Office of Responsible Research Practices
The Ohio State University

IRB News

Troubleshooting Informed Consent

Wed, 13th June, 2018

The Office of Responsible Research Practices and the Center for Clinical and Translational Science are offering a workshop on common informed consent screening and IRB review findings, and consent issues that arise during ongoing research projects. The session will:

  • Identify common submission screening questions
  • Examine IRB-required modifications related to the consent process
  • Discuss common post-approval monitoring findings
  • 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 26 from 8 to 9:30 a.m. in the James Cancer Hospital, Room B050, 460 West Tenth Avenue.

Registration requested.

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

Category : IRB / ORRP / Training

Updates to the Buck-IRB system

Fri, 1st June, 2018

New updates to the Buck-IRB submission system go live on June 2, 2018

Included in this update are significant revisions to the event reporting submission form for IRB-approved human subjects research. The revisions to the form include enhanced questions to allow investigators and IRB members to make informed and appropriate determinations regarding unanticipated problems and potential noncompliance. See the list below for some of the more significant changes to the form:

  • Categories of protocol deviations added to better clarify the event
  • Investigator determination of whether the event increased risk, was unexpected, and/or was potentially related to research activities is now required
  • The number of participants enrolled must be provided at the time of the event
  • Event timeline details are solicited to inform the IRB of not only when the event occurred, but when the investigator was notified
  • Clarified reporting options to other external/internal entities (such as sponsors and FDA)
  • Corrective action options revised

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

For additional information about this Buck-IRB update, please contact Michael Donovan at donovan.6@osu.edu.

Category : Buck IRB / IRB / ORRP

Human Subjects Research Newsletter (Spring 2018) now available

Tue, 8th May, 2018

The spring 2018 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 AAHRPP reaccreditation, a Common Rule update, Buck-IRB system updates, guidance for FDA inspections, and more.

Human Subjects Research Newsletter – Spring 2018

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

 

Category : Buck IRB / IRB / ORRP

Amendments and Buck-IRB

Wed, 4th April, 2018

The Office of Responsible Research Practices is 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 behavioral and social sciences researchers, anyone preparing IRB submissions is welcome.

The workshop will be held on Thursday, 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

Category : Buck IRB / IRB / ORRP / Training

Event Reporting in Human Subjects Research

Fri, 30th March, 2018

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

  • Provide an overview of the event reporting policy
  • Differentiate between investigator, sponsor, and IRB reporting requirements
  • Provide definitions and discuss case examples
  • 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 Wednesday, May 2, from 8 to 9:30 a.m. in the Biomedical Research Tower, Room 115, 460 West Twelfth Avenue.

Registration requested.

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

Category : IRB / ORRP / Training

Submission to Western IRB

Tue, 20th March, 2018

The Office of Responsible Research Practices and the Center for Clinical and Translational Science are presenting a session about Western IRB (WIRB) oversight of Ohio State human subjects research. The workshop will:

  • Provide an overview of the Ohio State and WIRB submission processes
  • Describe steps to navigate within the Buck-IRB system
  • Describe required submission components

The workshop will be held on Wednesday, April 18 from 8 to 9:30 a.m. in Room 115 Biomedical Research Tower, 460 West Twelfth Avenue.

Registration requested.

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

Category : Buck IRB / IRB / Training

Therapeutic Development in Academia and the Challenges of FDA-regulated Research

Fri, 2nd March, 2018

The Office of Responsible Research Practices and the Center for Clinical and Translational Science are offering a workshop on FDA considerations in drug and device research.  The workshop will:

  • Summarize the regulations governing development of investigational drugs and medical devices
  • Define FDA’s role in reviewing drug and medical device clinical trials
  • Explain what to expect during FDA inspections of clinical trials
  • Identify key resources for academic researchers embarking on their therapeutic development odyssey

The workshop will be held on Tuesday, March 20 from 8 to 9:30 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 : IRB / ORRP / Training

Initial IRB Submissions and Buck-IRB

Tue, 27th February, 2018

The Office of Responsible Research Practices and the Research Commons are offering a workshop on the Buck-IRB initial submission application. The session will:

  • Provide an overview of the Buck-IRB system and how to navigate through the Ohio State IRB initial application (not external or exempt applications)
  • Identify documents that typically accompany a complete initial application
  • Discuss common pitfalls and tips for successful submission
  • Focus on initial application sections specific to social & behavioral research

The workshop will be held on Wednesday, March 7 from 3 to 4:30 p.m. in the Research Commons, Third Floor 18th Avenue Library, 175 West 18th Avenue.

Registration requested.

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

Category : Buck IRB / IRB / ORRP / Training

Human Subjects Research Newsletter (Winter 2018) now available

Fri, 9th February, 2018

The winter 2018 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 the revised Common Rule implementation delay, an AAHRPP reaccreditation update, informed consent using e-signatures, and more.

Human Subjects Research Newsletter – Winter 2018

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

Category : Buck IRB / IRB / ORRP

IRB Overview for Graduate Students

Thu, 25th January, 2018

The Office of Responsible Research Practices is offering a workshop for graduate students on how to navigate the Institutional Review Board (IRB) process. The session will focus on the following key topics:

  • Understanding why we have an IRB process
  • Exploring types of research and levels of review
  • Reviewing application components
  • Tips for successful application completion
  • Finding out where to go for help

While the session will be tailored to social and behavioral sciences researchers, anyone preparing IRB submissions is welcome.

The workshop will be held on Wednesday, January 31, from 2:30 p.m. to 3:30 p.m. in the Research Commons, Third Floor 18th Avenue Library, 175 West 18th Avenue.

Registration requested.

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

Category : IRB / ORRP / Training