Office of Responsible Research Practices
The Ohio State University

IRB News

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

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