Regarding the IRB view of participants in research, who are the groups of people that the IRB considers vulnerable for research participation in the 45 CFR 46? In other words, what are the identified vulnerable groups of people for research that the IRB will focus on? Please answer these questiosn separated and use at least 2 sources no later than 5 years.
The Institutional Review Board (IRB) is responsible for protecting the rights and welfare of human research participants. The IRB recognizes certain groups of individuals as vulnerable and in need of additional protection when it comes to research participation. The Code of Federal Regulations (45 CFR 46) outlines these vulnerable groups and highlights the areas of focus for the IRB. To answer your question, I will discuss the identified vulnerable groups of people for research participation as recognized by the IRB.
One vulnerable group that the IRB considers is children. Children are considered vulnerable due to their limited decision-making capacity and potential for exploitation. The IRB pays special attention to research involving children to ensure that their rights and well-being are safeguarded. According to 45 CFR 46, children are defined as individuals under the age of 18. The IRB requires a thorough assessment of the risks and benefits of research involving children and ensures that informed consent is obtained from both the child and their legal guardian. Additional safeguards, such as assent from the child and the use of child-friendly language, are also implemented to protect their rights.
Another vulnerable group recognized by the IRB is prisoners. Prisoners are considered vulnerable due to their restricted liberty and potential coercion. Research involving prisoners is subject to heightened scrutiny to safeguard their rights and minimize exploitation. In such cases, the IRB requires that the research must have the potential to directly benefit the prisoner population, and that any risks to prisoners are minimized. The IRB also mandates independent review of research proposals involving prisoners and ensures that informed consent is obtained without undue influence or coercion.
Pregnant women and fetuses are another vulnerable group identified by the IRB. The IRB recognizes the need to protect the health and well-being of pregnant women as well as the potential risks to the developing fetus. Research involving pregnant women and fetuses must ensure that the potential benefits outweigh the potential harms. Special consideration is given to maintaining the confidentiality and privacy of the participants. Informed consent is required, and pregnant women have the right to withdraw from the research at any time without any repercussions.
The IRB also considers individuals with diminished decision-making capacity, such as individuals with cognitive impairments, as vulnerable. These individuals may have limited ability to understand the nature and potential risks of research participation. The IRB requires that additional safeguards be in place to protect their rights and well-being, such as obtaining informed consent from their legal representative and ensuring that they provide assent if possible.
In addition to these vulnerable groups, the IRB also takes into account other populations that may be vulnerable or at risk, such as individuals with mental health issues, individuals with limited English proficiency, and marginalized populations. These groups may face additional barriers to understanding and participating in research, and the IRB seeks to ensure that their rights and interests are protected.
Sources:
1. Code of Federal Regulations (45 CFR 46): Protection of Human Subjects. Retrieved from https://www.ecfr.gov/cgi-bin/retrieveECFR?gp=&SID=b1857a776ff032aa002366dca79276f0&mc=true&n=pt45.1.46&r=PART&ty=HTML
2. National Institutes of Health (NIH). (2018). Protecting Human Research Participants. Retrieved from https://phrp.nihtraining.com/users/login.php