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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, consistent with the revised regulations, as tools to assist investigators and IRBs. The charts are generalizations only and may not be specific enough for your particular project. Further, they do not address requirements that may be imposed by other organizations such as the FDA or NIH or our local government here in Oregon. The full text of an applicable regulatory provision will be considered by the PH IRB in making final decisions.

 

Data Request?

 

When PHD or MCHD data is requested for human subjects 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 for internal research teams at the PHD or MCHD is a Data Request Process Map. And for research teams external to the PHD or MCHD, the PHD "Scientific Merit, Risks, and Mitigation Review Tool" which is expected to be completed by an internal Sponsor prior to submission of paperwork to the PH IRB (See pg. 2 of the IRQ "NOTE: External Investigators" for more information).

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
  • Research Protocol
  • 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 23 of the Public Health IRB Policy & Procedures Manual"Information the Investigator Provides" and guidelines throughout the above mentioned IRQ and Personnel Tracker.
 

Submit material electronically to alayna.n.forrest@state.or.us 

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.

  • 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, among 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 occurrences must occur in a timely, meaningful way so that human subjects can be better protected from avoidable harms while reducing unnecessary burden.
  

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