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Human Research

Ethical Principles
All research at UT Arlington that involves human participants is guided by the ethical principles set forth in the report of the National Commission for the Protection of Human Participants of Biomedical and Behavioral Research entitled "Ethical Principles and Guidelines for the Protection of Human Subject of Research (Belmont Report)". The Belmont Report identifies three fundamental ethical principles for all human subjects research: respect for persons, beneficence, and justice. The federal regulations found at 45 CFR part 46 are based in large part on the Belmont Report and were written to offer basic protections to human subjects involved in both biomedical and behavioral research conducted.

What is human subject research?
The federal regulations define human subject research as "any research involving a living individual about whom an investigator (whether professional or student) conducting the research obtains (1) data through intervention orinteraction with the individual, or (2) identifiable private information." Additionally, the research must be "asystematic investigation, including research development, testing, and evaluation designed to develop or contribute to generalizable knowledge." For more information to determine if your research is human research, please review this guidance: https://www.uta.edu/ra/real/protocols/irb/is_human_subject_research.htm

The Institutional Review Board (IRB)
The federal regulations establish a reviewing body to ensure the protection and welfare of human subjects, called the Institutional Review Board (IRB). Any activity conducted by UT Arlington faculty, staff, or students and involving human subjects must first be reviewed and approved by the UT Arlington IRB. Please visit the Human Subjects page for more information. Individuals who conduct human subject research are required to complete Human Subjects Protection (HSP) Training; please log in to this site using your UTA net ID and password.

Investigator Responsibilities

 Primary responsibility for assuring that the rights and welfare of research participants are protected lies with the Principal Investigator (PI) conducting the research. Others engaged in the research share this responsibility. Faculty who assign or supervise research conducted by students or staff have an obligation to consider carefully whether those individuals are qualified to adequately safeguard the rights and welfare of participants.

Investigators play a crucial role in protecting the rights and welfare of human subjects and are responsible for carrying out sound ethical research consistent with research plans approved by an IRB. Along with meeting the specific requirements of a particular research study, investigators are responsible for ongoing requirements in the conduct of approved research that include:

  • obtaining and documenting informed consent of subjects or subjects' legally authorized representatives prior to the subjects' participation in the research, unless these requirements have been waived by the IRB;
  • obtaining prior approval from the IRB for any modifications of the previously approved research, including modifications to the informed consent process and document;
  • ensuring that progress reports and requests for continuing review and approval are submitted to the IRB in accordance with the policies, procedures, and actions of the IRB;
  • providing to the IRB prompt reports of any unanticipated problems involving risks to subjects or others;
  • providing to the IRB prompt reports of serious or continuing noncompliance with the regulations or the requirements of the IRB; and
  • keeping certain records as required by the HHS regulations for at least three years after completion of the study.

For more information, including instructions for submitting a protocol for IRB review, please complete the Human Subjects Protection (HSP) Training or visit the Human Subjects website.


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The University of Texas at Arlington: Online Training Instructions 
Collaborative Institutional Training Initiative (CITI)

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Additional Resources

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The University of Texas at Arlington: IRB Standard Operating Procedures
Institutional Review Board for the Protection of Human Subjects

 

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Federal Regulations: Protection of Human Subjects, 45 CFR 46
Office for Human Research Protections (OHRP)

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Investigator Responsibility: Frequently Asked Questions

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The Belmont Report
The National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research

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Human Subject Regulations Decision Charts
Office for Human Research Protections (OHRP)

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Federal Regulations: Protection of Human Subjects, 21 CFR 50
U.S. Food and Drug Administration (FDA)

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Federal Regulations: Institutional Review Boards, 21 CFR 56
U.S. Food and Drug Administration (FDA)

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Tips on Informed Consent
Office for Human Research Protections (OHRP)

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Available Forms

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The University of Texas at Arlington: Electronic IRB Protocol Application

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