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Research Compliance - Human Subjects

The Human Subjects Committee (also known as the Institutional Review Board, or IRB) assures that risks to human research subjects are minimized, consent is voluntary and informed, and confidentiality is protected. The Committee upholds the principles articulated in the Belmont Report and applies the regulations articulated in the Common Rule.

To determine if your study/research/project requires Committee review, go to: https://decisionchart.questionpro.com and answer a few targeted questions.

 

Training:

All researchers conducting human subjects research are required to complete training in the protection of human research participants found at www.citiprogram.org.

Submitting a proposal:

Any research project in which University faculty, staff, or students will collect and analyze data on human subjects must be reviewed and approved by the IRB before data collection begins. Application forms can be found and submitted on InfoReady, SDSU’s internal submission platform. 

Amendments to approved proposals should also be submitted via InfoReady.

Reporting a problem:

Researchers must report any incident that is unexpected (given the research procedures and population), may have been caused by the procedures involved in the research, and suggests that the research places subjects or others at a greater risk of harm (including physical, psychological, economic, or social harm) than was previously known or recognized. In addition to adverse events/effects, you should also report any breaches of confidentiality and complaints about the study from subjects or staff.

If any such problem occurs, please take the following action:

  1. Attend to the safety and care of the research participant.
  2. Consider whether any more participants should be used in the research and consider immediately stopping the study until the occurrence is investigated.
  3. If the problem is serious (harmful, fatal or life threatening), report the event either orally or in writing to the Research Integrity and Compliance Officer within three days. [Dianne.Nagy@sdstate.edu; 605-688-5051]

For all problems, submit the Unanticipated/Serious Problem Reporting Form on InfoReady within ten working days. The Research Integrity and Compliance Officer will review the report to follow up and take appropriate action.