Responsibilities of the Principal Investigator for Research Involving Human Subjects

The Principal Investigator (PI) assures the following criteria are met when conducting or overseeing research involving human subjects:

1. The PI (or Faculty/Staff investigator or supervisor) assures that all those persons listed on the application who are involved in the research have completed in IRB human subjects training requirements. Online training is available, at no cost to the investigator, through  CITI. Student researchers under the supervision of faculty/staff PI’s are covered by the PI’s CITI training.
2. The PI assures that human subjects will voluntarily consent to participate in the research when appropriate (e.g. surveys, interviews, interactions with participants) and will provide subjects with pertinent information (e.g. the activity involves research, a description of procedures, that participation is voluntary, risks and benefits, contact information for PI, etc.). Such information should be included in the instructions on the survey.
3. The PI assures that human subjects will be selected equitably, so that risks and benefits of the research are justly distributed;
4. The PI assures that the IRB will be immediately informed of any information or unexpected or adverse events that would increase the risk to the human subjects and cause the category of review to be upgraded to Expedited or Full
5. The PI assures that the IRB will be immediately informed of any complaints from participants regarding their risks and
6. The PI assures that confidentiality and privacy of the subjects and the research data will be maintained appropriately to ensure minimal risk to subjects, and there are adequate provisions are in place to maintain the confidentiality of the data if there is any recording of identifiable

The PI acknowledges these criteria with his/her signature on the IRB Review Form.