Research Conduct and QI Project Support for KPNW

Even though you may have access to medical records in your role at Kaiser Permanente, it is a violation of HIPAA to view or share private patient data without a specific purpose. Viewing or sharing data with anyone, within or without Kaiser Permanente, to conduct research or quality assurance activities is only permitted if it has been reviewed and approved by the IRB, and proper data use and transfer agreements are in place. These agreements must be reviewed by Kaiser Permanente legal departments and cannot be entered into independently by providers with outside entities.

Maintaining the integrity of research and quality improvement activities at Kaiser Permanente is a priority.  Compliance with all regulatory, privacy, and confidentiality rules and completing all associated training to perform the work is essential.  This includes maintaining appropriate IRB compliance if applicable and keeping up to date with all necessary reviews and reporting.  Non-compliance puts you, our members, and the organization at risk of conducting future research.  You are expected to fully understand and comply with these requirements.  Please ensure you are willing and able to adhere to these standards before embarking on your work. CHR can help you determine what reviews and approvals are necessary to access and share data. Connect with us by filling out a form here.

Connect with us by filling out a form here:

Agreements for Specimen and Data Sharing

Before any Kaiser data, specimens, or confidential information can be shared with external parties or individuals, there usually needs to be some type of agreement in place (e.g., non-disclosure agreement (NDA), confidential disclosure agreement (NDA), data use agreement (DUA), etc.). Any legal document must be reviewed and signed by the appropriate Kaiser Permanente Northwest individual representative. This process must be facilitated by the Center for Health Research.

Please visit our Data Access and Sharing site for more information.

Data and Analytics Support

Our team members can consult with you to identify what data or variables are necessary to evaluate your project’s outcomes.

Depending on your needs, members of our CHR team or the KPNW Insight team may be able to support your proposed project. KP Insight is a data and analytics team that supports a broad range of enterprise and market products, ranging from application of cutting-edge data science techniques to KP national strategic initiatives.

Projects involving Kaiser Permanente Northwest staff time or resources may require funding. Most research is supported through external funding through grants from agencies such as the National Institutes of Health or private foundations. Some QI projects may be supported through departmental funding. CHR may be limited in how we are able to support your research or QI project if you do not have funding. Please consult with us to see what might be possible. We can try to facilitate connections among investigators at Kaiser Permanente Northwest and affiliated research networks to identify funding opportunities.

There are requirements to be, and responsibilities associated with, serving as a Principal Investigator (PI). The CHR team can explain those requirements in more detail.

Connect with us by filling out a form here:

To promote the ethical conduct of research, the protection of human subjects, scientific integrity, and the privacy and security of information, Kaiser Permanente Northwest (KPNW) researchers are required to complete comprehensive training in research ethics and compliance, as applicable to their research, and before conducting research. Typical trainings include:

• Financial Conflict of Interest (FCOI)
• Good Clinical Practices (ICH-GCP)
• Human Subjects Protection (HSP)
• HIPAA Privacy Rule as it applies to research

Our CHR team will assist researchers, and their team, in identifying which specific courses are required and how to access the courses.

Who Needs GCP Training?

• Individuals who are engaged in human subjects research on a Clinical Trial or protocol that requires compliance with GCP.
• The NIH requires GCP training for individuals involved in the design, conduct, oversight, or management of clinical trials, funded in part of whole, by the NIH.

Considerations before you begin your work: Most publications will require documentation of IRB review, regardless of whether your project is QI or research. Formal documentation from the IRB would include either an approval letter if it is research or a determination that the project is QI and not research. IRB will not review a project retroactively.

Before you submit your manuscript for review: Please share a draft of your manuscript with the CHR team prior to publishing. Our CHR team can help to identify appropriate and required language when publishing. They can also help to make organizational leaders aware of your research and identify any other organizational requirements prior to publishing.

Connect with us by filling out a form here:

The CHR team provides  guidance, consultation and facilitation of the following:

1. Determining the scope and scale of your project
2. Determining feasibility and needed resources to conduct your project
3. Determining if your project is research or QI
4. Institutional Review Board requirements
5. Research design and study development
6. Construction of limited datasets for chart review for data analysis by investigators
7. Facilitation of any required agreements or contracts (e.g. data sharing agreements, NDA, CDA)
8. Budget development for projects
9. Facilitating connections among investigators at Kaiser Permanente Northwest and affiliated research networks
10. Accessing and using available biospecimens for research

Connect with us by filling out a form here:

KP Research Bank resources include biospecimens, genomic data, and self-reported health survey data, linkable to KP clinical data. Access to KP Research Bank resources by non-KP researchers requires collaboration with a KP researcher, who can help refine the phenotype of interest. Use of KP Research Bank resources is intended to facilitate publishable, public domain research that will advance the understanding of health and disease and improve care delivery.

Release of KP Research Bank resources is contingent upon study funding sufficient to cover the KP team’s scientific and administrative efforts, as well as KP Research Bank programming fees for preparation of de-identified datasets and/or biospecimens, IRB approval, and execution of appropriate material and/or data use agreements. Visit this site to learn more about using KP data or biospecimens in your research.

KP Research Bank: For Researchers

You will need to apply directly through the KP Research Bank:

Apply for access

The Institutional Review Board (IRB) is a committee of people who review plans for scientific studies that involve people. The committee’s job is to make sure that the studies protect the rights and welfare of research participants.

In most cases, human research cannot be done without the approval of an IRB. After research studies are started, the study staff is also required to report progress to the IRB. These reports help the IRB ensure all research rules and regulations are followed throughout the entire time a research study is done.

An IRB has at least five members, with varying backgrounds to promote complete and adequate review of research activities commonly conducted by the institution. An IRB must be sufficiently qualified through the experience and expertise of its members, and the diversity of the members, including consideration of professional experience, affiliation with the institution, race, gender, cultural backgrounds, and sensitivity to such issues as community attitudes, to promote respect for its advice and counsel in safeguarding the rights and welfare of human subjects. Each IRB member agrees to make decisions they think are best for the community and are not for their own interests. The Kaiser Permanente interregional IRB meets once a month.

All projects involving KPNW data and/or specimens must be submitted to the KPiIRB for review before activities can begin. The board will determine whether IRB oversight is required for a given project or if the proposed activities fall outside of their purview. The KPiIRB can serve as the IRB of record for a study, cede oversight to another IRB for a given study, or serve as the IRB of record for multi-site studies. Our team can help you navigate this process.

To conduct research at KPNW, you...

• Must be employed by or collaborate with an employee of a Kaiser Permanente Northwest (KPNW) entity.
• Need to identify a CHR investigator to collaborate with or work with our Learning Health Systems (LHS) team.

Collaborating with a CHR investigator or working with our LHS team ensures that proposed projects are consistent with Kaiser Permanente Northwest policies and that any potential effects on the care-delivery system are addressed.

*This is true for research proposed by KPNW affiliate faculty members, Kaiser Permanente Northwest staff, or Northwest Permanente Medical Group staff, and researchers affiliated with other institutions.

If you are proposing research at Kaiser Permanente Northwest, we must review your project before any activities can occur. Or if you are proposing a project and not sure if it qualifies as research or quality improvement, you must engage with CHR to guide a research determination.

• Complete the review questionnaire here
• We will review your application and will follow up with you by e-mail within a week after submission. 
• Note: Studies that collect Kaiser Permanente Northwest data as their primary source of data must have any resulting publications reviewed by Kaiser Permanente Northwest before publication. See more about data access and sharing requirements here.

Connect with us by filling out a form here:

If your proposed research is a clinical trial or clinical research, has an industry sponsor, and/or is federally regulated you must work with the Clinical Research and Clinical Trials Unit (CRTU) within CHR. The CRTU department specializes in the conduct of clinical research trials. Email CHR_CRTU_Regulatory_OIC@kpchr.org for guidance on how to proceed with your project.

While determinations about QI versus research are made on a case-by-case basis formally through our local IRB, a member of our team can help you understand if your proposed project is Quality Assurance or Quality Improvement (QI) or research.

Whether your project is QI or research you must receive formal documentation from the IRB, either an approval letter if it is research or a determination that the project is QI and not research, before beginning activities.

What are some differences between QA and Human Subjects Research*?

Good Clinical Practice, usually referred to simply as GCP, is used interchangeably in reference to both a broad concept and a single document.

GCP is often used broadly to describe what are considered best practices when conducting clinical research. The term GCP is also used more narrowly to describe the International Council for Harmonisation (ICH) GCP E6 (R2) document itself. GCP describes the unified, international standard for the European Union, Japan, the United States, Canada, and Switzerland to facilitate the mutual acceptance of data from clinical trials by the regulatory authorities in these jurisdictions.

When must GCP be followed?

The applicability and application of GCP differs based on the specifics of the study so understanding GCP requirements at the earliest stages of study start-up is crucial.

In general, adhering to GCP is required when any of the following are true:

• The study is a FDA regulated clinical trial,
• The data generated from the study is intended to be submitted to regulatory authorities, 
• The contract/agreement and/or protocol specifies the study will be conducted according to GCP,
• Any study for which the sponsor/funder requires it, and
• While the NIH requires GCP training for individuals involved in the design, conduct, oversight, or management of clinical trials, funded in part of whole, by the NIH, they do not require the study be conducted under GCP unless one of the above apply.

Who Needs GCP Training?

• Individuals who are engaged in human subjects research on a Clinical Trial or protocol that requires compliance with GCP.
• The NIH requires GCP training for individuals involved in the design, conduct, oversight, or management of clinical trials, funded in part of whole, by the NIH.