Office of Responsible Research Practices
The Ohio State University
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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 28th 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

Event Reporting Workshop

Tue, 10th January, 2017

The Office of Responsible Research Practices is offering a workshop on human subjects research event reporting.  The session will:

  • Provide an overview of the revised event reporting policy
  • Differentiate between investigator, sponsor, and IRB reporting requirements
  • Provide definitions and discuss case examples
  • 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, February 7 from 8-9 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 Training for Graduate Students

Mon, 9th January, 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 workshop will focus on the following key topics:

  • Understanding the ethical basis for IRB review
  • Exploring types of research and review requirements
  • Reviewing application components
  • Tips for successful application submission
  • Available resources
  • Q&A

The workshop will be held on Wednesday, February 1 from 4-5 p.m. in the Research Commons, Third Floor 18th Avenue Library, 175 West 18th Avenue.

Registration requested.

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

Category : IRB / ORRP / 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

International Research Workshop

Tue, 1st November, 2016

The Office of Responsible Research Practices is offering a workshop on creating and submitting proposals for researchers who plan to conduct research in international locations. This workshop will focus on regulatory requirements, review considerations (e.g., informed consent process), and the cultural context to be considered when planning a project. 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, November 29 from 4-5 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 / ORRP / Training

Graduate Student Overview of the IRB Process

Wed, 12th October, 2016

The Office of Responsible Research Practices is offering a workshop for graduate students on how to navigate the Institutional Review Board (IRB) process. The workshop will focus on the following key topics:

  • Understanding the ethical basis for IRB review
  • Exploring types of research and review requirements
  • Reviewing application components
  • Tips for successful application submission
  • Available resources
  • Q&A

The workshop will be held on Wednesday, October 19 from 4-5 p.m. in the Research Commons, 3rd Floor 18th Avenue Library, 175 West 18th Avenue.

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

Category : IRB / ORRP / Training

Human Subjects Research and the HIPAA Privacy Rule

Wed, 12th October, 2016

The Office of Responsible Research Practices is offering a workshop on the HIPAA Privacy Rule and HIPAA Security Rule and the measures needed when performing research involving protected health information.  The workshop will include a review of the HIPAA research authorization form, waivers of HIPAA research authorization, a review of device encryption policies, and tips on how to keep your research data secure.  Anyone involved in preparing medical (biomedical/cancer) IRB submissions is welcome.

The workshop will be held on Wednesday, October 19 from 8-9 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

Buck-IRB Submissions Workshop

Fri, 26th August, 2016

The Office of Responsible Research Practices is offering a workshop on creating human subjects research submissions within the online Buck-IRB system. This workshop will explain the system’s functions and how to navigate the different submission types (i.e., initial, exempt, amendment, continuing review, event report). Anyone involved in preparing IRB submissions is welcome. The workshop will be held on the following dates:

Wednesday, September 7th from 11:00am to 12:30pm in the Research Commons, Third Floor 18th Avenue Library, 175 West 18th Avenue. Registration requested at https://library.osu.edu/researchcommons/event/au16-buck-irb-submissions/.

Thursday, September 15th  from 9:30am to 11:00am in the David Heart & Lung Research Institute, Room 165, 473 West Twelfth Avenue. Registration requested at http://researchcalendar.osu.edu/index.php?eID=1192.

Thursday, September 22nd from 9:30am to 11:00am in the David Heart & Lung Research Institute, Room 165, 473 West Twelfth Avenue. Registration requested at http://researchcalendar.osu.edu/index.php?eID=1193.

 

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

Category : Buck IRB / IRB / ORRP / Training