Office of Responsible Research Practices
The Ohio State University

IRB News

Human Subjects Research Newsletter (Summer 2017) now available

Thu, 1st June, 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 SMART IRB, Common Rule changes, CITI training additions, event reporting guidance, and more.

Human Subjects Research Newsletter – Summer 2017

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

Category : Buck IRB / CITI / IRB / ORRP

IRB Submission Process Overview Workshop

Mon, 15th May, 2017

The Office of Responsible Research Practices and the Center for Clinical and Translational Science are offering an introductory workshop about the IRB submission process. The session will:

  • Provide an overview of informed consent alteration and waivers
  • Provide regulatory definitions and discuss case examples
  • Discuss Buck-IRB navigation
  • 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, June 20, from 8 a.m. to 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 : Buck IRB / IRB / Training

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

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

Mon, 6th February, 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

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

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