Office of Responsible Research Practices
The Ohio State University

IRB News

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

Delay in Common Rule Revisions Announced

Thu, 18th January, 2018

On January 17, 2018, the U.S. Department of Health and Human Services (HHS) and 15 other federal agencies announced an Interim Final Rule (IFR) to delay by six months the implementation date of the revisions to the “Federal Policy for the Protection of Human Subjects” (the Common Rule).  The IFR delays the effective date and general compliance date to July 19, 2018, allowing institutions like Ohio State further time to make the necessary changes to be compliant with the 2018 revisions.  The IFR can be accessed here.  HHS and the 15 federal agencies are in the process of developing a proposed rule to further delay implementation of the Common Rule revisions, for example until January 21, 2019.

Until July 19, 2018, all institutions must continue to follow the pre-2018 Common Rule.  The Office of Responsible Research Practices (ORRP) will keep the Ohio State human subjects research community up to date on any further changes to the effective date as they become available.  For questions, please contact Ellen Patricia at patricia.1@osu.edu.

Category : 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

Electronic Informed Consent in Human Subjects Research

Tue, 2nd January, 2018

The Office of Responsible Research Practices and the Center for Clinical and Translational Science are offering a workshop on the options for electronic informed consent.  The workshop will:

  • Explain the use of electronic systems and processes to obtain informed consent
  • Describe the available Ohio State electronic consent platforms
  • Discuss how to select the most appropriate method for specific projects
  • Review available resources and guidance

The workshop will be held on Tuesday, February 20 from 8 to 9:30 a.m. in the Biomedical Research Tower, Room 115, 460 W 12th Avenue.

Registration requested.

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

Category : IRB

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

Revised Common Rule Overview

Mon, 18th December, 2017

The Office of Responsible Research Practices will present an overview of the revised Common Rule that is currently scheduled for implementation on January 19, 2018, but will likely be delayed until January 2019.  The workshop will:

  • Describe the coming changes in regulatory requirements
  • Provide information about implementation at Ohio State

The workshop will be held on Wednesday, January 10 from 1 to 2:30 p.m. in the Smith Seminar Room, Physics Research Building, 191 West Woodruff Avenue.

Registration requested.

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

Category : IRB / Training

Submission to Western IRB

Mon, 16th October, 2017

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

  • Provide an overview of the Ohio State and WIRB submission processes
  • Navigate within the Ohio State and WIRB electronic platforms
  • Describe required submission components

The workshop will be held on Monday, October 23 from 2 to 3:30 p.m. in Room B050 James Cancer Hospital, 460 West Tenth Avenue.

Registration requested.

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

Category : Buck IRB / IRB / Training

Revised Common Rule Overview

Mon, 2nd October, 2017

The Office of Responsible Research Practices and Center for Clinical and Translational Science are presenting an overview of the revised Common Rule that is scheduled for implementation on January 19, 2018.  The workshop will:

  • Describe the coming changes in regulatory requirements
  • Provide a roadmap for implementation at Ohio State

The workshop will be held on Tuesday, October 17 from 8 a.m. 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

IRB and International Research Workshop

Wed, 20th September, 2017

The Office of Responsible Research Practices is offering an encore presentation on conducting human subjects research at international locations. The session will:

  • Debunk common myths about international research
  • Explain how to create and submit Buck-IRB proposals
  • Provide tips about the informed consent process, including scenarios when a waiver of consent documentation may be appropriate

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

The workshop will be held on Tuesday, October 24, from 2 to 3 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 / Training

Human Subjects Research Newsletter (Fall 2017) now available

Fri, 15th September, 2017

The fall 2017 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 Common Rule revisions, revised FDA guidance on consent waivers, NIH policy changes on certificates of confidentiality, grant congruency assistance, and more.

Human Subjects Research Newsletter – Fall 2017

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

Category : IRB / ORRP