Policy for Ancillary Studies

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An ancillary study is one that derives support from other than Framingham Study contract funds. Examples include studies funded by investigator-initiated NIH research awards (R01s), grants from academic institutions, private sources (e.g., drug companies), or those performed at no cost (generally because of the special interest of a researcher).

  1. Framingham Study investigators are encouraged to consider ancillary studies and to involve other investigators, within and outside of Framingham Study personnel. Participation in an ancillary study is subject to the approval of the Framingham Executive and Framingham Research Committees, the Framingham Observational Studies Monitoring Board (OSMB) and the National Heart, Lung, and Blood Institute (NHLBI). The Framingham Executive Committee will consider the following features in determining approval:

    1. Participant burden

      1. The proposed study must be acceptable to the participants (e.g. time, discomfort, privacy).
      2. The proposed study must not interfere with other parts of the Study.
      3. The proposed study must not hamper continued participation in the main study.
      4. The proposed study must put minimal demand on scarce Framingham Study resources such as blood samples.

    2. The proposed study must require the unique characteristics of the Framingham Study cohort(s).

    3. The proposed study must meet requirements of the highest scientific merit.

    4. The investigators must have adequate resources to effectively complete the project, including:

      1. Sufficient budget
      2. Staff having the requisite expertise to meet the objectives of the project.
      3. The investigators must agree to return the complete ancillary data set back to the Framingham Study.

  2. All proposed ancillary studies must be submitted to the Framingham Executive Committee in time for circulation to appropriate committees and subsequent review prior to submission to a funding agency. Studies submitted for review less than 6 weeks prior to a funding application deadline may not receive approval. The following are the elements to be included in an ancillary study proposal:

    1. A description of the goals and methods of the ancillary study, preferably not to exceed three single-spaced pages.

    2. Specific data collection methodology, including questionnaires and coding forms, if available.

    3. c. Specific answers to the following questions:

      1. What is the expected burden to participants? What are the time burdens, discomfort and expected participation rates?
      2. What Framingham core data and/or analyses are needed for the ancillary study?
      3. Are blood or other biologic samples (either fresh or from Framingham's repository of stored samples) required?
      4. What collaboration with Framingham investigators is planned? With whom? Have the collaborating investigators approved the proposal?
      5. What, if any, follow-up is needed? Specify length of time and events to be ascertained.
      6. How many participants are required?
      7. When will data be collected? Could the ancillary study be deferred to a later exam cycle?
      8. How will the ancillary study be funded? Would any additional un-reimbursed work or personnel time be expected of the Framingham Study?
      9. Where will the data analyses be conducted?
      10. How will the confidentiality and other aspects of protection of human subjects be maintained?
      11. When and in what form will a complete data set be returned to the Framingham Study?

  3. Any study that will utilize genetic resources must also obtain approval from the Framingham DNA Committee.

  4. Once an ancillary study is approved, if a change occurs in the structure or concept of the study, such changes should be disclosed to the Framingham Executive Committee (and if relevant the Framingham DNA Committee), the Framingham OSMB, and the NHLBI for review and approval.

  5. The investigator applying for an ancillary study must supply all additional funds needed to successfully complete the study. The Executive Committee will be concerned with both the obvious and the hidden costs to The Framingham Study entailed by an ancillary study. Provision of funds for these expenses are essential – an ancillary study cannot begin without such fiscal support to the core study. The need for such support must be stressed in research grant applications since this support is a mandatory ingredient. Such costs include, but are not limited to:

    1. The statistical staff for coordinating the additional data collection, and analyses.

    2. The Framingham Study expenses involved in altering key identifying data so that subject's confidentiality will be protected.

    3. Costs for notification of alert values.

    4. If work is to occur on site, rental of appropriate clinic, lab and office space,

    5. If subject recruitment outside of main exams is anticipated, subject coordinator to arrange subject appointments.

    6. Personnel, equipment and supplies necessary to complete the project.

  6. Confidentiality of Framingham participants must be guaranteed. All individually identifiable data must not be released. A signed consent must be obtained from every participant in the ancillary study.

    1. Any investigator or personnel having access to Framingham subject data should have received an orientation on the Framingham Study confidentiality policy and reviewed and signed the written confidentiality pledge. The policy and confidentiality pledge are attached. Key personnel of the ancillary study must be certified in the NIH OHSR or equivalent training course.

    2. A copy of the IRB letter for the ancillary study is to be sent to Dr. Margaret Kelly-Hayes at BUMC. A copy of the signed ancillary study consent form for every individual participant is to be included in the Framingham Study record. A data file tracking all signed ancillary consent forms is to be maintained by the ancillary study and an electronic copy of that file is to be delivered to the Framingham Study.

  7. A Framingham investigator would usually be expected to be an investigator on an ancillary study. Often, the principal investigator of an ancillary study will be a Framingham Study investigator. This individual would be responsible for presenting the study to the Executive Committee, monitoring the study to assure continuing compatibility with Framingham Study and serving as a liaison to the Framingham Executive Committee. In addition, each manuscript and abstract would generally be expected to include a Framingham investigator, except under circumstances that should be stated and rationalized as part of the original submission to the Research Committee.

  8. All the publications, presentations and abstracts from an ancillary study must be reviewed and approved by the Framingham Research Committee prior to submission or presentation, in accordance with the general rules for publications and presentations. Ancillary studies are also encouraged to submit publications and abstracts to the NHLBI for review.

  9. As a general rule, no personally identifying data will be provided to ancillary studies' staff. In general ancillary studies will not be able to identify and contact subjects in the future. In rare circumstances, the Executive Committee will consider requests for exceptions to these policies.

  10. As outlined in previous communications from the NHLBI, for any collaboration with an outside for profit entity using Framingham Heart Study data, the approval of the NHLBI is required. For-profit collaborations involving DNA or genetic data will have to await study-wide reconsenting of the participants.

  11. In general, Framingham Study statisticians should conduct ancillary study analyses. The PI should provide evidence that adequate support for carrying out data analysis is available for the project. If it is anticipated that analyses will be conducted outside of this mechanism, the PI must demonstrate that his/her institution has the expertise and support to conduct these analyses.

  12. The data collected by the ancillary study are to be provided to the Framingham Study Statistical staff after the ancillary study has sufficiently cleaned the data set. Hard copies of all the completed data collection forms are to be provided to the Framingham Study by the ancillary study for inclusion in the Framingham Heart Study record. The ancillary study PI will be given the first and exclusive opportunity to analyze, present and publish data collected under the auspices of the ancillary study. After a reasonable time (in general, 24 months after data collection and cleaning are complete), the ancillary study data will be made available for additional uses by Framingham investigators, in collaboration with the ancillary investigators.

  13. A member of the research staff will be identified to assist the investigator in the preparation and processing of the proposal. The Executive Committee will discuss the proposal within 4 to 6 weeks. The investigator may be asked to make him/herself available by conference call at that time to address questions that may arise. A copy of the final proposal as submitted for funding should be submitted to the Ancillary Studies Committee.

The Framingham Heart Study Executive Committee may choose to refer a proposal of an ancillary study to the Framingham Research Committee for consideration and processing if the project is primarily a review of previously collected records or data and does not entail any additional participant burden or genetic component.

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