Prior to initiating research activities, you may need to determine whether the proposed project is Human Subjects Research (and governed by Federal regulations) or Not Human Subjects Research (e.g., quality improvement). Complete the linked form and submit as instructed and a determination will be provided; this review will determine the procedures to follow for review and approval of your project. Research Determination Form
If you have received a Research Determination that the project is Non-Human Subjects Research (NHSR) and you need data from business or operational analytics, complete the attached request form and submit the request with the Research Determination letter attached. NHSR Data Request Form
It is Kaiser Permanente Health Plan/Hospitals and Permanente Federation policy to require that:
– All investigators disclose all financial interests held by you or your immediate family in the company(ies) that sponsor your research or could potentially benefit from the outcome(s) of your research. Financial interests include anything of monetary value, including but not limited to salary or other payments for services (e.g., consulting fees or honoraria); equity interests (e.g., stock, stock options or other ownership interests); and intellectual property rights (patents, copyrights and royalties from such rights) from companies that are sponsoring the research.
– Declared interests will be reported to the Regional Financial Conflict of Interest (FCOI) Officer for Research, who may report this information to the IRB, which may require disclosure to potential study participants or other action.
– If an investigator or immediate family member has a leadership interest or Significant Financial Interest (SFI)(3), as defined below, in a company that sponsors research or otherwise has an interest in the outcome of research, the investigator cannot participate in the study unless s/he divests said interest. Investigator Financial Conflicts of Interest Attestation (internal submissions only)
Prior to submitting any proposal for funding, the Proposal Approval Form must be completed and returned for review. In addition to providing basic information about the proposal, other approvals may be required as outlined in the document (e.g., service chief or Associate Medical Director). CRE Proposal Approval Form
Investigators may wish to access a restricted amount of information in our HealthConnect system to assess the feasibility of a study under consideration (e.g., number of members with a specific diagnosis). Prior to requesting this Preparatory to Research Activity information (see associated information under “Policies” tab), investigators should complete the linked form and submit it as instructed. Preparatory To Research (PTR) Form
The Research Review Committee (RRC) is responsible for reviewing all Federally-defined research studies, prior to submission to the Institutional Review Board (this does not include Quality Improvement projects that do not meet the Federal definition). The RRC meets monthly (the first Wednesday of each month) to review projects, and considers the feasibility, acceptability, and institutional risks associated with the study. KPGA RRC Application
All manuscripts with a KPGA affiliated author must be reviewed by the Executive Director and other appropriate individuals prior to submission. This is primarily a review for institutional risks and opportunities for proactive communication with our employees, communication professionals, and media; this is not intended to be a scientific review. Manuscript Review