Collaborating with KP DOR
The Division of Research (DOR) has a long history of successful collaboration with academic and other research organizations. The following information will be helpful in planning, applying for, and implementing collaborative research projects with a KP collaborator.
Collaboration Query
If you have not identified an interested KP collaborator, please fill out a Collaboration Query. We will share the summary you provide with potential collaborators at DOR, and will get back to you shortly to let you know if we have identified anyone. If you have questions in the meantime, please contact Maureen Fitzpatrick at (510) 891-3133.
Preliminary Steps
Collaborators should discuss and agree upon the following issues prior to developing a proposal or submitting a joint application:
- Agree on the overall study Principal Investigator (PI)
- Delineate roles and expectations of team members
- Reach agreement on an adequate budget
- Clarify data transmission and data ownership policies
- Determine authorship of major papers
- Define PI % effort for each year
- Sign confidentiality agreements as appropriate
Approvals
The KP PI will ensure that all proposed research is approved in advance by the Director. The approval will be based primarily on the scientific merit and feasibility of the project, and secondarily on the relevance and value the project may have to Kaiser Permanente and its members. The approval process also serves to limit research overlap and encourage collaboration. The KP Investigator will also make sure that all research applications to funders are approved by Kaiser Foundation Research Institute (KFRI) and the KP Northern California IRB.
Proposal Preparation
The DOR Grants and Contracts team will assist with the KP portion of the research application; whether that is the Prime application, a subcontract packet, or a Multi-PI Application. The KP PI will work with the DOR Research Administrator to ensure that the budget will cover the study costs, including salaries and benefits of all staff, computing costs, and indirect costs (consistent with Federal guidelines and agreements). This includes the salary of the DOR investigator, who will usually be responsible for all administrative processes as well as for overseeing and participating in the day-to-day research. DOR will submit the required paperwork through KFRI for submission to the funding source.
Subcontracting institutions should submit the Subcontract Packet to DOR at least four weeks prior to the submission date.
Contracts/Consulting Agreements
A subcontract or consulting agreement must be in place for each collaboration, even in the rare situation in which no funding is involved. Specific topics that are covered in research agreements/contracts include:
- who will create the final datasets for analyses
- where the datasets will be kept and maintained during and after the study has ended
- who willconduct the data analyses
- when, how and by whom data will be presented publicly either orally or in written form
- how analyses outside the scope of the original project will be handled
- the necessity of KP involvement in all uses of the data (including membership in steering committees) and IRB approvals both at KP and, as appropriate, at participating institutions for all use of the data or biospecimens
- return of KP information after the end of the project (this often means the certifiable deletion of data from the computers of collaborators)
- language indicating plans for resolutions of conflicts and disputes
- language indicating when and how contracts can be revised or ended
Data Transmission and Data Ownership
The general expectation is that when collaborative projects involve only KP patients, data or biospecimens, all related databases and specimens should remain at DOR and all data analyses should be conducted at DOR (providing DOR has the expertise). There are many collaborative projects, particularly those that are multi-study, multi-site, and/or those requiring special expertise or extra resources, where sharing data with a collaborating investigator or laboratory is mutually beneficial and necessary for the conduct of the project. While often the information can be shared in aggregate, tabular or graphic form, sometimes a sponsor or collaborator may be given a de-identified and limited dataset, or biospecimens for a particular group of KP members.
When data and materials will be shared with outside collaborators, how the data and materials will be used, stored, analyzed, maintained and presented publicly should be described in detail in a written agreement before funded work on the project begins. When limited datasets are transferred to an investigator outside of DOR, the outside collaborator must sign a Data Use Agreement (DUA) in advance, except in situations where the disclosure is explicitly described in either the patient consent/authorization or the IRB has approved a waiver of consent/authorization.
Data Destruction
When IRB approval expires, it formally signals the end of a project and of any ongoing analyses. At that point, materials must be returned and/or data certifiably deleted from the non-KP computers by outside collaborators. Specific research agreements may also allow earlier termination of the collaboration. All terminations lead to the return of materials or deletion of data.
Post-Award Responsibilities for Both PIs
Oversee all aspects of the project and ensure that the work is performed as detailed in the agreed upon Scope of Work.
Ensure that the project is reviewed annually by the IRB at both institutions, or at only one institution if an agreement to cede authority was established.
For clinical studies, ensure that all activities adhere to Good Clinical Practice guidelines and FDA Code of Federal Regulations (CFR) for FDA regulated trials. Ensure that adverse events are reported to the approving IRB as required.Ensure that spending is within budget and follows federal guidelines for allowability. If a subcontract PI, ensure that invoicing is accurate and timely. Contact DOR’s Finance Team for questions about invoicing.
Maintain frequent communication with your collaborator to ensure compliance with reporting requirements, financial monitoring and other project management tasks.
Ensure that all agreements - Subcontracts, Consulting Agreements, and Data Use Agreements - are all up to date. Ensure that data is returned or destroyed at the end of the study as specified in the agreement.
Publications
All potential publications that include authorship by a DOR investigator require review by the Director of DOR. This review will focus on the merits of publication as they relate to the Kaiser Permanente organization, not necessarily for scientific quality.
It is important to give notice to all those involved or associated with a project when a manuscript is being published. This notice will provide an opportunity for everyone involved in the project to contribute to the publication based on their actual degree of involvement in the project.
