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Forms and applications are documents supplied by the Porter Adventist Hospital Joint IRB office to be submitted for review by the Porter Adventist Hospital Joint IRB with supporting documentation, as appropriate.
Required prior to submitting an application all Research Staff, to include Investigators, Sub-Investigators, Research Coordinators and Study Related Task Delegates must complete the online course in
Human Participant Protections Education for Research Teams
. If this is your first training session, you will need to register and obtain a password. Once complete print the certificate and submit with your submission to the JIRB. The training must be renewed every four years (NIH funded research projects may require a three year renewal). If similar training was completed within the last four years, please supply documentation for review by the IRB Office. You will be notified if the training will be accepted in lieu of the above-mentioned course.
If you know what type of IRB review that you need please follow the appropriate drop-down below for the required submission documents. If you are uncertain what type of IRB review that you need please start with the Project Determination drop-down below and then follow the appropriate drop-down for the required submission documents. The following drop-downs contain all of the necessary forms, templates and procedures for each type of IRB submission.
If non-Centura support staff will conduct study
related tasks within Centura Health facilities they must register on the Contractors
website to apply for the appropriate access (www.centura.org/contractors).
Frequently asked questions are answered in the IRB Q&A.
Please contact the IRB office at 303-778-2554 or via e-mail at PAHJointIRB@Centura.org with any questions or concerns that you have.
When you have a complete submission including all of the required forms and applicable supporting documentation please submit your documentation to PAHJointIRB@Centura.org A preliminary review will be conducted and you will be advised if any further documentation is required prior to review and/or when your submission will be reviewed.
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The Project Determination form will assist you in the determination of:
All research involving human participants must be reviewed and approved by the Institutional Review Board (IRB). To determine if you project qualifies as human subjects research please review the flow charts.
Non-exempt research may or may not pose greater than minimal risk to participants and does not qualify for exempt review as determined by completion of the Project Determination form. Non-exempt research which poses greater than minimal risk requires review by the convened IRB. Non-exempt research which poses minimal risk and meets expedited review criteria will be reviewed either at the convened IRB or during executive session whichever occurs first. The IRB does require a full submission for all non-exempt research regardless of whether it qualifies for expedited review.
Principal Investigators are invited to attend the convened IRB meeting during which their non-exempt research will be reviewed to present a summary of their research and answer any questions that the Board members may have.
The following are the Non-exempt application forms and applicable guidance documents:
Informed Consent & PHI Authorization
Recruitment and Advertising
Delegation of Study Related Tasks
Financial Conflict of Interest Disclosure
Exempt research does not pose greater than minimal risk to participants and meets an exempt category as determined by completion of the Project Determination form. Exempt research may be reviewed by either the convened IRB or in Executive Session by the IRB Chair and Board members with appropriate expertise. The IRB does require a full submission for review of all exempt research.
The following are the exempt application forms and applicable guidance documents:
Informed Consent and PHI Authorization
A Guide to Informed Consent - Information Sheet (Required elements of the informed consent)
HIPAA - Authorization for Use and Disclosure of Protected Health Information (PHI) for Research
Humanitarian Use Devices (HUD) used under the jurisdiction of the Porter Adventist Hospital Joint Institutional Review Board (PAH JIRB) are managed by the Centura Health Research Center. If you are interested in utilizing a HUD at Castle Rock, Littleton, Parker or Porter Adventist Hospitals please contact the Centura Health Research Center at 303-765-3703.
The following are the HUD application forms which the Centura Health Research Center will coordinate with you to complete.
All research conducted in a Centura Health facility requires both IRB and Facility Review approval. IRB and Facility Review are conducted simultaneously and the Investigator must receive both IRB and Facility Review approval before commencing research activities.
While the IRB process is independent of the Facility Review process the IRB will facilitate the initiation of Facility Review on behalf of the Principal Investigator. All required Facility Review documents should be included with the IRB submission so that the IRB may initiate this process on the Investigator's behalf.
The following are the Facility Review forms and applicable guidance documents:
Facility Review Guidance Algorithm
Facility Review Documents
Approved Study Research Participant Registration Form
The Porter Adventist Hospital Joint Institutional Review Board has developed an Informed Consent and a Protocol template for use by Investigators.
The following are the informed consent and protocol templates as well as the applicable guidance documents:
This section includes the Porter Adventist Hospital Joint Institutional Review Board's forms for continuing review submission, revision and amendment submission, adverse event as well as protocol deviation reporting.
Revision & Amendment
Unanticipated Problem / Event Reporting
Research Participant Registration Form
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