Important Additional Information for Ancillary Studies Investigators

Costs. The FHS Executive Committee and the Research Committee will be concerned with both the obvious and the hidden costs to FHS entailed by an ancillary study (such as the costs to the Data Management/Statistical Analysis groups for coordinating the additional data collection, costs to FHS for notification of alert values, or costs to the laboratory for retrieving samples).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 genetic material (DNA) have a separate 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.

Third Party participation. Proposals involving industry sponsorship, in kind services or collaboration with an investigator with industry ties will be evaluated in accordance with the procedures described here. It will be the responsibility of the Principal Investigator to initiate the agreement through an appropriate contractual mechanism. As an initial step in study planning, the PI should contact Heather Arruda (harruda@bu.edu) with any questions.

Status reports. The ancillary study PI should keep the FHS Research Committee apprised of major developments in the proposal, including success of funding, start date, changes in protocol, and any resulting publications or presentations. FHS will query PIs twice per year, or as needed, for a status update of their ancillary studies. There is a separate reporting process for genetic studies. Again, these are detailed in the link for genetic studies.

Revising and resubmitting proposals. Ancillary Studies that are not approved or not funded become inactive. The PI should notify FHS of intentions regarding the proposal or request that the proposal be deleted from the system. A summary of the main points of the critique, plus a summary of the PI's response to the critique should be attached to the on line proposal. Should the PI resubmit the proposal, an outline of the changes made should also be attached. The resubmitted proposal will be reviewed again by the relevant committee.

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 of any mitigating circumstances that would preclude the PI following these guidelines for data sharing.