Navigating IRB and Research Ethics

If your dissertation involves human participants – and most do – you will need approval from your institution’s Institutional Review Board (IRB) before you collect a single piece of data. For many students, the IRB process feels like a bureaucratic obstacle standing between them and their research. In reality, it is a critical safeguard that protects both your participants and you. Understanding the process and preparing thoroughly can make the difference between approval in weeks and a months-long cycle of revisions.

This guide demystifies the IRB process, walks you through the application materials, and helps you think about research ethics in ways that go beyond regulatory compliance.

What Is the IRB and Why Does It Exist

The Institutional Review Board is a committee that reviews research involving human participants to ensure it meets ethical standards. Every university and research institution in the United States that receives federal funding is required to have an IRB, and most international institutions have equivalent bodies.

The modern IRB system traces its origins to research abuses that shocked the public conscience. The Tuskegee syphilis study, in which African American men were deliberately left untreated for syphilis for decades, was the most notorious case, but it was not the only one. The Nuremberg Code (1947), the Declaration of Helsinki (1964), and the Belmont Report (1979) established the ethical principles that IRBs enforce today: respect for persons, beneficence, and justice.

These are not abstract concepts. Respect for persons means that participants must give informed, voluntary consent. Beneficence means that the potential benefits of the research must outweigh the risks, and that risks must be minimized. Justice means that the burdens and benefits of research must be distributed fairly – you cannot target vulnerable populations simply because they are easier to recruit.

Review Levels

Not all research requires the same level of scrutiny. IRBs classify studies into three review categories based on the level of risk to participants.

Exempt Review

Studies that pose minimal risk and fall into specific categories may qualify for exempt review. Common exempt categories include research involving educational tests or surveys where participants cannot be identified, observation of public behavior, and analysis of existing de-identified data.

“Exempt” does not mean you skip the IRB entirely. You still submit an application, and the IRB makes the determination that your study qualifies for exemption. You do not get to make that determination yourself.

Expedited Review

Studies that involve no more than minimal risk but do not qualify for exemption receive expedited review. This means one or two IRB members review the application rather than the full board. Common expedited categories include research involving collection of biological specimens by non-invasive means, collection of data through non-invasive procedures routinely employed in clinical practice, and research on individual or group characteristics or behavior.

Many dissertation studies involving surveys of adults, interviews, or focus groups qualify for expedited review.

Full Board Review

Studies involving more than minimal risk require review by the full IRB at a convened meeting. This includes research with vulnerable populations (children, prisoners, pregnant women, cognitively impaired individuals), research involving deception, and research where the risks exceed what participants would encounter in daily life.

Full board review takes longer – often four to eight weeks – because it must be scheduled for a board meeting. If your study requires full review, factor this into your timeline.

Completing Ethics Training

Before you can submit an IRB application, you must complete ethics training. Most institutions require the Collaborative Institutional Training Initiative (CITI) program, which offers online modules covering the history of research ethics, federal regulations, informed consent, and special topics relevant to your field.

CITI training takes approximately four to eight hours to complete, depending on which modules your institution requires. Your training certification is typically valid for three years, so if you completed it early in your program, verify that it has not expired.

Some institutions accept alternative training programs. Check with your IRB office to confirm which training they require and whether any previous certifications you hold are accepted.

Preparing Your IRB Application

IRB applications vary by institution, but most require the same core components.

Protocol Description

This is a detailed description of your research plan. If you have already written your proposal’s methodology chapter, much of this content can be adapted. The protocol should describe your research questions, your participant population, your recruitment strategy, your data collection procedures, and your data analysis plan.

Write the protocol in clear, jargon-free language. Remember that IRB members come from diverse disciplinary backgrounds – a biochemist may be reviewing your education study. Explain your methods as if writing for an intelligent reader who is not an expert in your field.

Participant Information

Describe your intended participants: who they are, how many you will recruit, how you will identify and contact them, and what inclusion and exclusion criteria you will apply. If you are working with vulnerable populations, explain the additional protections you will put in place.

Address recruitment specifically. How will you reach potential participants? Will you use email, flyers, social media, or personal contacts? Will anyone in a position of authority over potential participants be involved in recruitment? (If your advisor is a department chair and you want to study faculty in that department, this creates a power dynamic the IRB will scrutinize.)

Risk-Benefit Analysis

Identify all potential risks to participants, including physical, psychological, social, economic, and legal risks. For each risk, describe how you will minimize it. Then describe the potential benefits – both to participants directly and to the broader field.

Be honest and thorough. The IRB expects you to have thought carefully about risks. Claiming there are “no risks” is almost never accurate and raises a red flag. Even a simple survey can cause discomfort if it asks about sensitive topics. Acknowledge this and explain how you will mitigate it (providing referral resources, allowing participants to skip questions, etc.).

Data Security

Describe how you will protect participant data. Where will data be stored? Who will have access? Will data be encrypted? How long will you retain the data? How will you destroy it when retention is no longer necessary?

If you are collecting data electronically, your institution likely has specific requirements about which platforms are approved. Survey tools like Qualtrics are typically approved; free tools may not be. Check before you build your survey on a platform your IRB will not accept.

Drafting Informed Consent Documents

Informed consent is the cornerstone of ethical research. Your consent document must explain the study in language participants can understand and provide all the information they need to make a voluntary decision about participation.

Required Elements

Federal regulations specify the elements that must be included in informed consent. These include a description of the research and its purpose, the expected duration of participation, the procedures involved, any reasonably foreseeable risks or discomforts, any benefits to the participant or others, a statement about confidentiality, contact information for questions, and a statement that participation is voluntary and can be discontinued at any time without penalty.

Writing for Your Audience

Write your consent form at a reading level appropriate for your participants. The general guideline is an eighth-grade reading level, but adjust based on your population. Avoid academic jargon, lengthy sentences, and dense paragraphs. Use headers and bullet points to improve readability.

If your participants speak a language other than English, you will need to provide consent documents in their language. The IRB will want to verify the accuracy of the translation, so plan for this in your timeline.

Special Consent Situations

Some research situations require additional consent considerations. If you are studying minors, you need both parental permission and child assent (an age-appropriate explanation and agreement from the child). If you are recording interviews, you need explicit consent for recording separate from consent for participation. If your study involves deception, you must plan a debriefing process and explain it in your application.

For online research, electronic consent procedures have become standard, but your IRB may have specific requirements about how electronic consent is documented.

Common Reasons for Revisions

Most IRB applications are not approved on the first submission. Understanding common issues can help you avoid them.

Insufficient Detail

The most common reason for revision requests is vague or incomplete descriptions. “Participants will be interviewed” does not tell the IRB enough. They want to know where interviews will take place, how long they will last, whether they will be recorded, and what topics will be covered. When in doubt, include more detail rather than less.

Consent Form Issues

Consent forms that are too long, too technical, or missing required elements are frequently flagged. Have someone outside your field read your consent form. If they cannot understand it easily, revise it.

Inadequate Risk Mitigation

If your study involves sensitive topics (trauma, illegal behavior, health conditions), the IRB will scrutinize your risk mitigation plan carefully. Simply stating that risks are minimal is insufficient – you need to describe specific steps you will take.

Recruitment Concerns

The IRB pays close attention to whether recruitment methods could be coercive. If participants are your students, your employees, or anyone over whom you have authority, you need a recruitment plan that eliminates the possibility (or appearance) of coercion. Often this means having a third party handle recruitment so potential participants never feel pressured by your involvement.

Addressing IRB Feedback

When you receive a revision request, read it carefully and address every point. Respond systematically – many IRBs provide a response template where you list each concern and describe how you addressed it. Be thorough but not defensive. The IRB is trying to protect your participants and help you conduct stronger research.

If you disagree with a requested change, you can explain your reasoning. IRBs are generally open to dialogue, and reviewers may not have fully understood your design. A respectful explanation of why your approach is appropriate – supported by methodological literature if possible – is more effective than simply complying with changes that do not make sense for your study.

Amendments and Continuing Review

IRB approval is not permanent. If you need to change any aspect of your approved protocol – different recruitment methods, additional questions, a new data collection site – you must submit an amendment before implementing the change. Collecting data under an unapproved protocol is a serious compliance violation.

If your study extends beyond one year, most institutions require continuing review to maintain your approval. Set calendar reminders well in advance of your expiration date so your approval does not lapse.

Ethical Considerations Beyond IRB

IRB compliance is necessary but not sufficient for ethical research. The IRB evaluates your protocol against regulatory requirements, but ethical practice extends into every interaction you have with participants and every decision you make about your data.

Positionality and Power

Consider your relationship to your participants and your topic. Are you an insider studying your own community? An outsider studying a group you do not belong to? Both positions carry ethical responsibilities. Be transparent about your positionality in your dissertation and reflective about how it shapes your research.

Cultural Sensitivity

If your research involves communities different from your own – whether defined by race, ethnicity, language, socioeconomic status, or other factors – invest time in understanding the cultural context. Consult with members of the community during the design phase, not just during data collection. Culturally insensitive research designs produce poor data and can cause real harm.

Data Stewardship

You are the custodian of your participants’ information. Handle it with care that goes beyond minimum compliance. De-identify data as early as possible. Store it securely. Be thoughtful about what you report – even in qualitative research, detailed descriptions of participants’ experiences can sometimes make them identifiable despite pseudonyms.

For students conducting research in public health or clinical settings, the intersection of research ethics with professional practice standards adds another layer of responsibility. Resources at Public Health Practicum address these dual obligations in applied health research contexts.

Reciprocity

What do your participants get from your study? Even when you cannot offer direct benefits, consider how you can give back. Sharing your findings with participants, providing resources related to your topic, or volunteering with the community you study are all forms of reciprocity that reflect ethical practice.

Moving Forward

The IRB process can feel slow and frustrating, especially when you are eager to begin collecting data. Use the waiting time productively: finalize your instruments, refine your recruitment plan, practice your interview techniques, or begin drafting sections of your methodology chapter.

Once you receive approval, you are cleared to begin data collection – the stage where your research moves from plans on paper to actual engagement with the world. Keep your approved protocol accessible and refer to it regularly to ensure you stay within its boundaries. If circumstances change and you need to deviate from your plan, submit an amendment before proceeding.

The next stage in your journey is data collection itself, where all your planning comes to life.