The i-Share study welcomes the interest and proposals of external investigators. Collaboration is encouraged as it helps to maximize the scientific value of data made possible by the participation of more than 20,000 individuals who enrolled in the i-Share study over the past years. Outside investigators include researchers, PhD and MSc students, interns and other scientists who prove solid skills in public health and epidemiology.
A scientific collaboration with i-Share begins with a letter of intent explaining in a few lines the objective(s) and content of the research proposal. A response is generally provided within a couple of days and, if positive, researchers are asked to provide a synopsis of their research proposal stating the methodologies to be applied, the Study submission form, and the signed i-Share agreement. These three documents are reviewed by the i-Share Research Committee, which delivers a response within five working days. Researchers may be asked to make amendments to the research proposal, or are given positive or negative answer outright. If the answer is positive, researchers can proceed with implementing their research proposal.
WE WELCOME TWO TYPES OF RESEARCH PROPOSAL:
- Access to and analysis of existing data: researchers may analyze i-Share data directly at our site in Bordeaux, France
- Collection of new data: researchers may collect new data from i-Share participants through ad hoc questionnaires (survey data) or new tests (clinical/biological data)
The i-Share team will assess the costs of access to data or the costs required to set up ancillary studies and will communicate this to the researchers. The i-Share Data Management/Statistical Analysis group almost always incurs expenses for ancillary studies in providing support for data collection, data management, quality control, data analysis, study coordination and communication, and other functions.
All documents, from the letter of intent to the i-Share agreement, must be sent to the i-Share Scientific Collaborations Coordinator, Ilaria Montagni
Some ancillary studies will need significant funds for activities such as collecting new data or carrying out essays on the biobank. The i-Share team welcomes such initiatives and, in such cases, researchers should first consult with the i-Share team to determine what level of involvement will be required of the Data Management and Statistical Analysis group and the associated costs. Submit the outline of your project at least 6 weeks before the grant deadline to ensure time for correspondence and clarifications.
ACCESS TO EXISTING DATA:
- Scientific relevance
- Impact on the i-Share team’s workload
- Ethical issues
COLLECTION OF NEW DATA:
- What is the expected burden on participants?
- When will data be collected?
- Is follow-up needed? Specify length of time and events to be followed up on.
- Consent must be obtained from each subject in the ancillary study.
- Does the ancillary study interfere with or hamper participation in the main study?
Confidentiality and identification of i-Share participants. As a general rule, no personal identification of participants will be provided to ancillary studies staff.
Clinical implications of findings. The proposing researcher must clearly delineate any findings of clinical significance that may result from the study, and propose how these will be handled, including reporting to participants and their physicians and providing recommendations for follow up.
Biological and genetic studies. As stated above, requests for biological and genetic material (DNA, RNA) have a separate application, submission, and approval process. These studies can only include participants of the bio-Share ancillary study (N<2,000) who provided appropriate written informed consent. Investigators are invited to contact the bio-Share team for further information. Medical and other (ethical, legal, and social) implications of the findings and reporting of results must be addressed in the proposal.
Status reports. The ancillary study lead researcher should keep the i-Share Research Committee appraised of major developments in the proposal, including success of funding, start date, changes in protocol, and any resulting publications or presentations. i-Share will query researchers as needed for status updates on their ancillary studies. There is a separate reporting process for genetic studies. Again, these are detailed in the link for genetic studies.
For further information concerning data use, please see the i-Share agreement.