The IRB reviews all research activities, regardless of funding, which involves human subjects (Human Subject Research) for compliance with applicable federal, state, local, and institutional regulations, guidelines, and ethical research principles. All funded research involving human subjects must be reviewed and approved under IRB procedures, prior to receiving funding. The IRB has the authority to approve, require modifications in (to secure approval), and disapprove research proposals and to suspend or terminate research that is not conducted in accordance with the IRB’s requirements or that has been associated with unexpected serious harm to subjects.
AU Human Subject Research Policies and Procedures
(Currently Under Revision)
Clinicaltrials.gov Policy Statement and Sample Dissemination Plan
Policy Statement Clinicaltrials.gov Registration
Auburn University is committed to ensuring compliance with Federal and State law and funding agencies regulations to meet professional publication standards and requirements concerning the public availability of clinical trial data on ClinicalTrials.gov. AU Researchers have the responsibility to create and maintain records in ClinicalTrials.gov while making determinations about registrations required to comply with International Committee of Medical Journal Editors (ICMJE) and the Center for Medicare and Medicaid Services (CMS).
Sample NIH Plan for Dissemination
As Principal Investigator for this study, I will comply with the NIH Policy on the Dissemination of NIH-Funded Clinical Trial Information in NIH Guide Notice NOT-OD-16-149. All clinical trials for this project will be registered in ClinicalTrials.gov no later than 21 days after the first participant is recruited. As PI, I will be responsible for registering the trial and will ensure that information in the clinical trial record is updated at least once every 12 months, or more frequently as required, and I will ensure that results are reported no later than one year after the clinical trial primary completion date.
The consent form for this clinical trial will contain language specifying that the study is registered at clinicaltrials.gov. The required wording on all such consent forms by the Auburn University Institutional Review Board is:
A description of this clinical trial will be available on http://www.ClinicalTrials.gov, as required by U.S. Law. This website will not include information that can identify you. At most, the website will include a summary of the results. You can search this website at any time.
Auburn University (AU) Institutional Review Board has a policy statement on clinicaltrials.gov registration to help ensure that the clinical trials registration and results reporting occur in compliance with the NIH Policy on the Dissemination of Clinical Trial Information. The AU Office of Research Integrity & Compliance provides guidance and resources for investigators in meeting their policy and regulatory obligations.
- Exempt Overview EXEMPT studies are so named because they are exempt from some federal regulations (refer to §46.104). However, EXEMPT studies are not exempt from state laws, institutional policies, or the requirements for ethical research. Auburn University policy requires review by the HRPP Manager or an experienced reviewer for all research submitted as EXEMPT.
To request an EXEMPT determination, the Principal Investigator must submit (via IRB Submission Page) a completed and signed EXEMPT application form and a copy of other study materials (recruitment, consent, data collection forms, agreements, CITI training, etc.) The EXEMPT submission will be reviewed to determine whether the activities meet exempt categories of 46.104 and any Auburn University requirements related to exempt determination.
No continuing review is required for EXEMPT studies: EXEMPT studies do not have an expiration date; and only if a study requires changes should a MODIFICATION request by submitted, with any affected documents.
Reporting requirements of adverse events and non-compliance are found on the FORMS page of the IRB website.
- Exempt Categories
- Vulnerable Populations and Eligibility for Exemption? The involvement of a vulnerable population does not automatically disqualify studies from an exemption. The Common Rule allows for the involvement of most vulnerable populations covered by subparts B, C, and D (see table) assuming the study activities meet the requirements of an exemption. The AU IRB will consider the nature or characteristics of the vulnerability to determine eligibility.
- EXEMPT GUIDANCE For detailed information regarding practices of the AU IRB and research eligible for EXEMPTION determination, click here.
- Expedited Overview To request an Expedited Review, the Principal Investigator (PI) must submit a completed IRB Research Protocol Review Form which will be reviewed by the IRB. For projects to be “Expedited” (covered by Federal Regulations, but not requiring Full Board Review), the project must be determined by the IRB to meet the expedited categories of 45 CFR 46.110 and any university requirements for expedited status. Expedited Review is conducted by a member or members of the IRB as assigned by the IRB Chair. The expedited reviewer(s) may not reject an expedited request, but instead will refer the project to the appropriate IRB for consideration on the next IRB Agenda in which there is sufficient time for the committee to review the materials prior to the IRB meeting. Submission of Expedited Protocols, have no deadline and may be submitted to the ORIC for IRB review at any time. If approved as “Expedited”, the IRB may approve the project for no more than 1 year. A Request for Project Renewal Form must be submitted for any projects that will continue beyond the expiration date (usually 1 year). Renewal requests must be submitted by the PI prior to the expiration date of the protocol and with sufficient time for the IRB to review and respond to the submission before the protocol expires. A Request for Modification Form must be submitted to the IRB for review and approval prior to implementation of any changes to a project approved as “Expedited”. At the completion of the project, Final Report Forms are required to close Expedited Protocols. Reporting requirements to the IRB of events and non-compliance are described in the forms section on this site. See Expedited Process for more details.
- Expedited Categories
- Full Board Process To request a Full Board Review, the Principal Investigator (PI) must submit a completed IRB Research Protocol Review Form which will be reviewed by the IRB. Any project not determined by the IRB to be “Exempt” or “Expedited”, must be reviewed by the IRB at a convened meeting of a quorum of IRB members which must include at least one non-scientific member. Approval by the IRB must be by a quorum of the members present at an appropriately constituted IRB meeting. The IRB will determine if the projects approved by the Full Board are Minimum Risk “MR” or At Risk “AR”. Submission of Full Board Protocols, must be received in the ORIC by the IRB Deadline for the Full Board Agenda. The Full Board may approve a project for no more than 1 year. A Request for Project Renewal Form must be submitted for any projects that will continue beyond the expiration date (usually 1 year). Renewal requests must be submitted by the PI prior to the expiration date of the protocol and with sufficient time for the IRB to review and respond to the submission before the protocol expires. A Request for Modification Form must be submitted to the IRB for review and approval prior to implementation of any changes to a project approved by the Full Board. At the completion of the project, Final Report Forms are required to close Full Board Protocols. Reporting requirements to the IRB of events and non-compliance are described in the forms section on this site. See Full Board Process for more details.
|
