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.
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.
Forthcoming guidance (decision charts) have been promised by OHRP for the revised regulations that go into effect January 21, 2019. That guidance will be posted once it becomes available.
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.
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 firstname.lastname@example.org
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.