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ORRP News

Ohio State AAHRPP application for reaccreditation

Tue, 21st March, 2017

AAHRPPThe 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.

Category : IRB / ORRP

Human Subjects Research Newsletter (Spring 2017) now available

Tue, 21st March, 2017

The most recent 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 Ohio State’s AAHRPP reaccreditation, regulatory updates, leadership changes, researcher guidance and training, and more.

Human Subjects Research Newsletter – Spring 2017

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

Category : Buck IRB / IRB / ORRP / Training

Ebert named program director for IRB operations

Fri, 10th March, 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

Buck-IRB Continuing Review Submissions Workshop

Tue, 24th January, 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

Mon, 23rd January, 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

Thu, 19th January, 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

Tue, 17th January, 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

Event Reporting Workshop

Tue, 10th January, 2017

The Office of Responsible Research Practices is offering a workshop on human subjects research event reporting.  The session will:

  • Provide an overview of the revised event reporting policy
  • Differentiate between investigator, sponsor, and IRB reporting requirements
  • Provide definitions and discuss case examples
  • Review best practices and available resources

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

The workshop will be held on Tuesday, February 7 from 8-9 a.m. in the Clinical Skills Education and Assessment Center, Room 620, 6th Floor Prior Health Sciences Library, 376 West Tenth Avenue.

Registration requested.

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

Category : IRB / ORRP / Training

IRB Training for Graduate Students

Mon, 9th January, 2017

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 the ethical basis for IRB review
  • Exploring types of research and review requirements
  • Reviewing application components
  • Tips for successful application submission
  • Available resources
  • Q&A

The workshop will be held on Wednesday, February 1 from 4-5 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

Category : IRB / ORRP / Training

Updates to the Buck-IRB system

Tue, 3rd January, 2017

New updates to the Buck-IRB submission system go live on January 3, 2016.

Included in this update are features that will improve and enhance the Buck-IRB work experience for investigators and research staff. The following features are incorporated in this latest update:

  • The Ohio State approved research site list has been updated to include all 88 Ohio county extension offices, allowing investigators to select the specific extension research location(s)
  • Weekly reminder notices (sent on Friday mornings for outstanding investigator responses pending for seven days or longer) will include the submission type in the email subject line
  • Weekly reminder notices will begin to be sent for both exempt studies and event report submissions
  • ORRP staff will be able to assign an external ID to studies in Buck-IRB for tracking purposes. This may include a sponsor, internal, and/or external IRB-assigned number.

Other changes
Other changes are included with this Buck-IRB update, though the majority will occur behind the scenes with little or no direct impact on investigators.

Login to Buck-IRB at go.osu.edu/Buck-IRB.

For additional information about this Buck-IRB update, please contact Susan Ebert at ebert.55@osu.edu.

Category : Buck IRB / IRB / ORRP