The overall goal of monitoring, audits, and inspection activities is to: Ensure the protection of human research subjects and data integrity. Different disciplines have different practices about who should be included as an author. Breach of confidentiality from the focus group subjects (therapists). ... A professor at Big State University is writing a biography about Bill Gates and conducting oral histories with all of Bill Gates' friends, family members, and business acquaintances. Reviewers have a responsibility to promote ethical peer review by: Preserving the confidentiality of the submission. Some responses need to be seen by everyone, but not every response requires a full broadcast. In regard to reporting privacy or security problems, are the requirements for students the same as for regular workers? Which of the following statements most accurately describes the requirement for the documentation of minors' assent to participate in research? There is no official, federal standard for the number of consecutive words that can be used. Records must be maintained for all but which of the following? Award documentation is typically required to be prepared and submitted within how long after the end of a project period: Which of the following most accurately describes an 2 CFR Part 200.425(2) audit? Consent to participate in research is an ongoing process. A general requirement for informed consent is that no informed consent may include any exculpatory language. Which of the following would be the most appropriate course of action? Specific clients of the therapists will not be discussed. A researcher proposes to join a moderated support group for cancer survivors posing as a survivor. What "technical measures" do you usually need to take with an off-site computer? Which response below contains the correct four? Adjudication of research participant's bills allows which department to direct charges to the correct payer? Which of the following is correct about email transmission and storage? Healthcare providers, health plans, and health information clearinghouses, as well as their business associates and by extension the workers for those organizations. This incident constitutes: As part of a research study, a physician plans to review medical records to explore factors related to 50 of her patients who require magnetic resonance imaging (MRI) scans for clinical treatment. Employees and students have strong privacy protections with respect to their emails, so they cannot be inspected by employers or educational authorities without a search warrant. Even though VHA requires that investigational drugs be stored and dispensed by Pharmacy Service, FDA requires that the Investigator bear primary responsibility for all aspects of investigational drug accountability. The investigator should do which of the following? To determine compliance with regulatory requirements, including those relating to protecting research subjects. During an Institutional Review Board (IRB) meeting, any IRB member who may have a potential COI with a study under review should: Disclose their potential COI and may answer questions, but recuse themselves from voting. Which of the following is a correct statement about malware? 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. Which of the following is most likely to be a deemed export: The transfer of information to a foreign national in the United States. Which of the following correctly describes a dictionary or brute force attack? Submit the research protocol to the IRB for review and submit an IND application to the FDA before conducting the research. Non-licensed clinicians can dispense and educate subjects about their medication. Parental notification, in lieu of active parental permission, is allowed when: An IRB has approved a waiver of the requirement for parental permission. Which of the following statements about review of the revised protocol is accurate? What is excused? Which example of research with prisoners would be allowable under the regulations? The HIPAA "minimum necessary" standard applies... To all human subjects research that uses PHI without an authorization from the data subject. Inducements constitute an "undue influence" if they alter a potential subject's decision-making processes, such that they do not appropriately weigh the risk-benefit relationship of the research. A subject in a clinical research trial experiences a serious, unanticipated adverse drug experience. Some types of radiation can penetrate the body and cause biological harm. Students and professors will find thorough, current coverage of all business research topics presented with a balance of theory and practical Which of the following is not a correct statement about the security risks of email attachments and links embedded within emails? She employed: Malcolm conducted a survey of the students in his introductory biology class in which he could identify a given person's responses but promised not to do so publicly. A researcher's study uses a dataset of prisoner demographic characteristics. Such notices should be included if an organization's policies require it, but cannot be counted upon as legal protection. Select all of the following that are considered Essential Documents for the Investigator File: (Select all that apply). Into which category does information related to research, marketing, and fundraising go? To have a misconduct finding, the action must have been committed intentionally, knowingly, or recklessly. "Tastes, Ties, and Time (T3)" study (2006-2009). According to federal regulations, is review required at the foreign site? When an IRB is reviewing a research study and they are considering if a potential subject population is vulnerable, they should consider: Is there a power differential between researchers and subjects? An intelligence quotient (IQ) is a total score derived from a set of standardized tests or subtests designed to assess human intelligence. Which of the following will be the most important issue for the researcher to consider when planning the research? Enrollment was twelve-hundred (1200) subjects. 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. Yes. It means that the cost share is quantified in the proposal but not required by the sponsor. She is also a doctoral candidate who proposes using data she has and will collect about the children for a case-based research project. Which of the following sources describe the principles of Good Clinical Practice (GCP)? How often should research administrators or PIs initiate a routine "New Proposal Financial Interest in Research Report" for each project in eCOI? Which of the following techniques of data collection is MOST likely to make a guarantee of anonymity difficult? Identifies, evaluates, and reports safety data to the IRB and Sponsor. He is eligible for a clinical trial using a new investigational drug that aims to treat lung cancer. HIPAA protects a category of information known as protected health information (PHI). Use of social media tools and other new technologies to facilitate training-related communications is: Depends on the organization's policies, so you should check with your organization's officials about what is allowed or prohibited. Management plans are often created to reduce the impact of conflicts of interest. Part 20 requires contamination surveys be performed to detect accidental spread of radioactive material in the course of routine use. Which of the following statements most accurately describes the mentoring relationship? Researcher access to confidential records adds to the vulnerability of workers who participate in workplace studies. Which of the following statements is true regarding the responsibilities of a reviewer? Only data on computers that are guaranteed to contain no sensitive information, or where the physical and technical security of the device is assured, can safely be left unencrypted. Encouraging trainees to receive mentoring from a collection of individuals. For health information privacy and security, are the legal and regulatory requirements for students different from those for regular members of the healthcare workforce? What does that include? His laptop is stolen. Development of most new drugs, from discovery to marketing approval, usually takes: Adults with more than a twelve (12)-month history of migraines were assigned randomly in a double-blinded study to receive treatment with experimental drug X (10 or 20 mg/day) or placebo. Confidentiality of the individual subject's responses. a. Assess the following: the sensitivity of the information, the length of time the information is being held, the usefulness of the information collected, and the ability to protect the information. He plans to go back to the medical record, so the HIV status information is stored along with subject identifiers in a database that he keeps on his laptop computer. OHRP is an oversight body primarily concerned with: When the FDA conducts an inspection, the inspectors will: When a patient enters a clinical facility, they must inevitably surrender control of their information for a broad range of uses and disclosures. Software on a desktop or laptop computer should be: Installed or updated only from trusted sources to be certain that it is a legitimate version. Allowing a browser to save the password, or using a password management tool to record passwords, can be a safe alternative but only if used appropriately. A 510(k) Premarket Notification is submitted: When the new device to be marketed is substantially similar (equivalent) to one already on the market. Assuming that the basic research design could be approved by the IRB and the school, which of the following requirements must be met before an IRB could waive parental permission? Individuals who do not meet the criteria for authorship but who have made a noteworthy contribution are normally listed in the acknowledgments section. Officials of the institution may overrule an IRB approval. What statement about risks in social and behavioral sciences research is most accurate: Risks are specific to time, situation, and culture. An investigator uses his Facebook wall to post a URL link to a survey he is hosting on SurveyMonkey. Exposure to levels at or below those established for occupational radiation workers significantly increases the likelihood of developing cancer. Additional safeguards that may be included in a social and behavioral study may include: Remove all direct identifiers from the data as soon as possible. Uses or disclosures that generally require specific written authorization. Designing the survey so that subjects are not forced to answer one question before going to the next. The provisions of Subpart D, of the HHS regulations, Additional Protections for Children Involved as Subjects in Research apply to: According to federal regulations, "children" are defined as: Persons who have not yet attained the legal age of consent under the applicable laws in the jurisdiction in which the research will be conducted. ICH E6 describes standards that apply to: In the United States, following the ICH E6 guideline is: Voluntary for FDA-regulated drug studies. According to the federal regulations, which of the following studies meets the definition of research with human subjects? The patient authorization and consent form: (Select all that apply). Report adverse events of both a broken wrist and a mild concussion. The nature of the resource a particular password protects will affect, to some degree, how strong it needs to be. Adequate measures will be instituted to obtain informed consent and ensure that there is no breach of confidentiality. A simple delete assures that messages are no longer accessible. ________ is guaranteed in a research project when neither the researchers nor the readers of the findings can identify a given response with a given respondent. What kinds of content should generally not be sent in email? Which of the following is the least important activity when protecting human subjects in international research? A faculty member makes identifiable data about sexual behavior available to graduate students, although the subjects were assured that the data would be de-identified. 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. To avoid or minimize these risks, the study design must include adequate safeguards to protect the confidentiality of the information collected. Under HIPAA, "retrospective research" (a.k.a., data mining) on collections of PHI generally ... Is research, and so requires either an authorization or meeting one of the criteria for a waiver of authorization. During the conduct of the study and at termination. Sarah is a student at Lake Wobegon University and wishes to complete a study on students' living arrangements and academic engagement. No, they are not engaged because they are only informing the subjects and not consenting or performing any research procedures, or receiving or sharing any private, identifiable information. Set standards for the design, conduct, monitoring and reporting of clinical research. The researcher submits the research proposal to the institution's IRB. An investigator conducting a study of a medical device under an IDE is required to complete and sign which of the following? The primary ethical issue in Laud Humphreys' study of homosexuals was: The primary ethical issue in Stanley Milgram's study on obedience (electric shocks) was: The ethics of social research deals mostly with the methods employed while political issues tend to center on the substance and use of research. Some would say it is higher, because patients do not always benefit from students' access to their data. Broadly speaking, the compromise of personal information falls under the heading of identity theft. Which of the following statements is NOT found in the AAPOR Code of Professional Ethics and Practices? If investigators are complying with ICH E6 guideline, they must: Clearly disclose to subjects in the informed consent form that the monitor, auditor, IRB/IEC, and the regulatory authorities may have access to the subject's medical records. When a subject signs a consent document, a note in the research record should include: Which of the following should be part of the FDA inspection process? Which of the following statements best characterizes what occurred? With respect to workplace use of messaging, such as text messages or messaging applications, which of the following is incorrect? What kinds of persons and organizations are affected by HIPAA's requirements? symbol, or to request a read receipt for an important message. Treat the patient with the drug based on physician's best medical judgment. The parents of the children might feel pressure to give permission to the therapist to use their children's data so that she will continue to provide services to their children. He is able to express interest, shows a basic understanding of the nature of the trial, and gives his assent to participation. It is permissable to use or store radioactive material in an area that has not been designated for its use or storage. The researcher did not participate in the initial collection of the data.

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