Office of Responsible Research Practices
The Ohio State University

Buck-IRB News

Updates to the Buck-IRB system

Mon, 3rd December, 2018

New updates to the Buck-IRB submission system went live on December 3, 2018.

This update involves the Final Study Report.  This is the second in a series of revisions that will take place over the next few months in preparation for the Common Rule changes that take effect on January 21, 2019.  This update involves adding the Final Study Report application form to Buck-IRB. See the list below for more information regarding this change:

  • The Final Study Report will now be completed in Buck-IRB rather than requiring submission of a separate form by email
  • Automatic correspondence confirming study closure will be sent once the Final Study Report has been confirmed
  • Some study-specific information (e.g.,  descriptions for amendments approved since the last review, maximum number of participants, etc.) will automatically populate in the form for ease of completion
  • Researchers will be able to view actions related to the Final Study Report in the action history list

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

Informed Consent Requirements under the Revised Common Rule

Tue, 6th November, 2018

How will the informed consent process change after the revised Common Rule is implemented? The Office of Responsible Research Practices and the Center for Clinical and Translational Research are offering a workshop to:

  • Review 2018 Common Rule changes related to informed consent
  • Describe the transition plan for ongoing research
  • Examine the revised Ohio State consent templates

The workshop will be held on Tuesday, November 27, from 8 to 9:30 a.m. in the Biomedical Research Tower, Room 115, 460 West Twelfth Avenue. The session will also be available via live stream.

Registration requested.

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

Category : Buck-IRB / IRB / Workshops

Updates to the Buck-IRB system

Fri, 2nd November, 2018

New updates to the Buck-IRB submission system went live on November 1, 2018.

This update involves the Waiver of Consent/Assent/Parental Permission pages and Alteration of Consent/Parental Permission pages.  This is the first in a series of revisions that will take place over the next several months in preparation for the Common Rule changes that take effect on January 21, 2019.  This update involves an additional question added to the above-mentioned pages for studies requesting a consent waiver and/or alteration for the use of identifiable private information and/or bio-specimens. See below for more information regarding this change:

  • The new question requests that a rationale be provided to justify why the research could not be practicably conducted without using information or bio-specimens in an identifiable format
  • Implementing the question now allows new IRB applications and amendments involving consent waivers/alterations to be reviewed in a manner that will be compliant with both the current and revised Common Rule
  • Reduces the need for researchers to submit a separate amendment to address this new criterion after January 21, 2019
  • No revisions were made to the HIPAA waiver and/or alteration pages

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

Updates to the Buck-IRB system

Tue, 9th October, 2018

New updates to the Buck-IRB submission system go live on October 10, 2018!

Included in this update are significant revisions to the Risk Assessment page of the continuing review form for IRB-approved human subjects research. The form revisions include  clarifications regarding reporting requirements at the time of continuing review and  more specific selection options to ease form completion. See the list below for the more significant changes to the page:

  • Revised instructions to clarify the IRB’s review of information relating to the risk/benefit assessment, and to define the meaning of unanticipated problems involving risks to subjects or others
  • Added instructions for sponsor-investigators for research involving an Investigational Device Exemption (IDE)
  • Revised/added questions to describe the reporting summary needed at the time of continuing review (unanticipated problems involving risks to subjects or others, serious and/or continuing non-compliance, suspensions, and clinical holds)
  • Added event reporting submission instructions  for any items that should have been previously reported to the IRB, but were not
  • Removed unnecessary questions after the rephrasing of other questions/instructions
  • Added selection options for studies using a Data and Safety Monitoring Board (DSMB) to help researchers clarify when the DSMB has not yet met, is no longer meeting, or when a report is/is not available
  • Restructured the risk/benefit assessment question to only prompt for an updated assessment if there have been changes to the risks/benefits
  • Clarified which supporting documents should be uploaded

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

Initial IRB Submissions and Buck-IRB

Thu, 12th July, 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 / Workshops

Human Subjects Research Newsletter (Spring 2018) now available

Fri, 8th June, 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

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

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 / Workshops

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 / Workshops

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 / Workshops