As mandated by our Federal Wide Assurance with the federal government (45 CFR 46) and TAMU System Policy 15.99.01, all research projects involving human subjects, conducted by Texas A&M International University (or other agency of The Texas A&M International University) faculty, employees, graduate students, undergraduate students or postdoctoral fellows or using members of the Texas A&M International University Community as subjects (regardless of the source of funding), must be approved by the University’s Institutional Review Board (IRB). Any outside agency performing research using Texas A&M International University facilities and using members of the Texas A&M International University community will first seek approval of the Texas A&M International University IRB.
The guiding principles for such research are based on The Belmont Report-Ethical Principles and Guidelines for the Protection of Human Subjects of Research (National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research, April 18, 1979).
Purpose: the purpose of the IRB is to ensure that the rights and welfare of the human subjects are properly protected.
Procedure: All documents are submitted to the Office of Research and Sponsored Projects (KL326), which assists IRB Chair1. Complete the Determination of Human Research form, attach your survey, grant application etc. and submit the documents to KL326. This short form may be all that is needed. IRB will review Determination of Human Research form and either:
a. email you that the form meets criteria for review as exempt protocol
b. email you to inform you that you need to submit the full IRB Protocol Form with the Consent Form, Surveys, Instruments, Grant Application, etc.
2. If applicable, you need to obtain Independent School District (ISD) approval
3. Complete necessary training Training - Required
Review Process:
1. Protocol will be reviewed to determine if it is complete. If it is incomplete you will be notified what needs to be done to complete the application. The application will not be reviewed until it is complete.
2. Once the application is complete it will be determined if the study is exempt, expedited, or requires full review. The IRB will determine which category the research falls into.
3. Studies that require full review will be reviewed by a convened committee within 30 days whenever possible.
4. Once the study is reviewed modifications/clarifications will be requested or it will be approved or disapproved.
No human research may be done at TAMIU, or conducted by/involving TAMIU faculty, employees, graduate students, undergraduate students or postdoctoral fellows or other members of TAMIU until the TAMIU IRB has reviewed, and approved the research
If you are an outside investigator TAMIU IRB will in general accept a copy of your application to your local IRB, and associated correspondence instead of having to fill out our forms. The TAMIU IRB reserves the right to require our forms.
HIPAA - if you are reviewing medical charts or other protected health information you must submit an IRB application to the IRB. Additional documentation may be required.
THE MOST COMMON DELAYS ARE:
1. Informed Consent Problems: Insufficient informed consent- not containing all of the elements of consent, not written in the 1st person of the subject, not written in simple language.
2. Not all adequate information regarding the procedures, e.g. instruments, experimental procedures is present. Procedures need to be explained exactly as you would do them, and include sufficient detail that a person using your protocol could do the experiment.
3. Failure to complete training. Final approval can not be given until principal investigators have completed training.
Other Important Information
Any adverse reactions and any research related problems or complaints must be reported immediately and in writing to the IRB chair.
All Human Research documents must be retained for a minimum of three years AFTER completion of the study.
The IRB is required to ensure compliance with federal regulations. In order to do this the IRB will review (at random) principal investigators conducting human research at TAMIU.