IRB News
Human Subjects Research Newsletter (Fall 2017) now available
Fri, 15th September, 2017
The Fall 2017 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 the Common Rule revisions, revised FDA guidance on consent waivers, NIH policy changes on certificates of confidentiality, grant congruency assistance, and more.
Human Subjects Research Newsletter – Fall 2017
For additional information on the newsletter or any topics contained therein, please contact Ellen Patricia.
IRB Training for Graduate Students
Tue, 1st August, 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 session will focus on the following key topics:
- Understanding why we have an IRB process
- Exploring types of research and levels of review
- Reviewing application components
- Tips for successful application completion
- Finding out where to go for help
While the session will be tailored to social and behavioral sciences researchers, anyone preparing IRB submissions is welcome.
The workshop will be held on Wednesday, August 30, from 2:30 p.m. to 3:30 p.m. in the Research Commons, Third Floor 18th Avenue Library Library, 175 West 18th Avenue.
Contact: 614-688-8641 or meadows.8@osu.edu
Research Recruitment and Participant Compensation
Thu, 27th July, 2017
The Office of Responsible Research Practices, Center for Clinical and Translational Science, College of Optometry, and Office of Sponsored Programs are offering a workshop on participant recruitment and compensation. The workshop will:
- Review recruitment methods and considerations
- Discuss participant compensation and how to select the best option
- Discuss administrative requirements to pay participants and monitor compensation
The workshop will be held on Tuesday, August 15 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.
Contact: 614-688-8641 or meadows.8@osu.edu
IRB Reliance Models for Ohio State Researchers Collaborating with External Partners
Mon, 10th July, 2017
The Office of Responsible Research Practices and the Center for Clinical and Translational Science are 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 Tuesday, August 8 from 11 a.m. to 12:30 p.m. in the Clinical Skills Education and Assessment Center, Room 620, 6th Floor Prior Health Sciences Library, 376 West Tenth Avenue.
Contact: 614-688-8641 or meadows.8@osu.edu
Amendments and Buck-IRB Workshop
Sat, 1st July, 2017
The Office of Responsible Research Practices and Center for Clinical and Translational Science are offering an advanced workshop on amendments to approved human subjects research and the Buck-IRB system. The session will:
- Describe the amendment process
- Review relevant HRPP policies and regulations
- Provide guidance and tips on amendment submission via Buck-IRB
- Explain how to expedite the amendment screening and review processes
While the session will be tailored to medical researchers, anyone preparing IRB submissions is welcome.
The workshop will be held on Tuesday, July 18, 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.
Contact: 614-688-8641 or meadows.8@osu.edu
New CITI GCP Course Available for SBS Researchers
Wed, 28th June, 2017
A new Collaborative Institutional Training Initiative (CITI) course is now available for social and behavioral sciences researchers engaged in clinical trials of drugs, devices, biologics, and/or behavioral interventions. The CITI Good Clinical Practices for Social and Behavioral Researchers course 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.
To access CITI, log on at http://go.osu.edu/citi with your Ohio State Internet Username (last name.#) and Password. To enroll in the course, click on “Add a Course” and then check the box for “Good Clinical Practices for Social and Behavioral Researchers”.
For questions, please contact Ellen Patricia at patricia.1@osu.edu.
Updates to the Buck-IRB system
Wed, 21st June, 2017
New updates to the Buck-IRB submission system go live on June 21, 2017.
Several foundational changes are included in this update to prepare for future enhancements to Buck-IRB’s management of collaborative research projects. While other changes are being implemented, the majority will occur behind the scenes with little or no direct impact on investigators. The following features are incorporated in this latest update:
- The initial IRB application pages were reorganized to open in a different order (see below) to permit future multi-site research system enhancements:
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- Study Identification
- Type of Review
- Review Board
- Location
- Multi-site
- Study Personnel
- External Collaborators
- Funding
- Addition of a general study correspondence feature to permit ORRP staff to contact investigators and research staff through Buck-IRB; this email communication will be stored in the system for future reference.
- Improved instructions added to the Privacy page.
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.
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.
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.
Contact: 614-688-8641 or meadows.8@osu.edu
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.
Contact: 614-688-8641 or meadows.8@osu.edu
