- Is Online Submission Training Available?
- Routing, Certification and Department Approval
- Consent Forms
- Naming (or renaming) your consent forms and attachments
- Accessing your approval letter and document list
- Responding to IRB Stipulations
- Human Subjects Research Ethics Training
- Data Security
- Team members not affiliated with UNC
- Reliance on External IRBs
Is training for using the new online submission system available?
Future training sessions will be posted here. In addition, web based training modules and task-specific training aids are accessible by clicking HELP on the online application task bar, as well as at the OHRE website. You may also request assistance from IRB Coordinators David Tegnell and Catherine Ford at 966-3113.
When I submit a study, to whom is it routed? In what order?
After submission, the PI and Faculty Advisor (if relevant) are prompted to certify it. Next, the Home (appointing) Department of the PI and then, as relevant, the Administering Department (the department where the research is being conducted, if other than the Home Department) must approve it. After departmental approval, if the CTRC and PRC are involved in the research, they must certify it. The submission is then passed to the IRB. See routing chart.
Who approves the submission in the Home and Administering Departments?
Just as investigators submit electronically, their departments also approve IRB applications online, as part of the routing process. The expectation is that approval is being given on behalf of the head of the Department, Division, or Center. If the Chair or Director is an investigator on the project under review or is otherwise conflicted in approving it, the Vice-Chair or Chair’s designee should review it. As relevant, the department may have a pre-IRB review committee in place whose reviewers will advise the Department Chair or designated approvers as to whether or not a submission should be approved. No submission can be accepted by the IRB until approved by the relevant department(s).
What does the Home or Administering Department approve?
By approving, the Home or Administering department affirms that:
- The research is appropriate for the investigator and his/her Department
- The investigator(s) are qualified to conduct the research
- There are adequate resources (financial, support, and facilities) available
- For units that have a local review committee for pre-IRB review, this requirement has been satisfied
- The department supports the application and its review by the IRB
- The department agrees to accept responsibility for managing data security risks in consultation with departmental or campus security personnel
How do designated departmental reviewers access submissions for review?
All designated reviewers and approvers are notified by email when a submission is ready for review. This email contains a link to the IRBIS (i.e., IRB-Information System) home page where the online submission can be reviewed. The instructions are also found here.
Can a Department Approver review a study on which he or she is named as study personnel, but is not the PI?
Must both the Home and Administering Department conduct a pre-IRB review?
If both a Home and Administering Department are named on a submission, each must certify the submission. However, pre-IRB review is not required by the IRB, rather this is a process put in place by individual departments. When there is both a “Home” (PI’s home department) and “Administering” (where study is conducted) department, the PI should either speak with the relevant people in each department to coordinate where a pre-IRB review is most relevant, or representatives from the two departments may confer and agree on the extent of the each department’s review responsibilities.
How is a departmental approval indicated?
When departmental approval is granted, the name of the approving individual is inserted at the bottom of the pdf copy of your application. These electronic “signatures” are recognized as being in compliance with Federal (FDA 21 CFR 11) standards.
What if a Department does not approve a submission?
If the Department rejects your submission, the reviewer will provide you with specific feedback. You will receive an email informing you that your submission was rejected, and providing you with a link to the reviewer’s comments in IRBIS. After you address the reviewer’s concerns by revising your online application, you will resubmit it and it will be again routed to the department or entity that did not approve it as well as any department/entity that has not yet reviewed it. See the Routing (Investigator): Revising and Resubmitting training aid.
Will my response to changes requested by the IRB also be routed for department approval?
No. You will resubmit your revised application directly back to the IRB.
How do local review committee members (Pre-IRB review) provide feedback?
Local review committee members communicate their concerns to the designated Department Approver(s) external to IRBIS. The Department Approver then summarizes and conveys the committee’s feedback via the routing comments function within IRBIS.
How does IRBIS “build” a consent form?
Based on your application responses, IRBIS selects from a library of basic templates (e.g., adult consent form, child assent) to be used in your study. This template is then customized from your responses to key questions. On the Consent Forms screen, you may download this template and further edit it to create a consent form that reflects the particulars of your study. (See training video here.)
Can one member of my study team work on consent forms, while another completes the application?
Team members may collaborate on the online application. However, the entire application must be completed BEFORE the consent form templates are edited, since the consent form template is built from the application responses.
Are consent forms that are generated by the online system “stamped” to indicate approval by the IRB?
No. Effective August 20, 2012, the IRB ceased electronically “stamping” forms upon approval. Instead, researchers are now afforded the opportunity to generate a list of documents included with an approved submission. Because this Document List identifies documents by file name, it is important that file names are accurate, recognizable and distinguishable from others. This may be especially important to researchers who are subject to external monitoring or sponsor requirements. For more information, click here.
What conventions should I adopt in naming my supporting documents?
Efective Monday, August 20, 2012, ceased electronically stamping consent forms and attachments. Instead, researchers are now afforded the opportunity to generate a list of documents included with an approved submission. Therefore, it is important that you provide a unique name for each supporting document, using the following suggested guidelines:
- Make the file name sufficiently descriptive and the context of the file clear.
- Avoid using certain special characters in a file name (& * ? < # as they may cause problems and may prevent upload of the document. A dash (-), black space or underscore (_) may be used.
- Format dates consistently and choose a clear standard. Always include the year. For example, March 24, 2011 might be represented as 24MAR2011 or 2011_03_24 or 03-24-11.
- Use version numbers to manage revisions (e.g., V1, V2, V3). This may be useful for Protocols where both a date and version number are used to identify the document.
- Be consistent. Develop a naming convention and have all study team members use it. As relevant, document your naming convention in your study file and share it with team members, monitors and auditors.
- Abbreviate standard document types to reduce file name length (e.g., MP: Master Protocol, CF: Consent Form, AF: Assent Form, IG: Interview Guide)
- Consider including the document file name in small font in the footer of the document. If you do this, remember to update the footer each time the document is revised.
Must I submit a modification to rename my existing documents?
Yes. However, a mechanism is provided on both the Consent Forms and Attachments screens to facilitate the renaming of existing documents, without opening them. Please click here to see the guidance. Also, please keep in mind that you may now modify your study when renewing.
How do I access my approval letter and document list?
Effective Monday August 20, 2012, the IRB will no longer be stamping approved documents. From this point forward, you will have the opportunity to generate a list of documents included with an approved submission.
Why is my approval letter not signed?
Effective May 2011, written notifications from the IRB will no longer be signed as they are generated and delivered electronically by the IRB information system. It is important to note that signatures are not required by Federal Regulations. See the letter to University researchers and sponsors.
How will I be notified of the completed IRB review and any stipulations that I need to address?
You will be notified by email of any changes stipulated by the IRB. This same email will also be sent all members of your study team whom you designate to receive IRB correspondence. The email will contain a link to the IRBIS home page where all IRB correspondence requiring your attention is listed.
May any member of my study team respond to IRB stipulations?
Yes. Although the PI is responsible for the conduct of the study, he/she may delegate responsibility for responding to stipulations to others, as relevant.
How do I respond to stipulations?
You can reply to stipulations about the application itself using an interactive webpage that will direct you to the exact location in the online application where the stipulation was noted. Through this interactive webpage, you will be able to respond to the IRB about this and other stipulations, eliminating the need for a point-by-point response memo. In addition, IRBIS makes available to you Word copies of your consent forms and attachments, with the IRB’s edits and comments in track-changes. You will be expected to make the requested changes within this marked up document, and then replace your original document with a clean revised version.
Does my response to stipulations require PI or Faculty Advisor re-certification?
Does my response to stipulations require departmental approval?
How do I indicate that my study team members who are employed by UNC-Chapel Hill have completed CITI training?
You need do nothing. Certification is reported directly to the IRB processing system for all UNC Personnel completing the CITI modules.
How do I indicate certification of my study team members who are employed by UNC-Chapel Hill, but who previously completed the CITI course at another institution?
Please ask these study team members to: (1) access their CITI accounts; (2) affiliate with UNC-Chapel Hill; (3) update their personal profile; (4) select Human Subjects Protection (IRB modules); and (5) select the appropriate CITI training group. This certification will then be reported directly to the UNC Human Research Ethics training database and to the IRB processing system.
How do I indicate that my study team members who are employed by other institutions have completed ethics training?
Upload the certification document from the member’s home institution as an attachment.
What about Data Security issues?
The move to online IRB applications is also bringing a change in the way the IRB (and the rest of campus) approaches data security. Recent episodes involving computer breaches have highlighted the need for a more rigorous, informed approach to protecting research data in the digital environment, including more active involvement and control by departments and schools. The revised IRB application moves away from a process that relied on the researcher to provide technical details and the IRB to review those details, accepting that neither of these parties were necessarily expert in modern data protection standards. The new application keeps track of certain parameters (e.g., the collection of personal identifiers and/or sensitive information), assigns a “security threat level” based on the combination of identifiability and sensitivity, and informs researchers what must be done to protect their data in accordance with ITS policies. Investigators are also asked to provide information about their IT support staff who will be helping them meet those standards. These IT experts will also receive reports of studies in their area, so they are in better position to assist in the oversight and management of research data. This is ultimately a shared responsibility across investigators and the units in which they work.
How can a member of the study team who is not affiliated with UNC get access to IRBIS?
Individuals may access IRBIS only by logging in with an ONYEN, UNC’s campus-wide electronic service identifier. To obtain an ONYEN, one must first obtain a PID (Person ID Number), a unique identification number assigned to each person with a University relationship.
If you are not affiliated with UNC-Chapel Hill, but are a member of a UNC based research study team, and have a need to create or edit an IRB application, you may obtain a PID by first applying for “Other Affiliate” status. Complete the Affiliate Application Form (Select from “Important Links and Documents” at the bottom of web page), then print out the completed form (or save electronically) and hand deliver (or email) it to the HR Facilitator of the Principal Investigator’s department.
The HR Facilitator should enter the information from the completed application into the online Affiliate Management System. The PID Office will then process (please be aware that PID processing can take 2 business days or longer).
Once the request is approved, the PID Office forwards the PID to the department’s HR Facilitator, who in turn must notify the “Other Affiliate.” With PID in hand, the “Other Affiliate” can then access the ONYEN Management web page and create an ONYEN.
A currently affiliated study team member must add the “Other Affiliate” to the IRB application’s Project Personnel list. Once added, he/she will be able use the newly acquired ONYEN to access IRBIS.
Does UNC accept reliance on central or independent IRBs for clinical trials?
Yes. Effective October 15, 2013, UNC will rely on the approval and oversight of the central/independent IRB already involved with an industry-sponsored, multicenter trial, provided certain criteria are met. Please CLICK HERE for a guidance document providing an overview of the process for requesting reliance on a central or independent IRB.
Informational sessions were offered to provide background, introduce the new policy, and demonstrate the abbreviated application used for this scenario. Please CLICK HERE for the slides used in these sessions.
How do I request that UNC rely on another institution’s IRB, or that another institution rely on UNC’s IRB for ethical oversight of my study?
For specific instructions on how to complete the Multi-site sections 5 and 5A of the online IRB application, click here.
Which central/independent IRBs are eligible for UNC investigators to use for industry-sponsored, multi-center clinical trials?
This reflects a change effective October 15, 2013: UNC has master service agreements in place with the following IRBs, and will rely on them when they have been designated by the sponsor/CRO as central IRB for a given clinical trial.
- Alpha IRB
- Aspire IRB
- Chesapeake IRB
- Compass IRB
- Copernicus Groups IRB
- Ethical and Independent Review Services
- IntegReview IRB
- IRB Company
- IRB Services
- New England IRB (NEIRB)
- Quorum IRB
- Schulman IRB
- Sterling IRB
- Western IRB (WIRB)
These additional independent/central IRBs are eligible but do not currently have agreements with UNC. If requested by investigators/sponsors, these IRBs may be relied upon on once agreements are in place:
- Biomedical Research Alliance of New York (BRANY) IRB
- Goodwyn IRB
- Harrison IRB
- Liberty IRB
- MidLands IRB