Things You Need to Know
- Activities requiring IRB review
- IRB review for Master’s thesis/doctoral dissertation vs. Class projects
- For those not sure if a project requires IRB review despite determination of the regulatory definitions of human subjects and research
- Collaborating with other institutions
- Research involving cooperation with an internal and/or external organization (i.e. K-schools, church, company, online organization)
- Human Subject Research Training Needed
- Common mistakes to avoid
- IRB Review Process
- Consent Form
- Information that must be included in a consent form
- Consent vs. Assent
- Obtaining consent from non-English speaking participants
- Waiving Consent
- Other Considerations
Determine Whether IRB Review is Required:
1. Activities requiring IRB Review
Any activity that meets either (a) the Department of Health and Human Services’ (DHHS) definitions of “research” and “human subjects” or (b) the Food and Drug Administration’s (FDA) definitions of “clinical investigation” and “human subjects” requires review and approval by the IRB.
a) The DHHS regulatory definitions (45 CFR 46) of research and human subjects must be met in order to require IRB review. If a project meets the regulatory definition of ‘research’ but not ‘human subjects’, then IRB review is not needed. And, vice versa, if a project meets the definition of ‘human subjects’ but not ‘research’ then IRB review is not needed.
Research means a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge. Activities which meet this definition constitute research for purposes of this policy, whether or not they are conducted or supported under a program which is considered research for other purposes. For example, some demonstration and service programs may include research activities.
The following offers further information on what constitutes systematic investigation and generalizable knowledge (note: these are not regulatory definitions but rather guidance):
- A systematic investigation is a cohesive, predetermined method for studying a specific topic or answering a specific question(s), involving data collection (quantitative or qualitative) from one or more individuals and analysis to address a question or test a hypothesis or developing theory.
- Generalizable knowledge includes results or outcomes (conclusions) gained from a systematic investigation, which are intended to be extended beyond a single individual (relevant beyond the specific participant population) or internal program that may be published, archived, presented, or viewed. Also included are activities where there is an intent to publish the results in a peer-reviewed journal or to present at regional or national meetings, as well as theses or dissertation projects.
A Human subject means a living individual about whom an investigator (whether professional or student) conducting research: (i) Obtains information or biospecimens through intervention or interaction with the individual, and uses, studies, or analyzes the information or biospecimens; or (ii) Obtains, uses, studies, analyzes, or generates identifiable private information or identifiable biospecimens.
Intervention includes both physical procedures by which information or biospecimens are gathered (e.g., venipuncture) and manipulations of the subjects or the subject’s environment that are performed for research purposes.
Interaction includes communication or interpersonal contact between investigator and subject.
Private information includes information about behavior that occurs in a context in which an individual can reasonable expect that no observation or recording is taking place, and information that has been provided for specific purposes by an individual and that the individual can reasonable expect will not be made public (e.g., a medical record).
Identifiable private information is private information for which the identity of the subject is or may readily be ascertained by the investigator or associated with the information.
An identifiable biospecimen is a biospecimen for which the identity of the subject is or may readily be ascertained by the investigator or associated with the biospecimen.
b) The FDA regulatory definition (21 CFR 56) is as follows;
A clinical investigation involves use of a test article (i.e., drug, device, food substance or biologic), one or more human subjects, meets requirements for prior submission to FDA, or results are intended to be part of an application for research or marketing permit.
A human subject is an individual who is or becomes a participant in research, either as a recipient of the test article or as a control. A subject may be either a healthy individual or a patient.
A human subject (FDA for medical devices) is a human who participates in an investigation, either as an individual on whom or on whose specimen an investigational device is used or as a control. A subject may be in normal health or may have a medical condition or disease. [21 CFR 812.3(p)] (Medical Devices)
For additional guidance regarding activities that MAY or MAY NOT require IRB review and approval, see the Guidance: Examples of Activities that Do and Do Not Require UNC Charlotte IRB Review and Approval document.
Classroom/Course Projects: Students conducting projects specifically to fulfill class/course requirements should review the above guidance document and consult with their class/course instructor BEFORE beginning the IRB review process.
2. IRB review for Master’s thesis/doctoral dissertation vs. Class projects
Graduate work (thesis or dissertation) that includes research involving human subjects requires IRB review and approval. Once the research is approved by the IRB, the protocol should remain open/active through thesis or dissertation defense.
Class project(s) or assignments involving collection of data from human subjects generally do not meet the definition of research. Generally speaking, if the data collected for class projects will go no further than presentation/discussion within the class (i.e., no poster sessions, presentations outside the class, publication, does not fulfill master’s or dissertation requirements) then IRB review is not needed. If the class project will be presented as part of a poster session, presentation at a conference or meeting, other publication or as fulfillment of a masters or dissertation requirement, then IRB approval is needed.
Students conducting projects specifically to fulfill class/course requirements should review the Guidance: Examples of Activities that Do and Do Not Require UNC Charlotte IRB Review and Approval document and consult with their class/course instructor BEFORE beginning the IRB review process.
Keep in mind that activities determined to not require IRB review should still follow ethical standards and course instructors are responsible for ensuring that activities are carried out appropriately. Course instructors are encouraged to call the Office of Research Protections and Integrity if they have any questions.
3. I have reviewed the Human Subjects and Research definitions and I’m not sure if my project requires IRB approval
Investigators should contact the Office of Research Protections and Integrity (ORPI) for support in making a formal determination. It is the responsibility of each investigator to obtain IRB review and approval prior to beginning any human subjects research. For additional guidance regarding activities that may or may not require IRB review and approval, see the Guidance: Examples of Activities that Do and Do Not Require UNC Charlotte IRB Review and Approval document.
ORPI will ask the investigator to submit detailed information about the proposed research (letter, memo, proposal, etc.), and in some instances, the investigator may be asked to complete a protocol application submission.
For questions regarding applicability of the requirements for IRB review, please contact ORPI at 704-687-1871 or 704-687-1876.
4. Collaborating with other institutions
IRB approval is required when an institution is “engaged” in research involving human subjects. A collaborative research study involving researchers at other institutions may require IRB review at the collaborator’s institution in addition to the UNC Charlotte IRB. UNC Charlotte may defer review and approval of the study to another IRB or vice versa – the collaborating institution may defer IRB review and approval to the UNC Charlotte IRB. Each situation is considered individually. Therefore, if your research study involves collaboration with colleagues at other institutions, please contact the Office of Research Protections and Integrity for guidance on how to proceed.
In general, an institution is considered to be engaged in human subjects research when its employees or agents obtains, uses, studies, analyzes, or generates any of the following for research:
- data or biospecimens about living individuals for research purposes through intervention or interaction with them
- identifiable private information and/or biospecimens for research purposes (45 CFR 46.102(e))
- the informed consent of human subjects.
Employees and agents, including students, are individuals performing institutionally designated activities and acting on behalf of the institution or exercising institutional authority or responsibility.
In general, an institution is considered to be engaged in human subjects research whenever it receives a direct HHS award to support such research, even if all human subjects activities will be performed by agents or employees of another institution.
In general, simply informing potential subjects about a research study is not considered engagement in research. Also, providing written information about a research study, including how to contact the investigators for information and enrollment, and seeking and obtaining prospective subjects’ permission for investigators to contact them are not considered engagement in research. However, seeking or obtaining informed consent from a research participant is considered engagement in research.
5. Research involving cooperation with an internal and/or external organization (i.e., K-12 schools, church, company, online organization)
There may be many ways that both internal (UNC Charlotte) and external individuals, organizations, companies, etc. support or assist a researcher in conducting his/her research. The IRB will request documentation of agreement from involved entities.
This documentation may include (but is not limited to) a letter of support from:
- a school principal allowing the recruitment of teachers as study participants
- agreement from a course instructor allowing the researcher to use class time to recruit students as study participants
- a church has agreed to allow the researcher to use the church newsletter/website to post study recruitment information
- a company has agreed to give researchers a list of all of their employee email addresses to be used for distribution of study recruitment information
- an online organization has agreed to give the research access to the organization listserv to distribute recruitment information.
6. Human Subjects Research Training Needed
All investigators, co-investigators, and research assistants (e.g. all study personnel) must complete human subjects research training, and the training must be current within the last four (4) years.
UNC Charlotte’s human subjects research training is through CITI (Collaborative Institutional Training Initiative).
If you are uncertain as to how to register for CITI or which training curriculum to complete, please contact the Office of Research Protections and Integrity for guidance.
Research team members who are not affiliated with UNC Charlotte must complete an Individual Investigator Agreement (Investigator Responsibilities) for all research determined to meet the criteria for Expedited or Full Board review.
The individual investigator agreement allows the UNC Charlotte IRB review to include oversight for the individual investigator.
7. Common mistakes to avoid
- Provide documentation of Human Subjects Research training (CITI) for all research team members. This information must be submitted with each protocol application. ORPI does not keep training completion certificates “on file.”
- Submit all recruitment materials and scripts that will be used (email, website postings, flyers, advertisements, etc.). This includes verbal scripts that will be used to introduce a study to individuals or groups.
- Submit letters of support if applicable. Letters should be on organization letterhead. If email correspondence is submitted in lieu of a letter, the email needs to be an original email and should include a clear indication of who the email is from (title – director, CEO, principal, etc.).
- Consent documents must include a “concise summary” at the beginning of the consent form and follow thereafter with more details. The concise summary should be a focused presentation of the key information that is most likely to assist a prospective participant in making a decision about participation. Concise summaries should be concise.
- Consent and assent documents should be written in clear, easy to understand language, avoiding the use of jargon or terms that may not be familiar to all prospective participants. Consider your audience when writing consent and assent documents.
- Consent and assent templates provided on the ORPI website should be used as the foundation for creating a consent document for a specific study. However, the templates are only examples. They are not intended to be absolute language/text and may not be applicable to all studies. Carefully consider the text and only use the example text that fits your study. Use the Consent Checklist document as a guide to ensure your consent document includes all the required information.
- The protocol application should describe in detail each step, procedure, study component, etc. that will be carried out. Once the IRB approves the research, only the procedures described in the protocol are approved. Any procedures or study components not described in the protocol cannot be used or implemented and would be considered deviations from the approved procedures and noncompliant. As an example, if the recruitment procedures will include reminder phone calls or emails the protocol should include this detail and provide the applicable scripts. If not, this follow-up/reminder procedure is not approved and cannot be done.
- Avoid the terms “anonymity” and “anonymous” unless the individual’s identity will not be known to anyone, including the researcher. Participants who sign a consent document, for example, are not anonymous. The data a researcher collects from a participant may be de-identified or collected without identifiers to maintain a person’s privacy and the data itself may be kept confidential using various data security, access controls, and dissemination plans.
- Avoid absolute guarantees of confidentiality. Explain instead the steps you will take to protect the privacy of study participants and steps you will take to maintain the confidentiality of the data (from collection to dissemination) to the extent possible.
IRB Review Process:
New Protocols:
8. IRB Review Process
All protocol applications are reviewed on a first-come-first-served basis.
- The Office of Research Protections and Integrity completes a preliminary review of the protocol application submission and works with the Investigator to address preliminary review comments. The level of review required is also determined at this point.
- The protocol application submission is submitted for IRB review (whether to the IRB Chair or at least one member of the Committee) and any IRB review comments are addressed by the Investigator.
The average review times are:
- Exempt = 10-20 days
- Expedited = 4-8 weeks
- Full = 1 to 3 months (NOTE: The Full IRB meets only once a month. Investigators planning research that requires Full Board review should plan accordingly and review the Full Board meeting deadlines.
Be aware that these review times are average times and the review may take longer depending on how quickly investigators work with the IRB and ORPI to resolve questions and review comments. In addition, the number of protocols being reviewed tends to increase around mid-semester until the end of each semester. Thus review times are often longer.
Investigators are asked to carefully consider their research schedule and allow adequate time for IRB review. Human subjects research may not begin until IRB approval is obtained.
Further, funded research is reviewed in the same manner and timeline research that is not funded. Investigators are encouraged to submit for IRB approval soon after submitting grant proposals. Investigators should also be aware that new awards will not be released by Grants & Contracts Administration (GCA) until all compliance items are resolved. This means that IRB approval is needed before GCA will release new awards for account setup and spending.
Consent:
9. Consent Form
Obtaining 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. Informed consent fulfills the basic ethical principle of respect for persons (The Belmont Report).
More information about informed consent is available on the Informed Consent page.
A consent form is a written document that explains the research study to potential subjects. This document is signed by the subjects and must contain information/statements to ensure that subjects are fully informed about the study.
It is important to understand that consent is a process that begins at the moment you start recruiting participants and continues through the duration of a participant’s involvement. The consent form documents required elements but the investigator must ensure participants understand the information provided to them throughout the study.
When developing your consent process/procedures, consider how you will ensure that participants understand what you are telling them (e.g., asking follow-up questions after reading and discussing the consent form with the potential participant). You may also routinely follow up with participants during the study to ensure they continue to understand what their participation entails and to answer any questions they may have.
Example consent documents are available on the Informed Consent page.
10. Information that must be included in a consent form
- The informed consent process must begin with a concise and focused presentation of the “key information” that is most likely to assist a prospective subject in understanding the reasons why one might or might not want to participate in the research. The informed consent must also be “organized and presented in a way that facilitates comprehension.”
- Consent forms must include one of the following statements:
- either that identifiers might be removed and the de-identified information or biospecimens used for future research without additional informed consent from the subject; or
- that the subject’s information or biospecimens will not be used or distributed for future research studies even if identifiers are removed.
- Consent forms must include the following additional information, when appropriate:
- biospecimens, even if identifiers are removed, may be used for commercial profit and whether the subject will share in the profit
- whether clinically relevant research results will be disclosed to subjects
- whether the research project might include whole genome sequencing.
- 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.
11. Consent vs. Assent
Consent forms are used with adults, typically individuals age 18 and older. Assent is a child’s/minor’s agreement to participate in research. The rule of thumb is that child assent is appropriate for children age 7 and older. When children are involved in a research project, parental consent is needed.
12. Obtaining consent from non-English speaking participants
Consent forms should be prepared in the language understandable to potential subjects, which means you will need to provide participants with a translated version of the consent document. If you are not fluent in the participant’s language, an interpreter should be available during the consent process and throughout the participant’s involvement as needed.
Researchers should take great care when obtaining informed consent from individuals who do not speak English or whose understanding of the language is limited.
13. Waiving Consent
It is the standard expectation that participants will provide documented informed consent. However, there are two waiver options under the federal regulations: 1) waiver of documentation of consent (45 CFR 46.117), and 2) waiver/alteration of consent procedures (45 CFR 46.116).
In most cases, documented informed consent is required. However, there are research designs and circumstances that may justify either a waiver of documentation of consent (e.g., waiver of signature on a consent form) or waiver of consent procedures (either waive entirely or alter the consent procedure in some manner, such as verbal presentation of consent or removal of some required elements of consent).
The IRB will determine if the research meets the criteria for waiving documentation of consent or waiving or altering the consent procedures. Please contact the Office of Research Protections and Integrity to discuss the options for your research. Additional information about waivers is available on the Informed Consent page.
14. Other Considerations
Student ID numbers: Student ID numbers and portions thereof are considered personally identifiable information under the Family Educational Rights and Privacy Act (FERPA). Accordingly, their use as identifiers in a research project is prohibited unless that information is redacted every time the research data or results are distributed. Given that restriction and the risk of inadvertent disclosure, it is the recommendation of UNC Charlotte’s Legal Counsel to not use portions of 800 numbers if at all possible and instead assign a new and unique identifier just for the study.
FERPA allows the release of de-identified student data from education records by attaching a unique code that allows the recipient to match information received from the same source, provided that:
- We do not disclose any information about how that code is generated or assigned or any other information that would allow a recipient to identify a student based on a record code;
- The code is used for no purpose other than identifying a de-identified record for purposes of education research and cannot be used to ascertain personally identifiable information about a student; and
- The code is not based on a student’s social security number or other personal information (including a student ID).
Incentives and Extra Credit: The regulatory criteria for approving research with human subjects includes determination that risks to participants are minimized and risks are reasonable in relation to benefits, either to the participants or benefits resulting from the knowledge that may result from the research. In addition, selection of participants must be equitable.
In applying this approval criterion, the IRB will consider incentives/inducements, including extra credit. It is important for the researcher to have an incentive plan that is reasonable in relation to what the participants’ will experience/do in the research in order to avoid undue influence. In addition, if extra credit in a course will be offered for participation in research, the course instructor (who may or may not be the researcher) must offer an equitable alternative means of earning the same amount of extra credit. The alternative should be equitable with respect to what is expected of the student (time and effort) as well as equitable with respect to the amount of extra credit to be earned.
The protocol application should explain the extra credit and provide information about the equitable alternative as well as provide documentation from course instructors agreeing to provide extra credit as well as an equitable alternative.
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