Office of Responsible Research Practices
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Office of Responsible Research Practices News

Ebert named program director for IRB operations

Posted: March 10, 2017

Susan EbertWe 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.

Category : IRB / ORRP

International Research Workshop

Posted: March 7, 2017

The Office of Responsible Research Practices is offering a workshop on conducting human subjects research at international locations. The session will:

  • Debunk common myths about international research
  • Explain how to create and submit Buck-IRB proposals
  • Provide tips about the informed consent process, including scenarios when a waiver of consent documentation may be appropriate

While the session will be tailored to social and behavioral sciences researchers, anyone preparing IRB submissions is welcome.

The workshop will be held on Tuesday, March 28 from 4 p.m. to 5 p.m. in the Research Commons, 3rd Floor 18th Avenue Library, 175 West 18th Avenue.

Registration requested.

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

Category : IRB / Training

New Good Clinical Practice (GCP) Training for SBS Researchers in BuckeyeLearn

Posted: February 6, 2017

A new e-learning training module is now available in BuckeyeLearn targeting 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. 

Training objectives:

  • Help assure the safety, integrity, and quality of clinical trials
  • Provide a standard for ensuring clinical trial compliance, implementation, data collection, monitoring, and reporting (e.g., safety data, accrual reports, study status, protocol deviations, unanticipated problems, or final data)
  • Outline the responsibilities of Institutional Review Boards (IRBs), investigators, sponsors and monitors
  • Address elements related to the design, conduct, and reporting of clinical trials.
Category : IRB / Training

Buck-IRB Continuing Review Submissions Workshop

Posted: January 24, 2017

The Office of Responsible Research Practices is offering a workshop on creating human subjects research continuing review submissions within the online Buck-IRB system. This workshop will:

  • Explain the needed associated submission materials
  • Discuss common errors found in screening and IRB review and ways to avoid them
  • Provide tips for navigating the Buck-IRB application
  • Clarify when an annual status report may be appropriate

Anyone involved in preparing IRB submissions is welcome.

The workshop will be held on Thursday, February 23 from 11 a.m. to 12:30 p.m. in the Research Commons, Third Floor 18th Avenue Library, 175 18th Avenue.

Registration requested.

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

Category : Buck IRB / IRB / ORRP

FDA Regulated Research Conference

Posted: January 23, 2017

Update 2/3/2017:  This event has reached capacity.  Registration is closed.

The Office of Responsible Research Practices in collaboration with the Center for Clinical and Translational Science and Nationwide Children’s Hospital will host an FDA-focused conference entitled “FDA Regulated Research: Innovation & Compliance” on March 3, 2017 at The Ohio State University Biomedical Research Tower. The conference will include a number of speakers from industry, regulatory experts, The Ohio State University, Wexner Medical Center, Comprehensive Cancer Center, and Nationwide Children’s Hospital and will focus on the following key topics:

  • Drug Development and Innovation
  • Device Innovation
  • Investigator Responsibilities
  • Partnerships with Industry
  • Innovation and Drug Development Strategies
  • Keys to Successful Translational Research
  • FDA Inspections
  • Research Resources Panel Discussion

An agenda and speaker list will be available soon.
Registration is limited to 150 participants.

Category : IACUC / IRB / ORRP

Changes to the Common Rule

Posted: January 19, 2017

The U.S. Department of Health and Human Services issued a press release January 18, 2017 about the final rule on changes in the regulations regarding the “Common Rule”.  “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. It also allows more flexibility in keeping with today’s dynamic research environment.”

Most provisions of the new rule will go into effect in 2018.  Over the next year, the Office of Responsible Research Practices will be developing an implementation plan to make changes in our local policies and workflow in order to be compliant on the effective date of the new rule, and to provide advance outreach and training for human subjects research teams at Ohio State.

To view the press release, click here.
To view the final rule, click here.

Category : IRB / ORRP

Consultation hours and workshops available for IACUC activities at the Research Commons

Posted: January 17, 2017

Do you need help preparing your animal study, navigating e-Protocol, organizing for semiannual facility inspections or responding to inspection outcomes? Do you want to learn more about the Institutional Animal Care and Use Committee (IACUC) review process, policies or best practices? Starting in February 2017, consultation hours will be held at the Research Commons (3rd floor, 18th Avenue Library, 175 W. 18th Avenue).

Melinda Bruns, quality improvement specialist from the Office of Responsible Research Practices (ORRP) IACUC office, will be available to help you prepare for IACUC semiannual inspections and respond to inspection outcomes. She can provide guidance on IACUC policies, the protocol review cycle and post-approval activities. Schedule a consultation (go.osu.edu/rc-iacuc). Select the service “Animals in Research (IACUC).”

Angela Phillips, protocol consultant from the Office of the Attending Veterinarian (OAV), will be available to help you prepare your animal study using e-Protocol and obtain veterinary consultation prior to the IACUC review. Schedule a consultation (go.osu.edu/rc-oav). Select the service “Animal Use Protocols (OAV).”

In addition, three workshops will be hosted from 11 a.m. to 12:30 p.m. at the Research Commons (60 minute workshop plus 30 minute question and answer):

These workshops are a great resource for investigators, post-docs, lab managers, graduate and undergraduate students listed on animal studies who are interested in learning more about the Animal Care and Use Program. Visit the Research Commons events webpage for more information. To register, click on the title of the workshop listed above.

For additional information or questions, please contact Melinda Bruns at bruns.159@osu.edu or 614-292-8621.

Category : IACUC / ORRP