Comments

1. This study has been approved for 200 participants. □

2. This IRB study application has been reviewed and approved by the IRB. □Research may begin on the approval date stated above. □

3. Research is to be conducted according to the study application approved □by the IRB prior to implementation. □

4. Any future correspondence should include the IRB study number and □the study title. □

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Investigators assume the following responsibilities:

1. Continuing Review: The study must be renewed by the expiration date in order to continue with the research. A Continuing Review application along with required documents must be submitted by the continuing review deadline. Failure to do so may result in processing delays, study expiration, and/or loss of funding. □

2. Completion Report: Upon completion of the research study (including data collection and analysis), a Completion Report must be submitted to the IRB. □

3. Unanticipated Problems and Adverse Events: Unanticipated problems and adverse events must be reported to the IRB immediately. □

4. Reports of Potential Non-compliance: Potential non-compliance, including deviations from protocol and violations, must be reported to the IRB office immediately. □

5. Amendments: Changes to the protocol and/or study documents must be requested by submitting an Amendment to the IRB for review. The Amendment must be approved by the IRB before being implemented. □

6. Consent Forms: When using a consent form or information sheet, the IRB stamped approved version must be used. Please log into iRIS to download the stamped approved version of the consenting instruments. If you are unable to locate the stamped version in iRIS, please contact the iRIS Support Team at 979.845.4969 or the IRB liaison assigned to your area. Human participants are to receive a copy of the consent document, if appropriate. □

7. Post Approval Monitoring: Expedited and full board studies may be subject to post approval monitoring. During the life of the study, please review and document study progress using the PI self-assessment found on the RCB website as a method of preparation for the potential review. Investigators are responsible for maintaining complete and accurate study records and making them available for post approval monitoring. Investigators are encouraged to request a pre-initiation site visit with the Post Approval Monitor. These visits are designed to help ensure that all necessary documents are approved and in order prior to initiating the study and to help investigators maintain compliance. □

8. Recruitment: All approved recruitment materials will be stamped electronically by the HRPP staff and available for download from iRIS. These IRB-stamped approved documents from iRIS must be used for recruitment. For materials that are distributed to potential participants electronically and for which you can only feasibly use the approved text rather than the stamped document, the study’s IRB Study Number, approval date, and expiration dates must be included in the following format: TAMU IRB#20XX- XXXX Approved: XX/XX/XXXX Expiration Date: XX/XX/XXXX. □

9. FERPA and PPRA: Investigators conducting research with students must have appropriate approvals from the FERPA administrator at the institution where the research will be conducted in accordance with the Family Education Rights and Privacy Act (FERPA). The Protection of Pupil Rights Amendment (PPRA) protects the rights of parents in students ensuring that written parental consent is required for participation in surveys, analysis, or evaluation that ask questions falling into categories of protected information. □

10. Food: Any use of food in the conduct of human research must follow Texas A&M University Standard Administrative Procedure 24.01.01.M4.02.

11. Payments: Any use of payments to human research participants must follow Texas A&M University Standard Administrative Procedure 21.01.99.M0.03.

12. Records Retention: Federal Regulations require records be retained for at least 3 years. Records of a study that collects protected health information are required to be retained for at least 6 years. Some sponsors require extended records retention. Texas A&M University rule 15.99.03.M1.03 Responsible Stewardship of Research Data requires that research records be retained on Texas A&M property.

This electronic document provides notification of the review results by the Institutional Review Board.