Office of Responsible Research Practices
The Ohio State University

Buck IRB News

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 / Training

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 / 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

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

Updates to the Buck-IRB system

Fri, 12th January, 2018

New updates to the Buck-IRB submission system go live on January 12, 2018

Updates to the Buck-IRB submission system will improve and enhance the Buck-IRB work experience for investigators and research staff and support the new NIH Policy on the Use of a Single IRB for Multi-Site Research. Included are features to facilitate the management of multisite, collaborative research, including when Ohio State serves as the IRB of record for one or all sites in a research project.

The following features are incorporated in this latest update:

  • Changes to the Multisite page to clarify when Ohio State will serve as the IRB of record and which site will serve as lead institution
  • Several revisions to the Research Locations (domestic and international) pages as follows:
    • Study activities performed at each location must now be confirmed by selecting options from a provided list
    • If Ohio State will serve as the IRB of record for a site, confirmation must be made on this page
    • If Ohio State serves as the IRB of record, a local context worksheet must be uploaded for each location relying on Ohio State
    • An upload box is available to provide any site-specific documents to be used by the relying site
  • An upload box is now available on the External Collaborators page to allow CV/resume, draft agreement, or other required document uploads for external individuals added to the study team
  • Changes were made to the management of external collaborators, as follows:
    • External collaborators cannot be added, removed or modified at the time of continuing review
    • Personnel change requests now permit the removal (only) of external collaborators
    • External collaborators can be added, removed, or modified, as always, through an amendment application submission

Other changes

  • ORRP staff will now be able to include attachments to correspondence initiated through the Buck-IRB system to facilitate communication with investigators and study teams
  • A new category to designate research documents was added to Buck-IRB. In addition to noting documents as “approved”, ORRP staff can now identify certain documents as “reference” documents. Reference documents include any supporting documents that are not provided to subjects or to manage the study, but are part of the IRB review materials. Examples of reference documents are drug/device manufacturing documents, IRB approvals from other sites and collaborative agreements.

Other changes will occur with this Buck-IRB update, though the majority will occur behind the scenes with little or no direct impact on investigators.

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

Using the Single IRB (sIRB) Model for Multi-Site Research

Mon, 25th December, 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:

  • Provide a general overview of the sIRB model for multi-site research
  • Provide information specific to Ohio State when using the sIRB model, including changes in Buck-IRB
  • Review study team and site responsibilities under the sIRB model

The workshop will be held on Tuesday, January 16 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 : Buck IRB / IRB / Training