Policies & Procedures

All protocol submissions must be typed and completed on the approved forms found under the "Forms" link in the navigation strip on the right. All protocol submissions will be logged in and subject to initial review when all of the required information has been submitted. For more information regarding the submission process, please refer to the "Submission Requirements" link on the right. The primary investigator (PI) is responsible for all aspects of the application process.

IRB Policy

Approval of Protocol: A properly submitted protocol application will receive the designation of "Approved" once the full committee, the Chair or a designee approves the protocol in writing under an assigned IRB protocol number. The standard approval period is for one year or 365 days from the issue date of the IRB's approval letter. While the IRB may send a reminder notice to any authorized PI when an approved protocol is about to expire, the PI bears ultimate responsibility for ensuring that all research or research-related activity is conducted under a valid and approved protocol.

Conditional Approval: A properly submitted protocol application will receive the designation of "Conditional Approval" once the full committee, the Chair or Co-Chair, or their designee has completed an initial review of the protocol. This means that the protocol application was complete and logged in, but still requires minor changes or modifications to be approved. The changes or modifications requested will be specified in writing and the PI will have sixty (60) days from the date of the notice of conditional approval to submit the necessary documentation required to receive approval. Minor changes may involve typographical errors in a consent document, revision to the consent document or the recruitment and consent process, clarification of statistical methods, or other research design related considerations. The proposed research study may not begin under these conditions. No data collection activities can occur when a protocol has only "conditional approval." Other aspects of the research process, however, may begin after consultation with the Chair of the IRB. These conditions may involve access to the research site and/or staff to gather additional information regarding research design, to grant "Letters of Access," or to further document or establish the conditions under which the research protocol may occur. If the changes or modifications are not submitted within the sixty (60) day timeframe, the proposal will be designated "Inactive." An inactive protocol may be rehabilitated without resubmitting an entire protocol within an additional thirty (30) days. Thereafter, the protocol will be administratively withdrawn and designated "Not Approved." This will require the resubmission of a new protocol application. At this point, the PI may be required to attend a full committee review of the protocol upon request of the IRB.

Inactive Protocol: The protocol (as submitted) was incomplete or in need of revision. The PI will have sixty (60) days to remedy the errors or omissions. If the changes or modifications are not submitted within the sixty (60) day timeframe, the proposal will be designated either "Not Approved/Inactive" for an additional thirty (30) days. An inactive protocol may be rehabilitated without resubmitting an entire protocol within an additional thirty (30) days. Thereafter, the protocol will be administratively withdrawn and designated "Not Approved." This will require the resubmission of a new protocol application. At this point, the PI may be required to attend a full committee review of the protocol upon request of the IRB.

Not Approved/Disapproval of Protocol: The protocol (as submitted) remains in need of significant revision or is incomplete. The proposed study may not begin until the IRB has granted authorization in writing. The IRB will notify the investigator that the protocol has not been approved or is being withdrawn. The PI is responsible for addressing the concerns raised in the notice before any additional action will be taken by the IRB. All requests for modifications must be submitted in writing to the IRB. If the IRB does not receive an adequate response from the PI, the protocol will be designated "Inactive" for a period of sixty (60) days. If the request for modifications or omissions in the protocol application are not submitted within this sixty (60) days, the proposal will be designated "Inactive." An inactive protocol may be rehabilitated without resubmitting an entire protocol within an additional thirty (30) days. Thereafter, the protocol will be administratively withdrawn and designated "Not Approved." This will require the resubmission of a new protocol application. At this point, the PI may be required to attend a full committee review of the protocol upon request of the IRB. The proposed research study may not begin under these conditions. No data collection activities can occur when a protocol has been designated "Inactive" or "Not Approved." A protocol may be designated as "Not Approved" for any and all of the following reasons:

1. The protocol application is incomplete (as submitted)
2. The PI did not conform to the timeframe listed above for revisions or any other request for modification that the IRB has requested
3. The proposal lacks merit and/or key information in the judgment of the Chair, Co-Chair, initial reviewer, or full committee. The lack of information or merit does not allow for a proper evaluation of the objectives, methods, endpoint criteria, benefits, and/or risks to the participants.
4. The protocol does not adequately address the measures needed to protect potential research subjects from risk and/or the risks in the study are not addressed
5. The risk to the potential subjects outweigh the potential benefits
6. The protocol contains a significant design flaw that prevents it from obtaining its proposed end or confounds significant research-related goals, outcomes, objectives, or aims in such a manner as to lack scientific merit
7. Any other deficiency deemed insufficient after a full committee review of the protocol.

The IRB will notify the PI in writing of any significant deficiency including the reasons for designating the protocol "Not Approved" unless a more expedient manner of notification occurs allowing the PI to make appropriate changes within the timeframe designated above. The PI must submit in writing all revisions or additional information that the IRB requests before approval can be granted. There is no formal appeal process once the IRB submits its final written decision.