Office of Responsible Research Practices
The Ohio State University

Office of Responsible Research Practices News

Secondary Analysis of Data and Biospecimens

Posted: July 24, 2018

The Office of Responsible Research Practices and the Center for Clinical and Translational Science are offering a workshop on the secondary analysis of data and biospecimens. The session will:

  • Review regulatory requirements
  • Discuss IRB review considerations
  • Explore scenarios involving secondary data and biospecimen analysis

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

The workshop will be held on Tuesday, August 21 from 8 to 9:30 a.m. in the Biomedical Research Tower, Room 115, 460 West Twelfth Avenue.  The session is also available for live stream attendance.

Registration requested.

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

Category : IRB / Training

Further Delay in Common Rule Revisions Announced

Posted: July 12, 2018

On June 19, 2018, the U.S. Department of Health and Human Services (HHS) and 15 other federal agencies announced a delay for an additional six months the general compliance date for revisions to the “Federal Policy for the Protection of Human Subjects” (the Common Rule).  The general compliance date is delayed to January 21, 2019, allowing institutions like Ohio State further time to make the necessary changes to be compliant with the 2018 revisions.  The Final Rule can be accessed here

While three burden-reducing provisions can be implemented before January 21, 2019, Ohio State will implement all aspects of the revised Common Rule on the general compliance date. The Office of Responsible Research Practices (ORRP) will keep the Ohio State human subjects research community up to date with additional information.  For questions, please contact Ellen Patricia at patricia.1@osu.edu.

Category : IRB / ORRP

Initial IRB Submissions and Buck-IRB

Posted: July 12, 2018

The Office of Responsible Research Practices and the Center for Clinical and Translational Science are offering a workshop on the Buck-IRB initial submission application. The presentation will:

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

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

The workshop will be held on Thursday, August 2 from 11:00 a.m. to 12:30 p.m. in the Biomedical Research Tower, Room 115, 460 West Twelfth Avenue.

Registration requested.

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

Category : Buck IRB / IRB / ORRP / Training

“Hot” Topics in Human Subjects Research

Posted: June 18, 2018

The Office of Responsible Research Practices and the Center for Clinical and Translational Science are offering a workshop on current human subjects research “hot” topics. The session will:

  • Present regulatory updates
  • Explain Ohio State’s implementation of recent human subjects research changes
  • 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, July 17 from 8 to 9:30 a.m. in the James Cancer Hospital, Room L035, 460 West Tenth Avenue.

Registration requested.

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

Category : IRB / ORRP / Training

Troubleshooting Informed Consent

Posted: June 13, 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

Human Subjects Research Newsletter (Spring 2018) now available

Posted: June 8, 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

Updates to the Buck-IRB system

Posted: June 1, 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