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Spring 2017


Ohio State AAHRPP application for reaccreditation

The Office of Responsible Research Practices (ORRP) submitted Ohio State’s Step 1 application for the Association for the Accreditation of Human Research Protections Programs, Inc (AAHRPP) reaccreditation on March 8, 2017. AAHRPP is an independent, non-profit accrediting body that promotes high-quality research through an accreditation process that helps organizations strengthen their human research protection programs (HRPPs). Maintaining AAHRPP accreditation assures research participants, researchers, sponsors, government regulators and the public that Ohio State is committed to scientifically and ethically sound research as well as continuous improvement of its HRPP program.
Ohio State was first accredited in 2010 and was reaccredited in 2013. The next steps in this every five-year reaccreditation cycle involve receiving feedback from AAHRPP reviewers on the Step 1 application, the subsequent submission of Step 2 (including a list of active protocols and key personnel from all parts of the HRPP), and a site visit by AAHRPP reviewers in the fall.

For more information, contact Ellen Patricia.

Ebert named program director for IRB operations

We are pleased to announce that Susan Ebert has accepted the position of program director for Institutional Review Board (IRB) operations, effective March 1, 2017. This new position represents a merger of the IRB operations manager role and Susan's previous position as eIRB program director. In her new role, Susan will provide leadership to the staff supporting the Behavioral and Social Sciences, Biomedical Sciences and the Cancer IRBs, and serve as an IRB committee member.

Susan, a Certified IRB Professional (CIP), brings a wealth of experience to this new position, having been with ORRP for nearly 10 years. She earned her Bachelor of Science in Dietetics from the University of Cincinnati and her Master of Science in Clinical Nutrition from Ohio State. Prior to joining ORRP, Susan served in multiple oncology research positions at Prologue Research International, Northwestern University and The Ohio State University Comprehensive Cancer Center.

The program director for IRB operations position was created, in part, by the departure of Adam McClintock, IRB operations manager. Adam accepted a position as human subjects protection manager at the OhioHealth Research Institute.

FDA regulated research conference

The Office of Responsible Research Practices, in collaboration with the Center for Clinical and Translational Science (CCTS) and Nationwide Children’s Hospital, hosted the Food and Drug Administration (FDA) Regulated Research: Innovation and Compliance conference on March 3, 2017, at the Biomedical Research Tower. The conference included speakers from industry, Ohio State and Nationwide Children’s Hospital, as well as regulatory experts. Over 145 attendees listened to presentations on FDA-related topics that included drug development, device innovation, industry partnerships and more. Recorded sessions from the conference are available on the CCTS website.

Fox named SBS vice chair

We are pleased to announce that Jesse Fox, assistant professor of communication, has been appointed the new vice chair of the Behavioral and Social Sciences (BSS) IRB, effective February 1, 2017. Jesse joins Howard Klein, professor of business management and human resources, as a vice chair of the BSS IRB. Current IRB membership rosters are available on the ORRP website.


Common Rule updated

The Department of Health and Human Services (DHHS), along with 15 other federal agencies, issued a final rule on January 18, 2017, updating the regulations that safeguard human research participants – generally known as the "Common Rule.” The majority of items in the rule go into effect on January 19, 2018. Portions of the rule that address cooperative research will not go into effect until January 20, 2020. Because the rule is subject to the Congressional Review Act, it is still possible for Congress to pass a resolution of disapproval for presidential signature (or veto) until the 60 legislative-day review period has ended.
DHHS states that the new rule “strengthens protections for people who volunteer to participate in research, while ensuring that the oversight system does not add inappropriate administrative burdens, particularly to low-risk research.” If implemented, the rule will enhance participant protections by establishing specific requirements for the informed consent process, including requiring a concise introductory explanation of key information about the study to assist potential participants in their decision-making. It will also streamline many of the regulatory processes for minimal risk research, including greatly expanding exemption categories. Ohio State is currently reviewing its policies and procedures in order to comply with the changing regulations.  
For more information, including the official press release and final rule, visit the DHHS Office for Human Research Protections.
For questions, contact Cheri Pettey.


Buck-IRB enhancements coming soon

Development is under way to add a number of important updates to Buck-IRB that will improve user experience and allow the submission process to be tailored to specific types of research. Examples of the new features to be implemented in the coming year include:
  • Improved capabilities for handling collaborative research studies involving multiple institutions and multiple IRBs
  • New expanded access applications, including studies involving the emergency use of drugs/devices
  • A new IRB member review module that will capture reviewer comments and IRB meeting minutes


FAQ enhancements

The Frequently Asked Questions (FAQ) section of the ORRP website has recently been revamped to include several new features designed to enhance user experience and allow articles (questions) to be located with greater ease and efficiency. These enhancements include an improved knowledge base-style organization and category use, article feedback collection and a dedicated, responsive search. In addition, several new FAQs and categories have been added, such as "Research Involving Secondary Use of Data and/or Specimens" and "Special Research Considerations." The human subjects FAQs includes 52 articles across six categories, with more being added regularly.

GCP training for SBS researchers

An NIH Good Clinical Practice (GCP) e-learning training module is now available in BuckeyeLearn that targets social and behavioral researchers engaged in clinical trials of drugs, devices, biologics and/or behavioral interventions.

This training supports the NIH policy (issued September 16, 2016) stating that NIH-funded investigators and staff “who are involved in the conduct, oversight, or management of clinical trials should be trained in Good Clinical Practice (GCP), consistent with principles of the International Conference on Harmonisation (ICH) E6 (R2).” GCP principles constitute an international ethical and scientific quality standard for designing, conducting, recording and reporting clinical trials. 


  • Ohio State AAHRPP application for reaccreditation
  • Ebert named program director for IRB operations
  • FDA regulated research conference
  • Fox named SBS vice chair
  • Common Rule updated
  • Buck-IRB enhancements coming soon
  • FAQ enhancements
  • GCP training for SBS researchers
  • By the numbers

Decision Sciences Collaborative Annual Research Forum

March 31, 2017
3 - 5:30 p.m.
Psychology Building (Room 035)
1835 Neil Avenue

Save the Date: 2017 OSU Materials Week

May 9-12, 2017
Blackwell Inn and Conference Center
Columbus, OH

IRB and International Research

March 28, 2017
4 - 5 p.m.
Research Commons
18th Avenue Library (3rd floor)

IRB Reliance Models for Researchers Collaborating with External Partners

April 12, 2017
11 a.m. – 12:30 p.m.
Research Commons
18th Avenue Library (3rd floor)

The Informed Consent Process

April 18, 2017
Time and Location TBA

Waivers of Informed Consent

May 16, 2017
Time and Location TBA

IRB Process Overview

June 20, 2017
Time and Location TBA

Amendments and Buck-IRB

July 18, 2017
Time and Location TBA

Buck-IRB General Training

Recorded Presentation

Susan S. Ebert
Office of Responsible Research Practices

If your department or research unit would like to request a training session for your area or if you have general questions regarding Buck-IRB, please contact Susan Ebert at 614-292-0184 or
Office of Responsible Research Practices

© 2017 The Ohio State University – Office of Research
Office of Responsible Research Practices – Human Research Protection Program
Research Administration Building, 1960 Kenny Road, Columbus, OH 43210
Phone: 614-688-8457 | Fax: 614-688-0366 | Email the IRB

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