Office of Responsible Research Practices
The Ohio State University

Training News

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.

Registration requested.

Contact: 614-688-8641 or meadows.8@osu.edu

Category : IRB / ORRP / Training

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.

Registration requested.

Contact: 614-688-8641 or meadows.8@osu.edu

Category : IRB / ORRP / Training

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.

Registration requested.

Contact: 614-688-8641 or meadows.8@osu.edu

Category : IRB / ORRP / Training

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.

Registration requested.

Contact: 614-688-8641 or meadows.8@osu.edu

Category : Buck IRB / IRB / ORRP / Training

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.

Category : CITI / IRB / ORRP / Training

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

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

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

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