Texas A&M International University IRB

Texas A&M International University
Institutional Review Board (IRB)

A Guide to the IRB Applications Process

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.

Criteria:  the following steps will enable you to complete an IRB application quickly and completely.

  • Read this entire packet including the document, Answers to Commonly asked Questions about the Use of Human Subjects in Research at Texas A&M International University.

Procedure

  1. Complete the IRB Protocol Form
  2. Attach Consent Form, Surveys, Instruments, Grant Application, etc. as needed
  3. (Obtain ISD approval if needed)
  4. Submit the signed copy of the IRB Protocol Form to the Office of Research and Sponsored Projects (KL326), which assists IRB Chair
  5. Complete annual training Training - Required

Review Process

  1. A member of the IRB will review the protocol 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.
    1. Exempt from complete review (studies are usually exempt from review if they pose no apparent risks for the research subjects).
    2. Expedited review (studies that have some risks, which are viewed as minimal).
    3. Full review (studies that have greater than minimal risks must receive a complete review).
  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 in stead of having to fill out our forms. The TAMIU IRB reserves the right to require our forms.

If the research is being performed at an institution, (e.g. schools, hospitals, clinics) then the appropriate administrator must also sign an approval of the research, as well as the subjects.

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.

Subjects participating in research must read and sign an informed consent document.  This section outlines the format you must follow and highlights points that you may need to include when creating an informed consent document. 

The following information is essential for the consent form.

Introduction of Research Activities:  consists of a designation that this activity is a study, the purpose of the study, and an explanation of study procedures. (NIH OHSR, 1991, 45 CFR 46.116a).

Description of Risks and Discomforts:  subjects are informed of any “reasonably foreseeable risks or discomforts” (physical, emotional, social, or economic) that might result from the study. (NIH OHSR, 1991, 45 CFR 46.116a).

Description of Benefits:  description of any “benefits to the subject or to others which may reasonably be expected from the research.” (NIH OHSR, 1991, 45 CFR 46.116a).

Disclosure of Alternatives:  investigator must disclose the “appropriate, alternative procedures or courses of treatment, if any that might be advantageous to the subject.” (NIH OHSR, 1991, 45 CFR 46.116a).

Assurance of Anonymity and Confidentiality:  subjects must be given a “statement describing the extent, if any, to which confidentiality of records identifying the subject will be maintained”.  They also must be assured that their identity will remain anonymous in presentations, reports, and publications of the study.  (NIH OHSR, 1991, 45 CFR 46.116a).

Compensation for Participation in Research:  for research involving more than minimal risk, the subjects must be given an explanation as to whether any compensation, medical, or psychological treatments are available if injury occurs. (NIH OHSR, 1991, 45 CFR 46.116a).

Offer to Answer Questions:  subjects are provided an “explanation of whom to contact for answers to pertinent questions about the research and research subjects’ rights, and whom to contact in the event of a research related injury.  (NIH OHSR, 1991, 45 CFR 46.116a).

Noncoercive Disclaimer:  a noncoercive disclaimer is a “statement that participation is voluntary, refusal to participate will involve no penalty or loss of benefits to which the subject is otherwise entitled.” (NIH OHSR, 1991, 45 CFR 46.116a).

Option to Withdraw:  subjects “may discontinue participation at any time without penalty or loss of benefits.”  (NIH OHSR, 1991, 45 CFR 46.116a).

Consent to Incomplete Disclosure:  in some studies, subjects are not completely informed of the study purpose, because that knowledge would alter the subjects’ actions.  However, subjects must know that certain information is being withheld deliberately.  The researcher ensures that there are no undisclosed risks to the subjects that are more than minimal and the subjects’ questions regarding the study are answered truthfully. (NIH OHSR, 1991, 45 CFR 46.116a).

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.

NOTE: you must report any adverse reactions and any research related problems or complaints 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.

 

 

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