IRB FAQs

General

Where is the IRB office?

•  2718 MHRA Building

 Who do I contact if I have questions?

• You can  email ori@uncg.edu

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)

Review Process

 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 (1-9)
• Exempt from full board review protocols
  • Less than minimal risk to participants
  • Research that is identifiable but not sensitive
  • Research that is identifiable, but appropriate confidentiality procedures are in place
  • Research that is sensitive but not identifiable
• Not Human Subjects 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?

• Researchers should allow for eight weeks for IRB review

 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

 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/Not Human Subjects  Research)
• The protocol is forwarded to the IRB chair (Expedited)
• The protocol is reviewed by the convened committee (Full Board)

Approval Period

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 weeks.

 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

Modification

When is a modification necessary?

• A modification is necessary whenever a PI deviates from the approved protocol. The modification approval process takes approximately 2 weeks. .

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

Consent

 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

 What information needs to be in the informed consent form?

For studies qualifying for expedited/full committee review:

(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 ; 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.

Training

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 Caysue  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 that will conduct an intervention/interaction with participants or will have access to identifiable data must complete human subjects research training.

Children

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?

• 5-6  years old – verbal assent
• 7-17 years old – written assent

 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/legal guardian before working with the child?

•  Yes, parental permission should be obtained prior to the child assent.

 Do both parents/legal guardians 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.

 Language Barriers

 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 to ensure that the procedures are fully understood and that informed consent can be reliably obtained.

 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.
• You should submit a plan to communicate information as appropriate to the population.

School Systems

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?

• Requirements within school districts can vary regarding conducting research. Some school systems may require an independent review of the research by a research review committee similar to an IRB, while others only need the superintendent or their designee to review and approve the research. Prior to IRB submission, the researcher should consult with the school district where the research will take place as to what their research policies are.

 If both the school system and UNCG IRB need to review the protocol, who do I submit to  first?

• It is preferred that school district approval is obtained prior to IRB submission, however, if the school district requires UNCG IRB approval first, accommodations can be made.

Visiting Researchers

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 UNCG Office of Research Integrity.

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 may no longer be able to be responsible for their study. The PI or Faculty Advisor will need to complete a closure form via the Cayuse 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.
• If the former student is not moving to an institution with an IRB, but wishes to continue their research, please contact the UNCG Office of Research Integrity at ori@uncg.edu for a consultation regarding next steps.

Reporting

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 Incident Report form in Cayuse and submit it to the UNCG ORI.