Review Process FAQ
Below are Frequently Asked Questions, organized as a guide to basic policies and procedures that govern IRB review and approval. These FAQs are one of a number of resources available to researchers from the UNC-CH IRBs. And while we serve a regulatory function, we take a collegial approach to consultation with researchers and their staff. Please feel free to call on us as you navigate the process. We are happy to respond to your questions.
Determine whether IRB review is required
- What is the IRB?
- What research has to be reviewed by the IRB?
- What is research?
- What is a human subject?
- What is meant by “under the aegis of UNC-Chapel Hill?”
- What about student research or class projects?
Data gathering considerations
- 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?
- What does it mean for data to be “de-identified”?
- What if I need to review medical records in order to identify subjects for recruitment?
- Do I have to get consent from study participants?
- Does UNC-CH have a consent form template?
- What information must be included in a consent form?
- How do I obtain consent from Non-English speaking participants?
- What are the exceptions to informed consent requirements?
Submission and review
- Where is the IRB located?
- What happens after submission?
- What kinds of IRB review are there?
- What are the possible outcomes of a review?
- How long does it take?
- How do I check the status of my submission?
- What happens after I receive approval?
- What is my responsibility to the IRB to report unanticipated problems or adverse events that may occur during the research?
- Does IRB approval need to be renewed?
- What if I want to modify the study?
- What happens when my study lapses?
- What records should investigators keep, and for how long?
If you have further questions…
- The Institutional Review Board (IRB) is a board 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.
The IRB reviews and monitors human subjects research conducted under the aegis of UNC-Chapel Hill.
What is research? (from SOPs)
- Research contributes to generalizable knowledge.
- Research is designed in advance.
- Research utilizes a systematic approach.
What is a human subject? (from SOPs)
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?” (from SOPs)
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.
- 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 is intended to help you decide.
- Submit an application using the online system (irbis.research.unc.edu/irb). Instructions accompany the application.
- 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 Ethics Training Page
- There are occasions within the research setting when an investigator either needs to or is required to collect the Social Security Number (SSN) of a subject. Most often, the SSN is collected for use as a unique identifier or it is collected as required by law, to comply with Internal Revenue Service (IRS) reporting requirements. Policy and details are in the IRB GUIDANCE: Collection of Social Security Numbers (or other selected “Personal Identifying Information”). The form used with subjects to obtain permission to collect Social Security Number for reimbursement is the SSN Collection Form on the OHRE Paper Forms page.
- Yes. There are detailed instructions within the IRB application and special consent forms, if these are needed.
What about HIPAA? (from SOPs)
- 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? (from SOPs)
- 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.
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?
- 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.”
- 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.
- Yes, UNC-CH uses common consent form elements produced by the online system.
What information must be included in a consent form? (from SOPs)
- 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? (from SOPs)
- 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? (from SOPs)
- 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.
Send all correspondence other than online application materials to:
Institutional Review Board
720 Martin Luther King Jr. Blvd.
Chapel Hill, NC 27599-7097
- 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.
- 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.
- The online application is a “smart application” and will, as appropriate, tailor the application to the type of submission.
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 Board then votes on whether or not to approve the study.
Expedited IRB review (from SOPs)
- 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 (from SOPs)
- 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.”
- A study may be approved; approved with stipulated changes; disapproved; deferred; or it may be deemed exempt from continuing review.
Approval of research
- Research may proceed on receipt of written documentation of IRB approval.
Stipulated minor changes or clarifications required prior to approval (from SOPs)
- 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 using the online system.
- If your response is acceptable, your project will be approved and you will receive an approval letter.
Deferral (full board action only) (from SOPs)
- 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) (from SOPs)
- 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.
- The IRB may determine that your study is not subject to continuing review.
- 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 Board 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.
How do I check status of my submission?
Click here for guidance.
You may begin your research.
You have a responsibility to report unanticipated problems or adverse events that may occur during the research to the IRB. (from SOPs)
- “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.
- Effective Monday, June 1, 2009, Unanticipated Problems and Adverse Events must be reported online. Click here for complete instructions, training, and access to the web portal.
- 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 using the online system (irbis.unc.edu).
- 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.
- 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 online system (irbis.unc.edu).
- The review of the amendment request may be expedited or may require full board review.
- When the IRB approval for a study lapses, all study related activities must cease. In cases where halting study related procedures would jeopardize the welfare of subjects, PIs must request in writing that currently enrolled subjects continue to receive study treatment or intervention(s).
- The HHS protection of human subjects regulations require institutions to retain records of IRB activities and certain other records frequently held by investigators for at least three years after completion of the research (45 CFR 46.115(b)). In addition, other regulations may apply and require retention of these records for a longer period of time. Documentation of the informed consent of the subjects – either the signed informed consent form or the short form and the written research summary – are records related to conducted research that are typically held by investigators and must be retained for at least three years after completion of the research, unless the IRB waived the requirement for informed consent or the requirement for documentation of informed consent (45 CFR 46.117).
- If investigators have been designated to retain certain records (e.g., informed consent documents signed by subjects) on behalf of the institution as required by the HHS regulations at 45 CFR 46.115(b), they must retain the records in some form. Such records may be preserved in hardcopy, electronic or other media form and must be accessible for inspection and copying by authorized representatives of HHS at reasonable times and in a reasonable manner (45 CFR 46.115(b)). Retention of multiple copies of each record is not required. Investigators should follow the institution’s policies and procedures for retaining records. If investigators who have been designated to retain records on behalf of the institution leave that institution, the investigators and the institution should identify the successor responsible for maintaining those institutional records, either at the original institution or wherever the records are relocated, for the period of time required under HHS regulations at 45 CFR 46.115(b).
- Other regulations or policies may apply to the retention of records, including study data. Also please check with your department for additional record retention requirements.
- Additional information regarding records retention and disposition can be found here. Specifically, please see Functional Groupings #6: Grants and Research Records.
- 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 Human Research Protection Program Standard Operating Procedures (SOP).
- 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.