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Butler Institute for Research & Scholarship

Institutional Review Board

At Butler University, responsibility for overseeing the policies and procedures for the protection of human subjects in research resides with the Provost/Vice President for Academic Affairs. Relevant functions and responsibilities include the development of an institutional policy, establishment of procedures to ensure protection for human subjects in research, continuing education of personnel with respect to the policy, modification of the policy to maintain its conformity with laws and regulations, and provisions of appropriate administrative support and legal assistance for the IRB. Management of compliance and maintenance of records also occurs under the aegis of the Office of the Provost, within the Butler Institute for Research and Scholarship (BIRS).

The IRB is the institutional body that governs the procedures to be used in research with humans, including protocol approvals as well as suspensions and terminations. The board ensures compliance with the Code of Federal Regulations and the Federal wide Assurance, a declaration of compliance for the protection of human subjects in research. Butler IRB members are appointed by the Provost/Vice President for Academic Affairs for three-year staggered terms. Butler IRB Policies

Revised Federal Policy on Human Subjects Research (Common Rule)

On January 19, 2017, the Department of Health and Human Services published revised regulations on the protection of human subjects in research (the “Final Rule”). The regulations governing research with human subjects, which mandate IRB review, were originally published by HHS and FDA in 1981, and adopted by 15 federal agencies in 1991. The revised regulations seek to strengthen protection of human subjects while decreasing administrative burden.

While there are many significant changes (Click to read the HHS.gov press release, and final rule full content), the following are the changes which will directly impact the Butler University research community. 

Revised regulations will take effect January 20, 2018. Until the new regulations are in effect, BIRS and the Butler IRB will continue to operate under the old regulations, in accordance with existing procedures and forms.

 

 

Applicability

BIRS IRB

Any research involving human participants that is conducted by faculty, staff, or students at Butler University must be submitted for review to the IRB. Similarly, any research conducted on the property of Butler University, regardless of the affiliation of the researcher, must be submitted for review. Review and approval by an IRB at another institution does not constitute an exemption from review by the Butler University IRB.

Human subjects research is defined as a systematic investigation designed to develop or contribute to generalizable knowledge. Human subjects are living individuals about whom an investigator obtains identifiable private information or data through an intervention or interaction. Research includes questionnaires, interviews, tests, observations, surveys, and other experiments under the auspices of the University.

Forms and Submission

All application forms, with backup documentation, should be submitted to the Butler Institute for Research and Scholarship—scanned pdfs can be sent to IRB@butler.edu, or hardcopy can be dropped off in JH 116 (unstapled and printed on one-side only).

IRB Training

All investigators are required to complete the IRB training prior research activity through the Collaborative Institutional Training Initiative (CITI). Following investigators' initial training, refresher courses must be taken every three years. Each module may take from 10 to 30 minutes to complete, and most contain a quiz. The modules do not have to be completed all in one session. 

  • If the investigator is mainly engaged in biomedical research, he or she must complete the Biomedical Researcher CITI component.
  • If the investigator is mainly engaged in social or behavioral research, he or she must complete the Social/Behavioral Educational Researcher CITI component.
  • Student researchers must complete the Student Researcher Course of CITI training.

If you have done CITI education for another organization, add Butler to your profile. You will be given credit for your previous courses to the extent they overlap with Butler's requirements.

 

Click here to view CITI training instructions for students.

Click here to view CITI training instructions for faculty/staff.

Members

Guidance Documents

Additional Resources