Human subjects – IRB
Compliance & Integrity
Human Subjects | IRB
The Institutional Review Board (IRB) is in place to ensure that human subjects involved in research are adequately protected and that the institution acts in accordance with the federal regulations regarding research with human subjects. Prior to the initiation of any research efforts that involve human subjects, an IRB review is required.
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IRB Topics
IRB Lifecycle
Step 1: How to determine if IRB approval is required
Any individual or group of individuals collecting data (questionnaires, surveys, interviews) on other individuals is required to determine if IRB approval is required. This process provides the individual(s) and participant(s) with protection regarding federal laws.
UNCG uses three screening questions at the beginning of the Cayuse IRB application to determine if IRB review is required. If you are affiliated with UNCG, a Cayuse IRB application is required to work on a project involving human subjects. Examples include sending a survey to students, faculty, staff or non-university affiliated persons. Even if you are working with another institution, an IRB application must be completed with UNCG (see multi-site research section below).
If you would like to make your own Not Human Subjects Research Determination, complete the Not Human Subjects Research Determination form. Please read the instructions included with the form carefully.
If you are not affiliated with UNCG and wish to conduct research on our campus, an application must be sent to ori@uncg.edu. This application must include: IRB approval letter, summary of the project, copy of the consent forms, and recruitment procedures.
Step 2: How to prepare and submit an application
Applications are submitted thru the Cayuse system. All members of the research team must complete CITI human subjects research training. Additional CITI training may be required for International Recruitment (International Researcher) and Clinical Trials (GCP). Additionally, there is an alternative human subjects research training outside of CITI available for eligible community partners.
All submissions with a student principal investigator must list a faculty advisor. The faculty advisor is responsible for reviewing the student submission, helping the student through the IRB process and is ultimately responsible for the project.
Find the required and recommended elements of IRB applications on our IRB Application page and in our IRB submission guide. The IRB submission guide provides step by step guidance for each question and section of the Cayuse IRB application.
Step 3: The IRB application review process
After the submission is received, it will be assigned to an IRB analyst. The analyst will complete initial review of the submission. If the submission is incomplete or does not contain enough information for a proper review, the analyst will return it to the PI for further clarification and/or correction. After the IRB analyst has completed their review, the submissions will either receive an IRB decision letter or it will be returned to the PI for response to analyst questions. It is normal for submissions to be returned to researchers.
Once the analyst has completed their review, they may be able to issue the researcher a determination letter. However, if the study is determined to likely be Expedited or require Full Board, it will be forwarded to an IRB Reviewer(s) for further analysis of the project. The IRB reviewer(s) will likely have additional questions and/or stipulations for the researcher. If the submission is sent to the full board for review, you will be asked to be available for any questions that may come up during the full board review process. After the review is complete and the study approved, an IRB decision letter will be issued.
Step 4: Your study is approved – additional responsibilities
Once a study is approved, you may be required to submit additional documents to the IRB or complete additional requirements.
Proposal Contingencies – Will be included in your initial IRB approval letter. Work cannot begin until these contingent items are submitted to the IRB.
Modifications – Are required anytime a change is made to your original approve submission. Modifications are submitted thru the Cayuse system.
Renewals or Administrative Check-Ins – Cayuse will generate an email letting you know that your project requires a renewal or administrative check-in. However, it is the researcher responsibility to make sure they are aware of these deadlines and submit the required forms well in advance of the deadline.
Post-Approval Monitoring – The ORI will also conduct Annual Post Approval Monitoring (PAM) Audits. Post Approval Monitoring is conducted to ensure that research is carried out according to the highest standards of scientific integrity and ethical behavior. The ORI will randomly select 5% of active nonexempt IRB protocols to be monitored.
Clinical Trials – If the IRB approves a study that has been determined a clinical trial, it may require registration on clinicaltrials.gov
Unanticipated/Adverse Events and Project Deviation/Violation – Must be reported to the IRB immediately by submitting a form in the Cayuse system.
Step 5: How to close the study
Researchers should close their study by completing the closure form in the Cayuse system. In general, studies may be closed when the involvement of human subject’s ceases. The Cayuse closure application lays out additional considerations.
IRB Turnaround Time
Recommended Elements of Recruitment
We recommend that all printed recruitment materials include certain elements. Please refer to our recommended elements of recruitment list on the Policies and Procedures page.
Multi-Site Research & Single IRB of Record (sIRB)
NIH: Effective for multi-site grant applications with due dates January 25, 2018 and beyond
DHHS: Effective as of January 20, 2020 – the single IRB-of-Record (sIRB) review requirement for all cooperative research projects sponsored by one of the federal Common Rule agencies.
Federally-funded cooperative (i.e., multi-site) human subjects research studies are required per the Common Rule (45 CFR 46.114) to utilize a single IRB-of-Record (sIRB) to streamline the human subject/participant protections review process and avoid duplicate review by an institutional review board at each site.
Under the sIRB model, an Institutional Review Board (IRB) at one of the collaborating institutions agrees to provide IRB oversight for all participating institutions via an authorization agreement (a.k.a. “reliance” or “collaborative” agreement). This legal contract documents the respective authorities, roles, responsibilities, and communication plans among the IRB-of-Record (i.e., the “reviewing IRB”) and the institutions relying on that IRB for project oversight. At UNCG, authorization agreements are signed by UNCG’s Office of Research Integrity Director.
The reviewing IRB centrally handles the IRB review functions only. Related local functions, such as ancillary committee reviews (e.g., conflict of interest review, verification of completed human subjects protections training) remain with the individual participating institutions. The conduct and reporting of the research remain the study team’s responsibility.
Study Teams
Always contact the UNCG IRB to discuss the sIRB options before you begin a funding application for a multi-site study involving human subjects research!
The UNCG IRB requires lead time to evaluate whether UNCG IRB can serve as the IRB of record (see criteria below).
If requesting a UNCG IRB to be the IRB-of-Record, contact the IRB at least 8 (eight) weeks prior to the grant application submission date. If requesting UNCG IRB to cede IRB oversight to an external IRB, contact the IRB at least 3 (three) weeks prior to the grant application submission date.
When will UNCG IRB act as the IRB of Record?
The UNCG IRB evaluates serving as the IRB of record on a case-by-case basis based on whether they can effectively serve as the IRB of record for a proposed multi-site project or if an external IRB should be used. The main evaluation criteria are:
- Whether the UNCG PI is the direct recipient of the federal grant
- The risk level to the human subjects
- At which site the majority of data collection will take place
- The number of collaborating institutions and the research activity to be conducted by those institutions
- The experience level of the UNCG PI/study team
- The involvement of the UNCG PI/study team
UNCG is a member of the SMART IRB organization, whose 600+ member institutions have agreed to streamline the process to cede review authority to an IRB of record by applying standard terms and conditions through the use of a common reliance agreement. When applicable, the UNCG IRB will utilize the SMART IRB reliance agreement template and processes to facilitate the establishment of an IRB of record for a project.
The UNCG IRB reserves the right to decline being the IRB of record on any project but will provide support to the UNCG study teams to locate an external IRB to act as the IRB of record.
Funding Proposals
For NIH-funded multi-site research, the study team must designate the IRB of record as part of the grant application at the time of proposal submission. If the IRB of record charges an IRB review fee, please consult with your Grants Specialist as to how this should be budgeted.
Some institutions (both healthcare and academic) charge IRB review fees. Commercial IRBs post their rates on their websites. Some academic IRBs may also charge a fee.
Please note, a collaborating institution charging an IRB review fee does not determine whether UNCG will serve as the IRB of record. See the criteria for UNCG serving as the IRB of record above.
Reminder: Contact the UNCG IRB eight weeks prior to the proposal submission date to determine whether UNCG IRB can act as the IRB of record for the project or whether UNCG will rely on another IRB for oversight.
When UNCG is the IRB of Record
- Login to Cayuse using your UNCG Credentials
- Once logged in, begin a new study application
- Complete the screening questions (under submission information section) as they apply to your study
- Under the Submission Information section, respond “yes” to the multi-site question – this will trigger the multi-site section
- Respond “yes” that UNCG will serve as the reviewing IRB
- Complete the other requested sections
- Click “Complete the Submission” (left-hand side of page) and follow the prompts to certify the submission
When ceding IRB review to an external IRB
- Login to Cayuse using your UNCG Credentials
- Once logged in, begin a new study application
- Complete the screening questions (under submission information section) as they apply to your study
- Under the Submission Information section, respond “yes” to the multi-site question – this will trigger the multi-site section
- Respond “No, an external institution will serve as the IRB of record”
- Complete the multi-site section as prompted
- Select the research activity type
- Complete the other requested sections
- Click “Complete the Submission” (left-hand side of page) and follow the prompts to certify the submission
If a UNCG researcher plans to conduct research with an individual who does not have an IRB, an Individual Investigator Agreement may be appropriate. Please contact ORI at ORI@uncg.edu for more information.
Additional Resources
Standard Operating Procedure for Research Conducted at Cone Health
IRB Authorization Agreement between the University of North Carolina (UNC) School Systems and Cone Health (CH)
Cone Health IRB has signed Authorization Agreements to rely on the IRBs at the University of North Carolina located at Greensboro, NC and Chapel Hill, NC (UNC School Systems) for review of research proposals in which investigators at UNC School Systems plan to collaborate with the Cone (CH).
For more information regarding the Cone Health IRB, please visit the Cone Health IRB website.
Initial Review of a study:
- Follow the general process for submitting a research proposal to the UNC School Systems IRB.
- After UNC School Systems IRB approval, contact the CH Coordinator@Conehealth.com (phone: 336-832-2330) for assignment of a CH IRB #. Please Note: All nursing studies are required to be presented to the Nursing Research Review Committee; contact is marjorie.jenkins@conehealth.com.
PLEASE NOTE THE FOLLOWING CHANGES implemented in June 2016:
- Cone Health has developed a flow chart to clarify “the” place to start when nurses are beginning a QI, Evidence-Based Practice or Research project. The goal is to avoid wasted efforts in premature work, incomplete requirements and misguided intent. No longer should nurses wonder “How do I start?”
- The tool is accessible here: https://conehealth.sharepoint.com/teams/nursing-research/SitePages/Doing%20A%20Project.aspx (While the flow charts themselves are on the open web, some of the supporting material is behind Cone Health firewall and some parts may not be accessible to non-Cone Health persons).
PLEASE NOTE:
- Each project whether QI, EBP or Research must have a Cone Health PI/Co-I.
- UNCG members should go through UNCG IRB first before sending to Cone Health for approval.
- UNCG faculty members MUST approve the projects and be named on the projects regardless of project type (if the project is for a student or staff member)
- If the research is to be carried out in a division, department or unit of Moses Cone Health System, (e.g., Pharmacy Division; Emergency Department; Nursing Unit) the department director/supervisor must be consulted in advance. Approval to pursue the project must be obtained so as to assure that there are no conflicts in the use of human or financial resources of the unit.
- Submit the following to Cone Health IRB: A completed CH IRB form UNC-A-01, the approval letter from UNC School Systems’ IRB, and a copy of the original initial application submitted to the UNC School System IRB.
- The Cone Health IRB will maintain a file with the above information in their IRB office.
Please Note: Cone Health would like to receive notification of annual renewals, closure notices, and SAEs/Unanticipated Problems for all Cone Health System patients. These submissions will be reviewed and placed in the appropriate file. FORM UNC-A-01 – Request to Rely on the University of North Carolina School Systems
Please click here for the UNC-A-01 – Request to Rely on the University of North Carolina School Systems Form.
IRB Committee Members 2024-2025
| Department | Name | Category |
| KIN | Dr. Laurie Wideman Gold (Chair) | Scientist |
| ORI | Ms. Megan Barton | Non-Scientist |
| ORI | Ms. Melissa Skillings | Scientist |
| CED | Dr. Kelly Wester (Co-Chair) | Scientist and Prison Rep |
| PSY | Dr. Christopher Wahlheim | Scientist |
| ELC | Dr. Lalenja Harrington | Scientist |
| GENC | Ms. Rachel Mills | Scientist |
| ITS | Mr. Casey Forest | Non-Scientist |
| CARS | Dr. Jin Su | Scientist |
| PHIL | Dr. Andew Ruble | Scientist |
| ORI | Ms. Megan Brimer | Scientist |
| HHS | Dr. Aubrey Kehoe | Scientist |
| ORI | Dr. Heather Emmons | Scientist |
| External | Dr. Samantha Goldenstein | Scientist |
| ORI Alternate | Mr. Kevin Todd | Scientist |
| External Alternate | Ms. Allie Arpajian | Non-Scientist |
IRB full board meetings are held on the 2nd and 4th Wednesday of each month at 3pm. During the summer break full board meetings are held on an alternate schedule.
