Individual Investigator Agreement

• When is an Individual Investigator Agreement Form used?
• Requirements
• Submission Instructions
• Individual Investigator Agreement Form
• Approval Period, Continuation Review Requirements and Ending the Relationship with the Collaborating Investigator

When is an Individual Investigator Agreement Form used?

This form is used when FHCRC engages in research with:

1. The investigator is not affiliated with FHCRC and
2. The investigator is affiliated with an institution/hospital/clinic that does not have its own IRB to review the study
3. An investigator who is not acting as an employee of any institution with respect to his orher involvement in the research being conducted by FHCRC.

Requirements

1. Belmont Report
2. DHHS/NIH/OHRP Human Subject Regulations, 45 CFR Part 46
3. FHCRC Federal Wide Assurance (FWA)- To obtain a copy of FHCRC's FWA, please contact James Riddle, IRO Assistant Director or at (206) 667- 6501. You can also obtain a copy of FHCRC's FWA by visiting OHRP's website at OHRP.

Submission Instructions

• The new application must include a description of the individual investigator's involvement in the research study.
• The FHCRC PI prepares the Individual Investigator Agreement Form and forwards it to the Individual Investigator for his/her signature.
• The FHCRC PI forwards to the IRO:
  • the signed Individual Investigator Agreement Form
  • a copy of the Individual Investigator's human subject training (per paragraph 5 of the agreement)
  • a letter of support from the non-assured institution if the collaborating investigator is an employee or agent of the non-assured institution. This letter of support states that the non-assured institution is aware and supports that the research activity will take place at their site. [download sample letter (Word)]

•    Individual Investigator Agreement Form

• The FHCRC PI submits a completed Protocol Modification Form adding the Individuals Investigator to the study and describing his/her role to the study. Revise any documents (e.g. consent forms, protocols), if appropriate.