Skip to Content

Submissions :: Before you submit :: Responsibilities

Responsibilities of a Human Subjects Researcher and Team

The relationship between a principal investigator (and anyone else on the research team) and the participant is a relationship of trust. When you take on the responsibility of working with participants in a research study, you are committing to a new level of precision and care in your work. Your commitment to excellence can make the difference in a participant’s experience and can directly impact their safety. The following items outline the baseline expectations for a human subjects researcher:

  • Experience: We require that researchers are prepared to handle the projects in which they are proposing to do.  Research is an exploration and it is impossible to predict every outcome. However, the Board requires that the level of risk in a study is equal to the researcher’s experience in handling similar situations.

  • Education: All members of the research team (including non U.Va. personnel) are required to have active certification for human subjects research. Our office uses the CITI module and all U.Va. researchers conducting human subjects research are required to complete the training before a protocol can be approved. In addition to the CITI training, our office offers opportunities for continuing education as well as additional resources including our Researchers Guide published on this website. It is important to stay in contact with our office and stay current with our office policies, particularly if you will continue to submit new protocols.

  • Precision: Most of the requirements we make regarding protocol submissions, etc, are mandated by federal regulations so thus it is important that you carefully follow our procedures. It is vital that you provide us with a complete protocol that outlines what you will do in the study.  Even more importantly, you must follow your protocol when you conduct the study and use the official versions of your consent forms (when applicable).  If you need to modify your protocol, request a continuation, and/or if you have an unexpected adverse event, you need to notify our office. Please keep your study files organized and in good order.  When you are done with the study and your analysis is complete, submit a Study Closure form.

  • Compassion: Beyond the rules and regulations, the ethical principles are a paradigm for interacting with research participants.  Approaching your participants with respect, beneficence, and justice will do more to protect them than simply following regulations (though you are required to do both).

All of the above elements combine to make a responsible researcher.  When you submit your protocol, you will sign an Investigator’s Agreement in which you will agree to following the policies and procedures of the IRB-SBS. We hope that you will take this Agreement and the above mentioned responsibilities seriously when you conduct your research. We look forward to working with you to accomplish these requirements.

Previous :: Choosing the right IRB: SBS vs. HSR
Next :: Return to Before you submit