Skip to main content
Oregon.gov Homepage

Guidelines


Is the PHD or MCHD considered engaged in this research? If so, follow the guidelines provided on this page as a PH IRB review will be required. If unsure, the PH IRB Coordinator can assist you with this determination.


OHRP

The Office for Human Research Protections (OHRP) created the following Decision Charts as tools to assist investigators and Institutional Review Boards in deciding if an activity is research involving human subjects that must be reviewed by an IRB under the requirements of The Common Rule (45 CFR 46). These charts do not address other requirements that may be imposed by other organizations such as the FDA or NIH.

 

Data Request?

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 for both internal research teams at the PHD or MCHD and external research teams requesting data for purposes of research. Resulting Data Use Agreements should be submitted to the PH IRB.


Submission 

Investigators wishing to pursue PH IRB approval for a research project must submit the following information (See 'Forms' page for links to documents):

  • Initial Review Questionnaire (IRQ)
  • Personnel Tracker
  • Protocol and grant application
  • Data Use Agreement(s)
  • 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 22 of the PH IRB Policy & Procedures Manual"Information the Investigator Provides" and guidelines throughout the above mentioned IRQ and Personnel Tracker.

All material must be submitted 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:

  • IRB Coordinator
    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.

Consent and HIPAA Authorization Forms

Informed consent provides research subjects with a description of the study and of its anticipated risks and/or benefits, and a description of how the confidentiality of records will be protected,a mong other things.

An Authorization focuses on privacy risks and states how, why, and to whom protected health information (PHI) will be used and/or disclosed for research. Per the Privacy Rule, covered entities are only allowed to use and disclose PHI for research if authorized to do so by the subject (there are a few exceptions to this Rule).

If the Privacy Rule applies, an Authorization may be a separate document or the elements of an Authorization may be imbedded in the Consent Form.


Adverse Events and Unanticipated Problems


Review and reporting of these occurances must occur in a timely, meaningful way so that human subjects can be better protected from avoidable harms while reducing unnecessary burden.

Your browser is out-of-date! It has known security flaws and may not display all features of this and other websites. Learn how

×