Adding External Investigators
If you are a Lead Principal Investigator wishing to add External Investigators to your INSPIR study, then there are important points to consider:
- If this is a multi-site study that has not yet been submitted to the IRB, and the Relying Sites will be recruiting and consenting subjects, then please send an email to email@example.com to inquire if the BMC/BU Medical Campus IRB will agree to be the IRB of record for the prospective study.
- If adding External Investigators to an approved INSPIR study, then only the External Investigators who are “engaged in research” (interacting directly with subjects for the purpose of collecting research data; and/or accessing individually identifiable data for research purposes) need to be listed on your INSPIR study and require IRB oversight through a reliance agreement. If you have any questions, send an email to firstname.lastname@example.org.
- If adding External Investigators from an institution with a Federalwide Assurance Number to an approved INSPIR study for which there is already a signed reliance agreement with the institution, then no additional amendments need to be submitted for any additional External Investigators from the same institution. The Lead Principal Investigator should confirm that the additional External Investigators have notified their home institutions of their participation in the study; and have completed the appropriate CITI training and GCP training for clinical trials (either through their home institution or Medical Campus CITI training – see http://www.bumc.bu.edu/ohra/required-training)/.
- Exceptions are External Investigators from (1) BU Charles River Campus; (2) the Boston HealthNet Community Health Centers; and (3) students from other institutions obtaining academic credit: Amendments must continue to be submitted after a signed reliance agreement so that the BMC/BU Medical Campus can verify their Medical Campus CITI/GCP training.
The following resources provide guidance and detailed step-by-step instructions:
- For general guidance on reliance agreements, SMART IRB, and different types of External Investigators, see the October 2019 CR TIMES Feature Article, SMART IRB and You.
- See Adding External Investigators From Institutions with a Federalwide Assurance Number to Your INSPIR Study.
- If an external investigator has a home institution and the institution does not have a Federalwide Assurance Number, then see Collaborating Institutional Investigator Agreement.
- If an external investigator is independent and unaffiliated, and is not performing research activities on your study in connection with an employer or institution, or is not seeking academic credit, then see Individual Investigator Agreement.
- BUMC Not Engaged in Human Subjects Research Agreement