Ethical Considerations in Human Subjects Research, Exams of Business Economics

Download Ethical Considerations in Human Subjects Research and more Exams Business Economics in PDF only on Docsity! CITI Training, Modules 1-24 (Biomedical Research) Questions with Complete Solutions 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: A. Persons with diminished autonomy should only participate in no more than minimal risk research. B. Persons with diminished autonomy should be excluded from research. C. Persons with diminished autonomy are entitled to protection. D. Persons involved in research cannot financially benefit. - Correct Answer: C. Persons with diminished autonomy are entitled to protection. Which of the following is an example of how the principle of beneficence can be applied to a study employing human subjects? A. Ensuring that persons with diminished autonomy are protected. B. Providing detailed information about the study and obtaining the subject's consent to participate. C. Determining that the study has a maximization of benefits and a minimization of risks. D. Ensuring that the selection of subjects includes people from all segments of the population. - Correct Answer: C. Determining that the study has a maximization of benefits and a minimization of risks. Which of the following are the three principles discussed in the Belmont Report? A. IRB Review, Federal Regulations, Declaration of Helsinki B. Privacy, Confidentiality, Equitable Selection of Subjects C. Informed Consent, Institutional Assurance, Researcher Responsibility D. Respect for Persons, Beneficence, Justice - Correct Answer: D. Respect for Persons, Beneficence, Justice When an IRB is reviewing a research study and they are considering if a potential subject population is vulnerable, they should consider: A. Are there adequate resources to conduct the study? B. Is there a power differential between researchers and subjects? C. Has the researcher completed required training? D. Are the research procedures greater than minimal risk of harm? - Correct Answer: B. Is there a power differential between researchers and subjects? Which is an example of a situation where deferential vulnerability might be a factor? A. An army medical officer recruiting subjects among lower ranks B. A college professor recruiting among their students C. A physician recruiting patients to be subjects D. An employer recruiting among persons who directly report to them - Correct Answer: C. A physician recruiting patients to be subjects In considering NBAC's analytic approach, an otherwise competent person who is acutely ill might be considered at especially high risk of harm for: A. Economic vulnerability B. Situational cognitive vulnerability C. Capacity-related cognitive vulnerability D. Communicative vulnerability - Correct Answer: B. Situational cognitive vulnerability Identify the following groups that are protected in the federal regulations (45 CFR 46), specifically in Subparts B, C, and D with additional protections: A. Pregnant women, prisoners, and mentally disabled B. Children, prisoners, and terminally ill C. Prisoners, children, and elderly D. Pregnant women, prisoners, children - Correct Answer: D. Pregnant women, prisoners, children The NBAC looks at characteristics individuals might have that would prevent them from being able to provide voluntary informed consent. The traits may be thought of as falling into six broad areas: cognitive or communicative, institutional, deferential, medical, economic, and social. Prospective research subjects who are not able to comprehend information, deliberate, and make decisions about participation in a proposed research study have a: A. Institutional vulnerability D. The study involves no more than minimal risk and meets one of the allowable categories of expedited review specified in federal regulations - Correct Answer: D. 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: A. They only involve changes to the consent form. B. The changes must be immediately implemented for the health and well-being of the subject. C. They are eligible for review using expedited procedures. D. The investigator keeps careful records of all changes and includes them in the final report. - Correct Answer: B. The changes must be immediately implemented for the health and well-being of the subject. IRB continuing review of a greater than minimal risk approved protocol that is currently enrolling subjects must: A. Include copies of all signed consent forms. B. Occur at least annually. C. Be conducted by an expedited review. D. Occur only when the level of risk changes. - Correct Answer: B. Occur at least annually. 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? A. In the event of any injury you may have related to this research, you will be given medical treatment. B. Your participation in this research is voluntary. If you choose not to participate, or change your mind later, your decision will not affect your relationship with your doctor or your right to health care or other services that you may be eligible for. C. The investigator may stop you from participating in this research without your consent if you experience side effects that make your condition worse. If you become ill during the - Correct Answer: D. 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: A. Submit a research protocol to the IRB and justify an expedited review approval of the consent document so test article can be used immediately. B. Use the test article without obtaining consent from the subject or the LAR then notify the IRB. C. 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. D. Do not use the test article - Correct Answer: C. 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. An elderly gentleman, whose wife is his legally authorized representative (LAR) since his strokes 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? A. 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. B. Exclude the man from the study. C. Consult a colleague about his opinion. If the colleague agrees, enroll the man without a signed consent. D. The investigator can go ahead and enroll the man without a signed con - Correct Answer: A. 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: 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. B. To obtain a signature from a study subject in order to protect the investigator, the study staff and the institution. C. To obtain a signature from a study subject in order to document his or her agreement to participate in research. D. To document the investigator's participation in the consent process. - 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? A. Do not tell the subject about the new drug because physicians have the right to try out new treatments with their patients. B. Withhold this new information to avoid confusing the subject with other treatment options or alternatives. C. 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. D. Tell the subject about the new drug but discourage him from switching treatments until the study is completed. - Correct Answer: C. 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 researcher is conducting a written survey about people's attitudes toward walking as an exercise option at the local shopping mall that supports a walking program. The survey is anonymous (without codes, names, or other information) and subjects may complete the survey and place it in a box at the shopping mall exits. Which of the following is the most important issue that the researcher addressed in planning the research? A. Possibility of emotional distress for subjects from the questions themselves B. Data analysis from a large sample size C. Confidentiality of the individual subject's responses D. Recruitment of subjects to ensure varied characteristics of the sample size - Correct Answer: C. Confidentiality of the individual subject's responses A researcher wants to invite therapists to participate in small focus groups to discuss their perceptions regarding "troubled" adolescent girls and the relationships they have with their parents. Specific clients of the therapists will not be discussed. Which of the following will be the most important issue for the researcher to consider when planning the research? A. Amount of compensation for the subject's (therapist's) time A. Understanding the risks involved in other genetic studies is critical in determining the risk involved in a new study B. All genetic studies should be considered greater than minimal risk C. All genetic studies should be considered no more than minimal risk D. Understanding the purpose and context of a specific study is critical in determining the risk involved - Correct Answer: D. Understanding the purpose and context of a specific study is critical in determining the risk involved Under which of the following conditions is it appropriate to re-contact the individuals who provided biological specimens? A. Subjects received financial compensation for participation in the study B. Original signed consent documents include provisions for recontacting subjects C. Discovery of related clinical information requires contacting subjects for follow-up D. Biological specimens need to be replenished - Correct Answer: B. Original signed consent documents include provisions for recontacting subjects Which choice best describes the purpose of most pharmacogenomic research? A. To evaluate the association between individual genotypes and the safety and efficacy of a particular drug or class of drugs B. To evaluate how different racial and ethnic groups respond to certain drugs or classes of drugs C. To evaluate how the genomes of infectious agents impact the efficacy of certain antibiotics D. To evaluate whether genetic testing can reduce the cost of pharmaceuticals - Correct Answer: A. To evaluate the association between individual genotypes and the safety and efficacy of a particular drug or class of drugs Investigator A conducts research on emphysema using biospecimens from human subjects. The consent form indicates that the research will focus exclusively on emphysema. Investigator B wishes to use the biospecimens for research on lung cancer. Can Investigator B use the specimens for cancer research without re-consent if the specimens are de-identified? A. No, because it would be unethical to conduct research that is not consistent with the consent form the subjects originally signed. B. Yes, if the biospecimens are de-identified then the research is no longer considered human subjects research. C. Yes, because research with biospecimens is minimal risk. D. No, the original research subjects must be re-consented for the cancer research. - Correct Answer: B. Yes, if the biospecimens are de-identified then the research is no longer considered human subjects research. Which choice is the best definition of "genetic determinism?" A. Genetic information about an individual can foster stigma and discrimination B. Genetic testing can determine appropriate treatments for certain health conditions C. Parents determine the nature of their children through the inheritance of genes D. Genes are primarily responsible for human traits, including health, behavior, and disease - Correct Answer: D. Genes are primarily responsible for human traits, including health, behavior, and disease Which choice best describes the purpose of most pharmacogenomic research? A. To evaluate whether genetic testing can reduce the cost of pharmaceuticals B. To evaluate the association between individual genotypes and the safety and efficacy of a particular drug or class of drugs C. To evaluate how the genomes of infectious agents impact the efficacy of certain antibiotics D. To evaluate how different racial and ethnic groups respond to certain drugs or classes of drugs - Correct Answer: B. To evaluate the association between individual genotypes and the safety and efficacy of a particular drug or class of drugs Under which of the following conditions is it appropriate to re-contact the individuals who provided biological specimens? A. Original signed consent documents include provisions for recontacting subjects B. Biological specimens need to be replenished C. Discovery of related clinical information requires contacting subjects for follow-up D. Subjects received financial compensation for participation in the study - Correct Answer: A. Original signed consent documents include provisions for recontacting subjects When conducting research that involves collecting biological specimens for genetic testing, which of the following issues is the most important for the IRB to consider? A. Need for publication of results B. Ownership of biological specimens C. Effects of findings on other family members D. Long term financial impact of results - Correct Answer: C. Effects of findings on other family members Identify which types of discrimination the Genetic Information Non-Discrimination Act (GINA) protects individuals from: A. Health insurance and employment discrimination B. Disability insurance and mortgage insurance C. Gender discrimination D. Long-term care insurance and religious discrimination - Correct Answer: A. Health insurance and employment discrimination The purpose of a federally supported research study is to examine the effect of scheduled cell searches on gang violence among men confined to drug treatment facilities under court order. Which of the following best describes the IRB's duties when reviewing this research? A. Because this research does not involve individual subjects who would be considered prisoners, the IRB does not have any additional duties B. Because this research involves individual subjects who would be considered prisoners and examines the possible causes, effects, and processes of incarceration, the IRB should ensure that the additional requirements for prisoner research are met C. Since this research is federally supported, the IRB does not have any duty to review this research D. Even though this research involves individual subjects who would be considered prisoners and examines an alternative to incarceration, the IRB does not have any ad - Correct Answer: B. Because this research involves individual subjects who would be considered prisoners and examines the possible causes, effects, and processes of incarceration, the IRB should ensure that the additional requirements for prisoner research are met When reviewing federally supported research involving prisoners, an IRB must have which of the following, in addition to the standard requirements for IRBs to ensure that the prisoners' perspective is represented: A. Two members who are currently prison guards, wardens or parole officers B. One member who is a health care provider at the local hospital where prisoner may be treated C. Two members who are employed by the federal penal system weeks pregnant and randomize them to either receive the intervention or placebo until delivery. The IRB determines this intervention presents greater than minimal risk to the pregnant women subjects, and potential direct benefit to both mother and fetus. Is this research permitted under Subpart B? A. Yes - this research is permitted. B. No - this research is not permitted with pregnant women. C. Yes- This research is permitted if because it may benefit the fetuses. D. No - this research is not permitted because it involves fetuses. - Correct Answer: A. Yes - this research is permitted. According to 1994 NIH Guidelines, which of the following is adequate justification for exclusion of women from NIH-funded research? A. There is compelling evidence that inclusion would be inappropriate with respect to the health of the subjects. B. Inclusion of women would complicate analysis of the results and increase the costs of conducting the clinical trial. C. The woman is of child-bearing potential. - Correct Answer: A. There is compelling evidence that inclusion would be inappropriate with respect to the health of the subjects. A research study wants to determine the effectiveness of two prenatal care group programs as compared to individual prenatal care in reducing the risk for HIV in young women during and after pregnancy. The IRB determines the research is no greater than minimal risk for the pregnant women and the fetuses. Is this research permitted under Subpart B? A. No - this research is not permitted because it involves fetuses. B. Yes - this research is permitted. C. This research is only permitted if it also presents a direct benefit to the mother and the fetus. D. No - this research is not permitted with pregnant women. - Correct Answer: Yes - this research is permitted. A researcher wants to collect data about fetuses that were exposed to high levels of lead during their mother's pregnancy. The researcher plans to review the medical records for a control group (not known to be exposed to high levels of lead) and an experimental group (exposed to high levels of lead) of fetuses from 12 weeks of gestation through delivery. Is this research permitted under Subpart B? A. No - research with vulnerable populations is not permitted under the federal regulations B. Yes - this research with fetuses is permitted because it holds the direct benefit to the mother C. No - the researcher cannot collect data once the fetus is born under Subpart B D. Yes - research with neonates of uncertain viability may be involved because there is no additional risk - Correct Answer: D. Yes - research with neonates of uncertain viability may be involved because there is no additional risk Pregnant women, fetuses, and neonates are often considered vulnerable categories of subjects. Additional protections are provided through regulation, however, the protections are meant to be inclusive and not exclusive of pregnant women in research. TRUE FALSE - Correct Answer: TRUE Can research subject to Subpart B and that includes pregnant women as subjects be exempt from the regulations, per 45 CFR 46, if all of the conditions of the exemption are met? A. No, research with pregnant women can never be exempt per 45 CFR 46.104. B. Yes, but only for certain exempt categories per 45 CFR 46.104. C. Yes, if there are limits on the blood draw amounts included in the research. D. Yes, each of the exemptions in 45 CFR 46.104 may be applied to research subject to Subpart B. - Correct Answer: D. Yes, each of the exemptions in 45 CFR 46.104 may be applied to research subject to Subpart B. A research study will compare a new combined behavioral and pharmacologic treatment with the standard behavioral treatment alone for individuals with severe seasonal affected disorder (SAD). The researcher wants to include pregnant women in the study. However, the pharmacologic treatment has not been previously studied in non-pregnant women, nor have preclinical studies on pregnant animals been conducted. Is this research permitted under Subpart B? A. Yes- This research is permitted if because it may benefit the pregnant women. B. No - this research is not permitted because it involves fetuses. C. No - this research is not permitted with pregnant women. D. Yes - this research is permitted. - Correct Answer: C. No - this research is not permitted with pregnant women. A research study aims to evaluate a new experimental type of fetoscopic laser surgery to correct a potentially life-threatening condition for the fetus prior to delivery. This research is to meet the health needs and directly benefit the fetus only. The pregnant woman is otherwise healthy. Per Subpart B, the investigator must obtain consent from whom? A. The father of the fetus only. B. The pregnant woman and the father of the fetus (except if he is unable to consent because of unavailability, incompetence, or temporary incapacity or the pregnancy resulted from rape or incest). C. The pregnant woman only. D. The state court where the research is taking place - Correct Answer: B. The pregnant woman and the father of the fetus (except if he is unable to consent because of unavailability, incompetence, or temporary incapacity or the pregnancy resulted from rape or incest). A sponsor proposes research to evaluate reengineering a commercially available pacemaker. It is hoped that the new pacemaker will pose fewer risks to individuals when compared to the current commercially available product. How should this device be classified? A. Significant risk device B. Non-significant risk device - Correct Answer: A. Significant risk device An adult with attention deficit hyperactivity disorder (ADHD) presents to a physician. To date, no behavioral or drug interventions have proven useful. The physician has just read several reports about a drug that is approved and marketed for another indication, but has shown some benefit for ADHD. The physician wants to prescribe this drug, in the labeled marketed dose, for the individual patient. Which of the following would be the most appropriate course of action? A. Treat the patient with the drug based on physician's best medical judgment B. Submit an Investigational New Drug (IND) application before treating the subject C. Submit a research protocol for IRB review and approval before treating the patient D. Inform the patient that the drug cannot be prescribed - Correct Answer: A. Treat the patient with the drug based on physician's best medical judgment An investigator proposes to study a marketed product sold to treat high blood pressure in individuals over age 12 using a liquid formulation for children under age 12. The drug sponsor hopes that the information from the research can be used to change the labeling for use of the drug in younger children. Which of the following is the investigator's most appropriate course of action? A. Submit an Investigational Device Exemption (IDE) application to the FDA B. Submit the research protocol to the IRB for review and submit an IND application to the FDA before conducting the research B. Individuals with Impaired Decision-Making Capacity C. Workers D. Prisoners - Correct Answer: C. Workers When workers are asked to participate in a research study, vulnerabilities related to the subject's employment may include: A. The employer may encourage or deny participation of workers. B. Employees may experience pressure from management to participate in the study because the employer perceives the study to be advantageous to the organization. C. Unions may encourage employees to participate with the expectation that "entitlements" may follow from study results. D. The research study's finding could affect an employee's pay, benefits, or promotion potential. E. All of the above - Correct Answer: E. All of the above Researcher access to confidential records adds to the vulnerability of workers who participate in workplace studies. Inappropriate release of identifiable private information could adversely affect a worker's retention of a job, insurance, or other employment related benefits. To avoid or minimize these risks, the study design must include adequate safeguards to protect the confidentiality of the information collected. A plan for the proper management of study data and records should clearly define: A. If the study results, if any, will be included in the employee's personnel records. B. If personal identifiers will be retained and used in the data analysis. C. How the data will be collected and secured. D. Who will have access to the data. E. All of the above - Correct Answer: E. All of the above When a research project includes the collection of biological samples, all planned future uses of the samples, identifiers, and the data obtained from the samples, must be fully explained to the research subject. A. True B. False - Correct Answer: A. True A study requires that each subject be given two study drugs. The first study drug is given on Day 1. A second study drug is given on Day 7 to counteract the toxicity of Drug 1. Subject # 4-706 is given Drug 1 on Day 1. Due to a snowstorm, Subject 4-706 is delayed for several days before returning to the site for Drug 2. Missing the administration of Drug 2 on Day 7 placed the subject at risk of significant toxicity. This event required the subject be notified of the increased risk and required close monitoring of the subject by phone. A. This is not an unanticipated problem because adverse weather is a possibility in the area where the site is located. B. This is not an unanticipated problem because the subject was required to return on Day 7. C. This is an unanticipated problem that does not include an adverse event. D. This is an adverse event, which does not require notification to the IRB. - Correct Answer: C. This is an unanticipated problem that does not include an adverse event. Housekeeping employees of the medical center were recruited for a federally funded study of blood pressure, blood count levels, infectious disease history, and job stress. The interviews and blood tests were conducted in a private location not affiliated with the study center. Follow-up interviews were conducted in the same location. The study coordinator stopped at the cafeteria on her way back to the study office after the second study visit for the last three study subjects and lost the three file folders. Records of one subject indicated he had a history of a sexually transmitted disease and another had recently been treated for tuberculosis. The subjects were notified of the loss. Following this event, the IRB approved a protocol change requiring that all records be transmitted electronically to the study office using the medical center's secure network. A. This is not an unanticipated problem because employees' - Correct Answer: C. This is an unanticipated problem and not an adverse event. A Data Safety Monitoring Board report for an investigator-initiated investigational drug study indicates a significantly higher than anticipated rate of an expected adverse event. This event required revision of the informed consent form to disclose the higher rate. A change in the eligibility criteria of the protocol to reduce the risk was implemented. Current subjects would be reconsented. A. This is not an unanticipated problem because the adverse event was acknowledged in the consent form. B. This is an unanticipated problem. C. Current subjects should never be reconsented. D. This study was an investigator-initiated study. There is no need to report to the IRB or any federal agency. - Correct Answer: B. This is an unanticipated problem. A subject received the wrong study drug resulting in severe nausea and vomiting, and a visit to the emergency room for treatment. The subject notified the study coordinator the day after the emergency room visit. The study coordinator reviewed the subject's study records and discovered the error. The coordinator notified the subject of the study drug error, which caused the nausea and vomiting. The investigator notified the IRB and the IRB approved a revision of the standard pharmacy procedure for administering investigational drugs. A. This is an adverse event that was anticipated because there is always a possibility of a pharmaceutical mistake. B. This is an unanticipated problem, which resulted in an adverse event. C. The subject should have contacted the study site for authorization before going to the emergency room. D. The IRB does not have authorization to require changes in the pharmacy procedures. - Correct Answer: B. This is an unanticipated problem, which resulted in an adverse event. An investigational biologic administered to the first two subjects in a Phase II clinical trial was not appropriately screened for two viral contaminants, HIV and Hepatitis B, due to human error in the screening process. Follow-up testing indicated that the subjects and their partners were not infected. The subjects and others were notified of the increased risk. A. There was no need to inform the IRB because this was a screening procedure. B. This is an adverse event, which is also an unanticipated problem. C. This is an unanticipated problem requiring notification to the IRB and FDA. D. This is neither an unanticipated problem, nor an adverse event. - Correct Answer: C. This is an unanticipated problem requiring notification to the IRB and FDA. The peer review process can create conflicts of interest because the choice of who reviews a potentially publishable project may show: A. There may be bias by the peer reviewer as to the area of research B. They are not informed of the area of work C. The project has a limited scope D. Their connections to the journal may yield some concern - Correct Answer: A. There may be bias by the peer reviewer as to the area of research The FDA regulations governing disclosure of individual COIs require: A. Sponsors to annually disclose to the FDA financial COIs of researchers who conducted clinical studies A clinician may use a HUD without IRB approval: A. In a clinical investigation to collect data on an HDE approved indication. B. For compassionate use where no alternative device is available for a patient's condition. C. If the clinician determines that approval from an IRB cannot be obtained in time to prevent serious harm or death to a patient. D. For clinical use only. - Correct Answer: C. If the clinician determines that approval from an IRB cannot be obtained in time to prevent serious harm or death to a patient. A Humanitarian Use Device (HUD) is a medical device: A. Used to treat or diagnose a very common serious disease or condition where the likelihood of death is high unless the device is used B. Used to treat or diagnose a common disease or condition in individuals who do not qualify for participation in a clinical trial. C. Used to treat or diagnose a disease or condition that affects not more than 8,000 individuals in the U.S. annually. D. That is proven to be safe and effective and is provided at no cost for qualifying patients. - Correct Answer: C. Used to treat or diagnose a disease or condition that affects not more than 8,000 individuals in the U.S. annually. Which of the following statements is true regarding IRB approval of clinical use of a HUD in a healthcare facility? A. After initial approval, the FDA allows an IRB to determine if it will require ongoing continuing review. B. Since a HUD is a marketed device, the regulations prohibit an IRB from imposing restrictions on clinical use of a HUD. C. Since a HUD is a marketed device, the regulations do not require IRB approval for clinical use. D. The clinician obtains initial IRB approval and ensures continuing review approval by the IRB. - Correct Answer: D. The clinician obtains initial IRB approval and ensures continuing review approval by the IRB. FDA approval of a Humanitarian Device Exemption (HDE) is based on all of the following criteria EXCEPT: A. No comparable marketed device is available to treat or diagnose the disease or condition. B. Assurance of safety and effectiveness. C. The manufacturer could not otherwise bring the device to market. D. Probable benefit to health outweighs the risk. - Correct Answer: B. Assurance of safety and effectiveness. The two-step process of obtaining an FDA marketing approval for a HUD includes: A. Obtaining a HUD designation then submitting a Humanitarian Device Exemption (HDE) to the FDA. B. Submitting a pre-market approval (PMA) to FDA then obtaining a HUD designation. C. Obtaining a HUD designation then submitting a pre-market approval (PMA) to the FDA. D. Obtaining a HUD designation then submitting HUD use to an IRB. - Correct Answer: A. Obtaining a HUD designation then submitting a Humanitarian Device Exemption (HDE) to the FDA. Although not required by regulation, which of the following actions does FDA guidance recommend for clinical use of a HUD outside of its approved indication(s)? A. Request that the HDE holder submit an HDE supplement to obtain FDA approval of use outside of the approved indication(s). B. Restrict use outside of approved indication(s) for situations that meet emergency use criteria. C. Obtain informed consent from the patient and ensure that reasonable patient protection measures are followed. D. Limit use outside of approved indication(s) as these uses count towards the FDA-assigned number of devices allowed to be shipped or sold in a year. - Correct Answer: C. Obtain informed consent from the patient and ensure that reasonable patient protection measures are followed. Which of the following most accurately describes the responsibilities of a trainee in the mentoring relationship? A. The trainee must take the lead in all aspects of the relationship. B. The trainee's primary role is to avoid seeking the mentor's advice in order to grow as a researcher. C. The trainee must take an active role in the relationship and clearly communicate needs and expectations. D. A trainee is too junior to have any responsibilities in the mentoring relationship. - Correct Answer: C. The trainee must take an active role in the relationship and clearly communicate needs and expectations. Which of the following is most likely to create a poor relationship between a mentor and a trainee? A. The mentor has experience and interest in the trainee's field of study. B. The trainee has an interest in learning more about the mentor's field of study. C. A mentor who recruits trainees merely for the mentor's own career advancement. D. The relationship includes clear discussions about each person's expectations. - Correct Answer: C. A mentor who recruits trainees merely for the mentor's own career advancement. Which of the following statements best exemplifies the importance of mentoring? A. The primary way for senior researchers to recruit a trainee to complete projects for them. B. A mechanism to get additional grant support. C. A narrowing of the circle of influence and learning. D. A mechanism to transmit values and standards of professional conduct. - Correct Answer: D. A mechanism to transmit values and standards of professional conduct. Which of the following most accurately describes good mentoring practice? A. Avoiding being a mentor unless one works in the same research field as a trainee. B. Informing trainees that they must rely on their adviser for all mentoring. C. Encouraging trainees to receive mentoring from a collection of individuals. D. Informing trainees that faculty are the only individuals who have enough experience to serve as mentors. - Correct Answer: C. Encouraging trainees to receive mentoring from a collection of individuals. What is the most appropriate course of action for a trainee who has a problem with a mentor? A. The trainee should assume that a special committee will be created to handle the circumstance. B. Provide a "gift authorship" to the mentor on the trainee's first publication. C. After trying to communicate directly with the mentor, the trainee should seek advice from a senior person that the trainee trusts. D. The trainee should rely on others to solve the problem and not get involved. - Correct Answer: C. After trying to communicate directly with the mentor, the trainee should seek advice from a senior person that the trainee trusts. The defining characteristic of a mentor is someone who: A. Advises a trainee on which academic courses to take. C. To assess whether the research team has completed data management training. D. To determine if authorship credit has been correctly specified. - Correct Answer: A. To determine compliance with regulatory requirements, including those relating to protecting research subjects. What are the three main goals of data lifecycle management (DLM)? A. Technology, sharing, and disposal B. Ownership, propriety, and control C. Confidentiality, availability, and integrity D. Secrecy, privacy, and disposal - Correct Answer: C. Confidentiality, availability, and integrity Which of the following is true regarding the reporting of research results? A. Details of data selection procedures should be omitted from publications unless requested. B. Details of study design and execution should be omitted from publications unless requested. C. Clear specification of the methods and procedures used is essential. D. A delay in reporting research results is not allowed by the U.S. government. - Correct Answer: C. Clear specification of the methods and procedures used is essential. In the research context, the term validity most commonly refers to: A. Whether operationalized terms actually measure what they purport to measure. B. Whether a project is worth pursuing. C. Whether a project has been approved by an oversight board. D. Whether funding has been obtained for the project. - Correct Answer: A. Whether operationalized terms actually measure what they purport to measure. Which of the following most accurately describes data lifecycle management (DLM)? A. It refers to the tools and processes for handling data during a research study and after it concludes. B. It refers to the obligation to uphold data confidentiality imposed by federal law. C. It refers to the obligation to share data imposed by professional journals. D. It refers to the data collection requirements of a particular organization. - Correct Answer: A. It refers to the tools and processes for handling data during a research study and after it concludes. Which of the following statements is true regarding authorship practices? A. In scientific fields, authors have to be listed in order of seniority. B. Journals do not permit a graduate student to be listed as the first author. C. Both within and between disciplines, practices differ with regard to who should be included as an author, and in what order they should be listed. D. In scientific fields, authors must be listed in alphabetical order. - Correct Answer: C. Both within and between disciplines, practices differ with regard to who should be included as an author, and in what order they should be listed. Which of the following statements is true regarding the International Committee of Medical Journal Editors (ICMJE) guidelines? A. The first author is the only person who is held publicly responsible for the contents of the paper. B. Individuals who do not meet the criteria for authorship but who have made a noteworthy contribution are normally listed in the acknowledgments section. C. Acquiring funding for a research project is sufficient to warrant authorship. D. Conducting the technical aspects of the research is sufficient to warrant authorship. - Correct Answer: B. Individuals who do not meet the criteria for authorship but who have made a noteworthy Which of the following most accurately describes the practice of ghost authorship? A. It is a situation where someone provides constructive comments on a manuscript before it is submitted. B. It is a situation where a high-profile researcher is added as an author to improve the chance of publishing a manuscript. C. It is a situation where the individual who wrote the manuscript is not listed as an author. D. It is a situation where someone does not publish all of the data that have been collected. - Correct Answer: C. It is a situation where the individual who wrote the manuscript is not listed as an author. Which of the following is true regarding an acknowledgments section? A. Journals typically request that the person who provides financial support for the research be listed as an author instead of being listed in the acknowledgments section. B. An acknowledgments section is necessary for disclosing if research is supported by federal funds, but the section is not necessary if a corporate sponsor supports research. C. The contributions of technicians and other researchers are often listed in the acknowledgments section if they do not meet all of the criteria for authorship. D. It is the norm that individuals should not be asked whether they want to be listed in the acknowledgments section. - Correct Answer: C. The contributions of technicians and other researchers are often listed in the acknowledgments section if they do not meet all of the criteria for authorship. Which of the following is a responsibility of each author? A. Corresponding with the journal editor. B. Directly observing data collection. C. Performing the data analysis. D. Confirming that data have been accurately presented in the paper. - Correct Answer: D. Confirming that data have been accurately presented in the paper. Which of the following statements is true regarding the responsibilities of a reviewer? A. A reviewer's expertise should be in a different field than that of the manuscript so the work can be evaluated from the perspective of a neutral reader. B. A reviewer's conflict of interest should be disclosed to the journal editor or grant agency. C. A professor can have a student complete the review without notifying the journal. D. A reviewer should evaluate a competitor's manuscript more critically than other manuscripts. - Correct Answer: B. A reviewer's conflict of interest should be disclosed to the journal editor or grant agency. Which of the following statements is true regarding the responsibilities of reviewers? A. Reviewers should be an advocate for the author and to help convince the editor to publish the manuscript. B. Reviewers are not supposed to turn down opportunities to review manuscripts even if they lack the relevant expertise. C. Reviewers should identify the positive and negative aspects of a manuscript, and indicate where improvements are needed. D. Reviewers can make use of the information in a manuscript before it is published, giving them an advantage over competitors. - Correct Answer: C. Reviewers should identify the positive and negative aspects of a manuscript, and indicate where improvements are needed. Which of the following statements is true regarding the regulations that govern research? A. International research collaborations involving U.S. funded researchers are not governed by U.S. regulations when the work takes place at a private university. B. U.S. funded research collaborations are often governed by U.S. regulations no matter where the research takes place. C. International research is governed by the United Nations instead of any specific country's regulations. D. The research of an international graduate student enrolled at a U.S. university is not governed by U.S. regulations unless the student plans to publish the results. - Correct Answer: B. U.S. funded research collaborations are often governed by U.S. regulations no matter The most important factor in determining whether a research collaboration will be successful is: A. Whether each research team member was trained in the same research methods. B. Whether each research team member has an equal share of resources. C. Whether there is ongoing communication among the team members about their goals and responsibilities. D. Whether the research team has access an effective Technology Transfer Office. - Correct Answer: C. Whether there is ongoing communication among the team members about their goals and responsibilities. Which of the following is true regarding academic-industry collaborations? A. Federal law does not permit an academic institution to own anything that is produced from the collaboration. B. Conflicts of interest are not common in these collaborations. C. They cannot happen because of the Bayh-Dole Act of 1980. D. The industry sponsor typically owns the data from research that it funds. - Correct Answer: D. The industry sponsor typically owns the data from research that it funds. What is the main function of a Technology Transfer Office with respect to collaborative research? A. It arranges movers to pack and ship equipment to a researcher's new facilities. B. It helps collaborative researchers to commercialize their work. C. It sets up new e-mail accounts. D. It arranges the purchase and delivery of new computer hardware for research teams. - Correct Answer: B. It helps collaborative researchers to commercialize their work. A research collaboration can be enhanced by: A. Discussing intellectual property issues while the collaboration is forming. B. Limiting the communication between researchers and industry partners. C. Waiting to discuss authorship issues until after data collection. D. Avoiding the issue of which journal to target since research team members might disagree. - Correct Answer: A. Discussing intellectual property issues while the collaboration is forming. Which of the following is true regarding industry-sponsored research? A. Industry sponsors of research may seek to place restrictions on the disclosure of research results. B. Industry sponsors are not permitted to review data from academic projects that they sponsor. C. Industry sponsors must give ownership of the data to the research team. D. The research must take place within the industry's facilities and not at a university. - Correct Answer: A. Industry sponsors of research may seek to place restrictions on the disclosure of research results. What is the most appropriate process for research collaborators to use in determining which journal they should submit their work to? A. The research team should discuss the issue early on and while the project is ongoing. B. Submit the work to several journals that represent the interests of all the authors. C. Obtain advice from the Technology Transfer Office. D. It is appropriate to submit the work to any peer reviewed journal. - Correct Answer: A. The research team should discuss the issue early on and while the project is ongoing. In any collaboration, data ownership is typically determined by: A. The individual who does the most work on the project. B. The relevant department chairs. C. The research team with access to the best lawyers. D. The type and source of funds used to support the project. - Correct Answer: D. The type and source of funds used to support the project. The three ethical principles discussed in the Belmont Report are: A. IRB review, Federal Regulations, Declaration of Helsinki B. Respect for Persons, Beneficence, Justice C. Informed Consent, Institutional Assurance, Researcher Responsibility D. Privacy, Confidentiality, Equitable Selection of Subjects - Correct Answer: B. Respect for Persons, Beneficence, Justice Which statement most accurately describes the process leading to the development of the Nuremberg Code: A. It was created by the federal government in response to poor research practices in U.S. hospitals. B. It was created in response to the harms caused by Nazi researchers around the time of the Second World War. C. It was created to resolve the issue of whether testing the reactions of pilots constitutes human subjects research. D. It was created in response to complexities emerging from research conducted by pharmaceutical companies. - Correct Answer: B. It was created in response to the harms caused by Nazi researchers around the time of the Second World War. Which statement best describes what an IRB is responsible for reviewing? A. Any research that receives federal funds B. Research involving a human subject C. Biomedical research D. Psychological research - Correct Answer: B. Research involving a human subject Which of the following most directly contributed to the establishment of the National Research Act and the creation of the Belmont Report? A. Stem cell research B. The Human Genome Project C. The Tuskegee Study D. Crash test research - Correct Answer: C. The Tuskegee Study