Institutional Review Board - Submission Process

 

Frequently Asked Questions

What Do I Need to Submit to the IRB for Initial Review?
-- Initial Review -- 

The Principal Investigator prepares and submits the following materials to the IRB Office:

  • A PeaceHealth Administrative Checklist.
  • Professional qualifications to do research (Principal Investigator, Co-Investigators, and Study Coordinator).
  • A cover letter.
  • A 1-2 page protocol summary written in lay language outlining the study design and goals.
  • A complete and final study protocol.
  • An informed consent form – consent forms provided by Sponsors should be modified to meet PeaceHealth IRB guidelinesA HIPAA compliant authorization form.
  • An Investigator Brochure and IND number or any available product information for studies using investigational drugs or devices. Package Inserts are requested for approved drugs.
  • Any advertisements to be used for the recruitment of subjects.
  • Any survey instruments or data collection forms to be used as part of the study.
  • The case report form (when one exists).
  • A completed copy of the PeaceHealth Statement of Ethical Commitment and Financial Disclosure.
  • $1500 initial review fee for initial protocol review, informed consent ($600 for annual continuing review). Check is to be made out to: Medical Research Administration. Fees may be waived by petition.
  • Processing fee waiver request form, if petitioning waiver.
  • Documentation showing the Principal Investigator, co-investigators, and study coordinator have received training in research methods and the protection of human subjects.

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.

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.

-- Reporting Modifications and Amendments --

All changes (no matter how minor) in study procedures, consent forms, questionnaires, advertisements, personnel etc. must be reported to and approved by the IRB before they are implemented. To request a change please submit the following to IRB Office:

  • A summary of the revision and/or amendment.
  • If the revision or amendment affects one of the already approved study documents (such as the protocol, consent form, questionnaire, recruitment letter) please submit the revised document with changes clearly marked.
  • If there is a change in the study protocol, a revised consent form with the changes marked must be submitted. See the Consent Form Approval and Revision Process for more information.

-- Reporting Adverse Events --

You must report any event that is unexpected, whether serious or not (21 CFR 312.32(a)(2)), and all expected events that are serious (21 CFR 108(b)(1)). Serious expected events are those that are fatal, life threatening, permanently disabling, require inpatient hospitalization, or are anomalies, are cancers, or are overdoses (21 CFR 312.32(a)(1)). All subject deaths must be reported for interventional studies, regardless of cause of death.

Submit reports of all fatal or life threatening events to the IRB immediately. Submit all other reports in a timely manner.

To submit an adverse event, please submit the following:

  • A completed and signed Sponsor approved Adverse Event Reporting Form.

-- Continuing Review --

A PeaceHealth Continuing Review Form (CRF) will be sent to the research contact person on an annual basis by the IRB office. The CRF outlines what materials are required at that time. Materials required for annual review include, but are not limited to, the following:

  • A completed and signed Continuing Review Form. In partial fulfillment of a federal requirement, you will be asked to report the gender and ethnicity of all subjects on the CRF.
  • Updated Consent form (see the Consent Form Approval and Revision Process for more information).

Timely submission of materials requested with the CRF is essential to avoid expiration of study approval.

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. 
The web site is: http://www.fda.gov/oc/ohrt/irbs/default.htm 
DHHS Guidelines from the Office for Human Research Protections (OHRP). DHHS guidelines govern all research done at PeaceHealth regardless of funding source. The web site is: http://ohrp.osophs.dhhs.gov/polasur.htm
National Bioethics Advisory Commission. Publishes reports on current ethical issues surrounding the use of humans in research. 
The web site is: http://www.bioethics.gov\

 

Institutional Review Board
1255 Hilyard St., Eugene, OR  97401
541.686.6949 phone - 541.685.1839 fax

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