Office of Responsible Research Practices
The Ohio State University

ORRP News

IRB Reliance Models for Ohio State Researchers Collaborating with External Partners

Fri, 31st March, 2017

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

  • Discuss the new NIH and Common Core Single IRB of Record (sIRB of Record) mandate
  • Describe when and how researchers may rely on a non-Ohio State IRB
  • Describe when and how researchers may obtain Individual Investigator Agreements
  • Provide a list of IRBs with whom Ohio State has standing reliance relationships

The workshop will be held on Wednesday, April 12 from 11 a.m. to 12:30 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 / ORRP / Training

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

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

Ohio State joins SMART IRB!

Tue, 13th December, 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

Update on NIH Policy on the Use of a Single IRB for Multi-Site Research

Thu, 8th December, 2016

Update – 12/16/2016: The NIH has delayed the effective date of the single IRB mandate from May to September 25, 2017.

The Office of Responsible Research Practices (ORRP) is in the process of identifying and implementing changes in local policies and workflow in order to be compliant with the NIH Policy on the Use of a Single Institutional Review Board for Multi-Site Research.  Progress thus far includes:

  • Ohio State joined the national SMART IRB reliance platform. Fifty institutions across the country have already joined.
  • ORRP is updating local policies and submission/review guidelines for requests to cede IRB review and to manage responsibilities if Ohio State is designated as the IRB of record
  • Additional ORRP staff and IRB reviewers are being trained to manage the anticipated increase in institutional agreements
  • Planned January build-out of Buck-IRB capacity to manage all multi-site IRB tasks for institutional agreements.

The current procedures to submit requests to cede review are as follows:

  • Begin a new application in Buck- Select “Create a New Study” and complete the application as requested.
  • Select “other external IRB” as the review board. Provide the name of the principal investigator and IRB contact information for the IRB of record for the external institution that will provide review.
  • Upload a copy of the IRB approval and/or IRB application form from the external institution as well as the protocol and any other relevant documents.
  • If the external IRB has already agreed to be the IRB of record and has provided an authorization agreement, upload it to Buck-IRB under “other files.”

For questions about institutional agreements, please contact Jessica Evans at Evans.309@osu.edu or 614-292-9832.

Category : IRB / ORRP

GCP and ICH CITI Training Update

Thu, 3rd November, 2016

Ohio State has added a Good Clinical Practice (GCP) and International Conference on Harmonisation (ICH) refresher course to its CITI course offering list.  Users first complete the basic course and then alternate between the refresher and basic courses every three years. The GCP and ICH CITI courses align with the new NIH policy issued on September 16, 2016 (Policy on Good Clinical Practice Training for NIH Awardees Involved in NIH-funded Clinical Trials; NOT-OD-16-148) stating that NIH-funded investigators and staff should be trained in GCP. This policy takes effect January 1, 2017.  The policy applies to all NIH-funded investigators and staff “who are involved in the conduct, oversight, or management of clinical trials” and states that the personnel “should be trained in Good Clinical Practice (GCP), consistent with principles of the International Conference on Harmonisation (ICH) E6 (R2).” The basic and refresher GCP and ICH CITI courses can be accessed via the Office of Responsible Research Practices (ORRP) website.

Please contact Ellen Patricia at patricia.1@osu.edu with questions.

Category : IRB / ORRP / Training

New Combined Consent and HIPAA Authorization Templates Available

Wed, 3rd August, 2016

Two new templates, The Ohio State University Combined Consent to Participate in Research and HIPAA Research Authorization (07/18/16) and The Ohio State University Combined Parental Permission and HIPAA Authorization for Child’s Participation in Research (07/18/16), are now posted online and available for use in research studies requiring written consent and HIPAA research authorization.

The combined forms can be used in submissions to any Ohio State IRB (Behavioral, Biomedical, or Cancer), allowing consent and HIPAA authorization to be obtained using a single form and signature.  Investigators can still chose to use a process involving a separate consent form alongside the stand-alone HIPAA research authorization form if desired, and such a process may be more appropriate or required for some studies.

The combined templates and guidance can be accessed at Consent, Assent, and Parental Permission.

For questions, please contact Cheri Pettey at pettey.6@osu.edu.

Category : IRB / ORRP