As the individual responsible for the conduct of research, the principal investigator bears direct responsibility for protecting every research subject. This responsibility starts with protocol design, which must minimize risks to subjects while maximizing research benefits. In addition, the principal investigator and all members of the research team must comply with the findings, determinations, and requirements of the IRB.
The principal investigator also is responsible for the adequacy of both the informed consent document and the informed consent process, regardless of which members of the research team actually obtain and document consent. Principal investigators have the following responsibilities:
- Human subject research which they conduct in this institution has received prospective review and approval by an IRB designated by this institution;
- Continuing review and approval of the research has been secured in a timely fashion;
- The research is conducted at all times in compliance with all applicable regulatory requirements and the determinations of the designated IRB. No changes in approved research may be initiated without prior IRB approval, except where necessary to eliminate apparent immediate hazards to subjects; and no research may be continued beyond the IRB-designated approval period.
- Principal Investigator must notify the IRB promptly of (1) any unanticipated problems or serious adverse events involving risks to subjects or others, and (2) any serious or continuing noncompliance with applicable regulatory requirements or determinations of the designated IRB of which they become aware.
If you are the PI, before initiating research subject to IRB review you should determine whether or not you are engaged in research.
Research, as defined by the regulations, is any systematic investigation designed to develop or contribute to generalized knowledge. Do you intend to publish or otherwise share the results outside the institution? If the answer is “yes” then the activity is research.
You also need to determine if human subjects are involved in research. If you answer “yes” to the following questions, the activity is human subject research:
- Does the research involve obtaining private information through an interaction or intervention with individual subjects?
- Is private information obtained that is individually identifiable, meaning the identity of the subject is known and easily obtained.
Information is considered private in this context if the information collected includes information about behavior that occurs in a context in which an individual can reasonably expect that no observation or recording is taking place, and information which has been provided for specific purposes by an individual and which the individual can reasonably expect will not be made public (for example, a medical record).