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.

Do you compensate participants who take part in your research? The Office of Responsible Research Practices, Center for Clinical and Translational Science, College of Optometry, and CHRR are offering a workshop on participant recruitment and compensation considerations in both medical and non-medical research. The workshop will:

• Review regulatory guidance and university policy regarding participant payments
• Discuss how to select the best compensation option
• Explore case examples of participant payment methods
• Review administrative requirements to pay participants and monitor compensation
• Identify available resources for managing research compensation

The workshop will be held on Tuesday, October 16 from 11 a.m. to 12:30 p.m. in the James Cancer Hospital, Room L045, 460 West Tenth Avenue. The session will also be available via live stream.

Registration requested.

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

The summer 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 upcoming programs in research ethics, a Common Rule update, Buck-IRB updates, post-approval monitoring, and more.

Human Subjects Research Newsletter – Summer 2018

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

The challenges that researchers encounter go beyond human subjects protection and research integrity as it is traditionally understood and defined by regulations. This lecture brings together regulators and researchers for a comprehensive discussion about the complex ethical dilemmas and challenges researchers face every day.

Featured Lecturer: David H. Strauss, MD

Tuesday, September 18, 2018
1:30 – 3 p.m.
170 Davis Heart and Lung Research Institute
473 W. 12th Avenue

Contact: Sandra Meadows
1.5 CME credits available

David H. Strauss is a psychiatrist with nearly 30 years of experience in assessment, pharmacologic treatment and psychotherapy with individuals with anxiety, mood and psychotic disorders. He consults widely on matters of human subjects protections and applied research ethics. Dr. Strauss is the director of research at the Austen Riggs Center, special lecturer at Columbia University and senior advisor to the Multiregional Clinical Trials Center (MRCT) at Brigham and Women’s Hospital and Harvard University. He is a former member of the Secretary’s Advisory Committee on Human Research Protections (SACHRP) and completed work as co-chair of its Subcommittee on the Inclusion of Individuals with Impaired Decision-making in Research. He currently serves on a SACHRP subcommittee charged with developing recommendations to enhance Subpart A, or the “Common Rule.”

You may also be interested in attending:

Neurology Grand Rounds by David H. Strauss, MD

Tuesday, September 18, 2018
7:30 – 8:30 a.m.
170 Davis Heart and Lung Research Institute
473 W. 12th Avenue

1 CME credit available

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, September 5 from 3 to 4 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

The Office of Responsible Research Practices and the Center for Clinical and Translational Science are offering a workshop on the secondary analysis of data and biospecimens. The session will:

• Review regulatory requirements
• Discuss IRB review considerations
• Explore scenarios involving secondary data and biospecimen analysis

While the session will be tailored to medical researchers, anyone preparing IRB submissions is welcome.

The workshop will be held on Tuesday, August 21 from 8 to 9:30 a.m. in the Biomedical Research Tower, Room 115, 460 West Twelfth Avenue.  The session is also available for live stream attendance.

Registration requested.

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

On June 19, 2018, the U.S. Department of Health and Human Services (HHS) and 15 other federal agencies announced a delay for an additional six months the general compliance date for revisions to the “Federal Policy for the Protection of Human Subjects” (the Common Rule).  The general compliance date is delayed to January 21, 2019, allowing institutions like Ohio State further time to make the necessary changes to be compliant with the 2018 revisions.  The Final Rule can be accessed here. 

While three burden-reducing provisions can be implemented before January 21, 2019, Ohio State will implement all aspects of the revised Common Rule on the general compliance date. The Office of Responsible Research Practices (ORRP) will keep the Ohio State human subjects research community up to date with additional information.  For questions, please contact Ellen Patricia at patricia.1@osu.edu.