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Understanding the Institutional Review Board (IRB) - Purdue University Global Academic Success Center

The Institutional Review Board (IRB) is a committee responsible for reviewing research involving human participants to help ensure that studies are conducted ethically and safely. Universities and research institutions use IRBs to protect the rights, privacy, and well-being of research participants.

Graduate and doctoral students conducting research involving human participants are often required to submit an IRB application before beginning data collection. Depending on institutional requirements and the type of study being conducted, IRB approval may be required for interviews, surveys, focus groups, observations, classroom research, or studies involving identifiable participant data.

Purpose of the IRB

The primary purpose of the IRB is to help protect human participants involved in research studies. The IRB reviews proposed studies to ensure that researchers:

The IRB process also helps ensure that research follows institutional, professional, and federal ethical guidelines.

What Counts as Human Subjects Research?

Human subjects research generally includes studies in which researchers collect data directly from individuals or obtain identifiable information about participants.

Examples of research that may require IRB review include:
• surveys or questionnaires
• interviews or focus groups
• classroom-based research
• observational studies
• studies involving audio or video recordings
• collection of demographic or personal information
• analysis of identifiable participant data

Some projects may qualify for exempt review or may not require formal IRB approval, depending on the institution and type of research being conducted. Researchers should always review institutional policies and consult with the IRB office if they are unsure whether approval is required.

Why IRB Approval Matters

IRB approval helps protect both participants and researchers throughout the research process. Ethical research practices help ensure that participants understand the study, voluntarily agree to participate, and are protected from unnecessary harm or risk.

The IRB process also strengthens the credibility and integrity of scholarly research by encouraging researchers to carefully plan procedures related to recruitment, confidentiality, data collection, and participant protections.

At the doctoral level, ethical research practices are an important part of conducting rigorous and responsible scholarship.

Types of IRB Review

Depending on the nature of the study and the level of potential risk involved, research may qualify for different levels of IRB review.  The three levels include exempt, expedited, and full reviews. 

Exempt Review

Exempt review generally applies to studies involving minimal risk to participants. Although exempt studies may involve less oversight, researchers are still expected to follow ethical research practices and institutional guidelines.

Examples may include:
• anonymous surveys
• educational research conducted in established settings
• studies using non-identifiable existing data

Expedited Review

Expedited review is used for studies involving minimal risk but requiring additional review of research procedures and participant protections.

Examples may include:
• interviews or focus groups
• collection of identifiable participant information
• audio-recorded research sessions

Full Board Review

Full board review is typically required for studies involving greater potential risk, sensitive topics, vulnerable populations, or more complex research procedures. These studies are reviewed by the full IRB committee.

Examples may include:
• studies involving children or vulnerable populations
• research involving sensitive personal topics
• studies involving physical or psychological risk

Components of an IRB Application

Researchers should ensure that all documents included in the IRB application are consistent and clearly explained.

Informed Consent

Informed consent is one of the most important components of ethical research. Informed consent allows participants to understand the purpose of the study and decide whether they would like to participate voluntarily.

Consent forms typically explain:
• the purpose of the study
• what participation involves
• potential risks or benefits
• confidentiality protections
• voluntary participation
• the participant’s right to withdraw
• contact information for questions or concerns

Consent language should remain clear, professional, and easy for participants to understand.

Recruitment and Ethical Considerations

Researchers should carefully consider how participants will be recruited and whether any ethical concerns may arise during the study.

Ethical considerations may include:
• avoiding coercion or pressure to participate
• protecting participant confidentiality
• minimizing potential harm or discomfort
• ensuring voluntary participation
• avoiding conflicts of interest
• protecting vulnerable populations

Researchers conducting classroom or workplace research should also consider potential power dynamics that may influence participant participation.

Common IRB Challenges

Graduate and doctoral students often encounter challenges when preparing IRB applications. Common issues may include:
• vague or inconsistent research procedures
• unclear recruitment plans
• weak confidentiality explanations
• insufficient detail about data storage
• inconsistent participant numbers across documents
• mismatch between research questions and methodology
• incomplete consent forms
• lack of alignment among study materials

Carefully reviewing all IRB documents before submission can help reduce delays or revision requests.

Tips for Navigating the IRB Process

The IRB process can feel overwhelming at first, particularly for new researchers. The following strategies may help students navigate the process more effectively:
• begin the IRB process early
• carefully review institutional guidelines
• ensure consistency across all study documents
• use clear and professional language
• align methodology and data collection procedures
• ask questions when clarification is needed
• allow time for revisions or additional review

Many IRB applications require revisions before approval, and revision requests are a normal part of the research process.

Conclusion

Although the IRB process may initially seem complex, careful planning and attention to ethical research principles can make the process more manageable. Beginning the application early, maintaining consistency across study documents, and following institutional guidelines can help reduce revisions and facilitate a smoother review process. Ultimately, understanding the IRB process enables researchers to protect participants, strengthen the quality of their studies, and contribute responsibly to the advancement of scholarly knowledge.

References

American Psychological Association. (2020). Publication manual of the American Psychological Association (7th ed.). https://doi.org/10.1037/0000165-000

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