Office of Responsible Research Practices
The Ohio State University

Office of Responsible Research Practices News

IRB Reliance Models for Ohio State Researchers Collaborating with External Partners

Posted: July 10, 2017

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

Category : IRB / ORRP / Training

Amendments and Buck-IRB Workshop

Posted: July 1, 2017

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

Category : Buck IRB / IRB / ORRP / Training

New CITI GCP Course Available for SBS Researchers

Posted: June 28, 2017

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.

Category : CITI / IRB / ORRP / Training

Updates to the Buck-IRB system

Posted: June 21, 2017

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.

Category : Buck IRB / IRB / ORRP

Human Subjects Research Newsletter (Summer 2017) now available

Posted: June 1, 2017

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.

Category : Buck IRB / CITI / IRB / ORRP

IRB Submission Process Overview Workshop

Posted: May 15, 2017

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

Category : Buck IRB / IRB / Training

Animal Care and Use Newsletter (Spring 2017) now available

Posted: April 28, 2017

The most recent edition of the “Animal Care and Use Newsletter” is now available on the IACUC Newsletters webpage.  The newsletter includes information about the recent results from USDA inspection, educational outreach opportunities (office hours), zoonotic fact sheets for working with poultry, ULAR required training and rodent colony health surveillance program, also includes IACUC policy updates and helpful e-Protocol tips and reminders.

Full Newsletter: Animal Care and Use Newsletter – Spring 2017

Contact: Melinda Bruns at bruns.159@osu.edu

Category : IACUC / ORRP