Frequently Asked Questions

The Institutional Review Board (IRB) is a federally mandated committee established to protect the rights, welfare, and privacy of individuals who participate in research. In accordance with federal regulations (45 CFR 46), the IRB is responsible for reviewing research projects involving human participants to ensure that ethical standards are upheld and that risks to participants are minimized.

The IRB reviews research protocols to confirm that:

• Participation is voluntary and based on informed consent;
• Risks to participants are reasonable in relation to anticipated benefits;
• Participant privacy and data confidentiality are protected; and
• Vulnerable populations receive additional safeguards, when applicable.

Any research involving human subjects conducted by faculty, staff, or students must receive IRB approval or exemption before recruitment or data collection begins.

All undergraduate student researchers must also complete CITI training; however, their certification process is shorter in length.

According to federal guidelines (45 CFR 46), a project requires IRB review if it meets both of the following criteria:

1. It is research – defined as “a systematic investigation designed to develop or contribute to generalizable knowledge.”
2. It involves human subjects – meaning you’re obtaining data through intervention or interaction with individuals, or accessing identifiable private information or biospecimens.
3. It includes a plan to contribute to generalizable knowledge – such as through publication, presentation, or sharing findings beyond the immediate program, classroom, or organization.

If your project does not meet both criteria, IRB review is typically not required. For example, classroom projects, internal program evaluations, or quality improvement efforts that aren’t intended for publication or presentation outside the institution may not need IRB review.

The key difference lies in the intent and use of the information collected.

• A class project is typically designed as a learning activity—to help students practice research methods, data collection, or analysis as part of a course. These projects are not intended to contribute to generalizable knowledge and are usually not shared outside the classroom (e.g., not published or presented publicly). Class projects generally do not require IRB review, unless there is intent to disseminate the findings.
• Research, as defined by federal regulations (45 CFR 46.102), is “a systematic investigation… designed to develop or contribute to generalizable knowledge.” This includes studies with the intent to publish, present, or otherwise share findings beyond the institution. Research involving human subjects must be reviewed and approved by the IRB before it begins.

If a class project shifts toward research (e.g., a student later wants to present findings at a conference), IRB review and approval must be obtained before using the data for research purposes.

Research involving human subjects must be reviewed at one of three levels, depending on the level of risk to participants and the type of activity involved:

Exempt Review

• Definition: Research that involves minimal risk and falls into specific federally defined categories (e.g., anonymous surveys, educational tests, or benign behavioral interventions).
• Although called “exempt,” these projects still require submission to the IRB for confirmation of exempt status. Researchers cannot be self-exempt.
• Examples: Anonymous classroom surveys, analysis of de-identified existing data.

Expedited Review

• Definition: Research that involves no more than minimal risk and fits into one of the federally designated expedited categories (e.g., blood draws, voice recordings, non-invasive data collection).
• Review Process: Reviewed by the IRB Chair or designated reviewers, not the full board. Elon’s Standard Operating Procedures require that two reviewers evaluate the application and provide feedback.
• Examples: Collection of saliva samples, interviews on non-sensitive topics, moderate exercise studies.

Full Board Review

• Definition: Research that involves more than minimal risk, includes vulnerable populations, or does not fit into exempt or expedited categories.
• Review Process: Reviewed at a convened IRB meeting with a quorum present.
• Examples: Studies involving children and deception, clinical trials, or sensitive topics like trauma or illegal behavior.

Minimal risk refers to “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” (45 CFR 46.102).

For additional information you will find the Human Subject Decision Charts via this link.

To conduct research involving human subjects, the PI must submit an application to the Institutional Review Board (IRB) and receive approval before beginning any recruitment, interaction, or data collection.

To begin this process:

1. Determine whether your project qualifies as human subjects research. If you are unsure, you can review these decision charts or you may contact the IRB for guidance.
2. Complete your CITI training, or make sure your training is up to date and uploaded to your PI documentation on IRB Mentor.
3. Complete the IRB application. Applications are submitted through IRB Mentor. The most current IRB application may be found on our website.
4. Prepare and attach all required supporting documents. These may include: A complete study protocol using the Elon IRB application, Informed consent or assent forms, Recruitment materials (emails, flyers, scripts), Surveys, interview guides, or other data collection instruments, Letters of permission or support (if conducting research in schools or other organizations)
5. Submit the application for review. Once received, the IRB will assess the project and determine the appropriate level of review: exempt, expedited, or full board.
6. Respond to any revision requests. The IRB may request clarifications or changes before final approval can be granted. Prompt responses help avoid delays.
7. Receive formal IRB approval before starting research activities.

Researchers should allow sufficient time for the review process, especially if full board review is required.

The length of the IRB review process depends on the level of review your project requires:

• Exempt and Expedited Reviews are conducted on a rolling basis and do not require full board meetings. Elon IRB reviewers have 14 days to complete their review once the application is assigned.
• Full Board Reviews are considered at scheduled monthly IRB meetings. Applications must be submitted in advance of posted deadlines to be included on the agenda. Final approval timelines may vary based on the study’s complexity and required revisions.

To avoid delays, make sure your application is complete and all required documents are submitted.

Informed consent is a required process that ensures participants voluntarily agree to take part in research with full knowledge of what the study involves. According to federal regulations (45 CFR 46.116), informed consent must be:

1. Obtained before participation begins. Participants must give consent before any research-related procedures are conducted.
2. Given voluntarily. Consent must be free from coercion or undue influence. Participants should feel free to decline or withdraw at any time without penalty.
3. Based on clear and understandable information. Consent documents must be written in plain language (typically at an 8th-grade reading level or lower) and must include: A statement that the study involves research, the purpose of the research, what participation involves, including time commitment, potential risks and benefits, confidentiality of data, whether participation is voluntary and that refusal will not affect current or future relationships with the institution, whom to contact for questions or concerns
4. Documented appropriately. Typically, participants sign a written consent form. In some cases, the IRB may approve a waiver of documentation or a waiver/alteration of consent if the research meets specific criteria outlined in 45 CFR 46.117.

Researchers are encouraged to think of informed consent not as a one-time event, but as an ongoing conversation with the people participating in their study. This means that if any new information comes up during the research—such as new risks, changes to the study design, or important findings—that might influence whether someone wants to keep participating, the researcher should share that information and may need to ask for the participant’s consent again. This process helps ensure that participants remain fully informed and able to make thoughtful decisions throughout the study.

Parental or guardian permission is generally required when minors (typically under 18 years old) are involved as research participants. Once permission is obtained and documented from parents or legal guardians, the child may then provide assent to take part in the research.

Assent is a child’s affirmative agreement to participate in research and is required, in addition to parental or guardian permission, for studies involving minors. Researchers must seek assent when children are capable of understanding the research in an age-appropriate way.

Assent forms should be written in simple, clear language that matches the child’s developmental level—free of jargon and complex terms. It should include why the research is being done, what the child will be asked to do, that participation is voluntary, and that they can stop at any time without consequences. The IRB may waive assent in limited circumstances, but this must be justified in the protocol.

All faculty, staff, and students working with minors must complete the Protection of Minors training course. Instructions for accessing the training module can be found here.

Any changes to an IRB-approved study, no matter how minor, must be submitted for review before they are implemented, unless the change is necessary to eliminate an immediate risk to participants.

To request modifications:

• Submit a Modification or Amendment Form through the IRB Mentor to the same approved protocol record.
• Clearly describe the proposed changes and explain the reason for the modification.
• Include any updated documents (e.g., revised consent forms, recruitment materials, data collection tools) with tracked changes if applicable.

Changes that require IRB approval include, but are not limited to:

• Changes to the research team (e.g., adding a co-investigator)
• Updates to recruitment methods or materials
• Revisions to consent/assent forms
• Modifications to data collection instruments or procedures
• New study sites or populations
• Increases in the number of participants
• Any changes that may affect risk to participants

Modifications will be reviewed at the same level as the original study (exempt, expedited, or full board), depending on the nature of the change.

Researchers are required to report any adverse events or unanticipated problems involving risks to participants or others to the IRB as soon as possible, in accordance with federal regulations (45 CFR 46.103(b)(5)).

An adverse event is any undesirable or unintended experience associated with a research intervention or interaction. Not all adverse events need to be reported to the IRB—only those that are unexpected, related or possibly related to the research, and suggest that participants or others may be at greater risk than previously known.

Examples of reportable events include:

• Unexpected harm or side effects experienced by participants
• Breaches of confidentiality
• Complaints or concerns from participants indicating possible harm
• Any incident that may affect the conduct of the study or alter the risk/benefit balance

To report:

• Complete the IRB’s Unanticipated Problem/Adverse Event Report Form.
• Submit the report through the IRB system within 72 hours of the event.

The IRB will review the report and determine whether additional actions are required, such as protocol modifications, temporary suspension of the study, or additional participant protections.

All researchers, including co-researchers, undergraduate and graduate students, and study personnel involved in human subjects research are required to complete human subjects protection training before beginning any research activities. This includes faculty, staff, students, and any other individuals who interact with participants, obtain informed consent, or access identifiable private data.

Elon requires that researchers complete IRB training through Collaborative Institutional Training Initiative (CITI Program). The training provides foundational knowledge of ethical principles, federal regulations (such as the Belmont Report and 45 CFR 46), and best practices for protecting human participants in research.

Key points:

• Training must be completed before IRB approval can be granted
• Documentation of completion (e.g., CITI certificate) must be uploaded to IRB Mentor and added to the PI Documentation page.
• Refresher training is typically required every four years, or as specified by your institution’s policies

Additional training may be required for researchers working with vulnerable populations or conducting research in specialized settings (e.g., international sites, schools, or medical facilities).

When collaborating on human subjects research with investigators from other institutions, federal regulations (45 CFR 46.114) require that each engaged institution ensure IRB oversight. This often involves establishing a written agreement—called an Institutional Authorization Agreement (IAA) designating one IRB to serve as the IRB of record.

At Elon University, Authorization Agreements are required only for studies reviewed at the Expedited or Full Board level. If your study qualifies as Exempt, Elon’s IRB does not require a formal agreement, though documentation of each institution’s exemption may still be needed.

Even when an IAA is not required, you are strongly encouraged to have a conversation with your collaborators about:

• Their institution’s IRB requirements and processes
• Who is responsible for obtaining and documenting informed consent
• How study documentation (e.g., consent forms, recruitment materials) will be managed
• Who will have access to identifiable data, and how data will be stored and shared securely

It is the responsibility of the study team to ensure that all collaborators are meeting their respective institutional requirements and that data privacy and participant protections are maintained across sites.

If you’re unsure whether an IAA is needed or who should serve as the IRB of record, contact Elon’s IRB for guidance early in the planning process.

Elon University has a campus-wide survey policy to ensure the appropriate coordination and use of surveys that target the university community. If your study involves administering a survey and you intend to enroll more than 300 participants, you must go through the University’s survey approval process after receiving IRB approval.

This policy applies to surveys distributed to students, faculty, or staff using Elon email lists, campus-wide tools, or other institutional resources. The survey review process helps manage survey volume, prevent duplication, and protect the integrity of the campus community’s experience.

More information about the survey policy and how to submit a request can be found here.

Researchers are responsible for obtaining both IRB approval and survey approval (when applicable) before launching any campus-wide recruitment or distribution.

Yes, researchers may compensate participants with gift cards as a form of appreciation for their time and involvement in a study. However, compensation must be handled in a way that is ethically appropriate, clearly described in the informed consent process, and aligned with institutional and IRB policies.

Key considerations:

• Consent Form Transparency: The amount and form of compensation (e.g., “a $10 Amazon gift card”) must be clearly stated in the consent document. Participants should understand that compensation is not contingent on completing the entire study unless justified.
• Non-Coercive: Compensation should not be so high that it could unduly influence someone’s decision to participate. It must be proportionate to the time and effort involved.
• Distribution and Tracking: Researchers must maintain documentation of gift card distribution (e.g., dates and participant codes) while protecting participants’ confidentiality. Personally identifiable information should not be linked to payment records unless required for financial reporting.
• Tax and Accounting Requirements: Depending on the amount and funding source, researchers may need to coordinate with Elon’s Office of Sponsored Programs to ensure proper tracking and reporting.

Researchers planning to use gift cards should consult the IRB or their department’s business manager to confirm that their method of distribution aligns with university policy.

Elon Purchasing: https://www.elon.edu/u/fa/purchasing/purchasing-procedures/

Elon Office of Sponsored Programs:

https://www.elon.edu/u/academics/sponsored-programs/

Beginning research involving human subjects before obtaining IRB approval is a violation of federal regulations and university policy. Any data collected before IRB approval may not be used for research purposes.

Researchers must wait for formal written IRB approval before starting any research activities, including recruitment or data collection.

Federal regulations prohibit the collection of any data from human subjects prior to receiving IRB approval. Starting research without approval is considered noncompliance and may jeopardize the project and funding.

IRB approval is generally valid for one year from the date of approval unless otherwise stated in your determination letter. For studies that require continuing review (typically greater than minimal risk studies), a continuing review application must be submitted before the expiration date.

Exempt studies do not require annual renewal but must submit an amendment if any changes are made to the study. Researchers will receive reminders from IRB Mentor about upcoming expiration dates but are responsible for ensuring timely renewal.

When your study is complete, including all data collection, analysis, and use of data, you must submit a study termination report. This can be completed via IRB Mentor at the bottom of the specific protocol.

Yes. Studies granted exempt status are still considered human subjects research and may be published or presented. The exempt determination simply means the study falls into a category of research with minimal risk and does not require ongoing IRB oversight.