KUMC Policy for Flexible IRB Review
Starting November 2018, the KUMC Human Research Protection Program (HRPP) will implement a new policy on flexible IRB review. Flexible IRB review means a review and oversight process that applies human subjects protections commensurate with risk while reducing administrative burdens for researchers and the IRB. Flexible IRB review allows abbreviated IRB applications and consent forms, streamlined review by IRB Chair or staff members and elimination of the continuing review requirement.
Why is this new policy being implemented?
Until January 2018, KUMC was required to apply federal regulations to all research regardless of funding source because of obligations made in our Federalwide Assurance. In January, our assurance was modified, in anticipation of changes that will go into effect when the Revised Common Rule is implemented. As a condition of our Federalwide Assurance, we must continue to apply federal regulations to research that is federally conducted or supported; however, we have flexibility in determining appropriate protections for research outside that criterion. Thus the HRPP have developed a new process for Flexible IRB Review.
When institutions adopt a flexibility policy, they must provide equivalent protections for research that is not under federal oversight. Core ethical principles of respect for persons, beneficence and justice remain the key components to equivalent protections. Equivalent protections also include IRB review, human subjects training and financial disclosures from study teams, agreement by participants for research involving direct interactions, provisions for confidentiality and security if data are identifiable, HIPAA protections when applicable, and reporting of unanticipated problems to the IRB.
What types of research can be reviewed under Flexible Review?
The minimal risk research covered by the Flexible IRB Review policy includes:
- Behavioral activities
- Analysis of data or specimens
- Biomedical studies
What are the eligibility criteria?
Research eligible for flexible review must meet three basic criteria:
- Minimal risk. Minimal risk means the probability and magnitude of harm or discomfort anticipated in the research are not greater in and of themselves than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests.
- Does not involve federal funding or support. Federal funding or support is defined as:
- Funded by a direct federal grant
- Funded through a sub-award or pilot grant associated with federal dollars
- Includes personnel on a federally-funded training grant
- Research conducted under a no-cost extension
- Data will be used to support a pending grant application or application for FDA approval (e.g., data collection in response to a scored grant submission with plans to re-submit)
- Involves an FDA-regulated product or dietary supplement
- Involves registries about FDA-regulated products
- Conducted under a contract that requires the investigator to adhere to federal human subjects regulations (e.g., 45 CFR 46, 34 CFR 97 or other references to the HHS Common Rule)
- Involves any services that could be billed to a federal program
- Does not involve reliance on KUMC's IRB by collaborating institutions or organizations that apply federal regulations to all research regardless of funding source.
How do I request Flexible IRB Review for my project?
Requests for Flexible IRB Review are made in the electronic IRB submission system, using a special application form specifically designed for this type of review. Required documents include:
- Project Description form "Request for Flexible IRB Review"* This document can be found on the Forms and Template page here.
- Study protocol
- Information sheets or consent forms using the specific templates designed for Flexible Review
- Data collection sheets, scripts, recruitment materials and other study documents
*Please note: only submissions accompanied by the Request for Flexible IRB Review will be considered under this policy.
How is informed consent different under Flexible IRB Review?
Because federal regulations do not apply to research conducted under flexible review, information sheets and consent form documents can be significantly shortened and streamlined. In certain circumstances, signature requirements can be waived.
Please refer to the Informed Consent Elements for Flexible IRB Review.
The KUMC HRPP has developed the following templates for studies that qualify for flexible review. These templates can be found on the Forms and Template page here:
- Flexibility Info Sheet - Survey with Identifiable Information
- Flexibility Info Sheet - Focus Group, no HIPAA
- Flexibility Consent form - Focus Group with HIPAA
- Flexibility Consent form - Registry
- Flexibility Consent form - Biorepository
- Flexibility Consent form - Minimal risk procedures
What are my responsibilities during the conduct of the research?
Regardless of funding source or type of review, investigators remain responsible for ethical conduct in research and for compliance with KUMC policies. Additional responsibilities under the policy for Flexible IRB Review include:
- Immediately notifying the IRB office if federal funding or support is obtained for the research or if any other of the eligibility criteria change during the study
- Submit changes to the study design, study personnel or information sheets/consent documents for IRB review and approval
- Report unanticipated problems as instructed on the Reportable Events webpage
- Close the study in the eIRB system at the time of completion
Where can I access more information?
Please refer to the following documents for more detailed information:
- KUMC Policy on Flexible IRB Review 01/2019
- SOP 20: Flexible IRB Review (found on the Policies and Regulations webpage)
For additional questions about Flexible IRB review, please contact IRBhelp@kumc.edu