General Submission Guidelines
- Principal investigators, including faculty advisors of student proposals, must submit evidence of completion of a course in Human Subject Protections accepted by NIH standards. e.g.: http://phrp.nihtraining.com/users/login.php . Equivalent web-based courses or documented training certifications are also acceptable e.g. CITI Program.
- For all proposals submitted to the TUC IRB for review, the investigator shall complete all sections of the “TUC IRB Standard Form” template, which contains specific information headings whose purpose is to assist the Committee in determining the type of review (Exempt, Expedited, or Full Committee) required under existing regulations. The investigator should provide along with the form, any additional supporting documents or information that will fully inform the TUC IRB as to the essentials of the proposed research most relevant to issues of concern to the IRB. The basic elements are listed below and described in more detail in the template:
- Title of Study
- Principal Investigator & Co-Investigators
- Introduction (Background and Significance)
- Study Design
- All documents related to the proposal shall be submitted to the appropriate IRB Sub-Committee Chairperson* who functions as the primary administrator of the proposal evaluation process.
*The procedures for formal submission of applications may differ between programs. Therefore, please contact relevant IRB sub-committee chairperson for program-specific submission requirements.
- Proposal material must be submitted to the IRB in electronic form via e-mail with ‘TUC IRB Proposal’ and the name of the investigator (e.g. “TUC IRB Proposal-Smith”) included in the e-mail subject line to specifically identify the communication as an IRB submission from the investigator.
- Once submitted, a proposal will be evaluated to determine its review status as:
- Exempted from IRB Review. Exemption from IRB review may be granted in accordance with federal guidelines when a study utilizing human subjects involves one or more broad research categories.
NOTE: The Principle Investigator of the study cannot request a review exemption. The decision to grant review exemptions is determined by the IRB. However, to examine whether a study might qualify for a review exemption, please review the following link: http://www.hhs.gov/ohrp/policy/checklists/decisioncharts.html.
- Full IRB Committee Review Required. Full review by the TUC IRB shall consist of at least a quorum of committee members who attend a meeting and review each considered proposal. In cases where a meeting is not assembled to review a proposal, a full review is defined as review by the full membership of the TUC IRB.
- Qualified for Expedited IRB Committee Review. Expedited reviews are evaluated by less than a quorum of reviewing members under specific circumstances (e.g. Sub-Committee Chairperson or one or more qualified members or non-members designated by the Sub-Committee Chairperson).
NOTE: The Principle Investigator of the study must request expedited review at the time a proposal is submitted. However, the final decision is made by the IRB. To examine whether a study may qualify for expedited review, see the following links: http://www.hhs.gov/ohrp/policy/expedited98.html.
- Proposals submitted to the TUC IRB shall be evaluated according to the following schedule**:
- Review and decisions on proposals requiring Full Committee Review and submitted on or before the 15th of a given month shall be completed on or before the 15th of the month following submission.
- Review and decisions on proposals granted Expedited Review or determined to be Exempt from IRB review and submitted on or before the 15th of a given month shall be completed within two weeks of submission.
**Applications presented for review outside of these formal submission timelines may be reviewed by the committee using electronic (email) or mail reviews and votes at the discretion of the chair.
- TUC IRB decisions on all proposals will be communicated by the Subcommittee Chairperson to investigators in writing or via e-mail:
- For exempt proposals, a “TUC IRB Exemption Letter” confirming exemption from further IRB review will be forwarded to the principal investigator/student advisor within two weeks of a decision.
- For approved proposals requiring formal review, a “TUC IRB Proposal Approval Letter” will be forwarded to the principal investigator/student advisor within two weeks of a decision.
- For disapproved and conditionally approved proposals requiring formal review, an explanation of the decision and a summary of the concerns and modifications requested by the Committee will be forwarded to the principal investigator/student advisor. All concerns and modifications must be addressed by the investigator if the proposal is to be re-submitted for full IRB approval. If disapproved or conditionally approved proposals are not re-submitted within three months of notification, the proposal will be inactivated. Submissions after this period are processed as new proposals.
- To minimize submission of incomplete applications, it is recommended that investigators review the IRB Review Form used by the TUC IRB to review proposals to ensure that all issues typically evaluated by the Committee are addressed.
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