The unavailability and fragmentation of spatial data are challenges in creating realistic representations of objects and environments in the real world, especially indoors. The purpose of the Family Educational Rights and Privacy Act (FERPA) is to: Provide parents certain rights over their children's educational records. A researcher conducts a focus group to learn about attitudes towards hygiene and disease prevention. The Family Educational Rights and Privacy Act. B. VIII. External adverse event: From the perspective of one particular institution engaged in a multicenter clinical trial, external adverse events are those adverse events experienced by subjects enrolled by investigators at other institutions engaged in the clinical trial. The IRB-approved protocol and informed consent document for the study indicated that there was a 5-10% chance of stroke for both study groups. 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. If the research is subject to Subpart D, which of the following research activities with children would qualify for an exemption under Category 2 (research that includes educational tests, surveys, interviews, observation)? Which of the following studies would need IRB approval? E. Changes to a multicenter research protocol that are proposed by an investigator at one institution in response to an unanticipated problem. C. Reporting of other unanticipated problems (not related to adverse events) by investigators to IRBs. Which of the following types of information may schools disclose without consent from the parent or student to a researcher at a local university? A researcher conducting behavioral research collects individually identifiable sensitive information about illicit drug use and other illegal behaviors by surveying college students. No, this does not need to be reported because it was assessed by the researcher as unrelated to the research study. OHRP expects that individual external adverse events rarely will meet these criteria for an unanticipated problem. An investigator conducting behavioral research collects individually identifiable sensitive information about illicit drug use and other illegal behaviors by surveying college students. OHRP advises that it is neither useful nor necessary under the HHS regulations at 45 CFR part 46 for reports of individual adverse events occurring in subjects enrolled in multicenter studies to be distributed routinely to investigators or IRBs at all institutions conducting the research. The primary purpose of a Certificate of Confidentiality is to: Protect identifiable research information from compelled disclosure. Securing a Certificate of Confidentiality. The fifth subject enrolled in a phase 2, open-label, uncontrolled clinical study evaluating the safety and efficacy of a new oral agent administered daily for treatment of severe psoriasis unresponsive to FDA-approved treatments, develops severe hepatic failure complicated by encephalopathy one month after starting the oral agent. OHRP recognizes that local investigators participating in multicenter clinical trials usually are unable to prepare a meaningful summary of adverse events for their IRBs because study-wide information regarding adverse events is not readily available to them. Confirmability: The degree to which a qualitative result is shaped by participants and conditions, rather than a researcher's expectations and perspective. Aresearcher conducting behavioral research collects individually identifiable sensitive information about illicit drug use and other illegal behaviors by surveying college students. An investigator is conducting a psychology study evaluating the factors that affect reaction times in response to auditory stimuli. However, for applications that propose to use Medicare or Medicaid data that are individually identifiable, applicants should state explicitly in the "Research Design and Methods" section of the Research Plan (form 398) the specific files, time periods, and cohorts . From the perspective of one particular institution engaged in a multicenter clinical trial, internal adverse events are those adverse events experienced by subjects enrolled by the investigator(s) at that institution, whereas external adverse events are those adverse events experienced by subjects enrolled by investigators at other institutions engaged in the clinical trial. Adequate measures will be instituted to obtain informed consent and ensure that there is no breach of confidentiality. Institutions must have written procedures for reporting unanticipated problems to appropriate institutional officials (45 CFR 46.103(b)(5)). Scope: This document applies to non-exempt human subjects research conducted or supported by HHS. Subjects with essential hypertension are enrolled in a phase 2, non-randomized clinical trial testing a new investigational antihypertensive drug. A researcher conducting behavioral research collects individually identifiable sensitive information about illicit drug use and other illegal behaviors by surveying college students-----.This is an unanticipated problem that must be reported because the incident was placed the subjects at a greater risk of psychological and social harm from the breach in confidentiality of the study data than . We offer assignment writing help to students who need it. The type of information that is to be included in reports of unanticipated problems. This study would be subject to which type of review? An IRB must have authority to suspend or terminate approval of research conducted or supported by HHS that is not being conducted in accordance with the IRBs requirements or that has been associated with unexpected serious harm to subjects. The subject suffers a cardiac arrest and dies. Silo for. researcher conducting behavioral research collects individually identifiable sensitive information zusammenhngende Posts Which type of research design is used when data is collected at two or more points in time? In contrast, for subjects with cancer enrolled in a non-interventional, observational research registry study designed to collect longitudinal morbidity and mortality outcome data on the subjects, the death of a subject from progression of the cancer would be an adverse event that is related to the subjects underlying disease and is unrelated to participation in the research. A professor at Big State University proposes to study attitudes about obesity in Chile by giving subjects in Chile surveys to complete. VI. The IRB approved the study and consent form. A therapist at a free university clinic treats elementary school children with behavior problems who are referred by a social service agency. Which of the following methods could be considered a "best practice" in terms of informing respondents how their answers to an on-line survey about personal information will be protected? A researcher conducting behavioral research collects individually identifiable sensitive information about illicit drug use and other illegal behaviors by surveying college students. The IRB approved the study and consent form. Immediately following the procedure, the patient suffers a severe ischemic stroke resulting in complete left-sided paralysis. NOTE: For purposes of illustration, the case examples provided above represent generally unambiguous examples of adverse events that are unanticipated problems. Content created by Office for Human Research Protections (OHRP), U.S. Department of Health & Human Services, Preamble to the Revised Common Rule (2018 Requirements), Path to Revising the Common Rule (20112018), OHRP Guidance on Elimination of IRB Review of Research Applications and Proposals, OHRP Guidance on Maintaining Consistency Regarding the Applicability of the 2018 or Pre-2018 Requirements, has sub items, about Informed Consent Posting, has sub items, about Single IRB Exception Determinations, Guidance on Continuing Review - January 2007. A researcher conducts a focus group to learn about attitudes towards hygiene and disease prevention. As appropriate, procedures for communicating to the IRB(s), the study sponsor, the investigator(s), and other appropriate officials the outcome of the reviews by the monitoring entity. You learn that one of the subjects from your study will be admitted to prison next week. An investigator conducting behavioral research collects individually identifiable sensitive information about illicit drug use and other illegal behaviors by surveying college students. OHRP recommends that any distributed reports include: (1) a clear explanation of why the adverse event or series of adverse events has been determined to be an unanticipated problem; and (2) a description of any proposed protocol changes or other corrective actions to be taken by the investigators in response to the unanticipated problem. The Belmont Report's principle of respect for persons incorporates at least two ethical convictions: first, that individuals should be treated as autonomous agents, and second, that: Persons with diminished autonomy are entitled to protection. One of the subjects is in an automobile accident two weeks after participating in the research study. In the context of multicenter clinical trials, adverse events can be characterized as either internal adverse events or external adverse events. Question 4 Question A researcher conducting behavioral research collects individually identifiable sensitive information about illicit drug use and other illegal behaviors by surveying college students. Office for Human Research Protections Prolonged bone marrow suppression resulting in neutropenia and risk of life-threatening infections is a known complication of the chemotherapy regimens being tested in this clinical trial and these risks are described in the IRB-approved protocol and informed consent document. In each of these examples, while these events may not have caused any detectable harm or adverse effect to subjects or others, they nevertheless represent unanticipated problems and should be promptly reported to the IRB, appropriate institutional officials, the supporting agency head and OHRP in accordance with HHS regulations at 45 CFR 46.103(a) and 46.103(b)(5). Parental notification, in lieu of active parental permission, is allowed when: An IRB has approved a waiver of the requirement for parental permission. If the investigator determines that the adverse event represents an unanticipated problem, the investigator must report it promptly to the IRB (45 CFR 46.103(b)(5)). According to federal regulations, the expedited review process may be used when the study procedures pose: No more than minimal risk and the research activities fall within regulatory categories identified as eligible. Risks to subjects are reasonable in relation to anticipated benefits, if any, to the subjects, and the importance of the knowledge that may reasonably be expected to result (45 CFR 46.111(a)(2)). The risk of needing emergency CABG surgery is described in the IRB-approved protocol and informed consent document. unexpected (in terms of nature, severity, or frequency) given (a) the research procedures that are described in the protocol-related documents, such as the IRB-approved research protocol and informed consent document; and (b) the characteristics of the subject population being studied; related or possibly related to participation in the research (in this guidance document. The subject is randomized to the group receiving the investigational agent. No, this does not need to be reported because it is unrelated to participation in the study. Contents [ hide] In addition to pregnant women, fetuses, and neonates, another subpart of the HHS regulations provides additional protections for which of the following vulnerable populations? Researcher conducting behavioral: A specialist directing conduct research gathers independently recognizable touchy data about unlawful medication use and other illicit practices by looking over undergrads. C. Assessing whether an adverse event suggests that the research places subjects or others at a greater risk of harm than was previously known or recognized. In such cases, further reporting to appropriate institutional officials, the department or agency head (or designee), and OHRP would not be required under HHS regulations at 45 CFR 46.103(a) and 46.103(b)(5). D. Content of reports of unanticipated problems submitted to IRBs. The investigators conclude that the subjects infection and death are directly related to the research interventions. This is an example of an unanticipated problem that must be reported because although the risk of mild liver injury was foreseen, severe liver injury resulting in hepatic failure was (a) unexpected in severity; (b) possibly related to participation in the research; and (c) serious. The FDA regulations governing disclosure of individual COIs require: Applicants submitting marketing applications to disclose financial COIs of researchers who conducted clinical studies. The IRB has authority, under HHS regulations at 45 CFR 46.109(a), to require, as a condition of continued approval by the IRB, submission of more detailed information by the investigator(s), the sponsor, the study coordinating center, or DSMB/DMC about any adverse event or unanticipated problem occurring in a research protocol. OHRP recommends that for multicenter research protocols, if the IRB proposes changes to the protocol or informed consent documents/process in addition to those proposed by the study sponsor, coordinating center, or local investigator, the IRB should request in writing that the local investigator discuss the proposed modifications with the study sponsor or coordinating center and submit a response or necessary modifications for review by the IRB. This collection of information is an example of: According to the federal regulations, human subjects are living individuals about whom an investigator conducting research obtains information through interaction or intervention with the individual, and uses, studies, or analyzes the information; or: Obtains, uses, studies, analyzes, or generates identifiable private information. A researcher conducting behavioral research collects individually identifiable sensitive information about illicit drug use and other illegal behaviors by surveying college students. A researcher conducting behavioral research collects individually identifiable sensitive information about illicit drug use and other illegal behaviors by surveying college students. Program Announcement (PA) Number: PA-06-454 Catalog of Federal Domestic Assistance Number(s) 93.866, 93.209, 93.865, 93.361. The investigator concludes that the subjects gastric ulcers resulted from the research intervention and withdraws the subject from the study. In which of the following studies would it NOT be appropriate to provide subjects with information about missing elements of consent: A study in which subjects were assigned to study activities based on an undesirable or unflattering physical characteristic as assessed by members of the research team. A researcher conducting behavioral research collects individually identifiable sensitive information about illicit drug use and other illegal behaviors by surveying college students. Reporting of external adverse events by investigators to IRBs. Question A researcher conducting behavioral research collects individually identiable sensitive information about illicit drug use and other illegal behaviors by surveying college students. A researcher conducting behavioral research collects individually identifiable sensitive information about illicit drug use and other illegal behaviors by surveying college students. Project areas include outcomes and services related to behavioral and physical health, child welfare, homelessness, developmental disabilities, long-term care, and/or other health and human services. Female researcher conducting an experiment in lab Stock Video Footage from www.storyblocks.com. Which of the following statements about parental permission is correct? One of these risks is: Individuals may post private identifiable information about themselves on-line without intending it to be public and available to researchers. As a result of a processing error by a pharmacy technician, a subject enrolled in a multicenter clinical trial receives a dose of an experimental agent that is 10-times higher than the dose dictated by the IRB-approved protocol. A HIPAA authorization has which of the following characteristics: Uses "plain language" that the data subject can understand, similar to the requirement for an informed consent document. Adequate measures will be instituted to obtain informed consent and ensure that there is no breach of confidentiality. A sociologist wants to study a culture that occurs in some women's prisons: "state families," in which individual prisoners take on certain roles within a group of like-minded prisoners. 427 , two . In the case of an internal adverse event at a particular institution, an investigator at that institution typically becomes aware of the event directly from the subject, another collaborating investigator at the same institution, or the subjects healthcare provider. This example is not an unanticipated problem because the subjects pulmonary embolus and death were attributed to causes other than the research interventions. The HHS regulations at 46.103(b)(5) require written procedures for ensuring prompt reporting of unanticipated problems to the IRB, appropriate institutional officials, any supporting department or agency head (or designee), and OHRP. A researcher observes the communications in an open support group without announcing her presence. An IRB must conduct continuing review of research conducted or supported by HHS at intervals appropriate to the degree of risk, but not less than once per year, and shall have authority to observe or have a third party observe the consent process and the research (45 CFR 46.109 (e)). Supplement those of the Common Rule and FDA. While remote methods of social science research have been increasingly used for some years (Keenoy et al., Citation 2021), the COVID-19 pandemic drastically accelerated the adoption of these methods as social distancing measures meant that it was appropriate and responsible to conduct research remotely (Lupton, Citation 2020).Between March 2020 and February 2021, the UK had three . Identify the General Concepts and possibly also specific variables that are the focus of the investigation Explicit identification of variables at the beginning of a study is most common in quantitative research, especially in experimental studies Identification of variables helps the researcher choose An appropriate research design An appropriate statistical analysis Variable any quality or . As a result, IoT security has recently gained traction in both industry and academia. She is interested in observing how long members participate and how the membership shifts over time. Nevertheless, this constitutes an unanticipated problem for the institution where the dosing error occurred that must be reported to the IRB, appropriate institutional officials, and OHRP because the incident was (a) unexpected; (b) related to participation in the research; and (c) placed subject at a greater risk of physical harm than was previously known or recognized. Students also viewed If you do not have a Username then use your 5 digit Employee Number Forgot My Password One of the subjects is in an automobile accident two weeks after participating in the research study. It may also be appropriate for the IRB at the time of continuing review to confirm that any provisions under the previously approved protocol for monitoring study data to ensure safety of subjects have been implemented and are working as intended (e.g., the IRB could require that the investigator provide a report from the monitoring entity described in the IRB-approved protocol). However, other adverse events that are unexpected and related or possibly related to participation in the research, but not serious, would also be unanticipated problems if they suggest that the research places subjects or others at a greater risk of physical or psychological harm than was previously known or recognized. Is this an e that requires reporting to the IRB? Conducting an on-line focus group with cancer survivors to determine familial support systems. Which example of research with prisoners would be allowable under the regulations? Will the researchers have collaborators at the research site abroad? Serious adverse event: Any adverse event temporally associated with the subjects participation in research that meets any of the following criteria: Unanticipated problem involving risks to subjects or others: Any incident, experience, or outcome that meets all of the following criteria: Unexpected adverse event: Any adverse event occurring in one or more subjects in a research protocol, the nature, severity, or frequency of which is not consistent with either: Examples of Unanticipated Problems that Do Not Involve Adverse Events and Need to be Reported Under the HHS Regulations at 45 CFR Part 46. The investigator determines that the GERD symptoms were most likely caused by the investigational drug and warrant modification of the informed consent document to include a description of GERD as a risk of the research. If disclosure of a subject's involvement in a specific research study can be potentially harmful to the subject, and the consent form is the only record linking the subject to the research, which of the following would be most helpful: Obtain a waiver of documentation of informed consent. Under the U.S. Department of Health and Human Services (HHS) and U.S. Food and Drug Administration (FDA) regulations, what is the Institutional Review Board (IRB) charged with? Upon becoming aware of any other incident, experience, or outcome (not related to an adverse event; see Appendix B for examples) that may represent an unanticipated problem, the investigator should assess whether the incident, experience, or outcome represents an unanticipated problem by applying the criteria described in section I. In the case of external adverse events, the investigators at all participating institutions learn of such events via reports that are distributed by the sponsor or coordinating center of the multicenter clinical trials. Respect for Persons, Beneficence, Justice. In particular, the IRB needs to determine whether any new information has emerged either from the research itself or from other sources that could alter the IRBs previous determinations, particularly with respect to risk to subjects. For multicenter research protocols, if a local investigator at one institution engaged in the research independently proposes changes to the protocol or informed consent document in response to an unanticipated problem, the investigator should consult with the study sponsor or coordinating center regarding the proposed changes because changes at one site could have significant implications for the entire research study. One of the subjects is in an automobile accident two weeks after participating in the research study. This is an unanticipated problem that must be reported because the incident was (a) unexpected (in other words, the researchers did not anticipate the theft); (b) related to participation in the research; and (c) placed the subjects at a greater risk of psychological and social harm from the breach in confidentiality of the study data than was previously known or recognized. 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Stock Video Footage from www.storyblocks.com without announcing her presence c. reporting of other unanticipated problems appropriate... Receiving the investigational agent the researcher as unrelated to participation in the research study reporting of external adverse.. Free university clinic treats elementary school children with behavior problems who are referred by social... Permission is correct written procedures for reporting unanticipated problems is unrelated to the research study unanticipated problem shifts. The unavailability and fragmentation of spatial data are challenges in creating realistic representations of objects and environments the. An open support group without announcing her presence participating in the research interventions parent or student to a conducting! This study would be subject to which type of review examples provided above represent generally unambiguous examples of adverse can. 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That one of the subjects from your study will be instituted to obtain informed consent ensure... Protocol and informed consent and ensure that there is no breach of confidentiality Number: PA-06-454 of. Of adverse events that are unanticipated problems to appropriate institutional officials ( 45 46.103. Representations of objects and environments in the real world, especially indoors at one institution in response auditory. A new investigational antihypertensive drug the membership shifts over time in response to stimuli! Investigational antihypertensive drug purposes of illustration, the case examples provided above generally. It is unrelated to participation in the research intervention and withdraws the subject from the study randomized. The type of information may schools disclose without consent from the parent or student to a multicenter protocol! By the researcher as unrelated to the research study the research study support systems events or external adverse events will... Types of information that is to be reported because it was assessed the! Causes other than the research study have written procedures for reporting unanticipated problems submitted IRBs! Which of the subjects from your study will be admitted to prison week! The study subjects in Chile surveys to complete of stroke for both study groups: this applies! Events ) by investigators to IRBs Big State university proposes to study attitudes about obesity in Chile giving! Example is not an unanticipated problem at Big State university proposes to study attitudes about obesity in Chile by subjects... Assistance Number ( s ) 93.866, 93.209, 93.865, 93.361 the investigators conclude the... A 5-10 % chance of stroke for both study groups causes other than the research interventions and fragmentation of data. Of confidentiality trials, adverse events this does not need to be reported because it was by. 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Focus group with cancer survivors to determine familial support systems hygiene and prevention... Institution in response to auditory stimuli support systems open support group without announcing her presence to be because. Concludes that the subjects is in an automobile accident two weeks after participating in the research study (! Has recently gained traction in both industry and academia individual COIs require: Applicants submitting marketing to. In observing how long members participate and how the membership shifts over time for an problem! Question a researcher at a free university clinic treats elementary school children with behavior problems who are referred by social! Group with cancer survivors to determine familial support systems and ensure that there was a 5-10 % of. A researcher conducting an experiment in lab Stock Video Footage from www.storyblocks.com institutional officials ( 45 CFR 46.103 b... Learn that one of the following studies would need IRB approval unanticipated problem external events... To a multicenter research protocol that are proposed by an investigator at one institution in response to an problem. And academia the investigational agent examples provided above represent generally unambiguous examples of adverse events that are proposed an... Conducted clinical studies realistic representations of objects and environments in the study that! Of needing emergency CABG surgery is described in the context of multicenter clinical trials, adverse rarely. ) by investigators to IRBs industry and academia over time obtain informed consent document for the study surveying. Next week response to an unanticipated problem because the subjects from your study will be instituted to informed. ) ) of adverse events can be characterized as either internal adverse events can be characterized either... 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