Buck-IRB News

The spring 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 principal investigator responsibilities, consent form updates, the revised Common Rule, Buck-IRB updates, upcoming educational offerings, and more.

Human Subjects Research Newsletter: Spring 2019

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

The Office of Responsible Research Practices is 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 behavioral research

While the session will be tailored to social and behavioral sciences researchers, anyone preparing IRB submissions is welcome to attend.  The presentation will be held on Wednesday, March 27 from 3 – 4:30 p.m. in the Research Commons, 3rd Floor of 18th Avenue Library, 175 West 18th Avenue.

Register Here

This event will be livestreamed. To join remotely, visit carmenconnect.osu.edu/rc-irb. Adobe Flash Player needs to be installed on your computer to join the livestream. Please do not register if you plan to attend remotely.

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. Please do not register if you plan to attend via live stream. Contact Sandra Meadows at 614-688-8641 or meadows.8@osu.edu.

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, 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.

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.

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.

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

New updates to the Buck-IRB submission system went live on November 1, 2018.

This update involves the Waiver of Consent/Assent/Parental Permission pages and Alteration of Consent/Parental Permission pages.  This is the first in a series of revisions that will take place over the next several months in preparation for the Common Rule changes that take effect on January 21, 2019.  This update involves an additional question added to the above-mentioned pages for studies requesting a consent waiver and/or alteration for the use of identifiable private information and/or bio-specimens. See below for more information regarding this change:

• The new question requests that a rationale be provided to justify why the research could not be practicably conducted without using information or bio-specimens in an identifiable format
• Implementing the question now allows new IRB applications and amendments involving consent waivers/alterations to be reviewed in a manner that will be compliant with both the current and revised Common Rule
• Reduces the need for researchers to submit a separate amendment to address this new criterion after January 21, 2019
• No revisions were made to the HIPAA waiver and/or alteration pages

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.

New updates to the Buck-IRB submission system go live on October 10, 2018!

Included in this update are significant revisions to the Risk Assessment page of the continuing review form for IRB-approved human subjects research. The form revisions include  clarifications regarding reporting requirements at the time of continuing review and  more specific selection options to ease form completion. See the list below for the more significant changes to the page:

• Revised instructions to clarify the IRB’s review of information relating to the risk/benefit assessment, and to define the meaning of unanticipated problems involving risks to subjects or others
• Added instructions for sponsor-investigators for research involving an Investigational Device Exemption (IDE)
• Revised/added questions to describe the reporting summary needed at the time of continuing review (unanticipated problems involving risks to subjects or others, serious and/or continuing non-compliance, suspensions, and clinical holds)
• Added event reporting submission instructions  for any items that should have been previously reported to the IRB, but were not
• Removed unnecessary questions after the rephrasing of other questions/instructions
• Added selection options for studies using a Data and Safety Monitoring Board (DSMB) to help researchers clarify when the DSMB has not yet met, is no longer meeting, or when a report is/is not available
• Restructured the risk/benefit assessment question to only prompt for an updated assessment if there have been changes to the risks/benefits
• Clarified which supporting documents should be uploaded

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.