Office of Responsible Research Practices News

The Office of Responsible Research Practices and the Center for Clinical and Translational Science are offering an educational session 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 biomedical/cancer research

The session will be tailored to medical researchers; however, anyone preparing IRB submissions is welcome to attend. The presentation will be held on Tuesday, March 5 from 8 to 9:30 a.m. in the Biomedical Research Tower, Room 115, 460 West Twelfth Avenue.

Registration requested.

Live streaming available upon request. Contact Sandra Meadows at 614-688-8641 or meadows.8@osu.edu.

The Office of Responsible Research Practices is offering a workshop for graduate students on how to navigate the Institutional Review Board (IRB) process.  The workshop will focus on the following key topics:

• Understanding why we have an IRB process
• Exploring types of research and levels of review under the 2018 Common Rule
• Reviewing application components
• Tips for successful application completion
• Finding out where to go for help

While this session will be tailored to social and behavioral sciences researchers, anyone preparing IRB submissions is welcome.  The workshop will be held on Thursday, February 28 from 11 a.m. to noon in the Research Commons, 3rd Floor of 18th Avenue Library, 175 West 18th Avenue.

Registration requested.

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

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.

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.

New updates to the Buck-IRB submission system went live on January 20, 2018.

This update involves the Exempt, Continuing Review, Annual Study 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.

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 1^st, 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.

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.