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CITI TRAINING EXAM Practice Questions with 100%
Correct Answers.
- An example of an institutional COI is: - Correct answer an industry sponsor pays for the construction of a new research laboratory at the organization
- The peer review process can create conflicts of interest because the choice of who reviews a potentially publishable project may show: - Correct answer there may be bias by the peer reviewer as to the area of research
- During an Institutional Review Board (IRB) meeting, any IRB member who may have a potential COI with a study under review should: - Correct answer disclose their potential COI and may answer questions, but recuse themselves from voting
- A researcher's membership on an advisory board with an organization sponsoring research can create a COI because: - Correct answer it may be difficult for the researcher to appear neutral, as the researcher may have an interest in the research's success
- The FDA regulations governing disclosure of individual cOIs require: - Correct answer Applicants submitting marketing applications to disclose financial cOIs of researchers who conducted clinical studies
- An example of an individual financial COI is: - Correct answer a researcher's spouse holds equity in a publicly traded pharmaceutical company that is also the sponsor of the researcher's study.
- A researcher calls you stating that he plans to submit a proposal to the NIH for a human subject’s research study. He wants to know at what point he and his study team must submit COI disclosures to comply with the PHS regulation. - Correct answer No later than the time of proposal submission
- For clinical trials, what should be reported to the Office for Clinical Research (OCR) to confirm ClinicalTrials.gov registration and for the purpose of ensuring Medicare reimbursement? - Correct answer NCT number
- The Sunshine Act requires manufacturers to report "payments of transfers of value" for how much annually? - Correct answer $10. 10)Which department reviews a sample of clinical trials being conducted in each department and provides education, tools, and corrective and preventative
action plans, when needed? - Correct answer Clinical Trials Audit and Compliance 11)Getting your proposal prepared for review and approval can be cumbersome. Which department in the Office of Research Administration assists with proposal preparation? - Correct answer Research Administration Services (RAS) 12)Which best matches the NIH definition of a clinical trial? - Correct answer a research study in which one or more humans subjects are assigned to evaluate the effects of those interventions involving health-related biomedical and behavioral outcomes. 13)Adjudication of research participant's bills allows which department to direct charges to the correct payer? - Correct answer Clinical Trials Billing Department (CTBD) 14)To facilitate Pre-award submissions and their approval, the study team should submit to the Institutional Review Board (IRB) at the same time they are submitting to OCR, and OSP/OTT. - Correct answer True 15)Non-licensed clinicians can dispense and educate subjects about their medication. - Correct answer False 16)Which system provides the status of a clinical trial agreement (CTA)? - Correct answer Emory Contracts Tracking System (sects) 17)If the FDA schedules an appointment to inspect your studies, which department at Emory should you contact first in preparation for the FDA visit?
- Correct answer Office of Compliance 18)How often should research administrators or PIs initiate a routine "New Proposal Financial Interest in Research Report" for each project in echoic? - Correct answer annually 19)The Prospective Reimbursement Analysis (PRA) and a Medicare Coverage Analysis (MCA) are used interchangeably. At Emory, the purpose of the PRA is to assist with research billing compliance, which is - Correct answer billing the appropriate party (i.e. Medicare, Insurance, or a grant) for subjects involved in a research study. 20)When patients receive a copy of an organization's privacy notice, why are they asked to sign an acknowledgment? - Correct answer it shows they received it.
21)HIPAA's "incidental uses and disclosures" provision excuses deviations from the minimum necessary standard. What is excused? - Correct answer truly accidental "excess" uses and disclosures, where reasonable caution was otherwise used and there was no negligence. 22)What kinds of persons and organizations are affected by HIPAA's requirements? - Correct answer Healthcare providers, health plans, and health information clearinghouses, as well as their business associates and by extension the workers for those organizations. 23)With respect to permissions for uses and disclosures, HIPAA divides health information into three categories. Into which category does information related to research, marketing, and fundraising go? - Correct answer Uses or disclosures that generally require specific written authorization. 24)HIPAA privacy protections cover identifiable personal information about the "past, present or future physical or mental health condition." What does that include? - Correct answer Health information in any form or medium, as long as it is identified (or identifiable) as a particular person's information. 25)Which of the following statements is true regarding the International Committee of Medical Journal Editors (ICMJE) guidelines? - Correct answer Individuals who do not meet the criteria for authorship but who have made a noteworthy contribution are normally listed in the acknowledgments section. 26)Which author is normally responsible for sharing reprints of a publication with readers? - Correct answer the corresponding author. 27)Which of the following is true regarding an acknowledgments section? - Correct answer 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. 28)Which of the following most accurately describes the practice of ghost authorship? - Correct answer it is a situation where the individual who wrote the manuscript is not listed as an author. 29)Which of the following statements is true regarding authorship practices? - Correct answer Different disciplines have different practices about who should be included as an author.
30)What is the main function of the Bayh-Dole Act of 1980 as it relates to academic institutions? - Correct answer it allows institutions to have control over the intellectual property from federally-funded research. 31)The most important factor determining whether a research collaboration will be successful is: - Correct answer whether there is ongoing communication about goals and responsibilities. 32)A research collaboration can be enhanced by: - Correct answer discussing intellectual property issues while the collaboration is forming. 33)What is the most appropriate process for determining which journal a collaborative research team should submit their work to? - Correct answer the research team should discuss the issue early on and while the project is ongoing. 34)Data ownership is typically determined by: - Correct answer the type and source of funds used to support the project. 35)Which of the following most accurately describes a conflict of commitment? - Correct answer it occurs when outside activities interfere with obligations to one's primary employer. 36)The main focus of NIH's conflict of interest policy is: - Correct answer Financial conflicts of interest 37)The entity that normally is supposed to determine whether an academic researcher's conflict of interest can be managed is: - Correct answer A conflict of interest committee 38)Which of the following is true about the management of conflicts of interest? - Correct answer Management plans are often created to reduce the impact of conflicts of interest. 39)Which of the following most accurately describes an institutional conflict of interest? - Correct answer it occurs when an institution's financial or non- financial interests could interfere with its research activities. 40)What is the primary responsibility of oversight bodies (such as an IRB or IACUC)? - Correct answer to determine compliance with regulatory requirements, including those relating to protecting research subjects. 41)Which of the following is true regarding data acquisition? - Correct answer Data acquisition should follow a detailed collection plan that is set in advance.
42)In the research context, the term validity most commonly refers to: - Correct answer whether operationalized terms actually measure what they purport to measure. 43)Which of the following is true regarding the reporting of research results? - Correct answer Clear specification of the methods and procedures used is essential. 44)Which of the following is true regarding data analysis? - Correct answer Data analysis methods should usually be specified in advance before a study begins. 45)The best time to prepare for an FDA inspection is: - Correct answer when you are initiating your study 46)The protocol, as approved by the IRB, must be followed even in those cases in which the specified activity would not be performed in a treatment situation except when it is necessary to eliminate an immediate hazard to human subjects. - Correct answer True 47)When a subject signs a consent document, a note in the research record should include: - Correct answer All of the above 48)Which of the following should be part of the FDA inspection process? - Correct answer All of the above 49)Failure to adhere to the protocol and the signed investigator statement/agreement is one of the most common inspection and audit findings. - Correct answer True 50)When an IRB is reviewing a research study and they are considering if a potential subject population is vulnerable, they should consider: - Correct answer is there a power differential between researchers and subjects? 51)A subject participates in a drug study because treatment is available at no or reduced cost, and he could not otherwise afford it. This is an example of: - Correct answer Economic vulnerability 52)Which is true of inducements in research? - Correct answer 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.
53)NBAC proposed a concept of vulnerability in research based on features of potential subjects or of their situation. Which of the following was not included as possibly leading to vulnerability? - Correct answer High potential for individual benefit from participating in research 54)According to the authors, there are four common abuses that historically are described as giving rise to vulnerability. Which response below contains the correct four? - Correct answer Physical control, coercion, undue influence, and manipulation 55)Which of the following was the result of the Beecher article? - Correct answer Realization that ethical abuses are not limited to the Nazi regime 56)The use of prisoners in research is a concern under the Belmont principle of Justice because: - Correct answer Prisoners may be used to conduct research that only benefits the larger society 57)The National Research Act of 1974 - Correct answer established the National Commission. 58)Which of the following is included in the Nuremberg Code: - Correct answer Voluntary consent 59)Issued in 1974, 45 CFR 46 raised to regulatory status - Correct answer US Public Health Service Policy 60)A subject in a clinical research trial experiences a serious, unanticipated adverse drug experience. How should the investigator proceed, with respect to the IRB, after the discovery of the adverse event occurrence? - Correct answer Report the adverse drug experience in a timely manner, in keeping with the IRB's policies and procedures, using the forms or the mechanism provided by the IRB. 61)How long is an investigator required to keep consent documents, IRB correspondence, and research records? - Correct answer for a minimum of three years after completion of the study 62)According to federal regulations, which of the following best describes when expedited review of a new, proposed study may be used by the IRB? - Correct answer the study involves no more than minimal risk and meets one of the allowable categories of expedited review specified in federal regulations
63)Amendments involving changes to IRB-approved protocols do NOT need prior IRB approval if: - Correct answer the changes must be immediately implemented for the health and well-being of the subject. 64)IRB continuing review of a greater than minimal risk approved protocol that is currently enrolling subjects must: - Correct answer Occur at least annually. 65)A 46-year-old man is currently enrolled in a Phase 2 study of a drug for severe diabetic neuropathy. While the study is on-going, a new drug becomes commercially available that may have equal or greater benefit to the subject. The investigator should do which of the following? - Correct answer Give the subject comprehensive information about the new drug, including its side effects. Discuss the pros and cons of both the investigational drug and the commercially available drug and then allow the subject to decide whether to withdraw from the research to take the new drug. 66)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. 67)Which of the following is the most appropriate action to take for the investigator? - Correct answer Send a copy of the informed consent via facsimile to the subject's wife. After she has had the opportunity to speak to the investigator, she can sign the informed consent and fax it back. 68)An investigator is confronted with a life-threatening situation that necessitates using a test article in a human subject who is unable to provide informed consent and there is no time to obtain consent from the individual's LAR and no alternative method or recognized therapy is available. Under the FDA regulations for using test articles, which of the following describes the best course of action for the investigator: - Correct answer the investigator and an independent physician agree that the situation necessitates the use of the test article. An exception or waiver for informed consent can be made under these circumstances. The IRB will be notified later. 69)The purpose of informed consent is: - Correct answer 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. 70)A general requirement for the informed consent form is that it may not include any exculpatory language. Exculpatory language is that which waives or
appears to waive any of the subject's legal rights or releases or appears to release those conducting the research from liability for negligence. Which of the following statements in a consent form is an example of exculpatory language? - Correct answer I waive any possibility of compensation for injuries that I may receive as a result of participation in this research. 71)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? - Correct answer Confidentiality of the individual subject's responses 72)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? - Correct answer Breach of confidentiality from the focus group subjects (therapists) 73)Which of the following most accurately describes the risks associated with SBR? - Correct answer less predictable, more variable, and less treatable than physical harms 74)Which of the following is considered a SBR data collection method? - Correct answer Interviews 75)A researcher wants to conduct a secondary analysis using a Centers for Disease Control and Prevention (CDC) database that was collected by the agency solely for surveillance purposes from 1996-2006. The researcher did not participate in the initial collection of the data. The database is publicly available. The database does not include any identifiers. The IRB makes a determination that the individuals whose records will be reviewed do not meet the federal definition of human subjects. 76)Which of the following considerations was relevant to the IRB's determination that this activity does not constitute research with human subjects? - Correct answer the researcher will not be interacting/intervening with subjects and the data has no identifiers. 77)An investigator obtains consent and HIPAA authorization from subjects to review their medical records and HIV status. 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. His laptop is stolen. This incident constitutes: - Correct answer A breach of confidentiality 78)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. The physician will review the medical records, and write down the clinical indication for the scans, any existing injuries, current prescriptions, as well as other clinical data. The clinical indication for the scans and the other clinical data will be collected in the medical records for treatment purposes as part of standard clinical care. The physician will use a coding system to be able to identify the patient's information; however, the "key" to the coding system will be stored separately from the data in a locked cabinet that only she will have access to. Which of the following is true? - Correct answer the study is human subject research which is eligible for expedited review. 79)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? - Correct answer significant risk device 80)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? - Correct answer Treat the patient with the drug based on physician's best medical judgment 81)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?
- Correct answer submit the research protocol to the IRB for review and submit an IND application to the FDA before conducting the research 82)The FDA's regulations related to electronic records and electronic signatures (21 CFR Part 11) are intended to: - Correct answer Allow the use of electronic documents and signatures in the regulatory process for drugs and devices.
83)An academic medical center is selecting a new database system for clinical research. The system needs to be "Part 11 compliant" in order to allow: - Correct answer the medical center to replace the use of paper records with electronic records for its research. 84)Under HIPAA, "retrospective research" (a.k.a., data mining) on collections of PHI generally ... - Correct answer is research, and so requires either an authorization or meeting one of the criteria for a waiver of authorization. 85)A covered entity may use or disclose PHI without an authorization, or documentation of a waiver or an alteration of authorization, for all of the following EXCEPT: - Correct answer Data that does not cross state lines when disclosed by the covered entity. 86)If you're unsure about the particulars of HIPAA research requirements at your organization or have questions, you can usually consult with: - Correct answer an organizational IRB or Privacy Board, privacy official ("Privacy Officer"), or security official ("Security Officer"), depending on the issue. 87)Recruiting into research ... - Correct answer Can qualify as an activity "preparatory to research," at least for the initial contact, but data should not leave the covered entity. 88)The HIPAA "minimum necessary" standard applies... - Correct answer to all human subjects’ research that uses PHI without an authorization from the data subject. 89)What are the main elements necessary for ensuring that costs are appropriately charged? - Correct answer applying allocable, allowable, consistent, and reasonable costing policies and procedures. 90)Which of the following most accurately describes voluntary committed cost sharing? - Correct answer it means that the cost share is quantified in the proposal but not required by the sponsor. 91)Which of the following most accurately describes the main purpose of the OMB Circulars? - Correct answer they outline the rules for the financial management of sponsored projects. 92)Closeout instructions on a sponsored project are most directly determined by:
- Correct answer the terms and conditions in the agreement with the sponsor.
93)Which of the following most accurately describes allocability? - Correct answer it refers to how direct expenses are calculated based on the benefit to the project. 94)Award documentation is typically required to be prepared and submitted within how long after the end of a project period: - Correct answer 90 days 95)Which of the following most accurately describes a 2 CFR Part 200.425(2) audit? - Correct answer it is an annual audit of an organization that receives over a certain threshold of federal funds each year. 96)What is the term for when a sponsor requests that the organization contribute financial support to a project? - Correct answer Cost Sharing 97)Crystal clear theory refers to the notion that: - Correct answer the financial details of a project should be explained plainly enough so that a non-expert would be able to understand them. 98)Which of the following most accurately describes good mentoring practice? - Correct answer Encouraging trainees to receive mentoring from a collection of individuals. 99)Which of the following statements about mentoring is true? - Correct answer Mentors can provide valuable advice to trainees regarding career decisions and contacts with leaders in their field of research.
- Which of the following statements best exemplifies the importance of mentoring? - Correct answer a mechanism to transmit values and standards of professional conduct.
- Which of the following is most likely to create a poor relationship between a mentor and a trainee? - Correct answer a mentor who recruits trainees merely for the mentor's own career advancement.
- Which of the following statements most accurately describes the mentoring relationship? - Correct answer Mentors teach trainees about aspects of academic life that are not covered in textbooks.
- Reviewers have a responsibility to promote ethical peer review by: - Correct answer preserving the confidentiality of the submission.
- Which of the following statements most accurately describes the review process for grant proposals? - Correct answer Funding agencies usually
have committees, often with external reviewers, that assess the quality of the proposal
- Which of the following is the most appropriate step to take if authors believe that their manuscript was reviewed unfairly? - Correct answer the author can contact the editor with their concerns.
- Which of the following statements is true regarding the responsibilities of a reviewer? - Correct answer 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? - Correct answer Reviewers should identify the positive and negative aspects of a manuscript, and indicate where improvements are needed.
- Which type of research misconduct most likely occurred if someone intentionally removes data points from the data set in order to generate a deceptive conclusion? - Correct answer Falsification
- Which of the following is true regarding the U.S. Federal Research Misconduct Policy? - Correct answer to have a misconduct finding, the action must have been committed intentionally, knowingly, or recklessly.
- According to the U.S. Federal Research Misconduct Policy, fabrication involves: - Correct answer Making up data or results and recording or reporting them.
- Which of the following is true regarding research misconduct? - Correct answer Federal funding agencies typically rely on an institution to make the initial response to an allegation of research misconduct.
- According to U.S. Federal Research Misconduct Policy, which of the following is considered to be research misconduct? - Correct answer Plagiarism
- Which statement best describes information that must be included in a consent form? - Correct answer a description of the research's potential benefits and risks
- Which statement best describes what an IRB is responsible for reviewing? - Correct answer Research involving a human subject
- Which statement best describes the role of an IRB: - Correct answer A committee that reviews different types of human subjects research
- Which of the following most directly contributed to the establishment of the National Research Act and the creation of the Belmont Report? - Correct answer The Tuskegee Study
- Which of following protocols is the one that is most likely to require IRB review? - Correct answer a study to evaluate a newly designed wheelchair by asking elderly individuals to use it.
- Which of the following is the agency that authorizes export licenses: - Correct answer The US Department of State
- The term dual use is normally defined as an item or technology that: - Correct answer has both civilian and military uses
- A publication restriction, such as DFARS 252.204-7000, is most likely to cause which of the following to occur: - Correct answer the project will no longer fall under the Fundamental Research Exclusion (FRE)
- Which of the following is most likely to be a deemed export: - Correct answer the transfer of information to a foreign national in the United States
- Which of the following most accurately describes the function of the Office of Foreign Assets Control (OFAC): - Correct answer it regulates economic and trade sanctions based on foreign policy and national security goals
- The National Security Decision Directive (NSDD) 189 defines: - Correct answer Fundamental Research
- When authors summarize the work of others, they typically should: - Correct answer Provide a condensed (shorter) version of the original material.
- According to federal research misconduct policies, what is the maximum number of consecutive words that one can use before it is classified as an instance of plagiarism? - Correct answer there is no official, federal standard for the number of consecutive words that can be used.
- An idea is most likely to represent "common knowledge" if: - Correct answer it can be safely assumed that the readers and the author are both thoroughly familiar with the idea and its source.
- Proper paraphrasing of a sentence written by someone else may be accomplished by: - Correct answer using your own words and writing voice to express the idea conveyed in the sentence.
- Unless the subject matter is considered common knowledge, citations are necessary when writing about: - Correct answer Ideas, methodologies, or data from other authors and also your own previously published ideas, methodologies, or data.
- How can faculty researchers avoid undue influence of student subjects? - Correct answer Avoid using their own students in their research
- Where could student researchers and/or student subjects find additional resources regarding the IRB approval process? (There may be more than one correct answer. Please be sure to select all correct answers.) - Correct answer Faculty advisor and IRB office
- A student is conducting a research project that involves using a survey. The survey asks subjects about their highest level of education, political affiliation, and views on various social issues. No identifiable information will be collected. This study would be categorized as which type of review? - Correct answer Exempt Review
- What is the Institutional Review Board (IRB) charged with? (There may be more than one correct answer. Please be sure to select all correct answers.) - Correct answer Reviewing subject recruitment materials and strategies.
- Assuring that all applicable institutional policies and federal regulations related to research with human subjects are followed.
- Protecting the rights and welfare of human subjects.
- The history of ethical regulations in human subject’s research began with the - Correct answer Nuremberg Code
- Humphreys collecting data for the Tearoom Trade study under the pretense that he was a lookout is an example of a violation of the principle of:
- Correct answer Respect for persons
- According to the Belmont Report, the moral requirement that there be fair outcomes in the selection of research subjects, expresses the principle of:
- The Belmont principle of beneficence requires that: - Correct answer Potential benefits justify the risks of harm.
- Which of the following studies is linked most directly to the establishment of the National Research Act in 1974 and ultimately to the Belmont Report and federal regulations for human subject protection? - Correct answer The Public Health Service Study of Untreated Syphilis in the Negro Male.
- The researcher's failure to protect research subjects from deductive disclosure is the primary ethical violation in which of the following studies? - Correct answer "Tastes, Ties, and Time (T3)" study (2006-2009)
- According to the federal regulations, which of the following studies meets the definition of research with human subjects? - Correct answer a cognitive psychologist enrolls undergraduate students for a computer-based study about the effect of mood on problem-solving behaviors.
- 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: - Correct answer Obtains, uses, studies, analyzes, or generates identifiable private information.
- A medical record is an example of: - Correct answer Private information
- According to the federal regulations, which of the following studies meets the definition of research with human subjects? - Correct answer an experiment is proposed on the relationship between gender-related stereotypes in math and the subsequent performance by males and females on math tests.
- 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. The researcher submits the research proposal to the institution's IRB. What action can he expect by the IRB? - Correct answer The IRB will not review this study because it is not research as defined by the federal regulations.
- According to the federal regulations, which of the following studies meets the definition of research with human subjects? - Correct answer a developmental psychologist videotapes interactions between groups of
toddlers and their caregivers to determine which intervention methods most effectively manage aggression.
- Census data (the final report as published by the Census Bureau) is an example of: - Correct answer Public information
- According to federal regulations, the expedited review process may be used when the study procedures pose: - Correct answer No more than minimal risk and the research activities fall within regulatory categories identified as eligible.
- Continuing review of an approved and ongoing study posing more than minimal risk that was initially approved by a convened IRB: - Correct answer must occur within 12 months of the approval date.
- In addition to pregnant women, fetuses, and neonates, another subpart of the HHS regulations provides additional protections for which of the following vulnerable populations? - Correct answer Prisoners
- Which of the following statements about the relationship between an institution and the institution's IRB(s) is correct? - Correct answer Officials of the institution may overrule an IRB approval.
- According to the federal regulations, research is eligible for exemption, if: - Correct answer the research falls into one of eight categories of research activity described in the regulations.
- Additional safeguards that may be included in a social and behavioral study may include: - Correct answer Remove all direct identifiers from the data as soon as possible.
- Risk of harm in social and behavioral sciences generally fall in three categories, which are: - Correct answer Invasion of privacy, breach of confidentiality, and study procedures
- Identify the example of when situation and time are key to assessing risk of harm in a research study: - Correct answer Asking women if they have had an abortion
- What statement about risks in social and behavioral sciences research is most accurate: - Correct answer Risks are specific to time, situation, and culture.
- The primary purpose of a Certificate of Confidentiality is to: - Correct answer Protect identifiable research information from compelled disclosure.
- A researcher wishes to study generational differences in coping mechanisms among adults who experienced abuse as children. Adequate measures will be instituted to obtain informed consent and ensure that there is no breach of confidentiality. The most likely additional risk is that some subjects may: - Correct answer Experience emotional or psychological distress.
- A researcher wants to do a web-based survey of college students to collect information about their sexual behavior and drug use. Direct identifiers will not be collected; however, IP addresses may be present in the data set. Risk of harm should be evaluated by: - Correct answer both the magnitude (and severity) and the probability (or likelihood) of harm.
- 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: - Correct answer Obtain a waiver of documentation of informed consent.
- A therapist at a free university clinic treats elementary school children with behavior problems who are referred by a social service agency. 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 statements about parental permission is correct? - Correct answer 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.
- A general requirement for informed consent is that no informed consent may include any exculpatory language. Exculpatory language is that which waives or appears to waive any of the subject's legal rights or releases or appears to release those conducting the research from liability for negligence. Which of the following statements in a consent form is an example of exculpatory language? - Correct answer Taking part in the research is voluntary, but if you choose to take part, you waive the right to legal redress for any research-related injuries.
- A criterion for waiving informed consent is that, when appropriate, subjects are provided additional pertinent information after the study. In which of the following studies would it NOT be appropriate to provide subjects with information about missing elements of consent: - Correct answer 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 waiver of the requirement for documentation of informed consent may be granted when: - Correct answer the only record linking the subject and the research is the consent document and the principal risk is a breach of confidentiality.
- As part of the consent process, the federal regulations require researchers to: - Correct answer Provide potential subjects with information at the appropriate reading comprehension level.
- Data are made anonymous by - Correct answer destroying all identifiers connected to the data.
- When a focus group deals with a potentially sensitive topic, which of the following statements about providing confidentiality to focus group participants is correct? - Correct answer the researcher cannot control what participants repeat about others outside the group.
- A researcher leaves a research file in her car while she attends a concert and her car is stolen. The file contains charts of aggregated numerical data from a research study with human subjects, but no other documents. The consent form said that no identifying information would be retained, and the researcher adhered to that component. Which of the following statements best characterizes what occurred? - Correct answer there was neither a violation of privacy nor a breach of confidentiality.
- In a longitudinal study that will follow children from kindergarten through high school and will collect information about illegal activities, which of the following confidentiality procedures would protect against compelled disclosure of individually identifiable information? - Correct answer securing a Certificate of Confidentiality
- Which of the following constitutes both a breach of confidentiality (the research data have been disclosed, counter to the agreement between researcher and subjects) and a violation of subjects' privacy (the right of the individuals to be protected against intrusion into their personal lives or affairs)? - Correct answer 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.
- A researcher is examining the quality of life for prisoners who are HIV- positive using surveys followed by interview. The IRB must ensure that: - Correct answer Confidentiality of the prisoners' health status is maintained.
- Neither Subpart C (Prisoners) nor Subpart D (Children) applies to juveniles in the correctional systems because wardens of juvenile prisoners (unlike those for adult prisoners) act in loco parentis for juvenile offenders. This statement is false because: - Correct answer both subparts apply, as these individuals are under the legal age of consent and are incarcerated
- A researcher's study uses a dataset of prisoner demographic characteristics. This dataset includes criminal history data that predates incarceration and includes data on disciplinary behavior while in prison. There is no interaction with prisoners. The researcher claims, and the IRB chair agrees, that the study is exempt from IRB review. This decision: - Correct answer is wrong because 46.104 states that research conducted in prisons is not exempt if the subject population is only prisoners.
- Which example of research with prisoners would be allowable under the regulations? - Correct answer examining age at first arrest as a predictor of adult criminal history.
- A researcher wants to contact former prisoners who are now on parole. She wants to study the difficulty of obtaining employment based on whether the subjects had been convicted of felony versus misdemeanor crimes. She needs to: - Correct answer Do nothing in regards the Subpart C because the research does not meet the criteria for prison research -- individuals on parole are not considered prisoners. The definition applies to both minors and adults.
- The provisions of Subpart D, of the HHS regulations, Additional Protections for Children Involved as Subjects in Research apply to: - Correct answer all research funded by HHS
- According to federal regulations, "children" are defined as: - Correct answer 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.
- A researcher wants to observe preschoolers at a local public playground to evaluate levels of cooperation. The researcher will not interact with the children or record information in such a manner that the identity of the subjects can be readily ascertained. Which of the following statements is true? - Correct answer this research would be eligible for exemption because the researcher is not interacting with the children and the playground is a public setting.
- The specific Department of Health and Human Services (HHS) regulations that apply to research with children are known as: - Correct answer Subpart D: Additional Protections for Children Involved as Subjects in Research
- Which of the following statements most accurately describes the requirement for the documentation of minors' assent to participate in research? - Correct answer Federal regulations do not require the documentation of minors' assent.
- According to Subpart D, research with children may be eligible for exemption under Category 2 when: - Correct answer the research involves the use of educational tests
- A study that involves interviews of adults is eligible for expedited review. The researcher wants to add an adolescent population (aged 12 to
- to the study and has designed a parental permission and assent process. No additional changes are planned. Which of the following statements about review of the revised protocol is accurate? - Correct answer unless the nature of the questions would raise the level of risk to more than minimal for adolescents, the research would still qualify for expedited review.
- A researcher asks an IRB to waive the requirement for parental permission for a study conducted in schools because the nature of the research requires participation of all the children present in classrooms on the day the research will take place. 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? - Correct answer the research must pose no more than minimal risk.
- PPRA gives parents some level of control over their child's: - Correct answer Participation in third-party survey research or exposure to instructional materials developed by researchers
- Parental notification, in lieu of active parental permission, is allowed when: - Correct answer An IRB has approved a waiver of the requirement for parental permission.
- The purpose of the Family Educational Rights and Privacy Act (FERPA) is to: - Correct answer Provide parents certain rights over their children's educational records.
- Which of the following types of information may schools disclose without consent from the parent or student to a researcher at a local university? - Correct answer Directory information.
- If research in a private school is directly funded by the Department of Education, then: - Correct answer PPRA applies.
- What are some considerations for a U.S. researcher conducting a study in a non-U.S. setting when obtaining informed consent from subjects? - Correct answer In addition to the consent of the research subjects, are there other individuals or groups whose permission must be sought?
- A professor at Big State University proposes to study attitudes about obesity in Chile by giving subjects in Chile surveys to complete. Which is a question that the Big State University IRB should ask the researcher in order to determine if this study should be reviewed by a local Chilean IRB or ethics committee, as well as the Big State University IRB? - Correct answer Will the researchers have collaborators at the research site abroad?
- The age of majority in international research is determined by the - Correct answer Laws, customs, and norms in the area in which the research will be conducted.
- A researcher proposes to conduct a study at a foreign site. The research has been determined to be exempt from the federal regulations by institutional policy. According to federal regulations, is review required at the foreign site? - Correct answer if a proposed study qualifies for exemption, federal regulations do not require review at the foreign site where it will be conducted.
- A researcher proposes a study and wants to recruit subjects from health care clinics in Jamaica. The survey will be conducted by the U.S. researchers at the clinic. The nurses at the clinic will inform prospective subjects about the availably of the research, but will not consent the subjects nor perform any research procedures (even screening procedures). Are the nurses engaged in the research according to federal regulations? - Correct answer 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.
- Which of the following is the least important activity when protecting human subjects in international research? - Correct answer assessing transportation conditions
- What procedures must be described in an agreement called an "assurance of compliance" with a U.S. federal agency? - Correct answer Procedures in place that ensure that subjects will be protected in a manner commensurate with the Common Rule, including review by an independent committee comparable to an IRB.
- Which of the following activities constitutes engagement in research? - Correct answer obtaining informed consent and conducting research interviews.
- What are some considerations for a U.S. researcher conducting a study in a non-U.S. setting when obtaining informed consent from subjects? - Correct answer In addition to the consent of the research subjects, are there other individuals or groups whose permission must be sought?
- Consent to participate in research is an ongoing process. Which of the following strategies would help ensure that participation in a survey about a sensitive personal topic remains voluntary throughout a study? - Correct answer designing the survey so that subjects are not forced to answer one question before going to the next.
- Which of the following on-line research strategies raises the most concerns regarding the ethical principle of respecting the autonomy of research subjects and the corresponding federal regulations requiring informed consent? - Correct answer a researcher proposes to join a moderated support group for cancer survivors posing as a survivor. She plans to insert comments to see how the members respond.
- The internet can be used as a research tool or as the object of a study. Which of the following examples best describes an investigator using the internet as a research tool? - Correct answer an investigator uses his Facebook wall to post a URL link to a survey he is hosting on Survey Monkey.
- To minimize potential risks of harm, a researcher conducting an on-line survey can: - Correct answer Design the survey so that no direct or indirect identifiers are collected.
- Researchers endeavoring to conduct an on-line study should consider that there are some potential risks of harm to subjects unique to internet- based research. One of these risks is: - Correct answer Individuals may post private identifiable information about themselves on-line without intending it to be public and available to researchers.
- Vulnerable persons are those who are less able to protect themselves than other persons in a given situation. The Common Rule (45 CFR 46, Subpart A) has specific requirements for the following vulnerable populations, except: - Correct answer workers
- The common rule applies to: Prisoners, Individuals with Impaired Decision-Making Capacity and Children
- When workers are asked to participate in a research study, vulnerabilities related to the subject's employment may include: - Correct answer the research study's finding could affect an employee's pay, benefits, or promotion potential.
- Unions may encourage employees to participate with the expectation that "entitlements" may follow from study results.
- Employees may experience pressure from management to participate in the study because the employer perceives the study to be advantageous to the organization.
- The employer may encourage or deny participation of workers.
- 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: - Correct answer how the data will be collected and secured.
- If the study results, if any, will be included in the employee's personnel records.
- Who will have access to the data?
- If personal identifiers will be retained and used in the data analysis.
- 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. - Correct answer true
- Development of most new drugs, from discovery to marketing approval, usually takes: - Correct answer 9 years or more
- 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. The primary efficacy measure was the reduction in severity of the migraine attacks. Enrollment was twelve-hundred (1200) subjects. Which of the following best describes the clinical phase of this study? - Correct answer Phase III
- Long-term toxicology of an experimental drug in animals most likely refers to which part of drug development? - Correct answer Preclinical
- Pharmacokinetics and pharmacodynamics of a new formulation of an investigational drug most likely refers to which clinical phase of a study in humans? - Correct answer Phase I
- For a Phase I knew drug study in humans, what is the primary source of the data included in the initial Investigator's Brochure? - Correct answer Preclinical data
- A primary purpose of the ICH is to: - Correct answer Minimize the need for redundant research.
- The ICH GCP guidelines: - Correct answer Set standards for the design, conduct, monitoring and reporting of clinical research.
- ICH E6 describes standards that apply to: - Correct answer Investigators, sponsors, and IRBs
- In the United States, following the ICH E6 guideline is: - Correct answer Voluntary for FDA-regulated drug studies.
- ICH E6 has broader requirements than FDA or HHS concerning confidentiality of medical records and access by third parties. If investigators are complying with ICH E6 guideline, they must: - Correct answer 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
- The new ICH E6 (R2) integrated addendum requires sponsors to implement systems to manage quality throughout all stages of the trial process. The system should use a risk-based approach including which of the
following? - Correct answer Identification of study risks to determine which may safely be omitted from continual monitoring.
- In terms of explaining the probability of assignment to trial arms in consent forms, which is true? - Correct answer ICH notes that it should be included, but does not specify how the information should be presented.
- Regarding subject receipt of a signed and dated copy of the consent forms, which is true about FDA regulations? - Correct answer The FDA regulations allow subjects or the legally acceptable representatives (LARs) to receive either a signed or unsigned copy.
- What is the status of ICH in U.S.? - Correct answer it is a FDA guidance.
- Which of the following is an acceptable criterion for determining that a study of an approved drug does not require an IND? - Correct answer the study is not intended to be reported to FDA to support a new indication or support a labeling change.
- When the sponsor-investigator holds the IND for an investigational drug he or she is responsible for annual reporting of which one of the following to FDA? - Correct answer IND report
- Who is responsible for making the initial risk determination for a device being used in a study? - Correct answer the sponsor-investigator.
- The investigator must report adverse events to the: - Correct answer Sponsor
- Which of the following is an investigator's commitment to the sponsor?
- Correct answer Submit a new Form FDA 1572 to the sponsor as needed
- Identify which party is responsible for reporting directly to the FDA the investigator's financial interests with the sponsor: - Correct answer the sponsor
- In completing Form FDA 1572, Statement of Investigator, the investigator agrees to - Correct answer Conduct or supervise the investigation personally
- When must the investigator update the IRB about the progress of a trial? - Correct answer during the conduct of the study and at termination