SOP 800 Responsibilities of Investigators (RI)
801 IRB-Required Investigator Actions
1. OBJECTIVE
Between IRB initial approval of a protocol and the time of continuing review of a study, it is the Investigator's responsibility to keep the IRB informed of unexpected non-serious and serious adverse events and other unexpected findings that could affect the risk/benefit ratio of the research. An investigator is responsible for the accurate documentation, investigation and follow-up of all possible study-related adverse events. Investigators are also responsible for informing government and other Sponsors of any unanticipated or serious adverse events, as appropriate.
Specific Procedures
1.1 IRB Review of Research
All human subjects research that is conducted by or under the direction of any employee, faculty, staff, student or agent of BRIGHAM YOUNG UNIVERSITY in connection with his or her institutional responsibilities must be reviewed by the IRB.
1.2 Informed Consent
The Investigator must obtain informed consent from subjects prior to their enrollment into the research. The Investigator must use the informed consent document approved by the IRB. Approval and expiration dates are indicated on the first page of the consent document. Consent documents are valid only during the dates indicated on the form; and the Investigator may use the forms only during the period for which they are valid.
1.3 Adverse Event Reporting
The IRB must be informed of any serious, unexpected or alarming adverse events that occur during the approval period. Investigators or Sponsors must also submit Sponsor-generated reports of adverse events occurring at other investigative sites.
1.4 Changes in Approved Research
Changes in approved research, during the period for which approval has already been given, may not be initiated without IRB review (or expedited review, where appropriate) and approval. Investigators must submit requests for changes to the IRB in writing. Upon receipt of the protocol change, the IRB Administrator will determine if the revision meets the criteria for minimal risk. If the change represents more than a minimal risk to subjects, it must be reviewed and approved by the IRB. Minor changes involving no more than minimal risk to the subject will be reviewed by the expedited review process.
1.5 Periodic Reports
The length of time approval is given to a research protocol will be no more than one year, and is dependent on the risk involved with the research. Investigators are responsible for requesting renewal in anticipation of the expiration of the approval period. A Renewal Application of Approved Research Form will be available to the Investigator for this purpose.
1.6 Student-Conducted Research
The IRB reviews human subjects research under federal regulations. As such, research is defined as a systematic investigation designed to develop or contribute to generalizable knowledge. Student-conducted research related to a class project does not generally qualify as research and therefore does not require IRB review. For questions of applicability, contact the IRB Office. Research conducted for master theses and doctoral dissertations do qualify as research – thus, any human subject involvement in theses or dissertations require confirmation of an exemption or IRB approval prior to being initiated. All students or fellows must obtain the participation of a faculty advisor as the primary investigator (PI) on the IRB application.
2. SCOPE
These policies and procedures apply to all investigators at BRIGHAM YOUNG UNIVERSITY.
3. APPLICABLE REGULATIONS AND GUIDELINES
45 CFR 46.102(d), 46.109, 46.111
21 CFR 56.102(c), 56.109, 56.111
4. REFERENCES TO OTHER APPLICABLE SOPs
This SOP affects all other SOPs.