IRB Submission Process Overview Workshop

The Office of Responsible Research Practices and the Center for Clinical and Translational Science are offering an introductory workshop about the IRB submission process. The session will: Provide an overview of informed consent alteration and waivers Provide regulatory definitions and discuss case examples Discuss Buck-IRB navigation Review best practices and available resources While the session will be tailored to medical researchers, anyone …

Ohio State AAHRPP application for reaccreditation

The Office of Responsible Research Practices (ORRP) submitted Ohio State’s Step 1 application for the Association for the Accreditation of Human Research Protections Programs, Inc (AAHRPP) reaccreditation on March 8, 2017. AAHRPP is an independent, non-profit accrediting body that promotes high-quality research through an accreditation process that helps organizations strengthen their human research protection programs (HRPPs). Maintaining AAHRPP accreditation assures …

Human Subjects Research Newsletter (Spring 2017) now available

The most recent edition of the “Human Subjects Research Newsletter” is now available on the Office of Responsible Research Practices (ORRP) IRB Newsletters webpage.  The new issue features information on Ohio State’s AAHRPP reaccreditation, regulatory updates, leadership changes, researcher guidance and training, and more. Human Subjects Research Newsletter – Spring 2017 For additional information on the newsletter or any topics …

Ebert named program director for IRB operations

We are pleased to announce that Susan Ebert has accepted the position of program director for Institutional Review Board (IRB) operations, effective March 1, 2017. This new position represents a merger of the IRB operations manager role and Susan’s previous position as eIRB program director. In her new role, Susan will provide leadership to the staff supporting the Behavioral and …

New Good Clinical Practice (GCP) Training for SBS Researchers in BuckeyeLearn

A new e-learning training module is now available in BuckeyeLearn targeting social and behavioral researchers engaged in clinical trials of drugs, devices, biologics and/or behavioral interventions. This training supports the NIH policy (issued September 16, 2016) stating that NIH-funded investigators and staff “who are involved in the conduct, oversight, or management of clinical trials should be trained in Good Clinical …

Changes to the Common Rule

The U.S. Department of Health and Human Services issued a press release January 18, 2017 about the final rule on changes in the regulations regarding the “Common Rule”.  “The new rule strengthens protections for people who volunteer to participate in research, while ensuring that the oversight system does not add inappropriate administrative burdens, particularly to low-risk research. It also allows …

Ohio State joins SMART IRB!

Supporting single IRB review on a national scale, advancing collaborative research For investigators pursuing National Institutes of Health (NIH) funded clinical research involving multiple sites, coordination of Institutional Review Board (IRB) reviews can be challenging. Streamlining this process has been a major concern for NIH. Ohio State is one of almost 60 institutions that have joined SMART IRB, a platform …

Update on NIH Policy on the Use of a Single IRB for Multi-Site Research

Update – 12/16/2016: The NIH has delayed the effective date of the single IRB mandate from May to September 25, 2017. The Office of Responsible Research Practices (ORRP) is in the process of identifying and implementing changes in local policies and workflow in order to be compliant with the NIH Policy on the Use of a Single Institutional Review Board for Multi-Site …

GCP and ICH CITI Training Update

Ohio State has added a Good Clinical Practice (GCP) and International Conference on Harmonisation (ICH) refresher course to its CITI course offering list.  Users first complete the basic course and then alternate between the refresher and basic courses every three years. The GCP and ICH CITI courses align with the new NIH policy issued on September 16, 2016 (Policy on …