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The Office of
Human Research Ethics
General Information
For Investigators
For Research Participants and the Public
A Guide to the IRB Process
We hope that this FAQ will orient you to basic policies and procedures for IRB review and approval. It is one of a number of resources available to researchers from the UNC-CH IRBs. Although we serve a regulatory function, we take a collegial approach to consultation with researchers and their staff. Feel free to call on us as you navigate the process. We are happy to respond to your questions.
What is the IRB?
- The Institutional Review Board (IRB) is a committee established to review and approve research involving human subjects.
- The primary purpose of the IRB is to protect the rights and welfare of the human subjects.
What research has to be reviewed by the IRB?
The IRB reviews and monitors human subjects research conducted under the aegis of UNC-Chapel Hill.
What is research? (SOP 8.1)
- Research contributes to generalizable knowledge.
- Research is designed in advance.
- Research utilizes a systematic approach.
What is a human subject? (SOP 8.2)
A human subject is defined by Federal Regulations as “a living individual about whom an investigator conducting research obtains (1) data through intervention or interaction with the individual, or (2) identifiable private information.” (45 CFR 46.102(f))
What is meant by “under the aegis of UNC-Chapel Hill?” (SOP 8.3)
Human subjects research that meets any of the following criteria is subject to review:
- The research is sponsored by UNC-Chapel Hill.
- The research is conducted or directed by any employee or trainee of the university in connection with his or her UNC-Chapel Hill responsibilities.
- The research involves access to any property or facility of UNC-Chapel Hill other than access to open spaces on the University campus that are readily available to the public at large.
- The research involves the use of non-public information in the custody of UNC-Chapel Hill to identify or contact human research subjects or prospective subjects.
What kinds of IRB review are there?
- There are three levels of IRB Review (full board, expedited, and determining if exempt from continuing review), determined by the nature of the protocol, level of potential risk to human subjects, and the subject population.
- The determination of level of review applicable to a particular study is made by the IRB.
- Regardless of the kind of review, all applications use the same submission form.
Convened IRB review (full board)
- Any study involving greater than minimal risk requires a review by the convened IRB. This includes studies with vulnerable populations and sensitive questions as well as studies with the possibility of physical risk.
- Each UNC-CH IRB has its own schedule, but all IRB’s meet at least monthly.
- Studies assigned to full board review are reviewed by members ahead of time, and then discussed at the meeting. The Committee then votes on whether or not to approve the study.
Expedited IRB review (SOP 13.2)
- Only research involving no more than minimal risk to subjects may be considered for expedited review.
- An expedited review is conducted by an individual reviewer or a few reviewers, rather than going to the full board.
- Federal guidelines provide categories for expedited review. Examples of categories include:
- blood sampling in minimal amounts
- review of records collected for non-research purposes (such as chart reviews)
- survey research
Exempt from continuing IRB review (SOP 15.2)
- Research with very minimal risk to human subjects as determined by regulatory guidelines may be exempted from continuing review at the discretion of the IRB.
- An exemption is granted by the IRB upon review of the application.
- Since this constitutes a review, protocols that are deemed exempt at UNC-Chapel Hill are effectively “exempt from continuing review.”
What about student research or class projects?
- Some student work is clearly research and requires IRB approval but other student class activities present a challenge to know if they fall under IRB governance. OHRE's "IRB Guidance for Student Research and Class Projects" (PDF) is intended to help you decide.
How do I apply?
- Submit an Application for IRB Approval of Human Subjects Research (see Forms). Instructions accompany the application.
What is the required human research ethics training?
- Human Research Ethics Training is required of all faculty, staff and students who are engaged in the planning, conduct or analysis of research at UNC-Chapel Hill that involves human subjects.
- Required Education Page
Do I have to get consent from study participants?
- The standard expectation is that all subjects will sign a document containing all the elements of informed consent.
- The informed consent process gives potential subjects a description of the study that is clear and complete enough for the individual to judge whether she or he wants to participate.
- The consent form should provide readily understandable information in an amount appropriate to the level of risk in participating.
- Some or all of the elements of consent, including signatures, may be waived under certain circumstances.
Does UNC-CH have a consent form template?
- Yes, UNC-CH uses common consent form templates. See the Forms page.
What information must be included in a consent form? (SOPs 28.1 and 28.2)
- 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 that are experimental;
- A description of any reasonably foreseeable risks or discomforts to the subject;
- A description of any benefits to the subject or to others that may be reasonably expected from the research;
- A disclosure of appropriate alternative procedures or courses of treatment, if any, that might be advantageous to the subject;
- A statement describing the extent, if any, to which confidentiality of the records identifying the subject will be maintained;
- For research involving more than minimal risk, an explanation as to whether any compensation and/or medical treatments are available if injury occurs and, if so, what they consist of, or where further information may be obtained;
- An explanation of whom to contact for answers to pertinent questions about the research and research subject’s rights, and whom to contact in the event of a research related injury to the subject, if relevant. Typically, questions concerning a research project should be referred to the PI for that project, whereas questions concerning the rights of human subjects should be referred to the IRB.
- A statement that participation is voluntary, that refusal to participate will involve no penalty or loss of benefits to which the subject is otherwise entitled, and that the subject may discontinue participation at any time without penalty or loss of benefits to which the subject is otherwise entitled.
- Other requirements may apply.
How do I obtain consent from Non-English speaking participants? (SOPs 28.12 and 28.13)
- Consent forms should be prepared in the language understandable to potential subjects.
- Researchers should be fluent in the subject's language or an interpreter should be available during the consent process and throughout the subject's participation as needed.
- When unexpected circumstances arise (e.g. single subject who does not speak/read English), it may be appropriate to consider use of a Short Form of Consent. This form has specific requirements that should be discussed with the IRB prior to use.
- Researchers should take great care when obtaining informed consent from individuals who do not speak English or whose understanding of the language is limited.
What are the exceptions to informed consent requirements? (SOPs 28.3, 28.4 and 28.7)
- The IRB may waive the requirement for written consent if the consent document is the only link between the subject and the research and the principal risk of harm would come from a breach of confidentiality.
- The IRB may waive consent if:
- The research involves no more than minimal risk to the subjects;
- The waiver will not adversely affect the rights and welfare of the subjects;
- The research could not practicably be carried out without the waiver;
- If appropriate, the subjects will be provided with additional information after participation.
- Consent may also be waived for some types of research regarding public service programs.
When are we required to collect Social Security Numbers, and how do we handle?
Are there special requirements for use of biological specimens?
What about HIPAA? (SOP 29.0)
- HIPAA stands for Health Insurance Portability and Accountability Act of 1996.
- HIPAA regulations are focused on privacy and security protections for individuals’ health care information: “protected health information” (PHI).
- Protected Health Information (PHI) includes individually identifiable health and health care payment information, including the demographic data that is a potential identifier of the individual, maintained in the records of health care providers.
- If a research study either uses or creates protected health information, documentation of the subject’s authorization to use such information is required.
Can HIPAA Authorization be waived? (SOP 29.3)
- Yes, when strict confidentiality measures are in place.
- Yes, when the research could not practicably be conducted without the waiver or without access to the PHI.
What if I need to review medical records in order to identify subjects for recruitment?
- You may request a limited waiver of authorization for recruitment purposes as part of your application process. To do so, answer the following questions in your application:
- Will the information collected be limited only to that necessary to contact the subjects to ask if they are interested in participating in the study?
- How will confidentiality/privacy be protected prior to ascertaining desire to participate?
- When and how will you destroy the contact information if an individual declines participation?
What does it mean for data to be "de-identified"?
- A de-identified data set may not include any direct identifiers of the
individual or of the individual's relatives, employers, or household members. See details at "De-identified Data". (PDF)
Where do I send the application?
- Send all applications and correspondence to:
Institutional Review Board
CB # 7097, Medical Building 52
105 Mason Farm Road
Chapel Hill, NC 27599-7097
What happens after submission?
- Your study will be assigned an IRB number that should be used on all correspondence relating to the study until the study is closed.
- The IRB will determine the level of review.
- The IRB will conduct the review and take one of the following actions:
Approval of research
- Research may proceed on receipt of written documentation of IRB approval.
Stipulated minor changes or clarifications required prior to approval (SOP 12.2)
- It is common for the IRB to request some changes to the consent form or protocol prior to approval. These are called “stipulated changes.”
- If there are stipulations, you will receive a communication from the IRB with details.
- You should respond to the communication in writing.
- If your response is acceptable, your project will be approved and you will receive an approval letter.
Deferral (full board action only) (SOP 12.3)
- Sometimes the IRB, in a full board review, determines that substantive changes must be made before approval may be granted.
- Full board review is required for responses to deferral.
Disapproval (full board action only) (SOP 12.4)
- If the IRB determines that the research cannot be conducted at UNC-Chapel Hill or by employees or agents of the University or otherwise under the auspices of the University, the project, as proposed, is disapproved and may not go forward.
Exemption
- The IRB may determine that your study is not subject to continuing review.
How long does it take?
- An expedited or exempt review typically takes about 10 business days.
- The IRB's determination about whether an activity constitutes human subjects research is generally communicated within 7 - 10 business days.
- Studies requiring full board review are scheduled for the first available
meeting. An application submitted by the published deadline will generally be assigned to that meeting. There may be circumstances when this is not possible, in which case it will assigned to the next available meeting. See IRB Committee Meeting Dates and Submission
Deadlines for more information.
- Correspondence from the IRB is sent to the Principal Investigator within
one week of full board review.
- The PI has a significant influence on length of time between submission
and approval.
- Well prepared applications result in fewer requests for stipulated
changes.
- Rapid response by the PI to requests for changes speeds the approval
process.
What happens after I receive approval?
You may begin your research.
You have a responsibility to report problems or adverse events that may occur during the research to the IRB. (SOP 19.0)
- “Adverse event” or “adverse experience” (AE) is an undesirable and unintended, though not necessarily unanticipated, injury or physical or emotional consequence to a human subject.
- “Unanticipated Problems” (UPs) may or may not include specific events experienced by individual subjects, but are developments within the research activity that suggest a potential for increased risks to subjects or others.
All projects are subject to renewal, usually annually.
- No approval is for longer than one year from the initial review.
- Near the end of the approval period you will receive a reminder notice.
If the research is continuing or data analysis is not yet completed, request renewal of approval using the Request for Renewal of IRB Approval or Study Closure
form (see Forms).
- Projects are subject to continuing review through the data analysis phase.
At completion of this phase, inform the IRB that your project is completed
so the IRB does not continue to inquire about renewal.
- Projects that the IRB determined to be exempt from further review receive an exemption notice,
and no renewal is required.
However, the IRB needs to review and approve
any modifications to the study in advance.
What if I want to modify the study?
- Once the project is submitted to the IRB, you may not make changes to
the study until the IRB has completed the approval process for your original
submission.
- Once your study is approved, you may submit modifications.
- All protocol changes must be approved by the IRB prior to implementation.
- All changes to documents used with subjects (consent forms, questionnaires,
recruitment materials, etc.) must be approved by the IRB prior to use.
- Use the form Modification of Approved Human
Subjects Research (see Forms) to explain to the IRB how you want to change
the protocol, and to request approval of the changes.
- The review of the amendment request may be expedited or may require
full board review.
Where do I get more information?
- This web site is a good source of additional information, providing links
to many ethics, research, and regulatory sites.
- The University of North Carolina at Chapel Hill Institutional Review
Board Standard Operating Procedures.
- Code of Federal Regulations: Protection of Human Subjects 45CFR46.
- We are happy to respond to your questions. Feel free to call or email
us. Go to Contact OHRE/IRBs for our contact information.
