ACRP-CP Exam Questions With Latest Solutions 2024

ACRP-CP Exam Questions With Latest Solutions 2024 Belmont Report (1979) - answerethical principles and guidelines for the protection of human subjects of research. respect for persons - answerindividuals should be treated as autonomous agents and persons with diminished autonomy are entitled to protection An autonomous person - answerA person capable of deliberation about personal goals and of acting under the direction of such deliberation Beneficence - answerDo not harm and maximize possible benefits and minimize possible harms Justice - answer1) 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 - answerinformation, comprehension, voluntariness What is an example of how the principle of beneficence can be applied to a study employing human subjects - answerDetermining the study has a maximization of benefits and a minimization of risks What are the three principles discussed in the Belmont Report? - answerRespect 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: - answerPersons with diminished autonomy are entitled to protection Nuremberg Code (1947) - answer1) 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) - answer1) 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 ( - answerIssued 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 - answerAlso 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 - answer1) pregnant women, human fetuses, and neonates 2) children 3) prisoners 21 CFR 50 - answerInformed Consent 21 CFR 56 - answerIRB 21 CFR 812 - answerInvestigational Medical Devices 21 CFR 312 - answerInvestigational Drugs and Biologics Declaration of Helsinki (1964) - answerRecommendations 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" - answerDocuments designed to serve as international guidelines for the review and conduct of research involving human subjects ICH E6 - answerGuideline for Good Clinical Practice The use of prisoners in research is a concern under the Belmont principle for Justice because: - answerPrisoners may not be used to conduct research that only benefits the larger society What was the result of the Beecher article? - answerRealization that ethical abuses are not limited to the Nazi regime Issued in 1974, 45 CFR 46 raised to regulatory status: - answerUS Public Health Service Policy What is included in the Nuremberg Code? - answerInformed consent Informed consent is considered an application of which Belmont principle? - answerRespect for persons IRB (Institutional Review Board) - answerA review committee established to help protect the rights and welfare of human research subjects Regulations require: - answerIRB 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: - answerApprove research, require modifications, disapprove research, conduct continuing reviews, verify no material changes occurred since previous review, observe, suspend/terminate approval Conveyed committee review - answerFull 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 - answerCan 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: - answer1) 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 - answer1) 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 - answerResponsible for 45 CFR 46 National Institutes of Health (NIH) - answerIncludes funding agencies that provide federal funding for biomedical research U.S. Food and Drug Administration (FDA) - answerOversees the use of all drugs, devices, biologics, etc. including their use in research with human subjects International Council for Harmonisation (ICH) - answeroffers 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? - answerReport the adverse drug experience in a timely manner, in keeping with the IRB's policies and procedures, using the forms or the mechanism provided by the IRB How long is an investigator required to keep consent documents, IRB correspondence, and research records? - answerA minimum of three years after completion of the study According to federal regulations, which of the following best describes when expedited review of a new, proposed study may be used by the IRB? - answerThe study involves no more than minimal risk and meets one of the allowable categories of expedited review specified in federal regulations Amendments involving changes to IRB approved protocols do NOT need prior IRB approval if: - answerThe changes must be immediately implemented for the health and well-being of the subjects IRB continuing review of a greater than minimal risk approved protocol that is currently enrolling subjects must: - answeroccur at least annually Informed consent - answerThe process that begins with the recruitment and screening of a subject and the signing of the consent document and continues throughout the subject's involvement in the research and beyond study termination Informed consent is mandated by the US Department of HHS at 45 CFR 46 and the US FDA at 21 CFR 50. These regulations were developed to: - answer1) protect human subjects 2) Ensure that potential study subjects clearly understand the benefits and risks associated with their participation in a study 3) Provide the potential study subjects with all information needed to reach a decision on whether or not to participate in a research study Broad consent - answerProspective consent for unspecified future research Legally Authorized Representative(LAR) - answerIndividual or judicial or other body authorized under applicable law to consent on behalf of a prospective subject to the subject's participation in the procedure(s) involved in the research. If there is no applicable law addressing this issue, LAR means an individual recognized by institutional policy as acceptable for providing consent in the non-research context on behalf of the prospective subjects to the subject's participation in the procedure(s) involved in the research