Office of Responsible Research Practices
The Ohio State University

Office of Responsible Research Practices News

University Laboratory Safety Committee Excellence in Safety Awards

Posted: January 31, 2019

The University Laboratory Safety Committee’s Excellence in Safety awards recognize a university faculty or staff member, student and a laboratory research group who have made a considerable contribution to improving laboratory safety on the Ohio State campus. Such contributions can be defined as actions taken to prevent injury or illness, outstanding response and cooperation given to resolve unsafe conditions, consistent improvement during laboratory inspections, or any other consistent and proactive demonstration of efforts in support of a positive laboratory safety culture.

Environmental Health and Safety and the Office of Research coordinate the University Laboratory Safety Committee (ULSC). The ULSC works to enhance the safety culture at Ohio State by helping to shape safety programs, review and distribute new regulatory information and provide feedback from the university community regarding current laboratory safety incidents or issues.

Nominations for 2019 individual, group and student awards will be accepted through February 25, 2019.

Read more.

Category : IACUC / IBC / IRB / ORRP

Continuing Review under the Revised Common Rule

Posted: January 26, 2019

What type of annual review will be required under the revised Common Rule? The Office of Responsible Research Practices and the Center for Clinical and Translational Research are offering a session to:

  • Review revised Common Rule changes related to continuing review
  • Detail Ohio State’s annual review requirements
  • Describe Buck-IRB modifications to accommodate the revised Common Rule
  • Discuss continuing review case examples

The presentation will be held on Tuesday, February 26 from 8 to 9:30 a.m. in the Ross Heart Hospital, Room H1213, 452 West 10th Avenue.

Registration requested.

  Live streaming available upon request. Contact Sandra Meadows at 614-688-8641 or meadows.8@osu.edu.
The Ohio State University Center for Continuing Medical Education designates this RSS (Regularly Scheduled Series) for a maximum of 1.5 AMA PRA Category 1 Credit(s)™. Physicians should claim only the credit commensurate with the extent of their participation in the activity.

 

Category : Buck-IRB / Educational Offerings / IRB / ORRP

Updates to the Buck-IRB system

Posted: January 21, 2019

New updates to the Buck-IRB submission system went live on January 20, 2019.

This update involves the Exempt, Continuing Review, Annual Status Report, and Final Study Report applications. The application revisions incorporate the Common Rule changes (http://orrp.osu.edu/irb/common-rule-revisions/) that take effect on January 21, 2019.

Exempt Application Updates:

  • The “Screening Questions” and “Exempt Categories” pages were substantially revised to accommodate new and revised exempt categories.
  • Exempt categories 2, 3, and 4 now require selection of a sub-category.
  • Minor revisions were made to the “Research Methods & Activities,” “Participant Population,” “Informed Consent Process,” and “Confidentiality of Data” pages to accommodate new and revised exempt categories.
  • New actions and correspondence were added to accommodate the new “limited IRB review” for certain exempt categories.

Study Management Updates:

  • Risk level will now be displayed in “Study Workspace.”
  • Buck-IRB will display either a “Start Continuing Review” or a “Start Annual Status Report” option 90 days before study expiration.
    • FDA-regulated studies will NOT qualify for an Annual Status Report (ASR).
    • Federally funded studies with initial approval prior to January 21, 2019, will NOT qualify for an ASR.
    • Greater than minimal risk studies will start in the continuing review (CR application), but may eventually be able to transition to an ASR.
  • IRB submission form HTML files found on the “Print/View Study” tab of the left-hand navigation menu will display either a “pre-2018 Rule” or “Final Rule” label at the top of the document, depending on if the initial IRB approval was prior to January 21, 2019, or after.

Continuing Review & Annual Status Report Application Updates:

  • Certain responses on the “Research Status” page in the CR and ASR applications will transition qualifying studies from one application to another (i.e., CR to ASR, CR to Final Study Report (FSR), or ASR to FSR).
  • The “Research Status” page was moved up in the CR application so that unnecessary parts of the form would not be completed should the system transition it to an ASR or a FSR.
  • Both CR and ASR applications will now automatically populate descriptions of amendments approved since the last review on the “Research Progress” page.

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 (Winter 2018) now available

Posted: December 20, 2018

The Winter 2018 edition of the “Animal Care and Use Newsletter” is now available on the Office of Responsible Research Practices (ORRP) IACUC Newsletters webpage.  The new issue includes information about rodent surgery cage cards to be used in ULAR housing effective January 1st, AAALAC to visit Ohio State, tricaine-S (MS-222), updates to the IACUC annual review process coming soon, acknowledgment for AALAS technician certifications, zoonotic fact sheets for working with fish, employee accident reporting procedures, IACUC policy updates; reminders about personnel and training requirements, check the phone number provided in e-Protocol, use of non-pharmaceutical grade compounds; also includes a helpful e-Protocol tip on what to include in your experience and training narrative.

Animal Care and Use Newsletter – Winter 2018

For additional information on the newsletter or any topics contained therein, please contact the IACUC office at IACUCinfo@osu.edu.

Category : IACUC / ORRP

Human Subjects Research Newsletter: Common Rule Revisions (Special Edition) now available

Posted: December 10, 2018

The ‘Common Rule Revisions’ edition of the “Human Subjects Research Newsletter” is now available on the Office of Responsible Research Practices (ORRP) IRB Newsletters webpage. This special issue is full of valuable information regarding the Common Rule revisions and its implementation at Ohio State.

Human Subjects Research Newsletter – Common Rule Revisions

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

Posted: December 3, 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

Posted: November 6, 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 / Educational Offerings / IRB