Repository Application Forms
Application Supplement
These additional agreements are required for all approved Repository applications for biospecimens.
Agreement to Return Data
Investigators agree to return data derived from received specimens back to the Repository within three years of
close of funding. (This point is included in the Material Transfer Agreement that will be executed between the
Repository and the Applicant’s Institution.)
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I understand and agree to this policy.
IRB Review and Human Subjects Training
Specimens made available through the SWAN Repository were collected from individuals who provided
documented informed consent that the specimens were being collected and would be made available to scientists
to expand our knowledge of the public's health. Nonetheless, investigators are required to provide
documentation of approval by an Institutional Review Board prior to the actual release of data or specimens.
There must be evidence that the project has been submitted for review by the applicant's local IRB. A plan for
notification of approval is necessary if approval does not accompany the application. Data and specimens will not
be released in the absence of documented approval.
Additionally, investigators and their key staff must provide written documentation that they have successfully
completed training about the ethical use of materials from human subjects, the role of informed consent and the
protection of confidentiality.
I understand these policies, and I will provide required documentation before specimens are released to me.
Genetic Counseling
If you are requesting DNA samples or Genetic Data, please provide a discussion that characterizes the likelihood
that the line of investigation you are proposing will lead to the need for further clinical evaluation and/or genetic
counseling in affected SWAN participants. NOTE that per the Repository’s standing DNA informed consent, SWAN
participants cannot be contacted. However, you will need to be prepared to provide individual results if a SWAN
participant contacts us inquiring about DNA testing. Our DNA consent form contains this language regarding test
results:
"LEARNING ABOUT YOUR RESULTS: You can learn about results obtained from your DNA if you
wish to do so. You can contact the SWAN Study, at xxx-xxx-xxxx, to see if your DNA was evaluated
by scientists. If so, SWAN will provide you with an address to write to for further information.
SWAN requires that the scientists using your DNA be prepared to provide information about the
study they have done, what it may mean to you, and if you still wish to know the results, share
your results with you (and only you), explaining how they may affect you. However, you must
contact SWAN; SWAN will not contact you. This is to protect you from learning something that
you do not wish to know."
Consortium and Contractual Arrangements
Some applications for specimens may include consortium and contractual arrangements. Documentation should
be submitted which identifies and explains arrangements that are proposed between the applicant organization
and the consortium organization(s). For example, two or more laboratories may embark upon a combined effort
to address a question.
All consortium investigators must sign a letter indicating their knowledge of the consortium and their agreement
to adopt and implement the policies of the Repository with respect to the utilization of the specimens, return of
the data, acknowledgement of the contribution of the Repository and the SWAN-designated co-investigator.
I understand this policy, and I will provide required documentation before specimens are released to me.
This policy does not apply to me.
Protection of Your Proprietary Information
Applicants are discouraged from submitting information considered proprietary unless it is deemed
essential for proper evaluation of the application. If the application contains information which the
applicant’s organization considers trade secrets or information which is confidential or privileged, identify
those sections in the application that contain this information.
When information in the application constitutes trade secrets or information that is commercial or
financial, confidential or privileged, it is furnished in confidence with the understanding that the
information shall be used or disclosed only for evaluation of the application. If specimens and data are
awarded as a result of or in connection with the submission of this application, the Repository retains the
right to use information to appropriately document methodology or quality assurance.
Dfd
Rev 09/27/13