NEW ACRP-CP UPDATED EXAM WITH Q&A 100% VERIFIED ANSWERS {CLEAN VERSION}

NEW ACRP-CP UPDATED EXAM WITH Q&A 100% VERIFIED ANSWERS {CLEAN VERSION} The Belmont Report (1979) - CORRECT ANSWER-ethical principles and guidelines for the protection of human subjects of research. respect for persons - CORRECT ANSWER-individuals should be treated as autonomous agents and persons with diminished autonomy are entitled to protection An autonomous person - CORRECT ANSWER-A person capable of deliberation about personal goals and of acting under the direction of such deliberation Beneficence - CORRECT ANSWER-Do not harm and maximize possible benefits and minimize possible harms Justice - CORRECT 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 - CORRECT 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 - CORRECT 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 - CORRECT ANSWER-information, comprehension, voluntariness What is an example of how the principle of beneficence can be applied to a study employing human subjects - CORRECT ANSWER-Determining the study has a maximization of benefits and a minimization of risks What are the three principles discussed in the Belmont Report? - CORRECT 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: - CORRECT ANSWER-Persons with diminished autonomy are entitled to protection Nuremberg Code (1947) - CORRECT 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) - CORRECT 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 ( - CORRECT 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 - CORRECT 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 - CORRECT ANSWER-1) pregnant women, human fetuses, and neonates 2) children 3) prisoners 21 CFR 50 - CORRECT ANSWER-Informed Consent 21 CFR 56 - CORRECT ANSWER-IRB 21 CFR 812 - CORRECT ANSWER-Investigational Medical Devices 21 CFR 312 - CORRECT ANSWER-Investigational Drugs and Biologics Declaration of Helsinki (1964) - CORRECT 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" - CORRECT ANSWER-Documents designed to serve as international guidelines for the review and conduct of research involving human subjects ICH E6 - CORRECT ANSWER-Guideline for Good Clinical Practice The use of prisoners in research is a concern under the Belmont principle for Justice because: - CORRECT ANSWER-Prisoners may not be used to conduct research that only benefits the larger society What was the result of the Beecher article? - CORRECT ANSWER-Realization that ethical abuses are not limited to the Nazi regime Issued in 1974, 45 CFR 46 raised to regulatory status: - CORRECT ANSWER-US Public Health Service Policy What is included in the Nuremberg Code? - CORRECT ANSWER-Informed consent Informed consent is considered an application of which Belmont principle? - CORRECT ANSWER-Respect for persons IRB (Institutional Review Board) - CORRECT ANSWER-A review committee established to help protect the rights and welfare of human research subjects Regulations require: - CORRECT 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: - CORRECT 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 - CORRECT 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 - CORRECT 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: - CORRECT 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 - CORRECT 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 - CORRECT ANSWER-Responsible for 45 CFR 46 National Institutes of Health (NIH) - CORRECT ANSWER-Includes funding agencies that provide federal funding for biomedical research U.S. Food and Drug Administration (FDA) - CORRECT ANSWER-Oversees the use of all drugs, devices, biologics, etc. including their use in research with human subjects International Council for Harmonisation (ICH) - CORRECT 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? - CORRECT ANSWER-Report 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? - CORRECT ANSWER-A 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? - CORRECT ANSWER-The 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: - CORRECT ANSWER-The 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: - CORRECT ANSWER-occur at least annually Informed consent - CORRECT ANSWER-The 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: - CORRECT ANSWER-1) 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 - CORRECT ANSWER-Prospective consent for unspecified future research Legally Authorized Representative(LAR) - CORRECT ANSWER-Individual 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 The emphasis of the discussion of informed consent is: - CORRECT ANSWER-on subject comprehension and presenting information that a "reasonable person" would want to have in order to make an informed decision to participate, and an opportunity to discuss the information According to 46/116(b), legally appropriate informed consent will include the following elements: - CORRECT ANSWER-1) a statement that the study involves research, an explanation of the research's purpose and the expected duration of the subject's participation, a description of the procedures to be follow, and identification of an procedures that are experimental 2) A description of any reasonably foreseeable risks or discomforts to the subject 3) A description of any benefits to the subjects or to others that may reasonably be expected from the research 4) A disclosure of appropriate alternative procedures or courses of treatment if any, that might be advantageous to the subject 5) · A statement describing the extent, if any, to which confidentiality of records identifying the subject will be maintained 6) For research involving more than minimal risk, an explanation as to whether any compensation and an explanation as to whether any medical treatments are available if injury occurs and, if so, what they consist of, or where further information may be obtained. 7) An explanation of whom to contact for answers to pertinent questions about the research and research subject's rights, and whom to contact in the event of a research-related injury to the subject. 8) A statement that participation is voluntary, that refusal to participate will involve no penalty or loss of benefits to which the subject is otherwise entitled, and that the subject may discontinue participation at any time without penalty or loss of benefits to which the subject is otherwise entitled. 9) One of the following statements about any research that involves the collection of identifiable private information or identifiable biospecimens: A statement that identifiers might be removed from the identifiable private information or identifiable biospecimens and that, after such removal, the information or biospecimens could be used for future research studies or In addition, if relevant to the research, legally effective informed consent will also include the following elements: - CORRECT ANSWER-1) Statement that the particular treatment or procedure may involve risks to the subject (or to the embryo or fetus, if the subject is or may become pregnant) which are currently unforeseeable 2) Anticipated circumstances under which the subject's participation may be terminated by the investigator without regard to the subject's consent 3) Any additional costs to the subject that may result from participation in the research 4) The consequences of a subject's decision to withdraw from the research and procedures for orderly termination of participation by the subject 5) A statement that significant new findings developed during the course of the research which may relate to the subject's willingness to continue participation will be provided to the subject · For research that is subject to HHS regulation at 45 CFR 46 (Protection of Human Subjects), the consent form must also include (if appropriate): - CORRECT ANSWER-1) A statements that the subjects biospecimens (even if identifiers are removed) may be used for commercial profit and whether the subject will or will not share in this commercial profit 2) A statement regarding whether clinically relevant research results, including individual research results, will be disclosed to subjects, and if so, under what conditions; and 3) For research involving biospecimens, whether the research will (if known) or might include whole genome sequencing (that is, sequencing of a human germline or somatic specimen with the intent to generate the genome or exome sequence of that specimen) The FDA does require the following statements in the informed consent form: - CORRECT ANSWER-1) Statement that the subjects' records may possibly be inspected by the FDA 2) Statement that the clinical trial will be listed in a registry. HHS regulations at 45 CFR 46.116 allow an IRB to waive or alter for informed consent under the following circumstances: - CORRECT ANSWER-1) Government projects 2) General waivers and alterations 3) Screening, recruiting, or determining eligibility FDA at 21 CFR 50.23 and 50.24 provides exceptions to the requirement for informed consent under the following circumstances: - CORRECT ANSWER-1) In situations where requirements for exception from informed consent are met for emergency research 2) In life threatening conditions involving an individual subject where requirements for an exception from informed consent are met and include documentation of all of the following: The researcher, with the concurrence of another physician, believes the situation necessitates the use of a test article The subject and/or LAR is unable to communicate consent There is insufficient time to obtain consent · No alternative exists that will provide an equal or better chance of saving the subject's life The IRB must be notified within a maximum of _____ days if a test article was used in an emergency situation for one individual are associated with an IRB-approved research study that involves research in emergencies - CORRECT ANSWER-5 1) An elderly gentleman, whose wife is his LAR since his stroke several years ago, was recently diagnosed with lung cancer. He is eligible for a clinical trial using a new investigational drug that aims to treat lung cancer. He is able to express interest, shows a basic understanding of the nature of the trial, and gives his assent to participation. The subject's wife is out of town on a business trip. Which of the following is the most appropriate action to take for the investigator? - CORRECT ANSWER-Send a copy of the informed consent via facsimile to the subject's wife. After she has had the opportunity to speak to the investigator, she can sign the informed consent and fax it back. The purpose of informed consent is: - CORRECT ANSWER-a. To provide a potential subject with appropriate information in an appropriate manner and allow that person to make an informed decision about participation in research. A 46 year-old man is currently enrolled in a Phase 2 study of a drug for severe diabetic neuropathy. While the study is on-going, a new drug becomes commercially available that may have equal or greater benefit to the subject. The investigator should do which of the following? - CORRECT ANSWER-Give the subject comprehensive information about the new drug, including its side effects. Discuss the pros and cons of both the investigational drug and the commercially available drug and then allow the subject to decide whether to withdraw from the research to take the new drug. A general requirement for the informed consent form is that it may not include any exculpatory language. Exculpatory language is that which waives or appears to waive any of the subject's legal rights or releases or appears to release those conducting the research from liability for negligence. Which of the following statements in a consent form is an example of exculpatory language? - CORRECT ANSWER-I waive any possibility of compensation for injuries that I may receive as a result of participation in this research An investigator is confronted with a life-threatening situation that necessitates using a test article in a human subject who is unable to provide informed consent and there is no time to obtain consent from the individual's LAR and no alternative method or recognized therapy is available. Under the FDA regulations for using test articles, which of the following describes the best course of action for the investigator: - CORRECT ANSWER-The investigator and an independent physician agree that the situation necessitates the use of the test article. An exception or waiver for informed consent can be made under these circumstances. The IRB will be notified later. The ethics of genetic and genomic research have received a great deal of attention due to several factors: - CORRECT ANSWER-1) Genetic testing can reveal a strong predisposition to future disease, making the information psychologically powerful and raising concerns about stigma or discrimination 2) Related individuals share many of the same gene sequences in their DNA, meaning that genetic information about one individual provides information about other individuals who may or may not have consented to genetic testing 3) Genetic testing can reveal characteristics of recent and distant ancestry that may conflict with peoples' family history, with their social history, or with their religious beliefs 4) Historically, genetic concepts and information have sometimes been misused to affect social and political ends genetic determinism - CORRECT ANSWER-The concept that the control of genes confers great power than can be used or misused As of January 2015, the NIH expects investigators to obtain the informed (valid) consent of research participants in NIH -funded genetic research for broad research use of data and data sharing, even if the cell lines or specimens are: - CORRECT ANSWER-deidentified When conducting research that involves collecting biological specimens for genetic testing, which of the following issues are the most important for the IRB to consider? - CORRECT ANSWER-Effects of findings on other family memebers Under which of the following conditions is it appropriate to re-contact the individuals who provided biological specimens? - CORRECT ANSWER-Original signed consent documents include provisions for recontacting subjects Which choice best describes the purpose of most pharmacogenomic research? - CORRECT ANSWER-To evaluate the association between individual genotypes and the safety and efficacy of a particular drug or class of drugs Identify which type of discrimination the Genetic Information Non-Discrimination Act protects individuals from: - CORRECT ANSWER-Health insurance and employment discrimination