Public Health Institutional Review Board (PH IRB)
Protecting the rights of persons participating in research
The Public Health Institutional Review Board serves as the IRB for both the Oregon Public Health Division (PHD) and the Multnomah County Health Department (MCHD). It is an established administrative body composed of PHD staff, MCHD staff, and select external volunteers with expertise in epidemiologic research, public health interventions, and social and behavioral science. It is the Boards' duty to protect the rights and welfare of human research subjects recruited to participate in research activities and the confidentiality of their data.
Both of these agencies have a Federalwide Assurance (FWA) filed with the Office for Human Research Protections (OHRP), formalizing their commitment to protect human subjects when engaged in research. These FWA's cover all federally supported or conducted research involving human subjects, however, both the PHD and MCHD have elected to apply 45 CFR 46 and all its subparts regardless of the source of support. As legally separate entities, the PHD and MCHD must have their own FWA's, however, both designate the PH IRB as the Institutional Review Board responsible for their reviews.
- PH IRB HHS IRB Registration Number: IRB00001099
- Oregon Health Authority - Public Health Division Federalwide Assurance: #00000520
- Multnomah County Health Department Federalwide Assurance: #00004186
What does the PH IRB review?
In accordance with 45 CFR §46.109 and 45 CFR §46.113, the PH IRB has the responsibility to review, approve, disapprove or require changes in research projects involving human subjects and the authority to suspend or terminate the approval at a later time in order to protect the subjects’ rights. PH IRB review is required for all research with human subjects if any one or more of the following applies:
· The research is sponsored by the PHD or MCHD;
· The research is conducted by or under the direction of an employee or agent of PHD or MCHD in connection with his/her agency responsibilities, or using any property or facility of PHD or MCHD;
· The research involves the use of PHD or MCHD’s data;
· The research involves the use of PHD or MCHD’s non-public information to identify or contact human research subjects or prospective subjects;
· Funding for the research will be handled through PHD or MCHD, but the research will be done at another location.
For more information on the PH IRB's authority and scope of expertise, please see the PH IRB Policy & Procedures Manual.
How to Submit a Research Project to the IRB
When PHD or MCHD data is requested for research, the PH IRB Coordinator will direct the investigator to first contact the Program to see if disclosure of the data is possible, and if so, what the program requires in order to agree upon its release. Below are process maps demonstrating the data request and IRB processes for both internal research teams at the PHD or MCHD and external.
Investigators wishing to pursue PH IRB approval for a research project must submit the following information:
- Initial Review Questionnaire
- Protocol and grant application
- Data Use Agreements
- All key personnel CV's and proof of human subjects research training
- If applicable: recruitment flyer, phone scripts, consent/assent forms, authorization form, assessment instruments or questionnaires, and any other material that a research subject may be reviewing.
- For more detailed information on the submission, please see Page 20 of the PH IRB Policy & Procedures Manual, "Information the Investigator Provides"
All material must be forwarded to the Public Health IRB Coordinator. It is asked that before obtaining the appropriate signatures and formatting the study documentation as a PDF, you save WORD copies for your files as revisions will likely be requested throughout the duration of your study. Submit material to:
OHA Public Health Division
800 NE Oregon St., Ste. 930
Portland OR 97232
Submissions which are found to be incomplete or where the information may be lacking, incorrect, or inconsistent will not be forwarded to the IRB Chair for final determination until such issues have been resolved. This applies to all submissions requiring full, expedited, or exempt PH IRB review.
Meeting Dates and Application Deadlines
Application material must be received by the deadline in order for the project to be reviewed at the appropriate PH IRB meeting. This applies to those studies in which a Full Board review will be required, meaning the research is not considered a minimal risk study. No exceptions will be allowed.