How do we protect KPNW members who join research studies?
The Research Subjects Protection Office (RSPO) administers the KPNW program for ensuring protection of human research participants. The RSPO guides researchers on the various federal and state regulations and regional policies that govern research with humans. Just as a medical ethics board reviews medical practice, an Institutional Review Board (IRB) reviews all regional research and ensures that the rights and welfare of research study participants are protected. KPNW requires that all research be reviewed and approved by the IRB regardless of funding source. To start the review process, you need to complete a new study submission form through the electronic IRB (eIRB) system at https://eirb.kpchr.org/.
See the Research Subjects Protection Office website at
http://www.kpchr.org/rspopublic/public/ for information about research protections at KPNW.
How do I submit a new study to the IRB?
While the forms are readily available through the electronic IRB (eIRB) system at
https://eirb.kpchr.org/, submitting a new
study requires an in-depth knowledge of what the review board expects to see and how to answer their concerns. If you do not already have research experience, we have experts who will help you through the forms and requirements. If your new study
submission is not done correctly (e.g., it is incomplete or not appropriate), it will delay (or halt) the start of your study.
What are the costs of submitting a new study to the IRB?
Costs vary depending on research project factors: oversight time, complexity, level of contact, vulnerable populations (e.g., pregnant women, children, disabled or impaired subjects), and level of human subjects contact. Roughly a new study submission
costs between $3000-$5000 (for about 50 hours of time). Simpler studies, such as data-only studies, would be at the low end of this range.
What is research compliance?
A research project must complete a number of different compliance documents (such as agreements for data use or transfers) before it may begin collecting and/or transferring data. CHR has established a Compliance Committee to ensure compliance with all applicable laws/regulations and reduce the burden on research studies. After you receive approval from the IRB, you can get information about any compliance needs your research might have by e-mailing Compliance@kpchr.org.
Why do I need a project manager?
Project managers provide oversight of your project. Research is a heavily regulated environment with numerous legal requirements and ethical concerns. A project manager can help you navigate the numerous federal regulations that protect research subjects. He or she can help you conduct a study efficiently by managing the budget, handling contracts, and coordinating CHR services to support your project.
Can I, or someone on my clinic staff, be my own project manager?
No. Managing a KP research project requires extensive research and procedural knowledge. Regulations are complex and specific. In the long run, a CHR project manager will save your research project time and money because he or she can keep your project running smoothly.