IRB News

The Office of Responsible Research Practices and the Center for Clinical and Translational Science are offering a workshop on collaborative human subjects research.  The workshop will:

• Discuss the new NIH and Common Core Single IRB of Record (sIRB of Record) mandate
• Describe when and how researchers may rely on a non-Ohio State IRB
• Describe when and how researchers may obtain Individual Investigator Agreements
• Provide a list of IRBs with whom Ohio State has standing reliance relationships

The workshop will be held on Tuesday, August 8 from 11 a.m. to 12:30 p.m. in the Clinical Skills Education and Assessment Center, Room 620, 6th Floor Prior Health Sciences Library, 376 West Tenth Avenue.

Registration requested.

Contact: 614-688-8641 or meadows.8@osu.edu

The Office of Responsible Research Practices and Center for Clinical and Translational Science are offering an advanced workshop on amendments to approved human subjects research and the Buck-IRB system. The session will:

• Describe the amendment process
• Review relevant HRPP policies and regulations
• Provide guidance and tips on amendment submission via Buck-IRB
• Explain how to expedite the amendment screening and review processes

While the session will be tailored to medical researchers, anyone preparing IRB submissions is welcome.

The workshop will be held on Tuesday, July 18, from 8 a.m. to 9 a.m. in the Clinical Skills Education and Assessment Center, Room 620, 6th Floor Prior Health Sciences Library, 376 West Tenth Avenue.

Registration requested.

Contact: 614-688-8641 or meadows.8@osu.edu

A new Collaborative Institutional Training Initiative (CITI) course is now available for social and behavioral sciences researchers engaged in clinical trials of drugs, devices, biologics, and/or behavioral interventions.  The CITI Good Clinical Practices for Social and Behavioral Researchers course 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 Practice (GCP), consistent with principles of the International Conference on Harmonisation (ICH) E6 (R2)”. GCP principles constitute an international ethical and scientific quality standard for designing, conducting, recording, and reporting clinical trials.

To access CITI, log on at http://go.osu.edu/citi with your Ohio State Internet Username (last name.#) and Password. To enroll in the course, click on “Add a Course” and then check the box for “Good Clinical Practices for Social and Behavioral Researchers”.

For questions, please contact Ellen Patricia at patricia.1@osu.edu.

New updates to the Buck-IRB submission system go live on June 21, 2017.

Several foundational changes are included in this update to prepare for future enhancements to Buck-IRB’s management of collaborative research projects. While other changes are being implemented, the majority will occur behind the scenes with little or no direct impact on investigators. The following features are incorporated in this latest update:

• The initial IRB application pages were reorganized to open in a different order (see below) to permit future multi-site research system enhancements:

• • Study Identification
  • Type of Review
  • Review Board
  • Location
  • Multi-site
  • Study Personnel
  • External Collaborators
  • Funding
• Addition of a general study correspondence feature to permit ORRP staff to contact investigators and research staff through Buck-IRB; this email communication will be stored in the system for future reference.
• Improved instructions added to the Privacy page.

Login to Buck-IRB at go.osu.edu/Buck-IRB.

For additional information about this Buck-IRB update, please contact Susan Ebert at ebert.55@osu.edu.

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 SMART IRB, Common Rule changes, CITI training additions, event reporting guidance, and more.

Human Subjects Research Newsletter – Summer 2017

For additional information on the newsletter or any topics contained therein, please contact Ellen Patricia.

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 preparing IRB submissions is welcome.

The workshop will be held on Tuesday, June 20, from 8 a.m. to 9 a.m. in the Clinical Skills Education and Assessment Center, Room 620, 6th Floor Prior Health Sciences Library, 376 West Tenth Avenue.

Registration requested.

Contact: 614-688-8641 or meadows.8@osu.edu

The Office of Responsible Research Practices and the Center for Clinical and Translational Science are offering an introductory workshop on the informed consent process. The session will:

• Provide an overview of informed consent
• Provide 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 preparing IRB submissions is welcome.

The workshop will be held on Tuesday, April 18, from 8 to 9 a.m. in the Clinical Skills Education and Assessment Center, Room 620, 6th Floor Prior Health Sciences Library, 376 West Tenth Avenue.

Registration requested.

Contact: 614-688-8641 or meadows.8@osu.edu

The Office of Responsible Research Practices is offering a workshop on collaborative human subjects research. The workshop will:

• Discuss the new NIH and Common Core Single IRB of Record (sIRB of Record) mandate
• Describe when and how researchers may rely on a non-Ohio State IRB
• Describe when and how researchers may obtain Individual Investigator Agreements
• Provide a list of IRBs with whom Ohio State has standing reliance relationships

The workshop will be held on Wednesday, April 12 from 11 a.m. to 12:30 p.m. in the Research Commons, 3rd Floor 18th Avenue Library, 175 West 18th Avenue.

Registration requested.

Contact: 614-688-8641 or meadows.8@osu.edu

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 research participants, researchers, sponsors, government regulators and the public that Ohio State is committed to scientifically and ethically sound research as well as continuous improvement of its HRPP program.

Ohio State was first accredited in 2010 and was reaccredited in 2013. The next steps in this every five-year reaccreditation cycle involve receiving feedback from AAHRPP reviewers on the Step 1 application, the subsequent submission of Step 2 (including a list of active protocols and key personnel from all parts of the HRPP), and a site visit by AAHRPP reviewers in the fall.

For more information, contact Ellen Patricia.

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 contained therein, please contact Ellen Patricia.