Policies and Procedures for Submitting
Addenda to Approved DNA Committee Applications
Policies and Procedures for Requesting Materials |
Please read the following information
carefully before completing the request forms for addenda to approved
applications.
IMPORTANT: A Biologic
Materials and Genetic Analysis Data Application and Proposal Form must be completed and approved by the DNA
Committee before an Addendum Application to an Approved DNA Application Form
can be submitted to the DNA Committee for review. While these forms may look similar, the
differences between them do not allow them to be interchanged under any
circumstances. Please e-mail the DNA Coordinator
with any questions concerning which
form to use.
When to Submit Addenda Applications
The Addendum Application to an Approved DNA Application Form allows
investigators to extend the scientific aims of the originally approved DNA
Committee application. This may involve
following up on original results by applying to perform additional genotyping using
either new DNA or already available DNA.
Sometimes an addendum application will propose analysis of new
phenotypes in relation to existing genotypes.
Applications that propose substantially new or substantially expanded
scientific aims are more appropriately considered as de novo applications, and
a
Biologic
Materials and Genetic Analysis Data Application and Proposal Form should be filled out instead. Evaluation of whether the
proposal qualifies as an addendum or requires a de novo application will be
conducted as described below under Procedure for Reviewing
Addenda Applications.
Procedure for Submitting Addenda
Applications
1. All addenda applications are submitted to the DNA
Committee quarterly on January 15, April 15, July 15, and October 15 of each
year. The DNA Committee will contact you
via e-mail and postal mail within 6-8 weeks after the application deadline.
2. All addenda applications must be submitted with the
following:
a. Addendum Application to an Approved DNA Application Form: a five-page form
detailing the extension of the previously approved DNA Committee application;
b. Supplemental Materials: any additional documentation that would be helpful in
evaluation of the addendum, such as the annual progress report on the existing
DNA application, a pending grant application, grant award statement, or a
manuscript, publication, or abstract;
c. Biosketch:
only applicable in rare cases when the scope of the project has not changed,
but the primary researchers involved may have changed due to rare circumstances
such as retirement; and
d. If
necessary, a current copy of the Human Subjects IRB Approval Letter from the
approved DNA application (must be updated annually).
3. All submissions must be sent by email to the DNA Coordinator.
4. Please note that if additional DNA is requested in the
addendum application, then a new Data and Materials Distribution Agreement must
be completed before any DNA or data can be released. Please mail a signed, hard copy to the DNA
Coordinator at:
Sara Cronin
DNA Coordinator, Framingham Heart Study
Boston University School of Medicine
715 Albany Street, B604
Boston, MA 02118
TEL: 617-638-6427
FAX: 617-638-8076
Procedure for Reviewing Addenda
Applications
1. All addenda application requests will be reviewed by
the DNA Committee coordinator, a member of the Framingham Genetics Steering
Committee, and the Chair of the DNA Committee to assess if the request
qualifies as an addendum or a de novo application.
2. Applications that are considered to be addenda will be
reviewed during the usual quarterly DNA Committee meeting by 3 Committee
members. Each reviewer will be provided the following materials:
a. Original DNA application
b. Letter of approval for the original DNA application
c. Copy of the original distribution agreement.
d. Application for an addendum.
3. Evaluation of the addendum by the DNA Committee will
take into consideration the following:
e. Is the addendum consistent with the approved project
and the existing IRB?
f.
Is the scientific
rationale substantially different from the original DNA application?
g. Is the study design substantially different from the
original DNA application?
h. Are the PI and Institution the same as on the original
approved project?
i.
Are new
phenotypes proposed, and if so, are they consistent with the original
scientific rationale?
j.
Is new genotyping
proposed?
If yes: (i) Are all new
genotypes listed?
(ii) Is new or more
DNA requested?
(iii)
Is the amount of DNA requested appropriate?
k. Is analysis of existing