Question12. What could have happened if IRB-s were not created?
Answer:
“IRB” is a generic term used by FDA (and the department of Health and Human Services (HHS)) to refer to a group whose function is to review research to assure the protection of the rights and welfare of the human subjects. Food and Drug Administration (FDA) and HHS, specifically OHRP, regulations have empowered IRBs to approve, require modifications in (to secure approval), or disapprove research. An IRB performs critical oversight functions for research conducted on human subjects that are scientific,ethical, and regulatory.
IF IRB’s were not created then there will be no one to assure that the rights and welfare of the research subjects has been protected.IRB human subjects protection system is an essential safeguard in clinical research. I identified several significant benefits of the overall system, including its function as a safeguard against overoptimistic investigators, protecting subjects against both nonphysical and physical harms as well as promotion of social justice .The presence of IRB system not only keep a proper check on clinical trials but also save researches to shut down which might happen because of some sloppy or unqualified researcher or because a subject is being harmed.
To accomplish its purpose, IRBs review research protocols and related materials (e.g., informed consent documents and investigator brochures) to ensure protection of the rights and welfare of human subjects of research. The chief objectives of every IRB protocol review are to assess the scientific merit of the research and its methods, to promote fully informed and voluntary participation by prospective subjects who are themselves capable of making such choices (or, if that is not possible, informed permission given by a suitable proxy) and to maximize the safety of subjects once they are enrolled in the project.
IRB’s make sure that the 3 areas for protectiong human research subjects has been safeguarded.These 3 areas are as follows:
1) Respect for persons
(2) Beneficence, and
(3) Justice.
A. Respect for Persons
Respect for persons involves a recognition of the personal dignity and autonomy of individuals, and special protection of those persons with diminished autonomy. Required by the moral principle of respect for person, informed consent contains 3 elements: information, comprehension, and voluntariness. First, subjects must be given sufficient information on which to decide whether or not to participate, including the research procedure(s), their purposes, risks and anticipated benefits. alternative procedures, and a statement offering the subject the opportunity to ask questions and to withdraw at any time from the research.
Second, subjects must be able to comprehend the information that is given to them. The presentation of information must be adapted to the subject’s capacity to understand it; testing to ensure that subjects have understood the information may be warranted.
B. Beneficence
The principle of beneficence requires both protecting individual subjects against risk of harm and consideration of not only the benefit for the individual, but also the future benefits that might be gained from the research.
In determining whether the balance of risks and benefits results in a favorable ratio, the decision should be based on thorough assessment of information with respect to all aspects of the research and systemic considerations of alternatives. The IRB requires the investigator to provide (1) the validity of the presuppositions of the research, (2) the of the nature, probability and magnitude of risk, with as much clarity as possible, and (3) the investigator’s estimates of the probability of harm or benefits are reasonable, as judged by known facts or other available studies.
The principle of beneficence requires both protecting individual subjects against risk of harm and consideration of not only the benefit for the individual, but also the future benefits that might be gained from the research.
In determining whether the balance of risks and benefits results in a favorable ratio, the decision should be based on thorough assessment of information with respect to all aspects of the research and systemic considerations of alternatives. The IRB requires the investigator to provide (1) the validity of the presuppositions of the research, (2) the of the nature, probability and magnitude of risk, with as much clarity as possible, and (3) the investigator’s estimates of the probability of harm or benefits are reasonable, as judged by known facts or other available studies.
Justice
Justice requires that the benefits and burdens of research be distributed fairly. The “justness” of subject selection relates both to the subject as an individual and to the subject as a member of social, racial, sexual, or ethnic groups.
With respect to their status as individuals, subjects should not be selected either because they are favored by the researcher or because they are held in disdain (e.g., involving “undesirable” persons in risky research). Further, “social justice” indicates an order of preference in the selection of classes of subjects (e.g., adults before children) and that some classes of potential subjects (e.g., the institutionalized mentally infirm or prisoners) may be involved as research subjects, if at all, only on certain conditions.
Subjects should not be selected simply because they are readily available in settings where research is conducted, or because they are easy to manipulate as a result of their illness or socioeconomic condition. Care should be taken to avoid overburdening patients that are already burdened in many ways by their infirmities and environments. Nontherapeutic research that involves risk should use other, less burdened populations, unless the research directly relate(s) to the specific conditions of the class involved
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