IRB-Research with Humans


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.

IRBProcessProtocols

Please contact the Office of Research & Sponsored Programs with questions.

IRB Information

University Procedure on IRB
IRB Review Board Members

Protocol Submission Schedule

FY2020 IRB Full Board Meeting & Protocol Submission Schedule

Instructions for Protocol Submission

The applicant (faculty and director level staff) should complete one of the required applications listed below and submit it to researchcompliance@tamuc.edu. All supporting documentation (consent forms, site support forms, etc.) must be submitted with the application.

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

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
                                       Personal Health Information Forms
PHI Participant Authorization PHI Use in Research
PHI Waiver of Consent

Templates and Samples

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

Sources and Information on the Protection of Human Subjects

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

Selected University IRB Homepages

http://www.irb.pitt.edu/