Texas A&M University-Commerce is committed to the protection of human subjects involved in research and other scholarly activities conducted by our faculty, staff or students.
Human Subjects research and other scholarly activities are defined as systematic investigations designed to develop or contribute to generalizable knowledge, which involves the collection of data from or about living human beings. In addition, all student research activities involving human subjects outside of the classroom are considered to be in this category. All research and other scholarly activities involving human subjects are required to be reviewed and approved by Texas A&M University-Commerce’s Institutional Review Board (IRB) prior to initiation of data collection. This requirement applies to all human subjects research and other scholarly activities conducted by faculty, staff, and students, on- and off-campus, regardless of the funding source, if any, for the project.
University Procedure on IRB
IRB Review Board Members
FY2020 IRB Full Board Meeting & Protocol Submission Schedule
Students are not allowed to submit their own applications. Any student working on his/her thesis, dissertation, or other research should be listed as “Additional Personnel” on an application submitted by their faculty advisors.
Any application that is incomplete will be returned to the applicant.
Forms |
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| Protocol Form - Exempt Review Use this form for all new protocols. |
Protocol Form - Expedited or Full Board Review |
| Protocol Amendment/Addendum Use this form if you have an approved protocol and need to make changes to the original protocol. |
External Grant Protocol Use this form if you are preparing/developing an external grant proposal and need conditional approval. |
| Request Continuing Review Form /Renewal Form Use this form if you have an approved protocol and need to continue beyond the 1 year approval date. |
Additional Team Member Form This form must be accompanied by an amendment form. |
| Prisoner Research Addendum Form Use this form if human subjects are confined in penal institutions. |
Adverse Event Form |
| Closure Form To close out research protocols |
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| Personal Health Information Forms | |
| PHI Participant Authorization | PHI Use in Research |
| PHI Waiver of Consent | |
Exempt Informed Consent Informational Letter
Child Assent With Signature
Child Assent Without Signature
Informed Consent (Online Survey)
Tips for Informed Consent (in Spanish & other languages)
Parental Permission With Signature
Parental Permission Without Signature
Site Letter Example
Deception/Concealment Form
Deception/Concealment Information
Expedited or Full Board Consent
Informational Letter
Child Assent With Signature
Child Assent Without Signature
Informed Consent
Parental Permission With Signature
Parental Permission Without Signature
Deception/Concealment Form
Deception/Concealment Information
Guidance on the Use of Audio/Video/Photography
Advisory Committee (SACHRP) - Recommendations-Internet Research
APA Ethics Office
ASA Ethics
Capacity to Consent: Points to Consider
Department of Education
Electronic Signatures - Informed Consent 45CFR46.117(c)
Federal Human Subjects Regulations (45CFR46)
Guidance on Reporting Incidents to OHRP
HIPAA Guidelines - DHHS
Office for Human Research Protection
Protection of Pregnant Women, Human Fetuses, and Neonates in Research
Protection of Children in Research - (45CFR46.101)
Protection of Children in Research - (45CFR46.102)
Provisions for Children - Minimal Risk - (45CFR46.408)
Protection of Prisoners in Research
Nuremberg Code - Drafted in 1947 in Nuremberg, Germany after WWII.
The Belmont Report - Protects human subjects of biomedical and behavioral research.
The Declaration of Helsinki - Ethical principles developed for the medical community to use regarding human experimentation. Adopted in 1964.
Protection of Human Subjects Workshop
(this workshop does not replace mandatory training in CITI)
http://www.youtube.com/watch?v=Tzu602lyi8k