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Institutional Review Board: Protecting human subjects in research


Because of new national standards, UNT researchers using humans as research subjects must complete an instructional program before submitting their research plans to UNT's Institutional Review Board, which works to ensure safe and respectful conditions for human research subjects.

The required training, a no-cost tutorial developed by the National Institutes of Health, is called Human Participant Protections Education for Research Teams and is accessible online at cme.nci.nih.gov.

The federally mandated duty of an IRB is to ensure that all projects, funded or not, involving research with humans as subjects meet three criteria: Projects must (1) have the promise of greater benefit than risk; (2) be conducted only with people who understand the possible risks and benefits to themselves and to society, and (3) respect and protect people – especially those who are vulnerable – who from fear or from hope of gain might be willing to endanger themselves. The role of the IRB is not to insulate subjects from any amount of risk stemming from research but to make sure that subjects fully understand risks before participating in a project.

Researchers must not take advantage of positions of power, such as that of employers over employees or teachers over students, because that might harm the subjects psychologically, socially or economically.

Federal regulations guide UNT's IRB in reviewing and approving research projects. The board's responsibility is to the subjects of research. It upholds ethical behavior and the common decency one human being should show for another in human subject research that contributes to developing generalized knowledge.

Research at UNT involving human subjects includes work with children with autism, college-age smokers, mainstream school students in a variety of learning settings, working moms, drug addicts and competitive athletes. Researchers study how humans make decisions, play musical instruments and react to health hazards such as sexually transmitted diseases, and they evaluate citizens' perceptions of public services. The IRB has reviewed 250 UNT projects thus far this year.

Applications seeking IRB approval of projects involving human subjects can now be made online. Visit UNT's IRB web site at www.unt.edu/ospa/irb/irb.htm or call the IRB office at (940) 565-3940.

Peter Shillingsburg, professor of English, is chair of the UNT Institutional Review Board.

   

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