September 2023

The IRB Review

A compilation of information, announcements, & updates for UK Institutional Review Board (IRB) members, research investigators, & others involved with human subject research.

Faculty Advisor Resources

Faculty Advisors play a key role in guiding students success with human subject research. ORI provides a brief video on advisor responsibilities and a workshop recording with tips for helping mentees navigate the IRB process.

Click to View

Decentralized Clinical Trials (DCT)

While DCTs evolved during the Covid-19 pandemic, the concept continues to expand as a means to improve efficiency, reach diverse populations, and ease burdens on research participants.

The Multi-Regional Clinical Trials (MRCT) Center of Harvard & Medable have published a toolkit with comprehensive considerations for everything from use of local providers to remote data collection. Although the guide is intended to assist those conducting ethical reviews of clinical trials, other stakeholders, such as investigators and trial sponsors, can use these materials as part of clinical trial planning.

MRCT Decentralized Clinical Trials Toolkit

Check out these sessions & REGISTER NOW

Human Research Protections:

Unstoppable

Virtual Conference

November 2-3, 12-3:30 pm ET

Early-registration rate of $65 through 10/2/23.

Join us November 2-3 for our annual human research protections conference, entitled "Human Research Protections: Unstoppable". This year's sessions will address issues of critical importance to human research protections!

Trust, Trustworthiness, and "Tuskegee,": The Legacy of the United Stated Public Health Syphilis Study
Reimagining Research in the Age of AI
From Validation to Clinical Workflow: Human Subjects Research (HSR) Protection & Regulatory Considerations for Artificial Intelligence/Machine Learning (AI/ML) Predictive Models
The Secrets of Big Data Research: Public, Private, or What?
Why DEI Initiatives in Research are Not Working: An Opportunity for a Deeper Dive
Ethical Review of Decentralized Clinical Trials (DCDs)

For full agenda and continuing education credit details, see the conference brochure.

To register:

Visit the Conference Website and Login or Create an Account.

Then, click the “Register” tab. Capacity is limited; please register early.

Questions: Please email orcraeducation@cchmc.org and reference the Human Research Protections conference.

Co-sponsored by Cincinnati Children’s, Northern Kentucky University, the University of Cincinnati, and the University of Kentucky, our 2023 conference promises to be another engaging and informative event for all members of the research community.

Test Your IRB Knowledge:

If research will be conducted at an international location, what do investigators inform the IRB regarding applicable local regulations, ethics review requirements, or cultural norms?

***Keep Reading for the Answer***

Upcoming ORI Office Hours

Tuesday, September 26, 1:00pm - 2:00 pm

Join Here

Click Here for All Office Hours Dates/Times

The Office of Research Integrity offers consultations by phone, Zoom, or in-person. Consultations are offered for studies in development (with or without an E-IRB submission) as well as approved research projects.

Click Here to Request a Consult

Answer to the Trivia Question:

For research conducted at an international location, the investigator identifies local regulations, laws, or ethics review requirements for human subject protection. He/she may refer to the annual International Compilation of Human Research Standards or the National Institutes of Health ClinRegs website. If the project has been or will be reviewed by a local Ethics Committee or IRB, the investigator provides the UK IRB with a copy of that review.

In addition, the investigator informs the IRB of any relevant cultural norms or customs particularly regarding recruitment or informed consent. The IRB obtains a cultural consultant to assist in the review of issues which require expertise beyond or in addition to that available on the IRBs. Cultural consultants provide comments, concerns, translations, in writing to the IRB on protocols involving non-English speaking subjects, and/or subjects from a foreign culture.