Unaffiliated Investigators

Overview

Researchers engaged in Lehigh University-initiated or centered research who are not employees of the university and not agents of an outside entity that can provide IRB review must sign an Individual Investigator Agreement to assure that they understand their obligations as human research personnel. The Individual Investigator Agreement serves as a written agreement between Lehigh University and a collaborating external investigator who will be engaged in non-exempt human subjects research that describes the external investigator's responsibilities and the Lehigh IRB's oversight of the research. Furthermore, the Individual Investigator Agreement allows Lehigh University to extend the applicabilty of Lehigh's institutional Federalwise Assurance (FWA) to cover collaborating external investigators.

Procedures

All research personnel meeting the definition of “unaffiliated investigator” must submit an Individual Investigator Agreement as part of the IRB submission package in IRBNet. The Individual Investigator Agreement can be found on IRBNet under "Forms and Templates". This agreement must be signed by both the unaffiliated investigator and the appropriate Lehigh Institutional Official (or designee) prior to IRB approval. Unaffiliated investigators are also required to complete any necessary human research protection training (i.e. PHRP; GCP) prior to approval. 

Please contact the Research Integrity office with questions.

For information about regulatory requirements involving external / unaffilated investigators: https://www.hhs.gov/ohrp/regulations-and-policy/guidance/extension-of-institutional-fwa-via-individual-investigator-agreement/