Studies with subject burden/outside funding or other ancillary studies requiring no funding or minimal funding.
Investigator's Responsibilities
- Costs. The investigator applying for an ancillary study must supply all additional funds required to conduct the study. The FHS Executive Committee and the Research and Publication Committee will be concerned with both the obvious and the hidden costs to FHS entailed by an ancillary study (such as costs to the Data Management/Statistical Analysis groups for coordinating the additional data collection, costs to FHS for notification of alert values, costs to laboratory for retrieving samples, etc).
It is important to note that the FHS Data Management/Statistical Analysis groups nearly always incur expenses on behalf of ancillary studies by providing support in data collection, data management, quality control, data analysis, study coordination and communications, events ascertainment, and other functions. These services can be of critical value to an ancillary study. Investigators who plan to propose an ancillary study with the intention of seeking grant funding should first consult with the FHS Director of Data Management and Statistical Analysis (Ralph B. D'Agostino) to determine what level of involvement will be required of the Data Management and Statistical Analysis group and the associated costs. It may result that a subcontract proposal be included in the investigator's grant application.
- Confidentiality and identification of FHS participants. Confidentiality of individually identifiable data about FHS participants must be assured. As a general rule, no personal identification of participants will be provided to ancillary studies staff. There are no assurances that participants will be able to be identified and contacted in the future for the purposes of an ancillary study.
- Clinical implications of findings. The proposing investigator must clearly delineate any findings of clinical significance that may result from the study, including genetic findings, and propose how these will be handled, including reporting to participants and their physicians and providing recommendations for follow up. This includes incidental findings, such as pathology identified from an imaging study that is not the focus of the study.
- Genetic studies. As stated above requests for genetics (DNA) studies include a special submission application, submission process and approval process. These studies can include only participants who provided appropriate informed consent. Investigators may need to consult the FHS Genetics Laboratory to determine the number of participant samples eligible for analysis based on responses from the appropriate informed consent. Medical and other (ethical, legal and social) implications of the findings and reporting of results must be addressed in the proposal.
- Timeline. All proposed ancillary studies must be submitted to the appropriate FHS coordinator as outlined above, and given in detail in the links, for subsequent circulation and review. Note that studies proposing genetic testing must also be reviewed by the DNA Committee and have submission and approval time lines specified in the DNA Application link. For other proposals, in general ancillary study proposals submitted for review less than eight weeks prior to a funding application deadline may not receive timely approval. Study proposals not tied to funding applications should receive the decision on approval within six weeks after submission.
- Industry participation. Proposals for industry sponsorship or collaboration will be evaluated in accordance with the procedures described above. In addition, it will be the responsibility of the Principal Investigator (PI) to obtain agreement through an appropriate contractual mechanism that all data relevant to the FHS ancillary study will be shared with the FHS. As an initial step in study planning, the PI should contact the FHS Project Officer to determine if an agreement between NHLBI and industry should be developed and implemented or to approve the agreement between industry and the investigator's institution. Industry-sponsored ancillary studies should comply with current NHLBI guidelines, which are available from the FHS or Project Office upon request.
- Status reports. The ancillary study PI should keep the FHS Research and Publication Committee apprised of major developments in the proposal, including success of funding, start date, changes in protocol, and any resulting publications or presentations. For non-DNA studies, the FHS Research and Publication will query PIs twice per year, or as needed, for a status update of their ancillary studies. There is a separate review process for DNA studies. Again, these are detailed in the link for DNA studies.
- Revising and resubmitting proposals. Ancillary Studies that are not approved or not funded become inactive. If the PI wishes to resubmit the proposal for funding, s/he must communicate this to the FHS Research and Publication Committee. A summary of the main points of the critique, plus a summary of the PI's response to the critique should be provided. A statement about changes to participant burden must be included. If the science, scope, or burden has changed, the revised proposal must be approved by the FHS Executive Committee and the FHS Research and Publication Committee.
- Review of publications and presentations. Manuscript proposals based on ancillary study data require approval of the FHS Research and Publication Committee. All the publications, presentations and abstracts from an ancillary study should be reviewed and approved by the FHS Research and Publication Committee. All publications should have the following statement or some version of it on the manuscript title page "From the Framingham Heart Study of the National Heart Lung and Blood Institute of the National Institutes of Health and Boston University School of Medicine. This work was supported by the National Heart, Lung and Blood Institute's Framingham Heart Study (Contract No. N01-HC-25195)."
Incorporation of ancillary study data into Framingham Heart Study database
The data collected by the ancillary study are first to be provided to the FHS Data Management and Statistical Analysis group for integration into the main database, after which the ancillary investigators will receive the integrated file containing necessary data from the main study. The ancillary study PI will be given the exclusive opportunity to analyze, present and publish data collected under the auspices of the ancillary study. After a reasonable time (in general, 12 months after data collection and cleaning are complete) the ancillary study data will be made available for additional uses by other FHS investigators in collaboration with the ancillary investigators. It is the responsibility of the ancillary study PI to state in writing to the FHS Executive Committee any special circumstances that would militate against these guidelines for data sharing.
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