Welcome to the University of Cincinnati Human Research Protection Program
Important Updates Clinicaltrials.gov
Effective January 18, 2017 more studies require registration in clinicaltrials.gov and the reporting requirements have increased. Investigators have 90 days to come into compliance. The NIH is mandating that all clinical trials with any NIH funding register. Summary results information must be submitted for more trials, including FDA-regulated products that have not yet been approved, licensed, or cleared by the FDA. Reporting changes include uploading the full IRB protocol and providing more information regarding adverse events. Clinicaltrials.gov reporting takes a substantial time investment, you should consider including effort in your proposal budget. Additionally, many journals require registration before the first research participant is enrolled. Enforcement for noncompliance includes the termination or withholding of grant funding. Approval Delays
The UC IRB is currently experiencing a backlog of protocols. Please plan accordingly. We anticipate clearing the backlog by the end of this month. We always encourage you to contact the person managing your protocol review if review is delaying funding (if you need for Just In Time) or have other extenuating circumstances. We apologize for the delays and are working diligently to both resolve the current situation and prevent it from recurring.
Exempt Study Amendments
Amendments are only necessary for exempt studies when the proposed modification are substantive or change the study procedure such that the study no longer qualifies for exempt review.
Examples of minor modifications to exempt studies that can be implemented without review include:
- Addition or removal of study personnel other than the PI
- Minor revisions to recruitment materials and methods. For example, a change to the phone number, or the addition of a newspaper ad when using similar language as an already approved flyer.
- Minor revisions to survey, interview, or focus group instruments that do not fall outside the scope of the original approved instruments. For example, wordsmithing, addition of clarifying questions, addition of very similar questions to those previously approved, or deletion of questions.
Examples of substantive modifications that require review:
- Change in PI
- Change in funding source
- Change to study purpose or procedures. For example, adding a survey on a different topic than previously approved or collection of data falling outside the parameters of the data collection previously approved.
- Changes to study population targeted for recruitment. For example, adding a new population or substantively revising the inclusion/exclusion criteria for the current population.
- Changes to the identifiability of the research data you will receive or record. For example, your exempt application states that you will not collect names with the surveys, but you now want to, or you now want to record identifiable data from an existing dataset
- Changes to the risks involved in the study
- Substantive modifications must be submitted to for review prior to their implementation. To request review, submit an amendment to the existing protocol
The University of Cincinnati is committed to the highest standards of ethical conduct in our Human Research Protection Program (HRPP). The protection of human subjects participating in research is a shared responsibility of researchers and the institution. Our policies and standard operating procedures (SOPs) ensure that we act responsibly, ethically, and in compliance with federal, state, and local regulations. Below is a description of the various services we have in place to protect human participants.
The Institutional Review Board (IRB) is a federally mandated committee comprised primarily of faculty researchers. The IRB reviews and oversees research that involves human participants in accordance with our Federalwide Assurance (FWA). The IRB is supported by Human Protection Administrators (HPAs) who facilitate the development and modification of protocols for IRB review.The IRB website contains information on the IRB, the protocol process, HIPAA waivers, forms, procedures, regulations, and FAQs.
Quality Assurance (QA) Monitoring is designed to ensure protection of study participants and also facilitate compliance. QA Monitoring is performed by Human Research Auditors who work with researchers to identify and rectify errors and/or omissions in research. All studies involving human subjects may be audited; however, emphasis is placed on studies with moderate to high risk to subjects, FDA regulated investigator initiated studies, studies involving vulnerable populations, studies for which there are or may be a conflict of interest, and studies where monitoring does not already occur. The QA Monitoring website contains information on FDA warning letters, regulatory mandates and policies, and FAQs.