Where is the IRB office?
- 2718 MHRA Building
Who do I contact if I have questions?
- You can call 336-256-0253 or email email@example.com
- You can also call 336-256-0253 or email firstname.lastname@example.org to make an appointment for an in-person meeting.
What regulations, guidelines, and policies must the IRB follow?
- Federal guidelines “The Common Rule (45 CFR 46)” is the foundation for IRB rules
- Additional rules/laws are applied by the state of NC
- The institutional policy Protection of Human Participants in Research
- The IRB Standard Operating Procedures (SOPs)
When is IRB review required?
- Any study that requires human participants and meets the definition of “Research”
- Research is defined by federal regulations as “a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge”.
- Generalizable knowledge draws conclusions from information obtained to apply to populations outside of the study (ex: professional association) usually through publication and or presentation
What are the different types of IRB review?
- Full Board protocols
- High level of risk to participants (above minimal risk)
- Research is identifiable and sensitive
- Research does not fit any of the Expedited categories
- Expedited protocols
- Minimal risk to participants
- Research is identifiable and sensitive and falls within one of the expedited categories (1-7)
- Exempt from full board review protocols
- Less than minimal risk to participants
- Research that is identifiable but not sensitive
- Research that is sensitive but not identifiable
- Research that is not sensitive and not identifiable
- Nonhuman Participant Research
- Research that involves no interaction with an individual and only de-identified data. UNCG researchers have no access to identifying information
- Research that is designed to preserve a historic event only and there is no attempt to draw generalized conclusions from data collected
- Research that does not ask about the participants, but may ask about a program, product, policies/procedures, etc.
How long does the initial review process take?
- A full board review protocol takes approximately six weeks if well written and the protocol is complete
- An Expedited review protocol takes approximately one month if well written and the protocol is complete
- An Exempt from further review protocol takes approximately two weeks if well written and the protocol is complete
- A Determination of not Human Participant Research takes approximately one week if well written and the protocol is complete
What if I don’t get approval from the IRB prior to conducting my study?
- Individuals that do not acquire IRB approval prior to data collection are noncompliant and are liable for any and all negative outcomes
When does a study require full board review?
- When research involves highly sensitive information/methodology and vulnerable populations with a lot of serious risks to participants
- When research does not fit in one of the expedited categories
- When research does not have clear benefits but does have a clear high level of risk
What happens with my protocol once I send it to the ORI?
- The protocol is reviewed by ORI staff
- Stipulations are sent to PI
Once stipulations are sent back and reviewed for accuracy, one of the following will occur:
- An approval is issued (Exempt/Non Human Participant Research)
- The protocol is forwarded to the IRB chair (Expedited)
- The protocol is reviewed by the convened committee (Full Board)
If you have submitted a new protocol in the online system, you can also login to the IRBIS online submission system and check the status of your application.
How long are IRB approvals valid?
- The approval period of an nonexempt protocol is determined by the IRB but not more than one year
How will I know when its time to renew my project?
- Renewal reminder notices are sent out 30 and 60 days in advance to the PI named on the protocol. However, these are courtesy reminders. It is ultimately the responsibility of the PI to ensure that the renewal is submitted prior to the renewal date.
What happens if I miss my renewal deadline?
- All research activities must cease until approval is obtained
How long does the renewal process take?
- If all documents are sent along with the renewal the review and approval process takes approximately 2-3 business days
If I submit a modification during my approval period does that count as a renewal of my protocol?
- No, a modification changes components of the currently approved protocol not the approval period
When is a modification necessary?
- A modification is necessary whenever a PI deviates from the approved protocol.
Can I make changes to my protocol and inform the IRB later?
- No, the IRB must approve any changes prior to implementation
Do I need to submit a modification when I add or remove research staff?
- Yes. Any time a research staff member (research assistants, co-investigators, etc.) is added or removed, a modification needs to be sent.
Please note that it is the lead investigators responsibility to keep UNCG approved human subject’s research training and signed statements of confidentiality on file.
If my protocol was initially reviewed by the full board do all of my modifications need to go back to the full board?
- For each modification the IRB will make a determination if the change will require review by the full board review
Why do I have to get informed consent?
- Informed consent assures that prospective human participants will understand the nature of the research and can knowledgeably and voluntarily decide whether or not to participate
Are there different ways that I can obtain informed consent?
- The long form consent should be used
What information needs to be in the informed consent form?
(1) a statement that the study involves research, an explanation of the purposes of the research and the expected duration of the subject’s participation, a description of the procedures to be followed, and identification of any procedures which are experimental;
(2) a description of any reasonably foreseeable risks or discomforts to the participant;
(3) a description of any benefits to the participant or to others which may reasonably be expected from the research;
(4) a disclosure of appropriate alternative procedures or courses of treatment, if any, that might be advantageous to the participant;
(5) a statement describing the extent, if any, to which confidentiality of records identifying the participant will be maintained;
(6) for research involving more than minimal risk, an explanation as to whether any compensation will be made and an explanation as to whether any medical treatments are available if injury occurs and, if so, what they consist of, or where further information may be obtained;
(7) an explanation of whom to contact for answers to pertinent questions about the research and research participants’ rights (Director of Office of Research Integrity, 336-256-1482); and
(8) a statement that participation is voluntary, refusal to participate will involve no penalty or loss of benefits to which the participant is otherwise entitled, and the participant may discontinue participation at any time without penalty or loss of benefits to which the subject is otherwise entitled.
Do I have to get the informed consent signed and dated?
- In most cases yes, the informed consent document has to be signed and dated
- The IRB can determine if the research meets the criteria for waiving documentation (signed informed consent)
Is it possible to get a waiver of informed consent or elements of informed consent?
- In most cases some form of informed consent is required
- The IRB can determine if certain elements of informed consent can be waived or the entire process of obtaining informed consent
Where can I find samples of informed consent forms?
- The ORI website under IRB consent form templates (http://integrity.uncg.edu/institutional-review-board/)
What options do I have for obtaining my training?
- UNCG’s IRB accepts certificates of training from the two below sources:
- CITI (online module). CITI training is not currently being linked to the new IRBIS online submission system. The IRB reviewer can verify your CITI training administratively through the CITI website.
- ORI sponsored in-person training workshops – your completion certificate must be uploaded to the attachments section of the application when your IRB application is submitted
PLEASE NOTE: RCR TRAINING IS SEPARATE FROM IRB TRAINING. SEE HERE FOR A HELPFUL EXPLANATION.
Which CITI modules are accepted by the IRB?
- We will only accept the Researcher module (Faculty/Staff) and the Student Researcher (student) modules
How long is my training certificate valid?
- 3 years
Does everyone on a research project need a certificate of training?
- Yes. All individuals listed on the study application must complete human subjects research training.
Can children consent to participate in research?
- No, children give their assent to participate in research
How old does a child have to be in order to give assent?
- 5 years old
Are the elements of informed consent the same as those for assent?
- For the most part yes but the age and cognitive abilities of the kid may merit a waiver of some of the elements
Do I have to obtain permission from the child’s parent before working the child?
- Yes, parental permission should be obtained prior to the child assent
Do both parents have to sign the informed consent form?
- Only when the research is of high risk and/or there is not direct benefit to the child
Is it possible to get a waiver of child assent?
- Yes, but the PI should provide adequate justification to the IRB
Is it possible to get a waiver of parental permission?
- Yes, but the PI should provide adequate justification to the IRB
Do I have to have an interpreter if I plan to work with non-English speaking people?
- No, however it is required that you have adequate plans to communicate with non-English speaking populations
Can the IRB waive certain requirements for conducting research with illiterate or deaf populations?
- Yes, however the PI must provide a plan to ensure that the participants understand what is going on in the research project
If there are language barriers what information do I need to submit to the IRB?
- Typically all research related documents must be translated into the appropriate language
- A plan to communicate information as appropriate to the population
If I conduct research in the school system do I need approval from the district or just the school in which I plan to conduct the research?
- All school systems don’t follow the same rules regarding conducting research in their school. Some school systems require an independent review of the research by a research review committee similar to an IRB. While others only need the principal to review and approve the research
If both the school system and UNCG IRB need to review the protocol, who do I submit to first?
- This decision is up to the investigator, however the ORI’s recommendation is that the PI submit the protocol to either UNCG or the school system for review first, but not simultaneously
Do individuals that are not currently employed or enrolled at UNCG need IRB approval before conducting the study?
Yes. Before visiting researchers can begin enrollment, the following will need to be reviewed by the ORI:
- Copy of the approval from the visiting researcher’s institution
- Summary of the research project
- Copy of the consent form(s)
- Recruitment procedures
Once these items have been reviewed, the visiting researcher will receive a letter from the Director of ORI.
Closing a protocol
If I am leaving the university and I have an open protocol, what should I do?
- Once a student graduates or a faculty member leaves employment, the UNCG IRB can no longer be responsible for their study. The PI or Faculty Advisor will need to complete a closure form via the IRBIS online system If leaving the university to work or attend another institution, then the PI/Student will need to seek approval for that study at the new institution since UNCG will no longer be responsible for the protocol. If a student leaves, but the PI wants to continue to collect data or publish/present the data, the PI will need to submit a modification to have the student removed from the study.
What should a PI do if a participant is physically injured, suffers personal loss, or psychologically traumatized when participating in an approved research study?
- The PI should promptly complete the Unanticipated Problem/Adverse Event Form and submit it to the ORI.