Office of Responsible Research Practices
The Ohio State University

ORRP News

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

Animal Care and Use Newsletter (Fall 2017) now available

Thu, 2nd November, 2017

The Fall 2017 edition of the “Animal Care and Use Newsletter” is now available on the the Office of Responsible Research Practices (ORRP) IACUC Newsletters webpage. The new issue includes information about the update to eIACUC protocol on November 2, new online risk assessment tool, rodent cage-side surgery records, per diem rate changes, AALAS technician of the year award acknowledgment, zoonotic fact sheets for working with cattle, IACUC policy updates, reminders for reporting animal concerns and accessing CITI also includes helpful e-Protocol tips.

Animal Care and Use Newsletter – Fall 2017

For additional information on the newsletter or any topics contained therein, please contact Melinda Bruns.

Category : IACUC / ORRP

New online risk assessment tool now available

Wed, 1st November, 2017

A new user-friendly web-based tool for conducting risk-based assessments – the Online Risk Assessment Tool (ORAT) is available as of November 1, 2017. The ORAT replaces the existing Occupational Health Registry. It is important to understand the potential risks associated with research or job-related duties – especially when there are potential risks due to contact with animals, hazardous agents, operations or environments. The ORAT employs a simple question and answer model that builds a personalized risk assessment designed to the specific hazards that may be encountered as part of work-related responsibilities.  More information is available on the IACUC Occupational Health Program webpage.

Category : IACUC / IBC / ORRP

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

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

Animal Care and Use Newsletter (Summer 2017) now available

Tue, 1st August, 2017

The most recent edition of the “Animal Care and Use Newsletter” is now available on the IACUC Newsletters webpage. The newsletter includes information about the CITI refresher training course, zoonotic fact sheets for working with sheep, ULAR environmental enrichment program, IACUC policy updates, reminders for semiannual inspections and manual reporting of animal numbers and also includes helpful e-Protocol tips.

Full Newsletter: Animal Care and Use Newsletter – Summer 2017

Contact: Melinda Bruns at bruns.159@osu.edu

Category : IACUC / ORRP

IRB Training for Graduate Students

Tue, 1st August, 2017

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, August 30, 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