The Office of Research Integrity

IRB FAQs

IRB FAQ’s

General

Where is the IRB office?

  •  2718 MHRA Building

 Who do I contact if I have questions?

  • You can call 336-256-0253 or email irbcorre@uncg.edu
  • You can also call 336-256-0253 to make an appointment for an in-person meeting.

What rules 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

What guidelines does the IRB follow?

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 (professional association) usually through publication and or presentation

Where is the IRBIS online submission site?

Is there a way to test the new online submission system without submitting an actual protocol?

  •  We have a test submission system that researchers are welcome to use. It is located at https://testuncg.myresearchonline.org/irb/ and is available for your use if you would like to test before you submit an actual protocol. If you later decide to submit a protocol you created in test, you must then submit the protocol in the production system. Protocols submitted in the test system are not reviewed by the ORI.

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.

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 2-3 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

Modification

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.

Are all modifications viewed the same by the IRB?

  •  There are two types of modifications minor and significant (see examples below)

Significant Changes

  1. Working with kids in standardized school and wanting to add kids from a school for adjudicated youth (Alternative Schools)
  2. Working with pregnant women and wanting to add pregnant minors.
  3. Incorporating invasive measures to a study such as therapy that could lead to depression or rekindled psychotic disorders
  4. Adding a site to conduct research that the PI has a clear conflict of interest
  5. Adding procedures that include the use of Personal Health Information (PHI)
  6. Adding procedures for data collection that involve student rights (FERPA)
  7. Changing survey procedures from anonymous survey to collecting identifiers (this could mean a new IRB application)

Minor Changes

  1. Increasing the sample size for a study
  2. Changing the stimuli for an experimental study (e.g., memory lists of words to memory lists of pictures, as long as the pictures are of the same caliber or similar response)
  3. Requesting additional contact information (email or fax number)
  4. Changing PI of equal capabilities or adding students to a project
  5. Adding sites to collect data of same caliber (another high school in the USA not a high school from overseas)

All minor changes must meet both of the following criteria:

  • All added procedures involve no more than minimal risk
  • All added procedures fall into categories (1)-(7) of research that could be reviewed using the expedited procedure

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

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?

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 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?

  •  5 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.

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 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

 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

 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

Cone Health (formerly known as Moses Cone Hospital)

What is the process for conducting research at Cone Health?

Process:
Initial Approval
1.    Research proposals that will be conducted out in a division, department or unit at Cone Health (e.g. Pharmacy Division; Emergency Department; Nursing Unit) should consult with the department director/supervisor in advance.

2.    Research proposals that fall under the above mentioned categories a or b must receive an initial approval from the Cone Health Institutional Review Board (IRB) office. Division, department, or unit approval must be indicated on the Cone Health submission materials to assure that there are no conflicts in the use of human or financial resources of the unit.
a.    Proposals in which the investigator(s) are UNCG faculty members or students and the proposed study will be conducted at any Cone Health facility or recruit Cone Health patients/employees as research participants.
b.    Proposals in which the investigator(s) serve dual roles at UNCG student and Cone Health employee and wish to conduct research at any Cone Health facility or recruit Cone Health patients/employees as research participants.
c.    Proposals in which the investigator(s) are Cone Health staff members and the proposed study will be conducted at any UNCG facility or recruit UNCG faculty/students/staff as research participants.

3.    Investigators for proposals requiring Cone Health initial approval should contact the IRB Coordinator, Krista Kenney at krista.kenney@conehealth.com to request assignment of a CH IRB # and for application submission inquiries.

4.    Cone Health IRB forms can be located under the “Forms” link on the Cone Health IRB website:
(http://www.conehealth.com/about-us/research-and-clinical-trials/institutional-review-board/).

5.    For all proposals falling under the above mentioned categories a, b, or c Cone Health IRB asks that the UNC-A-01 form be completed for studies using the Authorization Agreement. This form is located under the “Forms” link on the Cone Health IRB website:
(http://www.conehealth.com/about-us/research-and-clinical-trials/institutional-review-board/)

6.    Following Cone Health initial approval, CH IRB office will notify UNCG office of approval.

Are there any additional rules for Nursing Research in conjunction with Cone Health?

Nursing Research

All research proposals involving UNCG nursing students or Cone Health nursing staff must be presented to the Cone Health Nursing Research Council (NRC). The contact person for Nursing Research is Marjorie Jenkins at jenkins@conehealth.com. Contact her for submission guidelines and instructions.

  1. The NRC requires that you receive UNCG IRB approval prior to submission.
  2. Please note that materials must be submitted by the 1st Wednesday of the month in order to be reviewed by the NRC that month.

Please Note: The Cone Health IRB would like to receive notification of annual renewals, closure notices, and SAEs/Unanticipated Problems for all studies under this Authorization Agreement. These submissions will be reviewed and filed for record.

Are there any special requirements for working with medical records at Cone Health?

  • Yes, the PI must contact the IRB chair at Cone Health and provide them with a research summary. The Cone Health IRB Chair will make the necessary contacts to obtain access for the PI to the appropriate information.

Are there any additional documents required for recruiting participants or conducting research at Cone Health?

  • Yes, there may be additional documents to be reviewed. Please contact Krista Kenney at krista.kenney@conehealth.com for further information. There may be other steps you need to take.

 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?

  • 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

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 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.

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?

Pilot studies

Does a pilot study always have to go through IRB approval?

No, a pilot study doesn’t always need to go to the IRB for approval, however:

  • Consult with the ORI to determine whether or not your pilot study requires IRB approval.
  • There can be no mention of UNCG IRB in the consent forms.
  • There can be no language that indicates that there was IRB approval or that the IRB condoned the study.
  • The study results cannot be presented as research data.

Please see the OHRP site for further guidance.