Background
Generally, when subject information or biospecimens are released from one institution to another, a Materials Transfer Agreement (MTA) or a Data Use Agreement (DUA) are generally required. These types of agreements formalize the allowed uses of the information or biospecimens being released to the receiving institution and document the need to maintain confidentiality.
For these formal MTA or DUA agreements between institutions:
- Fred Hutch researchers, review Business Development's Agreement Form Questionnaire or contact Business Development at MTA@fredhutch.org for more information.
- UW researchers, contact the Agreements Group at mta-group@uw.edu.
Because Fred Hutch researchers frequently share information or biospecimens with other Fred Hutch researchers, the “model repository access confidentiality pledge” was developed many years ago. It serves in the place of a more formal MTA/DUA for sharing within the institution. It serves to document the confidentiality protections that must be honored by the research and staff who are receiving and/or using information or biospecimens from a Fred Hutch repository.
It is called a “model” meaning it is a template that can be used for many Fred Hutch studies.
The Confidentiality Pledge is required by the IRB for research repository files from which the PI plans to release information or biospecimens to other Fred Hutch researchers.
If the repository PI plans to release information or biospecimens to other institutions, including Cancer Consortium partners, a more formal agreement called an MTA or DUA should generally be used instead. Contact MTA@fredhutch.org or mta-group@uw.edu for more information about these formal agreements.
The Confidentiality Pledge is filled out by each researcher and any study staff whose new research activity involves access to/receipt of the repository's stored information and/or biospecimens.
The pledge is filled out by an individual receiving materials from the repository (not by the individuals releasing materials from the repository).
- Question 1: Describe the information and/or biospecimens that will be received from the repository, in detail
- Question 2: Write in the study title, IRB #, and Protocol # for the study that is receiving the information and/or biospecimens from the repository.
- Question 8: Fill in the name of the individual who will be receiving/using the information and/or biospecimens from the repository
Once completed and signed, the Confidentiality Pledge is maintained by the repository gatekeeper whose information and/or biospecimens were accessed for research.
The gatekeeper is the individual identified on the repository's protocol or on the Repository or Registry Supplement, who is responsible for the "gatekeeping" of the stored information and/or biospecimens that others may wish to access for research uses.
The original signed Confidentiality Pledge is kept with the repository's records by the gatekeeper responsible for oversight and release of records, data, and/or specimens.
Each year, a copy of each signed Confidentiality Pledge (or MTA or DUA) issued during the year must be submitted with the Continuing Review submission for the IRB file referenced in item 2 of the pledge.
The original signed Confidentiality Pledge remains with the repository's gatekeeper.
All Fred Hutch employees are required to sign a confidentiality agreement as a condition of employment. Contact Human Resources for more information.