IRB Approval for Your Thesis or Dissertation, Step by Step

No data collection begins until the institutional review board has approved your study. That rule is the reason approval matters so much to the schedule of a dissertation, and it is the one students most often underestimate. A study that collects data before approval can have its data disqualified, and at some universities the consequences go further.

The process differs between universities, and between countries. In the United States it rests on federal regulations for the protection of human participants, which every IRB applies in its own forms. Treat what follows as the common order of events and use your own IRB's instructions as the final word.

What an IRB does

An IRB reviews research involving people to check that participants are protected. It looks at risk to participants, whether they can give informed consent freely, how their information will be kept confidential, and whether the study treats participants fairly. It does not judge the quality of your research question. That judgment belongs to your committee.

The steps, in order

1. Complete the required training. Most institutions require that researchers finish a human subjects training course before applying. Many use the CITI program. Check the validity period, because certificates expire.
2. Pass the proposal stage. Many programs require committee approval of your proposal, including Chapter 3, before you may submit to the IRB. Some let you apply earlier. Ask your chair which applies to you, because the wrong order costs weeks.
3. Prepare the application. The package usually includes the application form, your research protocol, recruitment materials such as emails or flyers, the consent form, and your instruments, meaning the survey or the interview questions. All of these must describe the same study.
4. Get your chair's sign-off. Many institutions require your chair to review and approve the application before the board sees it.
5. Submit and wait. The board assigns the application to a category and a reviewer. Review time varies widely and may depend on the board's meeting schedule, so ask your IRB how long it normally takes and plan around the longer figure.
6. Respond to revisions. Boards often send an application back with questions or required changes. This is common and does not mean the study is weak. Answer each point directly and resubmit.
7. Receive the approval letter. Keep it. You will cite the approval number and date in Chapter 3, and your program may require the letter in an appendix.
8. Begin recruitment and data collection. Not before.
9. Keep the approval current. Some boards require periodic renewal for studies that run beyond a set period, and all require approval for changes. When the study ends, close it with the board if your institution asks you to.

Exempt, expedited, and full-board review

Boards sort studies by the risk they pose to participants. The names are standard in the United States.

Exempt studies are those that federal rules place in certain low-risk categories, such as some surveys and interviews with adults on non-sensitive topics, or research in ordinary educational settings. Exempt does not mean the board is not involved. At most institutions the board, and not the researcher, decides that a study qualifies.

Expedited review is for studies that involve no more than minimal risk but fall outside the exempt categories. A reviewer or a small group reads the application, and the full board does not meet on it.

Full-board review is for studies with greater than minimal risk or with vulnerable populations, such as children, prisoners, or people with impaired capacity to consent. It takes the longest.

You do not choose the category yourself. You can propose one in the application, and the board decides.

Why applications get sent back

The reasons repeat. The consent form promises something the procedures do not deliver, or the reverse. Recruitment materials are missing or describe a different process. The interview questions in the protocol differ from the ones attached. The application claims anonymity when the design records names. The relationship between the researcher and participants is not addressed, for example when the participants are the researcher's own students or employees. And the data storage plan says nothing about who has access.

Before you submit, read the application, the consent form, the recruitment text, and the instruments side by side. Every statement about what participants will do, what will be recorded, and who will see it should match across all four.

Planning the time

Approval usually sits between your proposal defense and the beginning of data collection, so any delay moves every date after it. Build the board's stated turnaround into your timeline, and allow for at least one round of revisions. Submit as soon as your program allows. If you plan to recruit participants through an organization such as a school, hospital, or company, you may also need that organization's permission, and it can take as long as the board's.

After approval

Report the approval in Chapter 3. Our article on what to write about IRB approval in Chapter 3 shows what to include. If you change your sample, your instruments, or your procedure afterward, ask the board before you make the change.

Students outside the United States work under the equivalent body at their institution, often called a research ethics committee, and some countries require a national research permit as well. Confirm the requirements with your university and the relevant national authority before you plan a timeline.

Chapter 3 places ethical approval within the whole design, and our article on methodology chapters that hold students back covers the design weaknesses that often surface during IRB review.

If you want an independent read on whether your design and procedures are described consistently, our research design and methodology review examines them. We do not prepare IRB applications or predict what a board will decide. Those matters belong to you and your institution.