The Institutional Review Board (IRB) is an independent administrative body responsible for protecting the rights and welfare of human subjects involved in research conducted under the institution’s oversight.
As a recipient of federal research funding, JMU is required to maintain an Institutional Review Board (IRB) that complies with federal regulations. The IRB is responsible for reviewing research protocols involving human subjects and evaluating both the potential risks and the measures in place to protect participants.
Additionally, JMU must register with the federal Office for Human Research Protections (OHRP) through a process known as Federalwide Assurance (FWA). As part of this registration, JMU must indicate whether the University and its IRB will apply federal regulations solely to federally funded research or to all research involving human subjects.
What the IRB Looks for When Reviewing Research
Before the IRB can approve a research study involving people, it must make sure the following conditions are met:
-
Risks to participants are minimized.
- By using procedures consistent with sound research design that do not unnecessarily expose subjects to risk.
- Whenever appropriate, by using procedures already being performed on the subjects for diagnostic or treatment purposes.
-
Risks are reasonable in relation to anticipated benefits, if any, to the subjects and the importance of the knowledge expected to result.
- The IRB should consider only those risks and benefits that arise directly from the research itself, not from long-term effects such as potential impacts on public policy.
-
Participants are chosen fairly.
- The IRB considers the purpose of the study and where it takes place.
- Special care is taken when the study involves vulnerable groups, such as children, prisoners, pregnant women, people with mental disabilities, or those who are economically or educationally disadvantaged.
-
Informed consent is obtained.
- Each participant (or their legal representative) must agree to take part after being fully informed about the study.
-
Informed consent is properly documented.
-
The study includes a plan to monitor participant safety, if needed.
-
Steps are taken to protect participants’ privacy and keep their data confidential.
-
Extra protections are in place for vulnerable participants to ensure their rights and well-being are safeguarded.
The IRB’s responsibilities include:
-
Ensuring that all reviewed projects comply with University policies and the federal Common Rule, particularly regarding the health, welfare, safety, rights, and privileges of human subjects.
-
Assisting investigators in complying with applicable federal and state regulations.
At JMU, any research that involves people or information about people must be reviewed by the IRB. This includes research that involves:
- Living humans (such as interviews, surveys, or experiments)
- Human tissues or biological samples
- Records or data collected about individuals (like medical, academic, or personal records)
What Is Research with Human Subjects?
Research is defined as a systematic investigation—meaning it follows a planned approach to collect and analyze data (quantitative or qualitative)—with the goal of contributing to general knowledge in a field.
Note: Your study doesn’t have to be repeatable by others, but it should aim to add to what is known in your discipline.
What Is a Human Subject?
A human subject is a living person from whom a researcher:
- Collects information or biological samples (like blood or saliva) through interaction (e.g., interviews, surveys) or intervention (e.g., medical procedures or environmental changes), and uses or analyzes that data; or
- Uses identifiable private information or biospecimens (e.g., medical or school records).
Key Terms Explained:
- Intervention: Any physical procedure (like drawing blood) or change to a person’s environment done for research purposes.
- Interaction: Any communication between the researcher and the participant—this can be in person, on paper, or online (e.g., surveys, interviews, or participant observation).
- Private Information:
- Behaviors people expect to remain unobserved (e.g., actions in a private setting).
- Personal data shared for specific reasons (e.g., medical or academic records) that are expected to stay confidential.
- This information must be identifiable, meaning it can be linked to a specific person.
Do I Need IRB Review?
You are conducting research with human subjects if:
- You are doing a systematic investigation, and
- You are collecting or using data from or about living individuals.
If you’re not sure whether your project qualifies, please contact the Office of Research Integrity (ORI) for guidance.
All research involving human participants must be submitted for review and approved by the IRB before the study begins. This includes studies using existing data, as well as any plans for advertising or recruiting participants.
Federal guidelines require that all researchers and key personnel involved in designing or conducting research with human participants complete proper training before beginning any work. This includes faculty, staff, and students. Faculty advisors overseeing student research must also complete the training.
No research involving human participants will be approved until this training is completed and verified by the Office of Research Integrity (ORI).
The IRB may accept training other than the standard CITI program if the researcher provides documentation that includes:
- The name of the training course(s)
- The institution that offered the training
- The date of completion
- The score received (if applicable)
This documentation must be submitted with the research protocol.
Please see Training for more information.
Yes, if your study meets the definition of research involving human participants, ,as explained above, it must be reviewed and approved by the IRB.
James Madison University (JMU) has a Federalwide Assurance (FWA) with the U.S. Department of Health and Human Services. This means all research conducted under JMU’s oversight must go through IRB review and approval.
You must have written IRB approval before starting any part of the study that involves people, including recruitment, surveys, interviews, or other interactions.
Yes, if your project involves collecting stories or information that may be used to draw broader conclusions about people, cultures, norms, or practices, even if you're not testing a specific hypothesis.
IRB review is not required if your project is only meant to document or report on events, situations, policies, institutions, or systems without trying to generalize findings or draw conclusions.
Review procedures for Expedited review and Full review are similar in several ways:
- Both use the same review criteria to evaluate research.
- In both cases, reviewers can:
- Request changes to the submission
- Approve new protocols
- Approve continuing reviews and amendments to existing studies
Key Difference:
-
Expedited reviewers cannot disapprove a study.
If they have concerns they cannot resolve, they must refer the study to the full IRB for review. -
All IRB members are notified of studies approved through expedited review.
Any member can request that the full IRB reconsider an expedited approval.
What About Exempt Research?
- Exempt research does not require IRB review.
- Instead, the IRB Chair or their designee determines whether a study qualifies as exempt.
Some research may be exempt from full IRB review if it falls into specific categories defined by federal regulations. Although there are eight federal exemption categories, JMU currently uses six. Of those, the three most commonly used in social and behavioral research are:
-
Educational Research
Research conducted in regular educational settings using normal educational practices. -
Surveys, Interviews, and Observations
Research involving educational tests, surveys, interviews, or observation of public behavior.Note: Exempt Category 2 (parts i and ii) may be applied to research involving children under specific conditions. However, there are important limitations when Subpart D regulations apply.
Limitations for Category 2 Research with Children:
Permitted Activities: Only educational tests and observation of public behavior are allowed.
Observer Role: If the research involves observing public behavior, the researcher must not participate in the activities being observed.
Restricted Use of Part (iii): Research approved under part (iii) of Category 2, which involves recording identifiable information and requires limited IRB review, is not permitted for research involving children. -
Use of Existing Data
Research using data or biological samples that were collected for other purposes, as long as:- The data is publicly available, or
- The researcher records it in a way that individuals cannot be identified.
Even though these studies may be exempt from full review, only the IRB Chair or their designee can make that determination—not the researcher.
What Qualifies for Expedited Review?
To be eligible for Expedited Review, a study must meet both of the following:
-
Minimal Risk
The risk to participants is no greater than what they would encounter in daily life or during routine exams. -
Eligible Research Activities
The study involves procedures listed in the federal expedited categories, such as:- Surveys, interviews, and data analysis
- Non-invasive medical procedures (e.g., blood pressure checks, MRIs, blood draws)
What Requires Full Board Review?
Studies are typically sent to the Full IRB Board if they involve:
- Vulnerable populations (e.g., children, prisoners, individuals with cognitive impairments)
- Sensitive topics, such as:
- Illegal behavior
- Drug or alcohol use
- Trauma or other potentially distressing experiences
Yes. JMU’s human subjects policy requires that the IRB Chair or their designee make the official determination of whether a study is exempt or not exempt from IRB review.
Faculty, staff, and students may not begin any exempt research until they receive written confirmation of exemption.
-
Anonymous means no one, not even the researcher, knows who the response came from.
Example: A survey returned with no name, ID, or any other identifying information. -
Confidential means someone (like the researcher) knows the identity of the participant, but takes steps to protect that information.
Example: You collect names but promise to replace them with code numbers and keep the list secure.
Important: Just removing names later doesn’t make data anonymous—because someone (you or your team) had access to the identities at some point.
Also, names aren’t the only identifiers.
If your class has only one non-traditional aged student and you ask for age, that person could still be identified. For data to be truly anonymous, there must be no way to trace it back to an individual.
If your study involves participants with limited English skills, it is your responsibility as the researcher to ensure they fully understand:
- The purpose of the study
- What participation involves
- Any potential risks or benefits
If participants are not fluent in English, you must:
- State in your protocol (not just the consent form) whether you will only include participants who have strong English reading, writing, and speaking skills.
OR - Provide translated consent forms in the participant’s native language.
Reminder: All consent forms must be written at an eighth-grade reading level and in the language understood by the participant.
Please refer to the JMU Financial Procedures Manual regarding payments to research subjects.
JMU IT provides Qualtrics as a web-based survey tool for specialized research or the approved collection of highly confidential data. For more information, please see: https://www.jmu.edu/computing/teaching-and-learning/survey-software.shtml.
QuestionPro is also available through the university; however, it is not approved for human subjects research.
Investigators should contact the ORI whenever collaborative research is occurring. Separate protocols for each institution may not be necessary.
If you already have an approved IRB protocol from another institution, you may not need to submit a new protocol to JMU’s IRB.
However, to proceed, you must provide:
- A copy of your currently approved IRB protocol that includes approval for JMU’s involvement
- Official approval documentation from your home institution’s IRB
- All required study materials, such as consent forms, surveys, and other tools
As long as all required information is submitted, JMU’s IRB can process your existing approval, helping you avoid unnecessary duplication of effort.
Yes. If you are JMU faculty, staff, or a student and you are the Principal Investigator (PI), the person responsible for the conduct of the study, you must obtain JMU IRB approval, regardless of where the research takes place.
Additionally, your project may also require local IRB or ethics committee approval at the research site, depending on the location and population involved.
You must receive written IRB approval before you begin:
- Recruiting participants
- Collecting data
- Analyzing data
You will receive an official approval notice via email once your project has been approved by the IRB.
Any changes to an approved research study must be submitted to the IRB for review and approval before they are implemented.
To request changes, please complete and submit a Modification.
No. Submitting and receiving approval for an amendment does not change the original project end date.
To avoid a lapse in IRB approval, please submit a Renewal before your project’s expiration date.
If your IRB approval expires, all research activities must stop immediately. This includes:
- Recruitment and advertising
- Screening and enrolling participants
- Obtaining consent
- Conducting interventions or interactions
- Collecting private, identifiable information
Continuing any of these activities without current IRB approval is a violation of federal regulations.
To avoid a lapse, you must submit a Renewal before your project’s expiration date. While the electronic Research Administration (eRA) software system sends reminders, it is your responsibility to ensure the review is submitted on time.
