Q. What is a Repository Access Confidentiality Pledge?
This Confidentiality Pledge serves to document:
IRB approval of the research involving access to repository data and/or specimens Confidentiality protections to be honored by the researcher and any study staff utilizing stored specimens and/or data
Q. When is a Confidentiality Pledge required?
The Confidentiality Pledge is required by the IRB for research repositories and for studies requesting a waiver of consent.
Q. Who needs to complete a Confidentiality Pledge?
The Confidentiality Pledge is completed by each researcher and any study staff whose new research activity involves access to the repository's stored specimens and/or data.
Q. Who maintains the Confidentiality Pledge(s)?
The Confidentiality Pledge is maintained by the repository gatekeeper(s) whose specimens and/or data are accessed for research. The gatekeeper is the individual identified on the protocol responsible for the "gatekeeping" of the stored specimens and/or data that you wish to access. The original signed Confidentiality Pledge is kept with the records of the repository's gatekeeper responsible for oversight and release of records, data, and/or specimens.
Q Are there any other requirements?
A copy of each signed Confidentiality Pledge must be submitted to the IRO at J6-110 and filed with the IRB file referenced in Item 2 of the pledge. The original signed Confidentiality Pledge remains with the repository's gatekeeper.
Q. Are there other Confidentiality Pledge(s) required by the Center?
All FHCRC employees and affiliates of the CRD, PHS and Administration Divisions are required to sign confidentiality agreements. To review the specific policies, please go to http://www.fhcrc.org/intranet/directors_office/privacy_security/training/basic/module6.html