As research progresses it may reach the stage where human clinical trials are needed in order to study the effect on the human body and to determine a product’s usefulness to society. It’s at this stage where The National Institute of Environmental Health Sciences (NIEHS) Institutional Review Board comes into play to ensure the safety and protect the rights of the human subjects. In the past, there were no ethical guidelines for human subject research and this resulted in an abuse of power, unethical studies, and significant harm caused to individuals by participation, often involuntary and without consent, in research (Solutions IRB, 2017).
The NIEHS Institutional Review Board is to provide ethical and regulatory oversight of research that involves human subjects. They do this by protecting the rights, welfare and well-being of participants recruited to participate in research; ensuring compliance with relevant local, state and federal laws and regulations; ensuring compliance with NIEHS policies and regulations; employing high ethical standards for protections in all human subjects research by adhering to the ethical principles outlined in the Belmont report (Respect for persons, Beneficence, Justice); and giving guidance to ensure sound research design, scientific integrity, and determining if the research contributed to generalizable knowledge and is worth exposing subjects to risk (NIEHS, 2015). In short, they ensure compliance of all rules and regulations, protect the rights of the subjects, and ensure that the proposed research’s benefit outweighs any risk that the subjects will be facing.
The NIEHS is one such organization that performs clinical studies that involves human research subjects. During clinical trials, when a new product or approach is being studied, it is not usually known whether it will be helpful, harmful, or no different than available alternatives (including no intervention). Researchers try to determine the safety and effectiveness of the product or approach by measuring outcomes in the participants such as giving a participant with hypertension a drug or treatment to see if their blood pressure decreases (Clinicaltrials.gov, 2015). In each one of the clinical studies open for recruitment, the NIEHS describes the study/trial background, whom is eligible (inclusion and exclusion criteria), what the participants will do, what NIEHS will do, location of the study/trial, contact information, and the investigators with their contact information. While there were no specified guidelines that are stated for conducting research on children, women, minorities, and cognitively impaired subjects, in the NIEHS available study of Pathogenic Studies in Families with Twins or Siblings Discordant for Systemic Rheumatic Disorders, the organization specifies “a subject willing and able to give informed consent” and that in the case of children, “the parent/legal guardian must also be willing and able to provide informed consent” (NIEHS, 2016). This suggests that both the minor child and the parent must understand and provide consent before considered eligible for the study. In addition, another study by the NIEHS, Effect of Innate Immunity on the Inflammatory Response to Endotoxin, states that one of the exclusion criteria is if the participant is pregnant or suspected of pregnancy (Clinicaltrials.gov, 2016). This indicates that there are specified guidelines or known information about the product or approach that could be harmful to a pregnant woman and their fetus. Since all studies performed by the NIEHS are also overseen by the International Review Board, all policies, regulations, ethical principles, and safety precautions must be followed to ensure that the human subject participant’s safety and rights are maintained.
Research and human clinical trials are necessary when it comes to determining the effectiveness of products and is extremely important to determine the effects of the product on individuals before gaining FDA approval and release to the public. In the past, studies on human research subjects came with high risk and often questionable methods; however, studies performed today are strictly regulated at every stage of the clinical trial. While any study contains its own risks, human research subjects today can rest assured that their rights and safety are being protected throughout the study.