What is an Institutional Review Board (IRB)?
An 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.
When does the IRB meet?
IRB meets at the end of each month.
What research has to be reviewed by the IRB?
The IRB reviews and monitors human subjects research conducted under the aegis of APUS (this includes American Public University APU and American Military University AMU, hereafter referred to as APUS). What is meant by “under the aegis of APUS ?”
- The research is sponsored by APUS
- The research is conducted or directed by any employee or trainee of the university in connection with his or her APUS responsibilities
- The research involves access to any property or facility of APUS
What is a human subject?
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)).
- Human participants include those who are actively involved in the research process (being interviewed, filling out surveys, etc.)
- They also include those provided medical samples, left records of their activities through applying for marriage licenses, etc.
The IRB reviews research that involves living individuals (1) about whom "an investigator conducting research obtains data through intervention or interaction with the individual" or (2) which contains "identifiable private information" (Title 45 CFR, Part 46.102.f). Secondary analysis of existing datasets where participants are individually identifiable should be reviewed by the IRB.
What is research?
- Research contributes to generalizable knowledge
- Research is designed in advance
- Research utilizes a systematic approach
Although biographers, historians, and other scholars may do a great deal of research in the course of their work, the knowledge they are developing is particular to the individual or individuals they are studying. Thus biography, most journalism, artistic endeavors, and other similar activities are outside the purview of the IRB and do not require review. Many projects fall into gray areas. If you are not sure about your own project, please contact the IRB.
Oral histories are NOT automatically excluded from oversight by IRBs. Also, please consider the following information when preparing your oral history project:
- Are the purposes clearly set forth? How realistic are they?
- What factors demonstrate a significant need for the project?
- What is the research design? How clear and realistic is it?
- Are the terms, conditions, and objectives of funding clearly made known to judge the potential effect of such funding on the scholarly integrity of the project?
- Is the allocation of funds adequate to allow the project goals to be accomplished?
- How do institutional relationships affect the purpose and objectives?
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.
Students seeking IRB approval for their research must first secure the approval of their professor prior to submitting their application.
How do I apply?
Submit an application for IRB Approval of Human Subjects Research. Follow the process as outlined on the application 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
Does APUS have a consent form template?
Sample consent forms can be found on our application page.
What information must be included in a consent form?
- 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 an 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.
See our application page for sample consent forms.
What is the difference between full, expedited and exempt review?
Full-Committee Review: Studies are reviewed by a fully-convened IRB committee. The committee discusses the study and makes a decision about the approval of the study. This type of review is carried out for studies greater than minimal risk to subjects.
Expedited Review: Studies are reviewed by a qualified member of the IRB committee. This member reviews the appropriate materials and consults with the PI if necessary to come to a decision about the approval of the study. This type of review is carried out for studies that involve minimal risk to subjects and fit into an expedited review category of research.
Only research involving no more than minimal risk to subjects may be considered for expedited review.
- Collection of data through noninvasive procedures.
- Research involving materials (data, documents, records, or specimens) that have been collected, or will be collected solely for non-research purposes.
- Collection of data from voice, video, digital, or image recordings made for research purposes.
- Research on individual or group characteristics or behavior.
- Continuing review of research previously approved by the convened IRB
- Continuing review of research, not conducted under an investigational new drug application or investigational device exemption where categories two (2) through eight (8) do not apply but the IRB has determined and documented at a convened meeting that the research involves no
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
- 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.
Note: Since this constitutes a review, protocols that are deemed exempt at APUS are effectively “exempt from continuing review".
What is considered minimal risk?
Minimal Risk: "The probability and magnitude of harm or discomfort anticipated in the research are not greater in and of themselves than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests" (from 45 CFR 46.102(i)).
When making a decision about minimal risk of research, consider both magnitude and likelihood of risk.
What is the difference between confidentiality and anonymity?
Confidentiality: Confidentiality is maintained when the information collected from research participants that identifies them individually is known only to the researcher/research team. Anyone outside of the project should not be able to connect individual subjects with their responses.
Anonymity: Collecting identifiable information from research subjects should only be done if it is essential to the project. Researchers who want to engage in the anonymous collection of data should not collect identifying information from individual subjects (e.g., name, rank, address, email address, etc.) or should not link individual responses with participants’ identities.
Is any special training required?
Yes, effective January 1, 2011, all investigators, students, and research staff conducting research with human subjects must complete CITI training PRIOR to submitting their IRB application. Research will not be approved until the training requirements are met. Documentation of training must be provided to the IRB Office with all new applications or renewals. (Log on to: https://www.citiprogram.org/ to complete the training. You will be able to create your own username and password).
What if I don’t get IRB approval?
Failure to obtain proper approval in advance may jeopardize your data, prevent you from publishing the results, and place you and the university in violation of federal regulations.
Who makes up the IRB?
The IRB is made up of 8 members including a chair. The members serve for a 2-year, staggered and renewable term. Each member will complete human subjects protections and IRB training prior to starting each term. The chair is selected by the academic dean and the remaining four members are drawn from APUS full-time faculty in accordance with §CFR 46.107 and with current OHRP guidance. Membership shall include both scientists and non-scientists as well as general community members. Outside members, who are those members not affiliated with APUS community, will be nominated by the chair and appointed by the academic dean.
If I am surveying APUS students or faculty, do I need IRB approval?
This depends upon whether your survey constitutes “research.” If it does, you must submit it to the IRB. When in doubt, contact the IRB at firstname.lastname@example.org for a determination.
Additionally, the Internal Research Review Board (IRRB) reviews all requests to conduct research with APUS students, faculty, and staff. Researchers interested in conducting research at APUS must submit a “Request to Conduct Research” application by emailing email@example.com. The application should be submitted by the principal investigator. If the proposed research is being done as part of a dissertation or advanced coursework, the dissertation chair or lead faculty member must sign the form.
Are there special considerations regarding online surveys?
- Online surveys should allow "no response" as an option for every question. That is, a survey design where one cannot proceed without answering the question is in violation of the respondent's right to withhold information.
- Sensitive data must be protected as it moves along communication pathways between computers. If using a commercial site (e.g., Zoomerang) the researcher should review the site's security measures for protecting respondent privacy and data confidentiality.
- The researcher's agreement with the commercial site should include specific provisions about how, and for how long, it will store the data.
Who do I contact for more information?
Contact the IRB at firstname.lastname@example.org.