Policy for EAGLE collaborations involving data sharing

We are dedicated to the widest possible use of our data in order to advance understanding of lung cancer and smoking persistence and welcome collaboration with other investigators. We have developed policies to allow public access to the data, to protect confidentiality and to encourage use consistent with scientific and ethical goals.
The EAGLE Advisory Board (EAB) will review data requests from both internal collaborators and external users according to the general guidelines listed below:

• Each original EAGLE PI shall have access to the data after the approval of the other PI. If needed, PIs can consult with the Board for advice or discussion.
• All data use requests shall be subject to existing ethical, legal, and administrative regulations, for example, requirements to maintain privacy, store data in a secure manner, use the data only for scientific and not commercial purposes, etc.
• New proposals are to be accompanied by a one-two page document that outlines: hypothesis and study questions (aims), all proposed collaborators and their related institutions, justification/suitability to the EAGLE study, analyses proposed, variables requested, timeline, source of funding, and key references. Documentation of ethical approval or waiver from the local institution of the requester shall be provided before a final dataset is released.
• Proposals will undergo a review process. The proposal must be deemed eligible by one of the PIs (Maria Teresa Landi and Neil Caporaso) or Coordinating Center Project Director (Pier Alberto Bertazzi) for consideration. Some proposals may be disqualified by a pre-existing project, ethical problem, or inability to fulfill a certain data requirement. Ineligibility will be documented and the reason provided; an appeal is available to the EAB if requested. We strongly encourage outside investigators who submit proposals to solicit collaboration from EAGLE PIs or other team members who were originally involved in the study (see “Collaborators” on the website) in order to benefit from their expertise as potential co-investigators. To ensure the highest scientific quality of the studies, EAGLE PIs may share the submitted proposals with members of the original study team to solicit their participation. Prospective collaborators who accept participation pledge their time and effort to the proposed project in a timely manner. If no original study team member is specifically interested in the project, one or more of the EAGLE PIs or their delegates may participate. The EAB will review the proposal for ethical, administrative aspects and scientific merit and make constructive suggestions. Review criteria include: significance, approach, innovation, qualifications and experience of the investigators, and whether the proposal is consistent with the scientific and ethical aims of the study. Further information or clarification may be required after review of proposals by the EAB.
• The EAB may issue recommendations if there are parallel or closely related investigations so the areas that each group is to cover are clear and potential conflicts avoided. Where feasible, groups will be encouraged to work together if they are interested in similar topics. In the event of a potential or actual conflict the EAB will provide directives to define the content of each report.
• Proposals are accepted on a rolling basis and reviewed approximately every 2 months. The requester will receive an electronic response at the contact address provided with the proposal submission.
• If the project is approved, EAGLE PIs (or the designated collaborators) will provide limited assistance to develop appropriate datasets to support the approved analyses. If required, appropriate modifications of the datasets will be made to protect confidentiality. Investigators requesting datasets will be required to defray the costs of database preparation, checking, transfer, etc. by providing resources to the contractor responsible for database preparation. Depending on the type of collaboration, role of internal collaborators, and complexity of the data tasks, charges may be reduced or waived.
• There will be a time limit negotiated for all analyses; if exceeded, after reasonable allowance for unavoidable delays and discussion between the PIs and the responsible requester, a dataset or area of investigation can become open for other investigators.
• Investigators who obtain EAGLE data agree not to share, transfer, or sell any data to outside parties, and to use the data solely for the project for which they have been approved.
• At project completion, Investigators who obtain EAGLE data shall provide to the EAGLE PIs or their delegates an electronic copy of the final analytic file used for the analyses, including derived variables used for the project. The analytical file returned shall be dated and accompanied by a cover letter signed by the responsible investigator.
• Investigators anticipating Intellectual Property issues or patent developments shall inform the PIs as these issues will require separate negotiation. NCI and Division of Cancer Epidemiology and Genetics policies will be followed. US Federal, NIH, NCI, EU and Italian policies may also be relevant.
• All publications shall undergo NCI clearance. All authors shall have the opportunity to review the manuscript and provide their comments prior to submission, and approve the final version. Criteria for authorship, poster and oral presentations shall follow standard guidelines for publication, presentations and credit. If necessary, any disputes will be addressed by the EAB in consultation with the EAGLE PIs.