Exam(Elaborations)ACRP-CP 2023 Correctly Answered

Exam(Elaborations)ACRP-CP 2023 Correctly Answered Belmont Report (1979) - Answer ️️ -ethical principles and guidelines for the protection of human subjects of research. respect for persons - Answer ️️ -individuals should be treated as autonomous agents and persons with diminished autonomy are entitled to protection An autonomous person - Answer ️️ -A person capable of deliberation about personal goals and of acting under the direction of such deliberation Beneficence - Answer ️️ -Do not harm and maximize possible benefits and minimize possible harms Justice - Answer ️️ -1) to each person an equal share 2) to each person according to individual need 3) to each person according to individual effort 4) to each person according to societal contributions 5) to each person according to merit Justice - Answer ️️ -· The selection of research subjects needs to be scrutinized in order to determine whether some classes are being systematically selected simply because of their easy availability, their compromised position, or their manipulability, rather than for reasons directly related to the problem being studied. Justice - Answer ️️ -· Whenever research supported by public funds leads to the development of therapeutic devices and procedures, justice demands both that these not provide advantages only to those who can afford them and that such research should not unduly involve persons from groups unlikely to be among the beneficiaries of subsequent applications of the research. Three elements of the consent process - Answer ️️ -information, comprehension, voluntariness What is an example of how the principle of beneficence can be applied to a study employing human subjects - Answer ️️ -Determining the study has a maximization of benefits and a minimization of risks What are the three principles discussed in the Belmont Report? - Answer ️️ -Respect for persons, beneficence, justice The Belmont Report's principle of respect for persons incorporates at least 2 ethical convictions: first, that individuals should be treated as autonomous agents, and second, that: - Answer ️️ - Persons with diminished autonomy are entitled to protection Nuremberg Code (1947) - Answer ️️ -1) a requirements for voluntary consent 2) the research must have scientific merit 3) The benefits of the research must outweigh the risks 4) Subjects have the ability to terminate participation in the research at any time National Research Act (1974) - Answer ️️ -1) Authorized the creation of the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research, which was charged with developing an ethical code and guidelines for researchers 2) Required the establishment of IRBs at organizations receiving PHS support for human subject's research The National Commission ( - Answer ️️ -Issued a series of reports on vulnerable populations (such as fetuses, children, prisoners, and the "mentally infirm") psychosurgery, IRBs, and other topics that included recommendations for regulating human subjects' research. These recommendations had significant influence on the development of the federal regulations governing human subject research. 45 CFR 46 - Answer ️️ -Also known as the Common Rule, this legislation established the role of institutional review boards (IRBs) for research on human rights. Additional protection for these individuals in research - Answer ️️ -1) pregnant women, human fetuses, and neonates 2) children 3) prisoners 21 CFR 50 - Answer ️️ -Informed Consent 21 CFR 56 - Answer ️️ -IRB 21 CFR 812 - Answer ️️ -Investigational Medical Devices 21 CFR 312 - Answer ️️ -Investigational Drugs and Biologics Declaration of Helsinki (1964) - Answer ️️ -Recommendations guiding medical doctors in biomedical research involving human subjects WHO Guidelines (1996) Standards and Operational Guidance for Ethics Review of Health- related Research with Human Participants" - Answer ️️ -Documents designed to serve as international guidelines for the review and conduct of research involving human subjects ICH E6 - Answer ️️ -Guideline for Good Clinical Practice The use of prisoners in research is a concern under the Belmont principle for Justice because: - Answer ️️ -Prisoners may not be used to conduct research that only benefits the larger society What was the result of the Beecher article? - Answer ️️ -Realization that ethical abuses are not limited to the Nazi regime Issued in 1974, 45 CFR 46 raised to regulatory status: - Answer ️️ -US Public Health Service Policy What is included in the Nuremberg Code? - Answer ️️ -Informed consent Informed consent is considered an application of which Belmont principle? - Answer ️️ - Respect for persons IRB (Institutional Review Board) - Answer ️️ -A review committee established to help protect the rights and welfare of human research subjects Regulations require: - Answer ️️ -IRB review and approval for research involving human subjects if it is conducted, supported, or regulated by US federal departments and agencies Federal regulations stipulate that an IRB can: - Answer ️️ -Approve research, require modifications, disapprove research, conduct continuing reviews, verify no material changes occurred since previous review, observe, suspend/terminate approval Conveyed committee review - Answer ️️ -Full committee review. Standard type of review described in the federal regulations. Must be used for the initial review of all studies that are not eligible for expedited review or exemption Expedited review - Answer ️️ -Can be used for established categories and minor changes in previously approved research, and for limited IRB review of select exemption categories Categories for expedited review: - Answer ️️ -1) The research does not involve more than minimal risk 2) The entire research project must be consistent with one or more of the federally defined categories (IND/IDE note required) Types of IRB submissions - Answer ️️ -1) Application for initial review 2) Application for continuing review: IRB must re-review greater than minimal risk not less than once per year 3) Amendments or modifications 4) Reports of unanticipated problems US Department of Health and Human Services - Answer ️️ -Responsible for 45 CFR 46 National Institutes of Health (NIH) - Answer ️️ -Includes funding agencies that provide federal funding for biomedical research U.S. Food and Drug Administration (FDA) - Answer ️️ -Oversees the use of all drugs, devices, biologics, etc. including their use in research with human subjects International Council for Harmonisation (ICH) - Answer ️️ -offers GP guidelines A subject in a clinical research trial experiences a serious, unanticipated adverse drug experience. How should the investigator proceed, with respect to the IRB, after the discovery of the adverse event occurrence? - Answer ️️ -Report the adverse drug experience in a ti