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Training News

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

Waivers/Alteration of Informed Consent Workshop

Wed, 19th April, 2017

The Office of Responsible Research Practices and the Center for Clinical and Translational Science are offering an intermediate level workshop on waivers/alteration of informed consent. 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, May 16, 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 / ORRP / Training

Informed Consent Process Workshop

Thu, 6th April, 2017

The Office of Responsible Research Practices and the Center for Clinical and Translational Science are offering an introductory workshop on the informed consent process. The session will:

  • Provide an overview of informed consent
  • Provide 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, April 18, from 8 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

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

International Research Workshop

Tue, 7th March, 2017

The Office of Responsible Research Practices is offering a workshop on conducting human subjects research at international locations. The session will:

  • Debunk common myths about international research
  • Explain how to create and submit Buck-IRB proposals
  • Provide tips about the informed consent process, including scenarios when a waiver of consent documentation may be appropriate

While the session will be tailored to social and behavioral sciences researchers, anyone preparing IRB submissions is welcome.

The workshop will be held on Tuesday, March 28 from 4 p.m. to 5 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 / 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