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.

• Chart 1: Is an Activity Human Subjects Research Covered by 45 CFR Part 46?
• Chart 2: Is the Research Involving Human Subjects Eligible for Exemption Under 45 CFR 46.104(d)?
• Chart 3: Does Exemption 45 CFR 46.104(d)(1) for Educational Practices Apply?
• Chart 4: Does Exemption 45 CFR 46.104(d)(2) for Educational Tests, Surveys, Interviews, or Observation of Public Behavior Apply?
• Chart 5: Does Exemption 45 CFR 46.104(d)(3) for Benign Behavioral Interventions Apply?
• Chart 6: Does Exemption 45 CFR 46.104(d)(4) for Secondary Research that Does Not Require Consent Apply?
• Chart 7: Does Exemption 45 CFR 46.104(d)(5) for Public Benefit or Service Programs Apply?
• Chart 8: Does Exemption 45 CFR 46.104(d)(6) for Food Taste and Acceptance Studies Apply?

• Chart 12: Waiver or Alteration of Informed Consent in Research Involving Public Benefit and Service Programs Conducted by or Subject to the Approval of State or Local Government Officials (45 CFR 46.116(e))
• Chart 13: When Can Informed Consent Be Waived or Altered Under 45 CFR 46.116(f)?
• Chart 14: Can Documentation of Informed Consent Be Waived Under 45 CFR 46.117(c)?

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.

• Internal Data Request Process
  
• External Data Request Process (contains the Pre-IRB Review Tool)
  
• Pre-IRB Review Tool (Scientific Merit, Risks, and Mitigation Review Tool)
  

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)
  
• Pre-IRB Review Tool, completed by a designated internal PHD/MCHD Sponsor
  
• Approval memo from a reviewing Advisory Committee or other IRB, if applicable
  
• 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@oha.oregon.gov 

Before obtaining the appropriate signatures and formatting the study documentation as a PDF, please 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.