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Buck IRB News

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

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

Buck-IRB Continuing Review Submissions Workshop

Tue, 24th January, 2017

The Office of Responsible Research Practices is offering a workshop on creating human subjects research continuing review submissions within the online Buck-IRB system. This workshop will:

  • Explain the needed associated submission materials
  • Discuss common errors found in screening and IRB review and ways to avoid them
  • Provide tips for navigating the Buck-IRB application
  • Clarify when an annual status report may be appropriate

Anyone involved in preparing IRB submissions is welcome.

The workshop will be held on Thursday, February 23 from 11 a.m. to 12:30 p.m. in the Research Commons, Third Floor 18th Avenue Library, 175 18th Avenue.

Registration requested.

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

Category : Buck IRB / IRB / ORRP

Updates to the Buck-IRB system

Tue, 3rd January, 2017

New updates to the Buck-IRB submission system go live on January 3, 2016.

Included in this update are features that will improve and enhance the Buck-IRB work experience for investigators and research staff. The following features are incorporated in this latest update:

  • The Ohio State approved research site list has been updated to include all 88 Ohio county extension offices, allowing investigators to select the specific extension research location(s)
  • Weekly reminder notices (sent on Friday mornings for outstanding investigator responses pending for seven days or longer) will include the submission type in the email subject line
  • Weekly reminder notices will begin to be sent for both exempt studies and event report submissions
  • ORRP staff will be able to assign an external ID to studies in Buck-IRB for tracking purposes. This may include a sponsor, internal, and/or external IRB-assigned number.

Other changes
Other changes are included with this Buck-IRB update, though the majority will occur behind the scenes with little or no direct impact on investigators.

Login to Buck-IRB at go.osu.edu/Buck-IRB.

For additional information about this Buck-IRB update, please contact Susan Ebert at ebert.55@osu.edu.

Category : Buck IRB / IRB / ORRP

Updates to the Buck-IRB system

Tue, 6th December, 2016

Several updates to the Buck-IRB system went into effect on December 6, 2016, many of which will improve and enhance the Buck-IRB work experience.

  • Investigators using the combined consent and HIPAA authorization template can now place the document in Buck-IRB as a combined document, requiring only one upload
  • Studies involving more than one student pool (e.g., REP, LOC) can now indicate all student pools used
  • Pending signatures (including personnel change requests) are now visible on the study workspace for all submission types. The “re-notify” button can be used to remind study team members of the signature requirement.
  • Investigator faculty appointment information is now displayed consistently across systems, including Buck-IRB and Study Team Look-up. If a faculty member has multiple appointments, all will be displayed.
  • In addition to date, the time will be displayed for all action history entries on the study workspace page

Other changes

Many other changes included in the update improve workflow for ORRP staff and IRB members, though the majority will occur behind the scenes with little or no direct impact on investigators.

Login to Buck-IRB at go.osu.edu/Buck-IRB.

For additional information about this Buck-IRB update, please contact Susan Ebert at ebert.55@osu.edu.

Category : Buck IRB / IRB / ORRP

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

Updates to the Buck-IRB system

Thu, 18th August, 2016

Several updates to the Buck-IRB system went into effect on August 18, 2016. A number of the updates address requests made by investigators and research staff to enhance the Buck-IRB work experience.

The updates are described below:

  • in order to prevent errors on the Informed Consent page, whenever a verbal or online script is selected, the request for waiver of consent documentation (or parental permission documentation, as appropriate) will automatically be made by the system
  • an alert has been added to the personal workspace for all Buck-IRB users to indicate if a study is pending signature(s)
  • a Final Study Report form and submission instructions are now available
  • an upload box is now available for studies requesting an Alteration of HIPAA Authorization
  • all personnel listings now have consistent displays of investigator financial conflict of interest (COI) information across all areas and access levels
  • a new action of ‘No Review Required’ was added to Buck-IRB for projects that either do not represent research involving human subjects or where Ohio State is not engaged in the research

Additional updates were made to satisfy regulatory or policy requirements. They are outlined below:

  • investigators studying investigational or FDA-approved drugs will be asked to confirm whether the pending research includes botulinum toxin in any form
  • continuing review expiration letters will state that study reactivation can only occur within 60 days of expiration or a new study must be submitted
  • new instructions are provided for investigators submitting a continuing review after the study has expired and has been terminated in the system

Many other changes will occur with this Buck-IRB update to improve workflow for ORRP staff and IRB members, though the majority will occur behind the scenes with little or no direct impact on investigators.

Log in to Buck-IRB at go.osu.edu/Buck-IRB.

For additional information about this Buck-IRB update, please contact Susan Ebert at ebert.55@osu.edu.

Category : Buck IRB / IRB / ORRP

Buck-IRB Updates

Fri, 1st April, 2016

New updates to the Buck-IRB submission system go live on April 1, 2016!

Included in this update are features specifically requested by investigators to enhance the Buck-IRB work experience. The following features are incorporated in this latest update:

  • Investigators and research staff can now notify co-investigators with outstanding signatures within the system;
  • Study options have been re-ordered in the study workspace to prevent inadvertent submission withdrawals;
  • Help text has been added to personnel change submissions to state why specific study team members may not be eligible for editing/removal;
  • Investigators will receive a list of all submitted documents with every submission notification;
  • Study team members can now track all study notifications, including PI notifications, and department chair and co-investigator signature reminders;
  • An alert has been added to the study workspace to indicate if an event report is pending submission;
  • The study number has been added to the subject line of all notifications to PIs to better track pending submissions; and
  • Amendments beyond personnel changes are now permitted on external studies (i.e., WIRB, NCI CIRB, NCH), including HIPAA authorization waiver requests, location changes, and requests for Human Subjects Radiation Committee (HSRC) review.

Other changes

Many other changes will occur with this Buck-IRB update to improve the submission experience, though the majority will occur behind the scenes with little or no direct impact on investigators.

Login to Buck-IRB at go.osu.edu/Buck-IRB.

For additional information about this Buck-IRB update, please contact Susan Ebert at ebert.55@osu.edu.

Category : Buck IRB / IRB / ORRP

Buck-IRB Updates

Fri, 15th January, 2016

New updates to the Buck-IRB submission system go live on January 15, 2016!

Annual status report

An important enhancement to the Buck-IRB system included with this update provides that, under certain conditions, the requirements for continuing IRB review can be satisfied by completing a brief annual status report.

The abbreviated, annual status report is available for minimal risk, expedited studies that are not FDA-regulated or federally funded. The annual status report is limited to questions regarding study changes over the previous year and current study status.

Unless the IRB requires that the study undergo continuing review, researchers can submit the annual status report for studies meeting all of the following conditions:

  • Studies considered minimal risk and qualifying for expedited review (even if the study initially received convened review),
  • Studies not supported by a federal agency or not having received federal funding (at any time during the research), including through a sub-award from another institution;
  • Studies not FDA-regulated (including studies involving drugs, devices, and data submission),
  • The investigators do not intend to make personnel changes at the time of the annual review. Personnel changes are not permitted with the annual status report (but continue to be available with the full, continuing review application).

Note: Investigators must continue to submit proposed changes (i.e., amendment submissions) and event reports for studies meeting the conditions for an annual status report.

Other changes

Many other changes will occur with this Buck-IRB update, though the majority will occur behind the scenes with little, direct impact on investigators. Other added features are intended to streamline submission screening within Buck-IRB for ORRP staff. One example is that ORRP staff will now be able to move submitted documents within Buck-IRB without asking investigators to perform this task, which will save screening time. Additionally, the management of external studies (e.g., WIRB, NCI CIRB, and NCH) will also be modified so that investigators can begin to submit personnel changes as soon as the research is ceded to the external IRB, providing more efficiency to this process.

Login to Buck-IRB at go.osu.edu/Buck-IRB.

For additional information about this Buck-IRB update, please contact Susan Ebert at ebert.55@osu.edu.

 

 

Category : Buck IRB / IRB / ORRP

Buck-IRB Updates

Fri, 6th November, 2015

Additional updates to the Buck-IRB online submission system will go live at 4pm on November 6, 2015!

The following new features have been added: IRB/exempt correspondence, such as approval letters and incomplete notices, will be generated from Buck-IRB and sent directly to investigators in email format (rather than as attachments); all sent correspondence will be stored and accessible to the study team in Buck-IRB; automated CITI training expiration notices will be sent from the system to all study team members on active protocols at 90, 60, and 30 days before expiration; and study expiration dates have been added to the personal workspace (in response to user feedback) for quick access.

Login to Buck-IRB at go.osu.edu/Buck-IRB.

For additional information on these updates, please contact Susan Ebert at ebert.55@osu.edu.

Category : Buck IRB / IRB / ORRP