Posted: November 18, 2022
Do you compensate participants who take part in your research? The Office of Responsible Research Practices and the College of Optometry are offering an updated workshop on participant recruitment and compensation considerations in both medical and non-medical research.
By the end of the session, participants will be able to:
Questions? Please contact Sandra Meadows
Posted: May 19, 2022
The Office of Responsible Research Practices, the Western-Copernicus Group (WCG) IRB, and the Center for Clinical and Translational Science are presenting a session about WCG IRB oversight of Ohio State human subjects research with WCG IRB representative, Christopher Gennai. The presentation will:
The session will be held on Monday, May 23rd, from 11 a.m. to 12 p.m. via CarmenZoom.
For more information, contact Sandra Meadows at 614-688-8641 or meadows.8@osu.edu.
Posted: January 19, 2022
On November 24, 2021, the USDA APHIS issued a final rule in response to the 21st Century Cures Act for the Institutional Animal Care and Use Committee at each facility to conduct a continuing review of research activities involving animals and review of such activities at least every three years. This change aligns with NIH OLAW timeline for completing a review. Therefore, the IACUC voted to eliminate annual reviews for approved protocols with the exception of studies funded by U.S. Department of Defense (DoD). This change is effective December 27, 2021.
In addition, the Institutional Biosafety Committee evaluated the annual review process and voted to eliminate submitting a form annually. In its place, an email notice will be sent requesting an annual protocol self-assessment to be performed to help determine if a protocol amendment is needed or changes to the study team. A list of items to review will be provided in the instructions of the notice. This change is effective January 13, 2022.
A renewal protocol is still required to be submitted. These changes do not affect the 3-year renewal process for IACUC protocols nor the 5-year renewal process for IBC protocols.
Posted: August 12, 2021
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 University Libraries 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:
While the presentation 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 Tuesday, September 28th, from 1:00 to 2:30 p.m. via CarmenZoom
For more information, contact Sandra Meadows at 688-8641 or meadows.8@osu.edu.
Posted: January 15, 2021
Beginning in January 2021, a new question will be added to the Continuing Review (CR), Annual Status Report (ASR), and Final Study Report (FSR) applications to capture changes made to research to eliminate apparent immediate hazards due to the COVID-19 pandemic. The question will remain in place for approximately 1 year, and then will be removed. The question will be located in the Research Progress section as follows:
Identify any changes made to the research procedures in response to the COVID-19 pandemic that were not previously submitted via amendment. Check all that apply.
* In-person activities were changed to remote visits
* Surveys were deployed instead of face-to-face interactions
* Consent/HIPAA authorization procedures were modified to obtain remotely
* Research procedures (e.g., laboratory blood draws) were missed or delayed
* Research data storage location was changed (e.g., from laboratory/office to home)
* Other (specify)
As a reminder, temporary changes to certain study procedures in response to the pandemic do not require an amendment if they meet specific criteria, as described in Ohio State’s guidance and FAQs on the impact of COVID-19 on human subjects research.
Please contact IRBinfo@osu.edu with questions.
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. 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:
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.
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:
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.
For more information, contact Sandra Meadows at 614-688-8641 or meadows.8@osu.edu.