Institutional Review Board (IRB)

IRB Process & Deadlines

Initial Submission Process

All human subject research at SCU requires IRB review and approval BEFORE the project may begin and may only take place within the approval period granted.

Initial Submission Packet:

Investigator Human Subject Regulations Decision Charts: 2018 Requirements to determine if the proposal meets the criteria for exempted research. If so, they complete the exempted application, if not, they should complete the non-exempted application. The initial application is due 3 weeks prior to the next scheduled meeting (if less than 3 weeks the proposal may be moved to the next scheduled initial review meeting session).

Submit the following in the proposal packet to IRB@scuhs.edu (include language translation copies for documents that may be provided to subjects or the public as well so they may be reviewed) 3 weeks prior to the initial review meeting (see meeting schedule):

• SCU IRB Exempted Application Form or SCU IRB Non-Exempted Application Form
• SCU IRB Informed Consent Form Template and/or HIPPA authorization Form Template
  • Or request for waiver as applicable (SCU IRB Informed Consent Waiver Request Form and/or SCU IRB HIPPA Authorization Waiver Request Form)
• Human subjects training certificate for each investigator
• Research protocol
• Proposed recruitment materials (if applicable)
• SCU IRB Experimental Subjects Bill of Rights Form (if applicable)
• Data collection instruments (Screening tools, Survey and/or questionnaires, etc)
• Grant/Sponsor protocol (if applicable)
• IND, IDE, and SR/NSR determination documentation (if applicable)

The IRB will verify that the correct application was completed and determine if the project can be reviewed utilizing expedited procedures. If non-exempted, the proposal packet will be distributed the packet to the IRB committee members for review.

Initial Review

Exempted or expedited review may be conducted by the IRB chair or a designated member of the IRB. Convened review will be conducted at a convened meeting of the IRB.

The IRB will utilize a review checklist to determine that the proposal, including the informed consent, meets the criteria for approval and will record the outcomes in the meeting minutes.  Requests for a waiver (full or partial) of any elements of the informed consent or HIPAA consent requires completion of the waiver proposal and will be reviewed by the IRB for applicability. If any portion of these consents are waived by the IRB the components of the waiver will be explicitly listed in the approval letter.

Be certain to apply for any IND or IDE through the FDA if applicable and include that documentation with the application. Consent documentation should include procedure for submitting subject complaints, problems, concerns and questions about rights as a research subject.

IRB Review Committee Decisions

Approval

IRB Approval indicates that the proposal may begin. Approvals are typically granted for a one-year period and may be renewed following the submission of a continuing review report and/or modification request (if applicable). The approval letter will include approval date and approval expiration date are clearly indicated on all notices sent to the PI and must be strictly adhered to.

Approval with contingencies

Approval with contingencies requires that the proposal be revised, but not subject to additional re-review so long as the contingencies are met. The list of contingencies will be included in the approval letter and may begin when the contingencies are met. The investigator should re-submit the package with the contingent modifications for the records and a letter of completion of contingency requests will be provided. The approval letter will include approval date and approval expiration date are clearly indicated on all notices sent to the PI and must be strictly adhered to.

Request for modification and re-review

Requests for modification with re-review may be made for proposals that require more than minor modifications and as such do not qualify for an “Approval” or “Approval with Modifications”.
The proposal should be resubmitted with the requested modifications and will be re-reviewed. It will then be either approved, approved with further contingencies, or denied approval.

Denial

The IRB will not re-review denied proposals without significant alterations and supportive evidence relating to the proposal.

Tabled and/or Deferred

The IRB will table and/or defer projects that are incomplete, that require additional research or consultation for review, or if they are not completed by the end of a convened meeting.

Single IRB and Reliance Agreements

The revised Common Rule requires that U.S. institutions engaged in cooperative research must rely on a single institutional review board (IRB) to review and approve the portion of the research conducted at domestic sites. See 45 CFR 46.114(b).

Please contact the IRB chair if you would like to submit a request for a reliance agreement.

Notification and Communication

The investigator will be notified of all final decisions via email with an attached letter (.pdf) for their records. Hard copies of decisions are available upon request. The outcome of the review and approval period (if applicable) will be recorded in the meeting minutes.

University, state, and federal offices are notified of IRB proposals and results as required for reporting purposes, but otherwise IRB proceedings are kept confidential during the approval period. A log of proposals with decisions and dates of approval periods is kept and reminders for continuing review and/or closure reports are made to prevent lapses in IRB approval and for insurance reporting. Study activities can only take place during the approval period, if a lapse in approval occurs all study activities must cease and an application for and extension must be approved via a continuing review report submission. Once approved, study activities may continue.

The investigator may appeal any decision by the IRB in writing and submitted for any of the review meetings.

Continuing Review Submission

Continuing review of research will be conducted by the IRB at intervals appropriate to the degree of risk and not less than once per year. Report due dates can be found in the proposal approval letter. Utilize the SCU IRB Continuing Review Report Form.

Under the revised Common Rule, continuing review is not required for:

• Research that is eligible for expedited review,
• Exempt research conditioned on limited IRB review,
• Research that has completed all interventions and now only includes analyzing data, even if the information or biospecimens are identifiable,
• Research that has completed all interventions and now only includes accessing follow-up clinical data from clinical care procedures.

The IRB can override this default and choose to require continuing review. If continuing review is required by the IRB in one of the conditions above, the minutes and letter to the investigator will record the reason for the requirement.

Exempted and Minimal Risk, Expedited Reviews

Exempted proposals and minimal risk proposals approved through expedited processes are generally not subject to continuing review.

Convened Reviews

Proposals approved through a convened process are subject to ongoing review. Generally, continuing review reports are due annually. More frequent review will be required if there is the probability of significant risk to research subjects (risk of death, disability, permanent injury, etc), if the subjects belong to a vulnerable population, the qualification of the investigators indicate a need for more frequent review, if the PI has a history of serious or continuing non-compliance, or if the novelty of the research results in the inability to ascertain the level of risk.

Review of informed consent documentation will occur at each continuing review to determine if alterations are required as a result of project outcomes.

Random audits of projects will be conducted to ensure that no deviations occur from the approved project protocols, methods, or materials. These audits may include requests of information from the investigator, sponsor, or third parties.

Modification Request

Any change to the forms, process, protocol, consent methods, procedures, etc. must be requested in writing by submission of the SCU IRB Modification Request Form. Please include a copy of any related, updated, materials (survey instrument, questionnaires, informed consent, protocols, etc.…).  Modification requests to proposals previously approved via exempted or expedited procedures may also be approved in that same manner. Projects that were approved via a convened process must be reviewed by a convened IRB and will take place during the revision meetings.

All research activities must stop during any time when modifications are being reviewed until such time as they are approved. Modifications to remove immediate risk to a subject must be reported to the IRB immediately if there was a life-threatening risk or within 10 days of the incident.

The IRB decision related to a modification request will be communicated via email with an attached .pdf letter outlining the decision. Modification approvals do not impact the approval period for the project unless an extension is requested with the modification submission.

Project Closure Report

Project Closure reports are due by midnight of the last day of the proposal approval period unless a request for extension and continuing review report has been submitted. Utilize the SCU IRB Project Closure Report Form.

Adverse or Unanticipated Events and Protocol Deviations

It is the responsibility of the principal investigator to immediately report any adverse or unanticipated events if they are serious or life-threatening. All other adverse or unanticipated events and protocol deviations must be reported within 10 days. Utilize the SCU IRB Adverse or Unanticipated Form or SCU IRB Protocol Deviation Form accordingly.

Suspension or Termination of Project

The principal investigator and the IRB have the authority to suspend or terminate any project that is found to be not following the approved methods and protocols, is outside of the approval period, any unlawful activity is discovered, or adverse/unanticipated events occur.

In the event of a suspension or termination by the IRB, the principal investigator will be notified in writing. The letter will include the date of the suspension or termination, if prior verbal notification was given and the date of that notification, the reason, what component(s) of the project must be ended, corrective actions needed, and a directive to inform the participants (if indicated).

MEETING SCHEDULE

Convened Meetings

Convened meetings of the SCU IRB occur 8 times a year on the first Friday of each indicated month indicated below.  These meetings will be held live via teleconference. A quorum for the SCU IRB is defined as a majority of members and must include one non-scientific member.  Attendance, discussion, and voting shall be recorded in the meeting minutes. Proxy voting is prohibited. IRB members must declare any potential conflict of interest prior to the discussion of any proposal. IRB members found to have conflict of interest will recuse themselves from the meeting for the period of time that proposal is under review.

Since the IRB may lose quorum if a member must recuse due to a conflict, or if the nonscientist has to leave the meeting or cannot attend, it is essential that all IRB members review the proposal packets and agenda prior to the meeting so the IRB chair can ensure a quorum can be present or if alternate members may be required for review.

The Initial Application Proposal Submission is due 3 weeks prior to the convened meeting. Only complete packages will be accepted for review. Re-submission of revised proposals following a request for revisions from the IRB must be submitted 1 week prior to the revision review meeting to which you are submitting.