IRB approval is needed when your project meets the definition of human subject research

Research means a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge (45 CFR 46.102).

• Generalizable knowledge includes information presented to a broader audience or published with the intent of drawing scientific conclusions or increasing the body of scientific knowledge and can be applied to populations outside of the specific study population.

Human subject means a living individual about whom an investigator (whether professional or student) conducting research (45 CFR 46.102):

• Obtains information or biospecimens through intervention or interaction with the individual, and uses, studies, or analyzes the information or biospecimens.
  • 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.
  • Private information includes information about behavior that occurs in a context in which an individual can reasonably expect that no observation or recording is taking place, and information that has been provided for specific purposes by an individual and that the individual can reasonably expect will not be made public (e.g., a medical record).
  • Identifiable private information is private information for which the identity of the subject is or may readily be ascertained by the investigator or associated with the information.
  • Identifiable biospecimen is a biospecimen for which the identity of the subject is or may readily be ascertained by the investigator or associated with the biospecimen.

Researchers who are in doubt about whether an activity constitutes research with human subjects should consult with the HRPP or the IRB Chairs.

IRB approval is needed prior to recruitment of participants, consent/assent process, data collection, and/or gaining access to identifiers.

In the Cayuse IRB submission, you will identify the research team and assign their roles. The Principal Investigator takes all responsibility for the research and team members. The principal investigator must be a full-time or tenured TTU faculty member, or full-time employee with a terminal degree in his or her discipline (Ph.D., Ed.D., J.D., or M.D.) (TTU OP 74.09).

The Primary Contact will receive all notifications generated in Cayuse IRB. There can be more than one primary contact.

Co-investigators are any researchers assisting with recruitment, consent/assent, data collection, and has access to identifiers. Co-investigators can edit the IRB document. However, the principal investigator must review and certify the IRB prior to submission.

Exempt & Limited Review

Research in the Exempt category includes research that involves minimal risk and fits certain precisely defined categories (45 CFR 46.104). The data is typically collected or received in a manner that is anonymous or de-identified. Exempt research still requires an IRB to be submitted through Cayuse IRB. A limited review is only required if the research involves identifiable information. Limited IRB review requires the IRB to determine that there are adequate provisions for protecting privacy and confidentiality.

Expedited

Project involves no more than minimal risk. Minimal risk means that the probability and magnitude of harm or discomfort anticipated in the research are not greater in and of themselves than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests.

Most studies that involve children, non-invasive/invasive, or sensitive data with personal identifiers will need Expedited review. Projects with children or other vulnerable populations must be approved by two reviewers.

Full Board

Full Board research projects are greater than minimal risk to human participants. Research that involves an interaction/intervention with prisoners will require a full board review.

Vulnerable Populations

Anonymous v. Identifiable Data

Modifications

After IRB approval, any subsequent changes to the study must be reviewed and approved by the IRB prior to implementation. This includes changes to the research team, recruitment process or material, consent procedures or materials, participant payment, data collection procedures, and target population. Protocol violations are changes in the approved IRB protocol that are under the investigator's control and made without prior IRB approval.

When changes to the IRB are necessary to immediately eliminate or reduce an apparent hazard to the safety of research participants or others, those changes may be initiated without prior IRB approval. This event must be reported to the IRB/HRPP within 10 working days of initiation. If there are subject safety concerns, contact the HRPP Director or IRB Chairs immediately.

Modifications are made and submitted in Cayuse IRB. Opening the approved IRB will take you to the study details page. Then click on New Submission and Modification. Researchers must complete the modification summary section. They must also edit appropriate sections of the IRB and attach revised documents.

Incidents

During the research, researchers may encounter certain types of unanticipated problems, adverse events or protocol deviations. Researchers must report these incidents to the IRB.

A protocol deviation is any change, deviation, or departure from the approved IRB and is under the researcher's control and has not been approved by the IRB. Upon discovery, the Principal Investigator and research team is responsible for reporting protocol deviations to the IRB.

Incidents are made and submitted in Cayuse IRB. Opening the approved IRB will take you to the study details page. Click on New Submission and Incident. After submitting the Incident, additional information may be requested by the IRB.

An IRB shall have authority to suspend or terminate approval of research that is not being conducted in accordance with the IRB's requirements or that has been associated with unexpected serious harm to participants. Any suspension or termination of approval shall include a statement of the reasons for the IRB's action and shall be reported promptly to the researcher, appropriate institutional officials, and the department or agency head. (45 CFR 46.113)

Renewals

Renewals are conducted at least once a year and used to re-evaluate the research protocol and risk to participants. The IRB can determine the length of approval and timeline for renewal. The rationale for doing so must be documented in the IRB approval letter. Renewals are submitted on a yearly basis until the research has been completed and the IRB protocol has been closed.

Renewals are submitted in Cayuse IRB. Opening the approved IRB will take you to the study details page. Click on New Submission and Renewal. Complete the submission and attach all consent and assent documents with updated expiration dates. The renewal submission should be submitted no sooner than 60 days but no later than 30 days before the IRB's expiration date. Expired IRBs are in non-compliance and must stop immediately until a renewal is approved. During this time no recruitment and/or data collection can occur.

The HRPP office will email the PI and primary contact of all approved IRBs NOT requiring renewal on a yearly basis. The email will serve as a reminder to submit any modifications or incidents for the approved protocol. The PI must inform the HRPP office that the research is complete and can close. This can be done by responding to the annual email or submitting a closure submission in Cayuse IRB. IRBs that remain active are subject to audit by the IRB.

Closures

If all research interventions or interactions with participants have been completed and collection and analysis of identifiable private data/biospecimens are finished, the study should be closed with the IRB. Once a study has been closed, investigators may keep the data collected (including identifiable, private data) if consistent with the IRB-approved protocol. Investigators should continue to honor any confidentiality protections of the data. Investigators should also honor any other commitments that were agreed upon as part of the approved research. For example, providing information about the study results to research participants or honoring reimbursement commitments for participation. IRBs that remain active are subject to audit by the IRB.

Closures are submitted in Cayuse IRB. Opening the approved IRB will take you to the study details page. Click on New Submission and Closure. Once the submission is approved, the study is considered Closed by the IRB and archived. If a researcher wishes to resume the research after the study has been closed or if the study is closed in error, a new study will have to be submitted.

The IRB Closure Guidelines can be used by the research team to assist with closing their IRB.

IRB Committee Members

The IRB is composed of faculty members from various disciplines within the education, social, and behavioral sciences as well as community members.

The IRB operates under the guidance of the Office for Human Research Protections (OHRP). OHRP provides clarification and guidance, develops educational programs and materials, maintains regulatory oversight, and provides advice on ethical and regulatory issues in biomedical and behavioral research.

CHAIRS

MEMBERS

ALTERNATES

EX-OFFICIO

Full Board 2025-2026 Calendar

The TTU Institutional Review Board convenes the full board on the first Tuesday of each month at 3 p.m.

To be assured of consideration, a full board initial proposal must be submitted to the HRPP at least 30 working days before the full board meeting.  A full board modification or renewal proposal must be submitted to the HRPP at least 15 working days before the full board meeting.  The researchers and primary reviewer must work together to prepare the proposal for presentation to the full board.  The primary reviewer will determine when the IRB proposal is ready to be added to the full board agenda, which is often when the researchers have addressed all of the primary reviewers’ initial concerns and comments.  Exempt, Limited, and Expedited proposals may be submitted at any time.

TTU IRB faculty reviewers will NOT conduct limited and expedited reviews when faculty are off-duty (Winter Break, May and Fall Intersessions).  If a review is needed during this time period contact the HRPP.

The TTU IRB Full Board will not have regularly scheduled meetings for the months of January, June, or August. If your research meets the criteria for a full board review, please contact HRPP Director, Dr. CassiDe Street at 806.742.2064.