Institutional Review Board (IRB)
An Institutional Review Board (IRB) is an ethical committee whose job is to review research methodologies in order to ensure that ethical standards are being practiced within a research setting. An IRB committee relies on federal regulations and ethical standards to offer guidance, and modifications for research designs. One such foundational document that reviews ethical principles is called the Belmont Report. Created in 1979 as a response to the many unethical research practices on fellow humans in the US and worldwide, the report lays out three key ethical principles to follow when conducting human subjects research: respect for persons, beneficence, and justice.
Respect for persons states that human participants are autonomous beings who are free to choose to participate or withdraw from a research study. In order to be able to make that choice, researchers must provide participants with all the necessary information of the study, such as the purpose of the study, what the individual is expected to do, and the potential risks of harm that ay occur due to the study. Additionally, respect for persons argues that those who do not have autonomy, such as children or prison inmates, must be protected. Beneficence refers to the idea of harm reduction. Researchers should do their best to maximize possible benefits of the research, while minimizing the potential risks involved. This means that the potential harm must be reasonable in comparison to the expected benefits of the information learned. Finally, the principle of justice argues that the burden of research must be equally distributed, and certain populations should not endure the harm for others to benefit from.
When reviewing a research design, IRB committee members consider many different rules. One common rule in reviewing is that the privacy and confidentiality of the participants must be reasonably maintained. This means that researchers have an obligation to give the participant control over what and how much information they share (privacy), as well as protecting the information that participants disclose (confidentiality). One simple way of protecting confidentiality is to de-identify participants information- or assign numbers to participants in order to make sure that personal information cannot be traced back to the participant. Additionally, privacy can be protected by taking appropriate data collection measures and reviewing research questions for privacy concerns. However, there are always nuances to these concepts, especially between cultures. What is seen as private information in some cultures, may not be so problematic to share in others, an example of this could be medical or income information. Therefore, it is also important for researchers to consider the cultural diversity of the population in question. This is known as cultural competency, and an IRB committee will be sure to determine if the research reasonably takes other cultures and identities into account.
Another important rule in the IRB review process is informed consent. As mentioned earlier, researchers have an obligation to inform participants of all the necessary information of the study so that they can make an informed decision on whether to participate. This information should be presented in a clear and simple manner, so that anyone not familiar with the study can understand what they are consenting too. Additionally, researchers should provide documentation that the participant consented to the study procedures and requirements, this is usually obtained in the form of a consent document signed by each participant. An IRB committee will review consent waivers for the required information; researchers should disclose the studies purpose and procedures, list potentials for harm and resources to deal with the effects of said harm, provide information on how privacy and confidentiality will be maintained, and list any incentives that participants will receive for taking part in the research. Additionally, if deception is necessary in a study, a researcher must inform the participant that they may be deceived over the course of the study. For participants who would not be considered autonomous, such as children, additional safeguards should be set in place to ensure that they are able to consent to the best of their ability. This can include tests to determine mental competency, and/or requiring consent from a legal guardian or caretaker.
Along with informed consent, an IRB will also assess the level of risk of harm in a research study. In any study, risk usually occurs from a breach in privacy, a breach of confidentiality, or from the study procedures themselves. While there are safeguards that should be in place to protect privacy and confidentiality, sometimes just participating in a study can cause harm. An example of this could be if a researcher is using a vulnerable population, such as abuse victims, the study procedures may retraumatize participants, thus causing psychological distress. The goal of a study should be to balance the potential risks with the expected benefits of the information learned. Therefore, if there are little benefits to using an abused population, the risk of retraumatizing them in your study may be too high of a risk. However, if a researcher plans to deceive their participants in order to learn a new truth of human behavior, the level of that risk may be acceptable for the benefit of the new information. The level of risk for each study is examined by the IRB and its members will determine if a study’s risk of harm is acceptable and will make suggestions on how to change the level of harm when necessary.
Once an IRB has reviewed the contents of a research study, they will process an experiment under three categories: exempt review, expedited review, and a convened review. Research reviewed as exempt are categorized as studies that involve no more than a minimal level of risk, and therefore do not need further review from the committee. An expedited review often involves some level of risk, but this risk is to a minimal degree. In this case, a few IRB members will review the study procedures and make suggestions to minimize the risk. Finally, a convened review involves research that poses a significantly higher risk than what would occur in participants’ day to day lives. In this case, the researcher may have to make significant changes to obtain approval to run the study. Additionally, an IRB requires than any changes made to a study after it has been approved must be reported back to the committee for another review of risk.
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