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 Framingham genetic data requested?