Welcome To The Human Research Protection Program
Texas Tech University is committed to protecting the rights and welfare of individuals participating in research. Texas Tech's Institutional Review Board (IRB) is charged with reviewing all human subjects research in accordance with federal regulations (45 CFR 46), state laws, and local and University policies (TTU OP 74.09).
The Human Research Protection Program (HRPP) serves as a liaison to the IRB and point of contact for participants and researchers.
Need an IRB? (see below)
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.
Cayuse IRB is the online system Texas Tech researchers will use for submitting their IRBs. All faculty can automatically login to Cayuse IRB by using their eraider and password through the HRPP website. TTU staff and students must request user access through the HRPP website.
Using branch logic, researchers will answer questions related to their study and skip irrelevant ones. For example, checking a box may prompt additional questions specific to that subject matter. Some questions are required, and some questions are not. As you complete each section, please provide answers to questions that are relevant to your study. Adequately answering questions will provide information to the IRB Reviewer to understand the study and facilitate the review process.
When you first create a study, you create the initial submission outlining the purpose of that study. In addition to this initial submission, there are five other types of submissions that IRB Users may submit during the course of your research. Here are directions for getting started. Quick Start for Cayuse IRB
The available submission types include:
Submission Types
- Initial - This is the first submission that you create when you enter a new study in the system. The initial submission describes the research you intend to do and the methodology you intend to use. The initial submission must be approved before any research can begin.
- Modification - If you wish to change any of the details of the study after it has been approved, you must submit a modification which must be approved before you can proceed with the changes.
- Provide a summary of your proposed changes or additions.
- Make the changes to the appropriate section(s) and field(s).
- Attach any revised documents that are relevant to your requested changes. Such as, revised surveys, additional recruitment messages, explanations of a different subject population.
- Renewal - When a study is nearing its expiration date, you must submit a renewal request in order to continue with the research. The renewal will need to be approved before you can continue with the study.
- Researchers must attach all consent forms to the submission with the updated expiration date.
- Incident - You must submit an incident report to inform the HRPP of any adverse incidents, as required by your institution.
- Incident reports may be submitted at any time after a study has been approved, including after it has been closed.
- More than one incident report may be created for a given study, as needed.
- Withdrawal - A withdrawal submission notifies the HRPP that you no longer wish to
submit your initial submission and want to withdraw the study.
- Withdrawn studies are marked as finalized and can no longer be modified. You may create a withdrawal submission at any point once an initial submission has been created, until it has been approved.
- If the initial submission has been approved, you must create a closure submission in order to close the study if you no longer wish to conduct the research. The Archive tab lists studies that have been withdrawn.
- Closure - A closure submission indicates that the research is complete and will not
be continuing.
- Closed studies are marked as finalized and can no longer be modified. The Archive tab lists studies that have been closed.
- Legacy - Used for studies imported from previous systems. The legacy submission replaces the initial submission for imported studies. Once the legacy submission is finalized, you can create additional submissions such as modifications, renewals, etc.
- Admin Closure - Allows a study to be administratively closed when needed, for example when the PI leaves the institution or chooses to let a study expire. The Archive tab lists studies that have been withdrawn.
- Admin Withdrawal - Allows a study to be administratively withdrawn when needed, for example when the PI leaves the institution. The Archive tab lists studies that have been withdrawn.
There are two additional submission types that are only available to IRB Analysts and Admins:
IRBs are assigned to reviewers every Monday based on the order the HRPP office receives the submission from the researcher. The reviewer then has 10 business days to complete each review. Most reviews will require two-to-three exchanges of revisions. TTU IRB faculty reviewers will NOT conduct reviews when faculty are off-duty (Winter Break, May and Fall Intersessions). If a review is needed during this time period contact the HRPP.
In Cayuse IRB, the status of your study can be found under the Submissions icon on the left side menu. You can also click on the specific submission for more details.
Status Definitions
- In-Draft: The submission has not been completed and is still being edited by the research team.
- Awaiting Certification: The submission is awaiting PI review and certification.
- Pre-Review: The submission is with the HRPP office for pre-screening.
- Under Review: The submission has been sent to the IRB Reviewer.
- Approved: The study has been reviewed and approved by the IRB.
- Closed: The study has been completed and closed.
- Expired: The study has not been renewed and the research procedures must stop.
IRBs reviewed and not returned with revisions will be administratively withdrawn after 90 days. IRBs created in the previous calendar year and not submitted for review will be administratively withdrawn in June of every year.
Researchers work with the IRB to reach an agreement on the best ways to protect human subjects while conducting research. In cases where the investigator and IRB reach an impasse, a decision by the IRB to not approve a project is final. Federal regulations specifically prohibit the university from approving a project that the IRB has disapproved.
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.
Exempt Categories
- Category 1: Established or Commonly Accepted Educational Settings
- Category 2: Educational Tests, Survey Procedures, Interview Procedures or Observation
of Public Behavior
- Limited review is required if identifiers are collected.
- Focus groups are allowed with a limited review.
- Category 3: Benign Behavioral Interventions in Conjunction with the Collection of
Information From Adult Subjects
- Limited review is required if identifiers are collected.
- Limited review is required if deception is a part of data collection. The participants must prospectively agree that they will be unaware of or misled regarding the nature or purpose of the research.
- Category 4: Secondary Research for Which Consent is Not Required
- Category 5: Research and Demonstration Projects that Are Conducted or Supported by a Federal Department or Agency
- Category 6: Taste and Food Quality Evaluation and Consumer Acceptance Studies
- Category 7: Storage or Maintenance for Secondary Use for Which Broad Consent is Required
- Limited review is ALWAYS required.
- Consultation with the HRPP Director or the IRB Chair is required before completing IRB application for Exempt Category 7.
- Category 8: Secondary Research for Which Broad Consent is Required
- Limited review is ALWAYS required.
- Consultation with the HRPP Director or the IRB Chair is required before completing IRB application for Exempt Category 8.
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.
Expedited Categories
- Category 1a: Drugs for which an Investigational New Drug Application (21 CFR Part 312) is NOT Required
- Category 1b: Medical Devices
- Category 2a: Collection of Blood Samples for Nonpregnant Adults who Weigh At Least 110 pounds
- Category 2b: Collection of Blood Samples from Other Adults and Children
- Category 3: Prospective Collection of Biological Specimens for Research Purposes by Noninvasive Means
- Category 4: Collection of Data Through Noninvasive Procedures Routinely Employed in Clinical Practice
- Category 5: Materials Collected, or Will Be Collected Solely for Nonresearch Purposes
- Category 6: Collection of Data from Voice, Video, Digital, or Image Recordings Made for Research Purposes
- Category 7: Individual or Group Characteristics or Behavior
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.
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
- Unanticipated problem is an incident or event that was unexpected by the research team. This incident or event has developed a new or increased risk to the participants and was possibly related to the research procedures. Anticipated problems are already described as potential risks in the consent form and described in the IRB.
- Adverse events are any unpleasant or unfavorable medical occurrence in a participant, including any abnormal sign, symptom, or disease, temporally associated with the research participation. Adverse events encompass both physical and psychological harms.
- A minor deviation or minor violation is viewed by the IRB as an event that does not impact subject safety, compromise the integrity of study data and/or affect a subject's willingness to participate in the study. Minor deviations or violations will be reviewed by the IRB Chair. The IRB Chair will determine whether the event is accepted as a minor deviation/violation and can recommend a corrective course of action.
- A major deviation or violation is viewed by the IRB as an event that may impact participant safety, affect the integrity of study data and/or affect a participant's willingness to participate in the study. Major protocol deviations/violations are treated as noncompliance. These incidents will be reviewed by the IRB Chair, the IRB committee and the Institutional Official to determine the appropriate course of action.
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.
Renewal Based On Review Type:
- Exempt – DOES NOT require renewal
- Limited Review - DOES NOT require renewal
- Expedited Approved before 1/19/2019 – REQUIRES renewal
- Expedited Approved on or after 1/19/2019 – DOES NOT require renewal
- Full Board – REQUIRES renewal
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.
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