The HPFS is a unique and valuable resource, and we welcome outside collaboration. Our goal is to gain maximal scientific discovery and public health benefit from the data. In addition to making the data available for use, we also have the responsibility to maintain scientific integrity, to honor the promise of confidentiality to participants, and to cover the
Costs. Below, we provide detailed instructions for potential users of HPFS data. The vast majority of outside collaboration proposals are approved, and all the procedures and processes that we describe apply equally to inside and outside investigators.
Guidelines for External Collaborators: Use of the Health Professionals Follow-Up Study Archived Data
- Submitting a Proposal
A.1. Letter of intent: Investigators wishing to develop a collaboration with the Health Professionals Follow-Up Study (HPFS) Research Group to use the HPFS data archive should first submit a brief (2-page) description of the proposed analyses (“letter of intent”) to Dr. Lorelei Mucci (firstname.lastname@example.org or Dr. Walter Willett, Principal Investigator (email@example.com.) The letter of intent should briefly outline the following:
- Hypothesis being proposed
- Scientific significance of the project
- Cohort participant data variables required for analysis
- Reasons for proposing use of HPFS data, rather than another source
Although the HPFS data are a unique resource, it is heavily used and added demands on investigator time must be clearly justified. Therefore, these data will only be used for analyses where other studies, cannot provide adequate or similar information. In addition, proposals to evaluate highly speculative hypotheses are not considered appropriate.
A letter of intent may be submitted at any time throughout the year. It will be reviewed by Dr. Mucci and the HPFS team of investigators at a regular bi-weekly study meeting. If a project is judged feasible (given database resources), of substantial scientific interest, is not currently being pursued by another investigator, and is not currently under consideration (typically listed as a specific aim of a submitted or funded grant), the letter of intent for collaboration will be approved. It is also possible that the applicant will be asked to submit additional information if it is unclear from the letter whether the research fulfills requirements. The applicant will be notified of the decision within approximately 14 days after the letter of intent was submitted.
A.2. Study proposal and appeals. If the proposed investigation outlined in the letter of intent is rejected and the applicant does not agree with the reason for this decision, the applicant can appeal the decision by submitting a proposal to the HPFS External Advisory Committee (submit through Dr. Mucci.) Submission deadlines are February 15, June 15, and October 15. The format of the proposal should be similar to a NIH grant (i.e., specific aims, background and significance, preliminary studies and methods) but should be no longer than 10 pages in length.
It is anticipated that Advisory Committee decisions will be made within four to eight weeks of proposal submission. The Advisory Committee will decide to accept, accept pending revisions, or reject a proposal. For either of the latter two outcomes, a summary of the reasons for the Advisory Committee decision will be provided. An “accept pending revisions” will be given if the proposal has considerable scientific merit, yet one or more issues need to be addressed before the project can proceed. Arrangements will be made to provide an expedited review of a revised proposal, which addresses the concerns of the Advisory Committee.
For proposals that will require the development of funding outside the proposing organization, the approval process described above must be factored into the timing of any grant application. The Advisory Committee and HPFS Investigators cannot take responsibility for missed deadlines.
- B. Conducting Studies Using the HPFS Archive
B.1 Collaborative agreement: If the proposal is approved, a primary HPFS investigator will be identified to work with the external collaborator to facilitate the research. The exact nature and scope of the project must be described in a written collaborative agreement and signed by the external collaborator and the primary HPFS investigator. Use of data from the HPFS cohort is limited to the defined, specific project for which approval was obtained. If further research or analytic activities develop from the original project, the external collaborator must obtain appropriate approval for such activities. In signing the agreement, external collaborators also will be confirming that they have read these guidelines outlined in this document and both understand and agree to comply with them.
B.2. Preliminary data: A HPFS investigator and programmer will provide approximate case numbers, exposure distributions, and other related data that may be used for preparing a grant application. Since no funds have been allocated to manage the development of these outside collaborative arrangements, all costs for this effort must be borne by the collaborating outside investigators institution based on the time required to produce the data. No charge will be made for minimal effort.
B.3. Grant funding: Outside collaborators must provide a draft of any grant proposal (e.g., NIH grant) to the collaborating HPFS investigator at least one month prior to the application due date. This will allow the HPFS investigator an opportunity to provide feedback, and will provide time to obtain any additional data, as noted above, that will maximize the probability of funding for the proposal.
In keeping with the policies of the Harvard School of Public Health, the final grant proposal must be reviewed by Dr. Walter Willett, Chair of the Department of Nutrition and Dr. Alan Flint, Director of the Health Professionals Follow-Up Study, at least 10 business days before submission. Failure to meet this deadline will result in delay of submission. This institutional policy also is followed by all HPFS investigators and cannot be circumvented. The primary HPFS investigator will provide a letter of support to the external investigator to be included in the application indicating Health Professionals Follow-Up Study interest in collaborating on the proposed study.
B.4. Study costs
(a) As noted above (Section B.2.), external collaborators must provide funds to cover the cost of initial programming by HPFS staff, needed to identify cases, exposure distributions or other related data if necessary.
(b) Should substantial pilot research be needed, the cost of all pilot studies required to determine the feasibility and validity of the proposed project must be assumed by the potential external collaborator.
(c) Because of the complexity of the database and the HPFS investigators’ knowledge of the strengths as well as the limitations of these data, substantial input is required of HPFS investigators to insure both valid and maximal use of available data. Therefore, at least one HPFS investigator must be included as a co-investigator on any grant proposal where use of HPFS data is proposed. Any nonacademic outside user (e.g., from a private company) similarly must be able to provide salary support for an investigator. The level of effort will vary according to the size and complexity of the project but will be expected to range from 5% to 10% FTE per year. For more complex investigations, funding for a HPFS statistician may also be required.
(d) To insure integrity of the HPFS data and comply with privacy commitments for our study participants, it is the policy of the HPFS that no data are copied from the Channing computer It is possible for all programming to be done by the external collaborator or a designated person at the collaborating institution. The programmer would need to learn our computer system, data files, and analysis methods, which may require a visit to the Channing Laboratory for an introductory session and the Harvard Chan School of Public Health. A Data Use Agreement would be signed and proof of Human Subjects certification (such as completion of the CITI course) must be submitted The program would be issued a logon to the Channing computer for remote access. Inevitably, even if outside collaborators do their own programming, some input from Channing programmers is needed, and those costs would have to be covered by the outside collaborator. Alternatively, the external collaborators may pay for the cost of having a HPFS programmer do all analyses, if one is available. The cost is dependent upon the complexity of the investigation but is typically about 20% FTE.
(e) The arrangement for payments will be through formal subcontracts with the Harvard Chan School of Public, including full overhead.
B.5. Human Subjects considerations: All projects must receive approval from the Harvard Chan School of Public Health Human Subjects Committee prior to implementation. Also all investigators who have access to HPFS data on the computer must complete a Human Subject certification, such as the CITI course.
B.6. Study Timeline: A proposed timeline for completion of projects should be discussed prior to submission of any grant. All projects need to be completed within the constraints of the current HPFS system. Although additional staff may be hired if they are needed consistently, it is not possible to substantially increase (and then decrease) staffing levels for any single project. HPFS facilities do not allow for such staffing changes and it is not possible to adequately train new technicians in a sufficiently short period of time to allow such changes. At the beginning of a project, external collaborators should review with the HPFS a proposed schedule for project completion and may contact the Project Director to discuss study progress.
B.7. Progress reports: The external collaborator must agree to keep the HPFS investigators updated on the progress of the study by providing either a written or verbal report at least every 6 months. Failure to adhere to a reasonable progress schedule (as assessed by the Advisory Committee) could lead to termination of the collaborative relationship with no further data tables or additional analyses provided.
C: Data Analysis and Publication Issues.
C.1. Use of HPFS Channing computer: As noted above (section B.4.d), all primary data computer programs, and analysis results must be maintained on the HPFS/NHS Channing computer, and all data analyses will be conducted on this computer. SAS is typically used for data analyses. If an external collaborator needs to use a different programming language, this must be discussed with the HPFS investigator before analyses begin.
C.2. Analysis plan and procedure: The most efficient way for these analyses to be accomplished will be for the outside investigator and the collaborating HPFS investigator to agree on the analysis plan in advance (to whatever extent possible). If analyses are being conducted by a HPFS programmer, the external collaborating investigator will provide a set of data analysis requests and a series of empty tables that indicate how the results are to be presented. In completing the analysis plan, the HPFS investigator also will work as needed with the statistician in supervising the HPFS programmer assigned to the project. The external collaborating investigator should forward all analysis results to the HPFS investigator for review and discussion.
C.3. Presentation of results: When data tables of results are finalized, these tables and a written abstract will be presented by the HPFS investigator at a regular HPFS study meeting. This provides opportunity for other HPFS investigators to comment and make suggestion for improvement. Based on comments, additional analyses may be required. Presentation of results at a study meeting is required for all research that uses HPFS data prior to submission for publication.
C.4. Review of computer programs: It is required that the programs used for analysis must be carefully reviewed and approved by an HPFS epidemiologist and statistician in addition to the study programmer and the external collaborating investigator. Importantly, the sign off must be by a HPFS investigator who understands how the cases and population for analysis are being defined, is familiar with HPFS variable definitions, and can understand the code generated by the programmer.
This program review is required for all investigators who use HPFS data, and a specific system is in place for such program review to ensure it is both accurate and timely.
C.5. Authorship and manuscript review: At least one member of the HPFS investigative team will be coauthor on any manuscript from this collaboration and, as such will need to sign-off on any manuscript prior to its submission for publication. All manuscripts must also be submitted to Dr. Lorelei Mucci, Co-Investigator for Channing Review and approval must be obtained before a manuscript can be submitted to a journal for publication. This additional review is required of all HPFS investigators.
C.6. Manuscript disputes: Any dispute regarding data interpretation may be brought to the Advisory Committee for consideration. Where appropriate, the Advisory Committee will seek additional consultation from independent experts. Since the Advisory Committee meets as a group only once per year, considerable delay in coming to a resolution could occur. Therefore, it behooves all collaborating investigators to work closely with the designated HPFS investigator in resolving any dispute. Final decisions rest with Dr. Willett, the HPFS Principal Investigator, in consultation with the Advisory Committee.