research for further action. The university is required to inform OHRP of any serious or continuing non-compliance.

IRB Submission Forms and Examples

Below is a list of forms and examples provided by TTU’s IRB to help speed up the submission process.

Informed Consent Examples

For adults: http://www.depts.ttu.edu/vpr/irb/downloads/consent-form-example.pdf

For minors: http://www.depts.ttu.edu/vpr/irb/downloads/HRPP_Assent_Form_Minors.pdf

Claim for Exemption

Required for submissions submitted for exempt review. Accessible here: http://www.depts.ttu.edu/vpr/irb/downloads/Claim-for-Exemption.pdf

Expedited Review Form

Required for submissions submitted for expedited review. Accessible here: http://www.depts.ttu.edu/vpr/irb/downloads/Expedited-Review-Form.pdf