Educational Offerings News

Are you new to human subjects research and in need of information to help you navigate the submission and review processes? If so, the Office of Responsible Research Practices and the Research Commons are offering an introductory presentation for you or anyone who needs a refresher. By the end of the session, participants will be able to:

• Explain why we have an IRB process
• List types of human subjects research and levels of review
• Outline Ohio State’s IRB review process, from pre-submission to approval
• Generate an action plan for completing a successful Buck-IRB application

While the session will be tailored to new social and behavioral sciences researchers and graduate students, anyone preparing IRB submissions is welcome. The session will be held on Wednesday, September 23 from 11 a.m. to 12:30 p.m. via CarmenZoom.

Registration requested.

For more information, contact Sandra Meadows at 614-688-8641 or meadows.8@osu.edu.

Although OHRP and FDA regulations are similar, differences exist based on FDA’s unique scope and requirements. The Office of Responsible Research Practices and the Center for Clinical and Translational Science are offering an FDA series. This second session will focus on research involving medical devices and the special considerations associated with obtaining IRB approval. By the end of the session, participants will be able to:

• Explain common regulatory terms in the context of FDA-regulated device studies
• Differentiate between clinical investigations requiring Investigational Device Exemptions (IDEs), Nonsignificant Risk (NSR) device investigations, and IDE-exempt investigations
• Identify and complete Buck-IRB application sections and documents required for medical device research
• Recognize how and when to consult the FDA

Please note, this intermediate-level webinar assumes a basic familiarity with the IRB approval process and Buck-IRB, and will not cover emergency use, expanded access, or Humanitarian Use Device (HUD) protocols. While the session will be tailored to medical researchers and research staff, anyone preparing IRB submissions is welcome. The workshop will be held on Tuesday, February 2nd from 9 to 10:30 a.m. via CarmenZoom.

Registration requested.

For more information, contact Sandra Meadows at 614-688-8641 or meadows.8@osu.edu.

Although OHRP and FDA regulations are similar, differences exist based on FDA’s unique scope and requirements. The Office of Responsible Research Practices and the Center for Clinical and Translational Science are offering an FDA series. This first session will focus on research involving drugs and how to navigate the IRB approval process. By the end of the session, participants will be able to:

• Explain common regulatory terms in the context of FDA-regulated drug studies
• Assess which regulations apply to clinical investigations involving drugs or biologics, including when an Investigational New Drug Application (IND) is required
• Identify and complete Buck-IRB application sections and documents required for FDA-regulated drug research
• Recognize how and when to consult the FDA

Please note, this intermediate-level session assumes a basic familiarity with the IRB review process and Buck-IRB, and will not cover emergency use or expanded access protocols. While the session will be tailored to medical researchers and research staff, anyone preparing IRB submissions is welcome. The workshop will be held on Thursday, September 10^th, from 9 to 11:00 a.m. via CarmenZoom.

Registration requested.

For more information, contact Sandra Meadows at 614-688-8641 or meadows.8@osu.edu.

It’s inevitable: research doesn’t always go as planned. The Office of Responsible Research Practices and the Center for Clinical and Translational Science are offering a session on when to notify the IRB about unexpected events or other problems. The session will:

• Provide an overview of the newly revised event reporting policy
• Differentiate between investigator, sponsor, and IRB reporting requirements
• Provide definitions and discuss case examples

While the session will be tailored to medical researchers and research staff, anyone preparing IRB submissions is welcome. The workshop will be held on Tuesday, June 23, from 9 to 10:30 a.m. via CarmenZoom.

For more information, contact Sandra Meadows at 614-688-8641 or meadows.8@osu.edu.

Are you new to human subjects research and in need of information to help you navigate the submission and review processes? If so, the Office of Responsible Research Practices and the Center for Clinical and Translational Science are offering an introductory presentation for you or anyone who needs a refresher. By the end of the session, participants will be able to:

• Explain why we have an IRB process
• List types of human subjects research and levels of review
• Outline Ohio State’s IRB review process, from pre-submission to approval
• Generate an action plan for completing a successful Buck-IRB application

While the session will be tailored to new medical researchers and research staff, anyone preparing IRB submissions is welcome. The session will be held on Wednesday, May 20 from 11 a.m. to 12:30 p.m. via CarmenZoom.

Registration requested.

For more information, contact Sandra Meadows at 614-688-8641 or meadows.8@osu.edu.

The Office of Responsible Research Practices, Advarra, and the Center for Clinical and Translational Science are offering an educational session about Advarra oversight of Ohio State human subjects research with Advarra representative, Kathleen Rankin, and Jessica Mayercin-Johnson from ORRP.  The presentation will:

• Provide an overview of the Ohio State and Advarra submission processes
• Navigate within the Ohio State and Advarra platforms
• Describe required submission components
• Review tips for successful submissions

The session will be held on Thursday, January 30 from 11 a.m. to 12:30 p.m. in the James Cancer Hospital, Room L045, 460 West Tenth Avenue.

Registration requested.

• Live streaming available upon request. Please do not register if you plan to attend via live stream. Contact Sandra Meadows at 614-688-8641 or meadows.8@osu.edu.

The Office of Responsible Research Practices and the Research Commons are offering an educational session for graduate students on how to navigate the human subjects research submission 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
• Learning where to go for assistance

While the session will be tailored to social and behavioral sciences researchers, anyone preparing IRB submissions is welcome. The presentation will be held on Wednesday, November 20th, from 3 to 4 p.m. in the Research Commons, Third Floor 18th Avenue Library, 175 West 18th Avenue.

Registration requested.

Do you compensate participants who take part in your research? The Office of Responsible Research Practices, Center for Clinical and Translational Science, College of Optometry, and CHRR are offering an updated workshop on participant recruitment and compensation considerations in both medical and non-medical research. The presentation will:

• Review regulatory guidance and university policy regarding participant payments
• Discuss how to select the best compensation option
• Explore case examples of participant payment methods
• Review administrative requirements to pay participants and monitor compensation
• Identify available resources for managing research compensation

The session will be held on Tuesday, October 22 from 8 to 9:30 a.m. in Room H1213, Ross Heart Hospital, 452 West Tenth Avenue.

Registration requested.

Live streaming available upon request. Please do not register if you plan to attend via live stream. CME credit is available only for in-person attendance. Contact Sandra Meadows at 614-688-8641 or meadows.8@osu.edu.

The Ohio State University Center for Continuing Medical Education designates this RSS (Regularly Scheduled Series) for a maximum of 1.5 AMA PRA Category 1 Credit(s)™. Physicians should claim only the credit commensurate with the extent of their participation in the activity.

The Office of Responsible Research Practices, Office of the Chief Information Officer, and the Center for Clinical and Translational Science are sponsoring a viewing session for the Office for Human Research Protections’ exploratory workshop on topics related to human subjects research and privacy considerations involving the secondary analysis of health data.

Agenda

Session I: Is Privacy a Casualty of Advancing Research?

The goals of this session are to explore the problem of privacy protection in a data-rich world, the tensions that exist between the societal good that could come from big data research and the real and perceived risks to individuals, and the public’s perspectives about broad data sharing.

Session II: Approaches to Protecting Privacy & Confidentiality

The goal of this session is to explore the challenges of privacy protection for health-related big data research conducted on a variety of platforms and in various settings.

Session III: Protecting Privacy & Confidentiality: A Shared Responsibility

The goals of this session are to discuss some of the challenges facing IRBs and institutions in the review of proposed data sharing options for research that falls under the Common Rule, and explore ethical oversight of big data research that falls outside the scope of the Common Rule.

The viewing session will be held on Thursday,September 19from 8:15 a.m. to 4:15 p.m. in Room 200,Prior Health Sciences Library, 376 West Tenth Avenue. A working lunch will provide stakeholders with an opportunity to discuss privacy implications and future strategies at Ohio State.

The Office of Responsible Research Practices and the Center for Clinical and Translational Science are offering part two of an educational series on collaborative research. The presentation will:

• Review external agreement requirements and corresponding reliance agreements
• Navigate through Buck-IRB external collaboration sections
• Introduce and practice using tip sheets and tools for collaborative research submissions

The session will be held on Tuesday, September 10 from 11 a.m. to 12:30 p.m. in Room 115, Biomedical Research Tower, 460 West Twelfth Avenue.

Registration requested.

Live streaming available upon request. Please do not register if you plan to attend via live stream. CME credit is available only for in-person attendance. Contact Sandra Meadows at 614-688-8641 or meadows.8@osu.edu.

The Ohio State University Center for Continuing Medical Education designates this RSS (Regularly Scheduled Series) for a maximum of 1.5 AMA PRA Category 1 Credit(s)™. Physicians should claim only the credit commensurate with the extent of their participation in the activity.