The Framingham Heart Study
DNA Data and Materials Distribution Agreement
It is imperative that the recipient agrees not to use the DNA or genetic data received, either alone or in conjunction with any other information, in any effort whatsoever to establish the individual identities or to make contact with any of the Framingham Study participants or their relatives.
The DNA Data and Materials Distribution Agreement describes the following restrictions placed upon the requester as a condition of receiving the DNA or genetic data set:
  1. use of the DNA or data for the sole purpose of the described research project;
  2. non-transferability of the DNA Data and Materials Distribution Agreement;
  3. prior notification of NHLBI and Boston University of upcoming publication;
  4. acknowledgment in publications of contributions of Framingham Study Investigators and support of NHLBI for data collection;
  5. agreement not to attempt to identify or contact study participants;
  6. agreement not to use biologic materials in human experimentation;
  7. compliance with subjects' informed consent;
  8. agreement to retain control over DNA and genetic data and to return or destroy unused DNA;
  9. agreement to return resulting genetic analysis data to NHLBI and Boston University for distribution to subsequent requesters;
  10. compliance with relevant IRB requirements.
Institutional Review Board Approval
Human Subject Protection for Framingham Heart Study Participants
All who request the data and/or DNA must comply with the DNA Data and Materials Distribution Agreement for ensuring study subject confidentiality. The IRB at the institution of each requester is responsible for determining whether the project protects the privacy and confidentiality of Framingham participants. An IRB approval (either full approval or expedited approval) is required. The Framingham Heart Study and the NHLBI cannot accept an IRB letter stating that the proposed study is exempt from review as there still exists a possibility an individual could be identified given the large amount of data, and as access to this data is not available unconditionally to the public but restricted to those agreeing to the terms of the Distribution Agreements. Investigators who do not agree to sign the Distribution Agreement or do not submit an IRB approval will not be sent the requested data or materials.
A copy of the IRB approval document should be sent to the DNA Coordinator along with the signed DNA Data and Materials Distribution Agreement Form.
Process for Review of Proposals
Committee Evaluation
Two committees, the Framingham Research Committee, and the Framingham DNA Committee review the applications for Framingham DNA or data. The DNA Committee is composed of a group of investigators and collaborators from various fields of study within the Framingham Study as well as independent investigators. The DNA Committee creates primary review teams for each application cycle, each consisting of a clinical investigator, a molecular geneticist and a biostatistician. The teams will fill out a review form, which details the evaluation of the application. The DNA Committee will evaluate the final reviews and forward its comments to the Project Director/Investigator with a summary recommendation.
Evaluation Criteria
The DNA Committee carefully evaluates the research proposal described in the "DNA/data Application" section. The Committee will also consider the following topics when evaluating a DNA/data application:
  1. Rationale: Scientific justification, logistics and robustness of the proposal
  2. Feasibility: Capability of the Framingham Study to provide the requested materials to the applicant
  3. Amount of DNA requested: A reasonable amount of DNA for the proposed methodology of the study
  4. Study Design, Statistical Analyses and Power: Appropriate study design and statistical analyses; strength of the study (power) to detect the proposed effect
  5. Preliminary Data: Supporting data that will confirm the validity of the study
  6. Scientific Merit: A reasonable hypothesis that follows the basic goals of the Framingham Study
  7. Strength of genotyping facilities: Experience of the affiliated laboratory with the proposed or similar DNA assays and an indication of familiarity with standard DNA methodologies
Review Outcome
Upon receipt of the DNA Committee's review, the DNA Coordinator will respond to the applicant usually within four to six weeks of the application review. Generally, there are three possible outcomes from an evaluation:
Approved
After notification of approval of the application, the requester will gather the necessary signatures for the DNA Data and Materials Distribution Agreement included in the application package and mail a signed original to the DNA Coordinator (listed below). Specific procedures for data and DNA distribution are determined by personal communication with the current Project Director. A timetable for DNA/data delivery is dependent upon the numbers of samples requested, and the number of requests that were approved on a given cycle. The Framingham Study will aim for delivery within four (4) weeks of receiving the DNA Data and Materials Distribution Agreement signed by the applicant's institution, Boston University and the NHLBI, and after receiving the copy of the IRB approval from the applicant's institution.
Disapproved
In the event that the application does not satisfy the major points of considerations for approval, the DNA Committee may reject it. The DNA Committee will detail the reasons for a negative outcome. Any disapproved application can be resubmitted for the next application deadline or any subsequent application deadline, if the investigator feels that the concerns of the committee can be adequately addressed. There is no limit to the number of resubmissions that may be made.
Postponed
An application approval may be postponed temporarily in the event that the review committee desires more information about the proposed study. Usually, when an application is postponed, it needs minor clarification of the application materials and the Committee expects that approval can be made without requiring a formal re-application. When the requested information is received, the primary review team reviews it and determines if a recommendation for approval can be made.
Contact
For general questions about DNA samples or data application and distribution process:
Heather Arruda
DNA Coordinator, Framingham Heart Study
Boston University School of Medicine
715 Albany Street, B604
Boston, MA 02118
TEL: 617-414-1244
FAX: 617-638-8076
Email: dnacoord@bu.edu
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