IRB Approval in Qualitative Research
What is the Institutional Review Board?
The Institutional Review Board (IRB), sometimes called the Independent Ethics Committee (IEC), is a committee or group established to review and monitor research involving human participants and ensure the rights and welfare of the participants are safeguarded. IRB is responsible for reviewing the appropriateness of research methods and determining whether they are ethical.
Most institutions that engage in research involving human participants have their own IRB, which is designated to review research proposals, conduct risks and benefits analysis, and determine if the proposals align with ethical standards and federal regulations.
Further, the requirements to get IRB approval may differ from one institution to another, depending on their funding sources, type of regulatory infrastructure in place, etc. This post will give a general overview of IRB. We recommend you check with your institution to determine the specific requirements to get IRB approval for your project.
The IRB in your institution can approve or disapprove research within its jurisdiction. The Institutional Review Board also has the authority to request a modification of the research methods before approving it. The minimum number required to form an IRB is five, and the board must include a scientist, a non-scientist, and a community member representing the research participants.
In addition, the members must have diverse institutional affiliations, expertise, and experience to provide a holistic review of the proposed research and identify its legal, social, and institutional implications. The main goal of IRBs is to protect the research participants from psychological or physical harm. IRBs also ensure participants are fully informed, and their participation is voluntary.
The Office for Human Research Protections (OHRP) administers and provides support for the IRBs. The office also receives reports of inappropriate research practices from the IRBs and investigates them when necessary.
What is the IRB approval process?
The IRB approval process includes the following:
Determine whether your research needs IRB approval
If you are unsure if your research needs IRB approval, the first step is to contact the IRB in your institution to determine if your study needs their approval.
Research Training
All applicants must complete the relevant research training before they can get IRB approval for their research. Each institution has its own IRB training requirement. For instance, Cornell University’s IRB requires researchers to complete a mandatory human participant research ethics training. On the other hand, the Penn State university’s IRB requires the completion of a Collaborative Institutional Training Initiative (CITI) program to get approval. So if you plan to get IRB approval for your project, make sure you undertake the training specified by the IRB in your institution.
Submit your application
The next step in the IRB approval process is to submit all application materials online. If you are seeking IRB approval for your research as a student, your faculty sponsor must certify your application before submitting it online.
Review of your application
The IRB will screen the submitted application for completeness. The board will assign your application a review category if it’s complete. The IRB will contact you to submit the missing materials if some elements are missing. The three IRB review categories are:
Exempt review - These studies do not require comprehensive review and monitoring by IRB. There are usually exempted from some IRB regulations.
Expedited review - These studies do not involve more than the minimal risk to the research participants. In other words, the research’s anticipated risk is not more than the risk the participants encounter in their daily life.
Full review - Research that does not qualify for any of the two categories above is subject to full review by IRB. Studies that can cause more than the minimal risk or involve protected participants, such as children, prisoners, educationally disadvantaged persons, etc., usually fall under this category.
Application Result
After review, IRB has the authority to approve or disapprove your research. IRB may also require some modifications before they approve your research.
What are the IRB approval requirements?
Your study must satisfy some requirements to get IRB approval. Make sure to check with your specific institution’s IRB for their requirements. Some examples of what you may need to show the IRB include:
Your research minimizes the risk to participants by adopting methods that do not unnecessarily put them at risk.
The risk to the research participants is reasonable in relation to the benefits the research will offer.
You selected the subjects of your study equitably.
You sought informed consent from all participants or their legally authorized representative.
You document the informed consent appropriately.
There is adequate provision to protect the safety and privacy of the participants.
You put additional safeguards in place where participants are vulnerable.
When is IRB approval required?
Are you wondering what type of research needs IRB approval or when IRB approval is required? Not all research requires IRB review or approval. However, you may need IRB approval if you plan to conduct scientific research involving interaction with human participants and their private information. We recommend you check in with the IRB requirements listed by your institution or university. For example, you can check out these criteria requirements from University of California San Francisco and Boston University)
Some types of research that need IRB approval include pilot studies involving human participants, projects requiring medical records, employment records and other personal records, Master’s theses, dissertations, and more. Studies that usually do not require IRB research review or approval include those that collect data for administrative purposes, projects designed for the evaluation or quality improvement of a program, single case studies, etc.
Are you unsure if your research needs IRB approval? Please contact your institution’s IRB to confirm if you need their approval to commence your research.
Samples of IRB application in qualitative research
Below are links to some sites with samples of IRB application in qualitative research to help you better understand what the forms look like and how to complete them.
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References:
Grady, C (2015). Institutional Review Boards. American College of Chest Physicians.
Enfield, K; Truwit, J (2008). The Purpose, Composition, and Function of an Institutional Review Board: Balancing Priorities. Respiratory Care