April 2024 IRB Review Newsletter

April 2024

The IRB Review

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

Human Research Protection Program (HRPP) Reaccreditation

The reaccreditation process involves assessment, peer-review, modifications, education, monitoring, site visit interviews, reporting, and other activities culminating with the final Council determination in 2025.

Researchers, IRB members, and others will be selected for interviews at the site-visit.

In preparation, ORI will provide education updates and training opportunities throughout 2024.

Watch for "Question of the Week" emails to prepare all constituents for site visit interviews.

Events and Resources provided on our AAHRPP Re-Accreditation Website.

Accreditation demonstrates UK's commitment to continuous improvement and the

highest ethical standards in conducting human research.

Step By Step: Adding Non-UK Study Personnel

New guidance is available to help researchers through the process of adding individuals to a research protocol as non-UK study personnel. Click on the link below to access.Link

Step By Step: Adding Non-UK Study Personnel

In 1974 the National Research Act was signed into law setting in motion a National Commission tasked with developing ethical principles for research involving human subjects. The National Commission met over a four-year period to define the three ethical principles that act as the backbone for human subject research today: autonomy, beneficence, and justice.

The commission’s report, Ethical Principles and Guidelines for the Protection of Human Subjects of Research, was released in 1978. On April 18, 1979 in human research history, the report, more commonly referred to as The Belmont Report, was published in the National Register.

Regulations outline the specific criteria the IRB considers in approving human research. In considering the Risk-Benefit ratio, the IRB must determine that:

A. Risks are reasonable in relation to anticipated benefits to subjects, science and society.

B. Risks are eliminated and research holds potential benefit to subjects, science, and society.

C. Research holds potential benefit to subjects, but not to science and society.

D. Research is approvable as minimal risk to human subjects.

***Keep Reading for the Answer***

Upcoming ORI Office Hours

Wednesday, May 1st - 1:00pm to 2:00pm

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:

Correct Answer: A. In order to approve human research, the IRB must determine that potential risks to subjects are reasonable in relation to anticipated benefits to subjects, science and society.