Welcome to the next article in our Research 101 series! We're excited to share with you some important information about Institutional Review Boards (IRBs), which are essential to the research process.
If you’ve ever thought about participating in research, you may have had some questions about how the research could affect you. You may have wondered:
- What are the risks and benefits?
- How will my data be used?
- How do I know I am safe?
Researchers care a lot about providing a safe and ethical study experience. One way we do this is by submitting our research protocols to an Institutional Review Board (IRB).
What is an IRB?
An IRB is a review board designed to protect the rights and well-being of research participants. It acts as a system of checks and balances for any research involving people.
IRBs work to ensure the following:
- Research studies have scientific merit and purpose
- The activities involved in the research are ethical
- All regulatory requirements are followed
Every IRB has at least five members with different backgrounds. The members may have training in scientific areas, have expertise and training in non-scientific areas, or be members of the community who may represent the people who would participate in the research study.
IRBs are the gatekeepers when it comes to being able to conduct research involving human beings. Without IRB approval, researchers are unable to conduct their research.
History of the Institutional Review Board (IRB)
The idea of an Institutional Review Board (IRB) began in 1974 when President Richard Nixon signed into law the National Research Act. The act led to the creation of the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. Events such as the Tuskegee Trials and the Willowbrook Experiments, where research was conducted in an improper manner, proved there was a need for unbiased oversight.
This commission was in charge of identifying the principles that should underlie the conduct of research. They also created guidelines to make sure research is carried out following those principles. In 1979, the commission published "Ethical Principles and Guidelines for the Protection of Human Subjects of Research," also known as the Belmont Report.
The Belmont Report is made up of three core principles:
- Respect for Persons - Giving people the right and capacity to make their own decisions.
- Beneficence - Minimizing potential harms and maximizing benefits
- Justice - Distributing benefits and risks fairly
IRBs were founded on these three basic principles which are still referenced when reviewing research proposals.
What does the IRB review?
The people who make up the committee carefully consider the following:
- Are procedures in place to reduce any harm or risks to the participants?
- Do the benefits outweigh the associated risks?
- Is the selection of participants equitable and fair?
- Are potential participants able and willing to give informed consent?
- Will a participant's consent (or permission) be properly documented?
- Do the researchers have a plan for monitoring the quality of the study data to ensure participant safety?
- Are there adequate procedures in place to protect the privacy of participants?
- Will the researchers be able to maintain the privacy of study participants?
- Are there protections in place for vulnerable populations?
- Does the research meet all regulatory requirements?
Evidation Studies & IRB Oversight
Research conducted by the Evidation Studies (formerly Achievement Studies) team often requires approval from an IRB. The decision to have a study approved by an IRB is based on the design of the study and what the researchers will use the results for.
At Evidation Studies, we have a dedicated team of researchers who help oversee the protection of our study participants every step of the way. Even when IRB approval is not required.
Our study participants can be confident that we’re committed to their safety and that our studies are conducted according to the highest standards.
Want to know more about any of our Evidation Studies and how to get involved? Reach out to us at email@example.com and one of our friendly team members can help you get started.
If you want additional general information on health research, we recommend checking out the following public resources:
- U.S. Department of Health & Human Services, Office for Human Research Protections
- FDA, Clinical Trials and Human Subject Protection
- National Institutes of Health (NIH), Educational Resources
- Clinical Research Resource HUB, Resources for Participants