Process

What Do I Need to Submit to the IRB for Review

SUBMISSION REQUIREMENTS (incomplete submissions will not be reviewed by the IRB):

A. Submission Requirements for Full Board or Expedited Initial Review 

    1. Research Project Application
    2. Administrative Checklist, signed by the appropriate institutional officials
    3. $2,250 initial processing fee, $1,500 expedited review
    4. Financial Disclosure Form
    5. Research protocol
    6. Proposed informed consent document/Assent and permission documents (if applicable)
    7. PeaceHealth Authorization to Use and Disclose Health Information (if applicable)
    8. Investigator Brochure, or device specifications
    9. Questionnaires & assessment instruments
    10. Supporting material, such as examples of recruitment advertising, etc.
    11. Documentation of completion of required human participant protections training (Principal Investigator, co-investigators, and study coordinator)
    12. Curricula vita
    13. FDA Form 1572 (drug study) or signed investigator agreement (device study)
    14. Contract of funding agency minus the budgetary pages (if applicable)
    15. Processing fee waiver request form (if applicable

B. Submission Requirements for Exempt Research

      1. Exempt Project Application
      2. Administrative Checklist, signed by the appropriate institutional officials
      3. A protocol summary
      4. Informed consent, if appropriate
      5. Questionnaires, survey, interview questions if used
      6. Advertisements, if used
      7. Documentation of completion of required training
C. Submission Requirements for Modification Amendment
      1. Project Modification Application
      2. $500 processing fee for substantive amendments to protocol and/or consent forms review (This includes all revisions that are reviewed by the Full Board) 
D. Submission Requirements for Continuation/Renewal
      1. Progress Report Form
      2. Copy of the current consent document(s)
      3. A copy of the current HIPAA Authorization document, if separated from the informed consent
      4. Any other relevant documents provided by the investigator
      5. $1000 processing fee
E. Additional Submission Requirements
      1. Change in Study Personnel
      2. Add, Remove, Change personnel Application
      3. Non-reportable Events (external SAEs from Sponsor)
      4. Tracking Log for Non-Reportable Events
      5. Local SAE, Unanticipated Problem, Protocol Deviation, Compliance Concern
      6. Unanticipated Problems Involving Risk to Participants or Others Form
      7. Study Closure
      8. Progress Report Form

How Long Does the Review Process Take?

The deadline for submission is two weeks prior to the full board meeting. If materials are complete and the study is placed on the next meeting’s agenda notification will be sent to the Principal Investigator within 5 working days. For more information see meeting dates and deadlines.

What Happens During the Initial Review Process?

  1. The IRB support staff will review the submitted materials for completeness and compliance with PeaceHealth IRB procedures and guidelines.
  2. The IRB Chair will determine the level of review (i.e., exempt, expedited, full board).
  3. After preliminary review, the IRB staff may return the materials to the investigator for modification; they may also request that the investigator submit additional materials prior to IRB full board review. Prompt response to IRB requests will significantly shorten the review process.
  4. Once preliminary review is complete, the study will be scheduled for review.
  5. If the study is judged exempt from IRB review, a confirmation letter will be sent to the investigator and no further action is needed.
  6. For expeditable studies, materials are reviewed administratively and the study contact is notified if changes are required.
  7. All initial study materials for studies requiring full board review are sent to a primary reviewer. A protocol summary and consent forms are sent to all IRB members attending the meeting at which the protocol will be reviewed.
  8. If the reviewers have questions prior to the meeting, they may try to contact the investigator to resolve any uncertainties. Returning reviewer phone calls promptly speeds the process!
  9. Investigators are encouraged to attend the IRB meeting.
  10. Following the IRB meeting, the investigator will be notified in writing of the IRB's recommendations, typically within 3-5 working days of the meeting.

What Are the Possible Outcomes of IRB Review?

Approved as Presented:
In this case the investigator is notified that the IRB application is approved and does not require modification.

In this case the investigator is notified that the IRB application is approved and does not require modification. 

Modifications Required:
If modifications are required by the IRB, the investigator must resubmit the necessary materials for subsequent review and approval. In most cases, the modifications will be reviewed and administratively approved. See the Consent Form Approval and Revision Process for more information.

Deferred:
If the proposal generates significant ethical questions, or appears to be scientifically unsound, the study will be deferred and further information will be requested. Studies may also be deferred if the protocol or consent documents are poorly written or do not provide sufficient information. If a study is deferred, the resubmitted materials must be re-reviewed at a subsequent IRB meeting.

Disapproved:
Studies will be disapproved if they are judged to be ethically or scientifically unsound. Investigators are not advised to resubmit disapproved studies without consulting the IRB. This is a rare - but possible - outcome.

What Happens After IRB Approval?

The investigator can proceed with the research agenda after:

  • IRB approval has been obtained
  • funding has been established
  • any needed approvals from other PeaceHealth committees have been granted

Further contact with the IRB is required: 

  1. If revisions or amendments to the research protocol or consent form are made. The investigator must receive IRB approval before initiating any change. See the Consent Form Approval and Revision Process for more information.
  2. When unexpected adverse events occur. These must be reported to the IRB in a timely manner. Deaths should be reported to the IRB immediately.
  3. For periodic review. This should happen no less than once per year or as directed by the IRB.

Who Can I Talk to for More Information?

Please see our staff page for the appropriate staff member to speak with, or contact the PeaceHealth IRB office at 541.686.6949.

Where Can I Get More Information About Federal Regulations Governing Human Subjects Research?

FDA Information Sheets provide guidance for IRBs and Clinical Investigators regarding regulations governing human subjects enrolled in research involving investigation drugs or devices. For more information visit the FDA website.

DHHS Guidelines from the Office for Human Research Protections (OHRP) governs all research done at PeaceHealth regardless of funding source.

National Bioethics Advisory Commission publishes reports on current ethical issues surrounding the use of humans in research.

PeaceHealth Institutional Review Board

770 E. 11th Avenue
Eugene, OR 97401
Phone: (541) 686-6949
Fax: (541) 338-1024