Office of Responsible Research Practices
The Ohio State University

Office of Responsible Research Practices News

Ohio State guidance and FAQs on the impact of COVID-19 on human subjects research

Posted: November 12, 2020

The Office of Research and Office of Responsible Research Practices (ORRP) continues to update guidance pertaining to human subjects-related research visits, with the goal of protecting research participants, researchers, and the larger Ohio State community from risk of infection with COVID-19, as well as to ensure ongoing access to research that may provide essential support and care to participants.

Staged approach to returning to on-campus human subjects research activities

The Office of Research has developed a guidance document, entitled Research Recovery Plan for Staged Reopening, and a webpage with many helpful resources. If after reviewing this information and working through your college you have additional questions, please direct emails to research@osu.edu.

For guidance specific to human subjects clinical research conducted at the Ohio State Wexner Medical Center or the James Cancer Hospital, please contact the following:

FAQS

Are ORRP and the Ohio State IRBs operating as usual?
Yes, the Office of Responsible Research Practices and Ohio State’s IRBs are fully functional and operating at standard capacity.

Can I submit new studies during the COVID-19 outbreak?
Yes, you may submit new studies in Buck-IRB. New studies will be screened and forwarded for expedited or convened IRB review in accordance with standard ORRP procedures and timelines. Refer to the Research Recovery Plan for Staged Reopening for additional guidance regarding on-campus research activities.

I need to modify my study procedures in response to COVID-19 precautions. How do I do that?
COVID-19-related study modifications DO NOT REQUIRE the submission of an amendment in Buck-IRB if they meet ALL of the following criteria:

  • The modifications are being made to comply with state, local, or institutional requirements such as the use of face masks or pre-visit mandated health screenings, or involve postponing or changing in-person research activities to being conducted remotely (see below if making changes to the consent process);
  • The modifications are TEMPORARY and will last only for the duration of the COVID-19 outbreak; and
  • They do not pose a significant increased risk to the participant.

Although use of remote platforms/applications may increase the possibility of participant identifiability and/or pose a risk to confidentiality, the temporary use of university recommended tools such as Qualtrics, Skype, Zoom, Box, and secure email do not require an amendment (as the risk of in-person visits offsets the limited risk of a breach of confidentiality).

Modifications to study procedures that do not meet the above criteria require IRB notification via an amendment in Buck-IRB.

How do I make changes to the consent process?
Unless the IRB has previously approved a waiver of consent documentation or a waiver of the consent process, investigators MUST continue to obtain a written signature from participants when conducting the consent process remotely. The signed consent form can be sent to the investigators via email, mail, or signed in-person upon arrival to the first in-person study visit. Changes to any other method of documentation (e.g., DocuSign, REDCap) require the submission of an amendment.

Investigators must incorporate all elements of consent into the discussion and document the remote consent discussion in the study files.

I temporarily modified my study procedures in response to COVID-19 precautions, and now I want to go back to the way the study was conducted before the outbreak. Do I need to notify the IRB? 
No. To continue with the study as it was approved before the outbreak, you do not need to notify the IRB of that change.

What additional requirements must be met in order to include prisoners or prisoner data in my study?
In addition to the regulatory requirements outlined in HRPP policy Research Involving Prisoners, all projects involving Ohio Department of Rehabilitation and Correction (ODRC) offenders, including non-interventional record review studies, must first be reviewed and approved by the ODRC Human Subject Research Review Committee (HSRRC). ORRP will facilitate the ODRC review process. For more information, contact Tish Denlinger at Denlinger.33@osu.edu.

Category : IRB / ORRP

Human Subjects Research 101: From Inspiration to Approval!

Posted: September 1, 2020

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.

Category : Educational Offerings / IRB / ORRP

FDA Series – Using Medical Devices in Human Subjects Research

Posted: August 10, 2020

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 Thursday, November 17th, 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.

Category : Educational Offerings / IRB / ORRP

FDA Series – Using Drugs in Human Subjects Research

Posted: July 28, 2020

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 10th, 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.

Category : Educational Offerings / IRB / ORRP

Event Reporting in Human Subjects Research

Posted: May 23, 2020

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.

Category : Educational Offerings / IRB / ORRP

Rescheduled – Human Subjects Research 101: From Inspiration to Approval!

Posted: May 12, 2020

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.

Category : Educational Offerings / IRB / ORRP

Update on Institutional Biosafety Committee (IBC) activities during the COVID-19 pandemic

Posted: April 22, 2020

The IBC is supportive of research efforts involving SARS-CoV-2.  Any research that includes handling samples with the virus or research with the virus requires IBC review.  To help expedite these reviews, the IBC is meeting on an as needed basis via videoconferencing to review these new protocols and amendments.

A guidance document is available to assist with protocol preparation.  Please be sure to read this document to ensure you are providing the information required by the IBC. The IBC consists of faculty members who are also experienced researchers. Your help in preparing a well-designed research protocol is appreciated. The IBC also recommends that a new protocol be submitted rather than amending an already approved protocol if the work is not related.

Examples of Activities that require IBC review

  • Creating recombinant or synthetic nucleic acid molecules  (vector plus gene) or inserting these molecules into cell lines/tissue cultures, whole animals, humans, or plants
  • Using or creating transgenic or knock-out animals
  • Using a microorganism that is pathogenic to humans (including immunocompromised individuals), plants, or animals (based on wild-type organism)

Examples related to SAR-CoV-2:

  • Using or collecting human or non-human primate materials (body fluids, tissues, cells and established cell lines, etc.)
  • Isolation of SARS-CoV-2 virus (BSL3)
  • Propagation of SARS-CoV-2 virus (BSL3)
  • Expression of SARS-CoV-2 proteins in non virus systems (typically BSL2)
  • Expression of SARS-CoV-2 proteins in heterologous virus systems (BSL2-BSL3)
  • Vaccination studies with SARS-CoV-2 proteins (BSL2)
  • Isolation of viral nucleic acids from clinical or environmental samples (BSL2)
  • Blood serology for antibodies to SARS-CoV-2 (BSL2)
  • Nucleic acid-based intestinal microbiome studies of infected individuals (BSL2)
Category : IACUC / ORRP