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Responsible Conduct of Research
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For Investigators

An introduction to research can be found in the Navigating the HIRB document.  This document is only an introduction to research; the Policies and Procedures should be reviewed before undertaking any research and when conducting human participant research after receiving HIRB approval.

Please note:  Undergraduate students conducting research without “on the ground” oversight by the PI are only permitted to conduct research that meets one of the exempt categories (http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.html). All students conducting research without “on the ground” oversight of the PI are highly encouraged to contact the HIRB as soon as they start seriously considering their research topic.  At this point, the IRB can guide the student on the type of research that will fall into one of the exempt categories and will also guide the student on how to minimize risks to participants.  IRB applications involving student-initiated international research must be submitted to the HIRB at least eight weeks in advance of the planned start date, although students are highly encouraged to contact the IRB well in advance of the eight week period.  Student-initiated international work submitted less than eight weeks in advance of the proposed start date will likely not be approved by the IRB in time.

All investigators and research team members must complete training in the protection of human research participants prior to submission of applications for HIRB approval. The Collaborative Institutional Training Initiative (CITI) offers a training module that can be completed online. Investigators should select the human subjects training that is most applicable to their research project, or if unsure, should complete the Social/Behavioral Training module or call the HIRB to ask which training is the most appropriate.  You do not need to complete the Responsible Conduct of Research Training for IRB purposes. 

Training is valid for five years.  Instructions for HIRB Training through CITI  (please read the instructions so you take the correct training)

 

Other resources that can assist investigators in conducting ethically sound human participant research include:

OHRP IRB Guidebook (Prepared by R. L. Penslar & J. P. Porter.)

The HIRB office also maintains a library of materials about human participant research that is available for the use of investigators.

In addition, most academic disciplines have a professional organization that offers guidance in research ethics, such as these:

American Anthropological Association. IRBs and Anthropology

American Psychological Association. Ethical Principles of Psychologists and Code of Conduct.

American Sociological Association. Ethics.

Investigators conducting research in foreign countries may find the following resources useful:

Research Ethics for International Research

OHRP  International Compilation of Human Subject Research Protections.