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Office of Responsible Research Practices News

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

Event Reporting Workshop

Posted: January 10, 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

Posted: January 9, 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

Posted: January 3, 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

Animal Care and Use Newsletter (Winter 2016) now available

Posted: December 15, 2016

The most recent edition of the “Animal Care and Use Newsletter” is now available on the IACUC Newsletters webpage. The newsletter includes information about the AAALAC accreditation at Ohio State, recent results from USDA inspection, educational outreach opportunities (office hours and workshops), notification on zoonotic fact sheets for working with pigs, semiannual inspection summary, also includes IACUC policy updates and helpful e-Protocol tips and reminders.

Full Newsletter: Animal Care and Use Newsletter – Winter 2016

Contact: Melinda Bruns at bruns.159@osu.edu

Category : IACUC / ORRP

Human Subject Research Newsletter (Special Edition – Fall 2016) now available

Posted: December 15, 2016

A special edition of the “Human Subjects Research Newsletter” is now available on the Office of Responsible Research Practices (ORRP) IRB Newsletters webpage.  The new edition features information regarding SMART IRB, regulatory and Buck-IRB updates, amendment guidance, and more.

Human Subjects Research Newsletter: Special Edition – Fall 2016

For additional information on the newsletter or any topics contained therein, please contact Ellen Patricia at patricia.1@osu.edu.

Category : IRB / ORRP

Ohio State joins SMART IRB!

Posted: December 13, 2016

Supporting single IRB review on a national scale, advancing collaborative research

For investigators pursuing National Institutes of Health (NIH) funded clinical research involving multiple sites, coordination of Institutional Review Board (IRB) reviews can be challenging. Streamlining this process has been a major concern for NIH.

Ohio State is one of almost 60 institutions that have joined SMART IRB, a platform designed to ease common challenges and burdens associated with initiating multi-site research. Smart IRB will allow institutions to minimize duplicative IRB reviews while maintaining appropriate oversight. It is also designed to provide a roadmap to implement the National Institutes of Health (NIH) Policy on the Use of Single Institutional Review Board for Multi-Site Research.

SMART IRB will help Ohio State researchers involved in multi-site, NIH-funded research streamline human subjects research, while ensuring robust protections for study participants. The platform can be used for a range from large, complex clinical trials to two-site collaborations. Clinical investigators will be able to obtain trial results faster and, ultimately, speed development of new diagnostics, treatments and preventative measures for patients.

The project is led by three members of the national Clinical and Translational Science Award (CTSA) consortium: Harvard Catalyst, Dartmouth Synergy and the University of Wisconsin-Madison. It is funded by the NIH CTSA program. SMART IRB will support and encourage nation-wide collaboration through a flexible master IRB reliance agreement, standard operating procedures and complementary tools and resources.

Enabling Single IRB Review

As part of SMART IRB, institutions may choose to rely on another IRB to review, approve and oversee a research study.

  • The Reviewing IRB takes on oversight responsibilities associated with that study for its duration
  • Relying institutions provide local information about state law, study team member training and qualifications and conflicts of interest
  • Investigators and institutions retain their responsibilities for the protection of human subjects, compliance with applicable laws, regulations, ethical standards and the terms of the institution’s Federal Wide Assurance (FWA)

How it works

The Overall Principal Investigator (PI) of a multi-site study works with the Points of Contact (listed on the SMART IRB website) for each participating institution to determine an appropriate reliance arrangement. Together they will identify a Reviewing IRB and determine which institutions will rely upon that IRB for the review and oversight of the research.

Additional details are available in the SMART IRB Standard Operating Procedures on “Establishing Reviewing IRBs and Relying Institutions” and “Initial Review Submission and Review Process.” See the Resources page.

Click on the link to SMART IRB for more information. Contact Ohio State’s SMART IRB point of contact at IRBAgreements@osu.edu.

Category : IRB / ORRP