The Case Western Reserve University Institutional Biosafety Committee (IBC) is charged with the responsibility for the oversight and approval of research activities involving recombinant DNA (rDNA) and synthetic nucleic acid molecules that take place at CWRU, MetroHealth Medical Center, Louis Stokes Cleveland Veterans Affairs Medical Center and University Hospitals Cleveland Medical Center.
The National Institutes of Health (NIH) Guidelines for Research Involving Recombinant or Synthetic Nucleic Acid Molecules provide safety considerations for covered experiments, including risk assessment and containment information.
To learn more about the NIH guidelines, please visit the NIH’s Office of Science Policy.
Research involving infectious agents, toxins and other biologicals not containing rDNA is reviewed by other institutional oversight entities, including the Environmental Health and Safety Office and the Biosafety Level 3 Advisory Committee.
Submissions to the CWRU IBC
Any experiment that falls under Section III-A through Section III-E of the NIH guidelines must be submitted to the CWRU Institutional Biosafety Committee (IBC) for review using the iRIS system. Some clinical studies will be reviewed by an external IBC - see additional information under Human Gene Transfer Studies.
- Pre-review: Once the submission has been received by the Office of Research Compliance, it will undergo a review by the office staff to ensure that the submission form has been appropriately completed, and all needed materials have been provided.
- Full committee review: Once the submission is considered complete, it will be assigned to an IBC member as a primary reviewer and put on the agenda for the next IBC meeting.
- Administrative review: Amendments limited to changes in study team or funding will be reviewed by the office staff.
Once a protocol is approved, an approval letter is sent listing the biosafety level and risk group set by the IBC, date of approval, and the date by which a continuing review is required for continuation of the study, and any additional requirements.
For projects conducted at BL-1 and BL-2, committee approvals are valid for three years from the date of approval. For all human studies regardless of the biosafety level or projects conducted at BL-3 committee approvals are valid for only one year.
IBC submissions are managed through iRIS; to access them, log in with your CWRU network ID and password.
- You can create a new project under the "Study Assistant" tab. There, select "Add a New Project."
- Complete the application step-by-step. You do not need to complete everything during one session. Be sure to select "Save and Continue" throughout.
- Key Personnel (Section 3 of study application), refers to those researchers who will need access to the study in the system and have user accounts in iRIS. (You may need to request user accounts for individuals.)
- Individuals who are participating in the research but do not need access in iRIS can be listed as a study team member (Section 7).
- The completed initial submission form can be submitted by the PI, and no additional approvals are required.
Submissions need to be received four weeks prior to an IBC meeting to be put on the next meeting agenda. Download the Initial Review Submission Guide.
A variety of investigational products involve the transfer of recombinant or synthetic nucleic acid molecules (r/sNAs) into human research participants, including but not limited to: vaccines, viral vectors and cell therapies. These studies will require review and approval by the IBC to maintain compliance with the NIH Guidelines for Research Involving Recombinant or Synthetic Nucleic Acid Molecules.
IBC Submissions for studies conducted at University Hospitals Cleveland Medical Center, MetroHealth Medical Center, and the Veterans Affairs Northeast Ohio Healthcare System are managed through iRIS; to access the system, login with your CWRU network ID and password.
Industry-sponsored clinical studies being conducted at University Hospitals or MetroHealth will be reviewed by an external IBC registered with the NIH Office of Science Policy. The process still requires submission of the study in iRIS, but additional information will need to be shared with the sponsor and the external IBC. View additional information about IBC review of clinical studies or contact case-ibc@case.edu for more information.
Download the Industry-Clinical Submission Guide (for Industry-sponsored clinical studies being conducted at University Hospitals or MetroHealth)
Download the Initial Submission Guide (for all studies at the VA or federally funded/PI-initiated studies at UH and Metro)
Please note, the research also requires review and approval by an Institutional Review Board (IRB) prior to initiation.
Download the Continuing Review Submission Guide.
A continuing review must be submitted to the CWRU IBC using the continuing review request form in the iRIS system.
Log in to iRIS with your CWRU network ID and password.
- Navigate to “Study Assistant” then “My Studies.” Select the icon to open the appropriate study.
- On the left, select the link for “Continuing Review/Termination Submission Form.”
- At the top, select “Add a New Form.”
- Complete the form, and if there are any personnel or experimental changes, please indicate and update the study application as needed.
- The completed continuing review submission form can be submitted by the PI, and no additional approvals are required.
The meeting schedule should be consulted to determine the IBC meeting date prior to the expiration date of the study, and the continuing review submission will need to be received by the office four weeks prior to that meeting date
If at any time during the approved research period you propose to make changes to the planned research, you must submit an amendment to the IBC for review and approval of the change or modification before it is implemented. Changes to the study personnel can be approved through an administrative process, with the exception of a change in PI. Changes to research location will be reviewed by the biosafety officer and may require review at a convened IBC meeting.
Login to iRIS with your CWRU network ID and password.
- Navigate to “Study Assistant” then “My Studies.” Select the icon to open the appropriate study.
- On the left, select the link for “IBC Amendment Form.”
- At the top, select “Add a New Form.”
- Complete the form, and if there are any personnel or experimental changes, please indicate and update the study application as needed.
- The completed amendment submission form can be submitted by the PI, and no additional approvals are required.
When the work of an IBC protocol has been completed or will no longer continue, a termination notification should be submitted to close out the protocol.
- Login to iRIS with your CWRU network ID and password.
- Navigate to “Study Assistant” then “My Studies.” Select the icon to open the appropriate study.
- On the left, select the link for “Continuing Review/Termination Submission Form.”
- At the top, select “Add a New Form.”
- Complete the form, checking "Notification of Termination" in section 2.
- The completed submission form can be submitted by the PI, and no additional approvals are required.
If a PI of an IBC protocol leaves the institution, the IBC protocol should either be closed through a notification of termination or transferred to another faculty member through an amendment submission.
IBC Contacts
Dr. Craig Hodges is chair of the CWRU Institutional Biosafety Committee.
Get in Touch
If you have questions or feedback for the IBC, email us at case-ibc@case.edu or contact a member of our team.
