CITI Training, Modules 1-24 (Biomedical Research)

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.

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.

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.

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

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?

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

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

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

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
B. Cognitive or communicative vulnerability
C. Physical vulnerability
D. Economic or social vulnerability

B. Cognitive or communicative vulnerability

The use of prisoners in research is a concern under the Belmont principle of Justice because:
A. Prisoners are less educated that the general population and have difficulty understanding research
B. Prisoners may not be used to conduct research that only benefits the larger society
C. Prisoners are not a representative sample of the general population
D. Prisoners are not free to say no

B. Prisoners may not be used to conduct research that only benefits the larger society

Which of the following is included in the Nuremberg Code:
A. Additional protection for vulnerable subjects
B. Equitable selection of subjects
C. Confidentiality of data
D. Voluntary consent

D. Voluntary consent

Which of the following brought increased public attention to the problems with the IRB system?
A. 1983 Presidential Commission Report
B. HHS Inspector General Report of 1998
C. "Shut Downs" by OHRP
D. Death of Research Subject (Jesse Gelsinger)

D. Death of Research Subject (Jesse Gelsinger)

Informed consent is considered an application of which Belmont principle?
A. Non-maleficence
B. Justice
C. Beneficence
D. Respect for Persons

D. Respect for Persons

The National Research Act of 1974
A. Required that all federal agencies have the same regulations governing human subjects research.
B. Identified guidelines to ensure the ethical conduct of research.
C. Established the National Commission.
D. Identified the basic ethical principles of human subjects research.

C. Established the National Commission.

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?
A. 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.
B. Report the adverse drug experience as part of the continuing review report.
C. Do not report the adverse drug experience to the IRB since it is a common adverse experience.
D. Report the adverse drug experience to the IRB only if there are several other occurrences.

A. Report the adverse drug experience in a timely manner, in keeping with the IRB's policies and procedures, using the forms or the mechanism provided by the IRB.

How long is an investigator required to keep consent documents, IRB correspondence, and research records?
A. As long as the investigator is at that institution
B. For a minimum of three years after completion of the study
C. Until data analysis is complete
D. Until the study is closed

B. For a minimum of three years after completion of the study

According to federal regulations, which of the following best describes when expedited review of a new, proposed study may be used by the IRB?
A. The study is required for a student research project
B. The study includes only research subjects that are healthy volunteers.
C. The study does not require informed consent or survey instruments.
D. The study involves no more than minimal risk and meets one of the allowable categories of expedited review specified in federal regulations

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.

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.

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 research, you may have to drop out.
D. I waive any possibility of compensation for injuries that I may receive as a result of participation in this research.

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 until either the subject or the subject's LAR can give consent.

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 consent.

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.

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.

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

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
B. Emotional distress from discussing the topic
C. Recruiting strategies to ensure quick enrollment and completion of the research
D. Breach of confidentiality from the focus group subjects (therapists)

D. Breach of confidentiality from the focus group subjects (therapists)

Which of the following most accurately describes the risks associated with SBR?
A. Less predictable, more variable, and less treatable than physical harms
B. More likely to be treatable by researchers than physical harms
C. Less serious and more frequent than physical harms
D. Shorter in duration and less frequent than physical harms

A. Less predictable, more variable, and less treatable than physical harms

Which of the following is considered a SBR data collection method?
A. Blood draws
B. Interviews
C. Hearing/audiological screenings
D. Physical exams

B. Interviews

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:
A. A FERPA violation
B. An invasion of privacy
C. A breach of confidentiality
D. All of the above
E. None of the above

C. A breach of confidentiality

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.
Which of the following considerations was relevant to the IRB's determination that this activity does not constitute research with human subjects?
A. The researcher will not be interacting/intervening with subjects and the data has no identifiers.
B. The data was collected between 1996-2006.
C. The database reflects data collected originally for surveillance purposes.
D. The CDC is a federal agency.

A. The researcher will not be interacting/intervening with subjects and the data has no identifiers.

In order to grant a waiver or alteration of the requirements of informed consent, an IRB must find which of the following:
A. The research involves benefit to the subjects.
B. The research plan includes a data safety monitoring board.
C. The research could not practicably be carried out without the waiver of consent.
D. The research plan includes data from individuals no longer living.

C. The research could not practicably be carried out without the waiver of consent.

Investigator A has biological specimens that are coded and linked to identifiers of the source individuals. Investigator A provides the specimens to Investigator B but does not provide the individual identifiers. Investigator B agrees not to re-identify the source individuals. Is Investigator B's research using the biospecimens human subjects research according to the definition of human subjects research in the federal regulations?
A. Yes, because Investigator A retains the identifiers and therefore the specimens are identifiable.
B. No, because Investigator B cannot readily ascertain the identity of the specimen sources.
C. Yes, because the specimens are from human subjects.
D. No, because Investigator B cannot readily ascertain the identity of the source individual and Investigator B has agreed not to attempt re-identification.
E. No, because Investigator B's research does not involve interaction with humans.

D. No, because Investigator B cannot readily ascertain the identity of the source individual and Investigator B has agreed not to attempt re-identification.

Which of the following statements is accurate in determining subject risk involved in a genetic study:
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

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

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

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.

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

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

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

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

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

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 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

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
D. One member who is a prisoner or prisoner representative

D. One member who is a prisoner or prisoner representative

When researchers plan to involve a prisoner population, which answer best describes the type of federally supported research that may be conducted?
A. Research that has the promise of benefit to society in general, but not necessarily the prisoner population
B. Research that involves only minimal risk to the prisoner population
C. Research that the researcher proposes and gets funded
D. Research that is relevant to prisoners and their conditions or situations

D. Research that is relevant to prisoners and their conditions or situations

Due to past abuses, which of the following groups of potential research subjects has specific Department of Health and Human Services (HHS) regulations to ensure additional protections when this population is being considered for research.
A. Men
B. The elderly
C. Mentally disabled persons
D. Prisoners

D. Prisoners

A federally funded research study involving children 8 to 12 years old involves collecting a single voided urine sample to assess the frequency of asymptomatic proteinuria (higher amounts of protein in the urine without any signs or symptoms of illness or infection). Your IRB has determined that assent of children age 8 and older is required for the study. A 10-year-old firmly declined to participate in the study described above. Which of the following procedures best describes the action to be taken by the investigator?
A. Consent both of the child's parents instead.
B. Request the child reconsider assenting to the study.
C. Honor the child's decision.
D. Seek permission from one of the child's parent instead.

C. Honor the child's decision.

A federally funded research study involving children 8 to 12 years old involves collecting a single voided urine sample to assess the frequency of asymptomatic proteinuria (higher amounts of protein in the urine without any signs or symptoms of illness or infection). According to 45 CFR 46, an IRB's risk assessment would likely conclude that this study involves:
A. No risk to the child and no further IRB review is required.
B. No more than minimal risk to the child.
C. More than minimal risk with no prospect of direct benefit to the child.
D. More than minimal risk with prospect of direct benefit to the child.

B. No more than minimal risk to the child.

An investigator proposes a study to determine the clinical relevance of a new assay technique to measure minimal residual disease (MRD) in adolescent (age 14-16) cancer patients undergoing chemotherapy. The study requires that two additional bone marrow aspirates be performed during the course of chemotherapy. The subject's chemotherapy will not be altered based on the results of the assay technique measures. However, future patients with cancer would benefit from improved interventions based on study findings. The IRB determined that the activity was a minor increase over minimal risk. Which of the following statements best describes the IRB approval requirements for involving adolescent cancer patients in the research study?
A. Assent of the child only is required.
B. Assent is not required, however, both parents must give permission for the inclusion of the adolescent child.
C. Assent is not required, however, one parent must give permission for the inclusion of the adolescent in this study.
D. Assent of the child and permission of both parents are required.

D. Assent of the child and permission of both parents are required.

Investigators wish to evaluate a new treatment for eclampsia (a life-threatening condition in pregnant women) in women 30 - 50 years of age. The research is intended to directly benefit the pregnant woman who is otherwise healthy and competent. The investigator must obtain consent from whom per Subpart B?
A. The pregnant woman and the father of the fetus.
B. The pregnant woman and her legally authorized representative.
C. The father of the fetus only.
D. The pregnant woman only.

D. The pregnant woman only.

A researcher wants to examine the efficacy of mushroom extract supplementation on fetal loss, low birth weight, and severe preterm birth in healthy pregnant women. She plans to enroll women who are 12-26 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.

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.

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.

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

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

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.

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.

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

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

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

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
C. Submit the research protocol to the Office for Human Research Protections (OHRP) for their review
D. Submit the research protocol to the IRB for review, but do not submit an IND application to the FDA since the drug is already approved and marketed for this indication

B. Submit the research protocol to the IRB for review and submit an IND application to the FDA before conducting the research

The FDA's regulations related to electronic records and electronic signatures (21 CFR Part 11) are intended to:
A. Require use of electronic records for all drug research.
B. Prohibit the use of paper printouts of electronic records.
C. Allow the use of electronic documents and signatures in the regulatory process for drugs and devices.
D. Provide specific standards for the informed consent process.

C. Allow the use of electronic documents and signatures in the regulatory process for drugs and devices.

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:
A. The database system to assign passwords.
B. The investigator to email subjects about the research.
C. The medical center to replace the use of paper records with electronic records for its research.
D. The use of paper records meeting FDA requirements.

C. The medical center to replace the use of paper records with

HIPAA includes in its definition of "research," activities related to:
A. Population health.
B. Anything a researcher does in a federally-supported laboratory.
C. Quality assessment and improvement.
D. Development of generalizable knowledge.

D. Development of generalizable knowledge.

The HIPAA "minimum necessary" standard applies...
A. To all human subjects research.
B. To all human subjects research that uses PHI without an authorization from the data subject.
C. To all human subjects research that uses PHI.
D. To all research where the data crosses state lines.

B. To all human subjects research that uses PHI without an authorization from the data subject.

HIPAA's protections for health information used for research purposes...
A. Replace those of the Common Rule and FDA for human subjects protection.
B. Only apply to research conducted inside covered entities.
C. May be used at the institution's discretion instead of the Common Rule and FDA protections.
D. Supplement those of the Common Rule and FDA.

D. Supplement those of the Common Rule and FDA.

A HIPAA authorization has which of the following characteristics:
A. Cannot be revoked by the data subject.
B. Cannot be combined with any other document related to the research.
C. Is provided at the investigator's discretion.
D. Uses "plain language" that the data subject can understand, similar to the requirement for an informed consent document.

D. Uses "plain language" that the data subject can understand, similar to the requirement for an informed consent document.

Under HIPAA, a "disclosure accounting" is required:
A. For all human subjects research that uses PHI.
B. For all human subjects research that uses PHI without an authorization from the data subject, except for limited data sets.
C. Solely at the principal investigator's discretion.
D. For all research where the data crosses state lines, otherwise state law applies.

B. For all human subjects research that uses PHI without an authorization from the data subject, except for limited data sets.

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:
A. Children
B. Individuals with Impaired Decision-Making Capacity
C. Workers
D. Prisoners

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

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

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

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.

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' medical records are on file in the medical center.
B. This is not an unanticipated problem nor an adverse event because it is not a clinical trial.
C. This is an unanticipated problem and not an adverse event.
D. The coordinator should assume that housekeeping staff will locate the files and return them to her at the end of the day.

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.

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.

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.

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

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
B. Researchers to annually self-disclose financial COIs to the FDA
C. Organizations to disclose financial COIs to the FDA no later than the time of submission of the IND application
D. Applicants submitting marketing applications to disclose financial COIs of researchers who conducted clinical studies

D. Applicants submitting marketing applications to disclose financial COIs of researchers who conducted clinical studies

A researcher's membership on an advisory board with an organization sponsoring research can create a COI because:
A. It may be difficult for the researcher to appear neutral, as the researcher may have an interest in the research's success
B. The organization can have policies that affect the research
C. The members of the advisory board know each other
D. The research result could be flawed from missing data

A. It may be difficult for the researcher to appear neutral, as the researcher may have an interest in the research's success

An example of an individual financial COI is:
A. A researcher is considering buying stock in a publicly traded company that specializes in making and delivering hand tossed pizza.
B. A researcher's spouse works at the same university as the researcher.
C. A researcher's 10-year-old child wins a local science competition, the prize for which is a $5,000 scholarship to a workshop sponsored by a local company that sponsors one of the researcher's ongoing projects.
D. A researcher's spouse holds equity in a publicly traded pharmaceutical company that is also the sponsor of the researcher's study.

D. A researcher's spouse holds equity in a publicly traded pharmaceutical company that is also the sponsor of the researcher's study.

The PHS regulations about financial conflict of interests require which party to disclose significant financial conflicts of interest?
A. IRB Member
B. Sponsor
C. Applicants submitting marketing applications for drugs, biologics, or devices
D. Organization
E. Researcher

E. Researcher

Unless the IRB or privacy board waives the requirement, HIPAA requires the patient's authorization for the use and disclosure of protected health information (PHI):
A. If the use or disclosure of PHI is for the purpose of treatment.
B. For clinical use, since IRB review and approval is required.
C. For reporting HUD safety information to the HDE holder.
D. If the use or disclosure of PHI is for the purpose of a clinical investigation with a HUD.

D. If the use or disclosure of PHI is for the purpose of a clinical investigation with a HUD.

All of the following regulatory requirements apply to an investigation of a HUD consistent with the HDE approved indication(s), EXCEPT:
A. HIPAA authorization requirements for covered entities.
B. Financial disclosure requirements.
C. Investigational Device Exemption requirements.
D. Human subject protection requirements.

C. Investigational Device Exemption requirements.

Clinicians using a HUD to treat or diagnose patients are responsible for:
A. Ensuring use does not exceed allowed number used annually in the US
B. Registering the HUD use on Clinicaltrials.gov
C. Submitting medical device reports to the HDE holder
D. Labeling the device with the FDA-required HUD statement

C. Submitting medical device reports to the HDE holder

An investigation to collect data on a new indication of a significant risk HUD requires:
A. IRB approval and an Investigational Device Exemption (IDE).
B. IRB approval and a revised Humanitarian Use Device (HUD) designation.
C. IRB approval without an Investigational Device Exemption (IDE).
D. IRB approval and a revised Humanitarian Device Exemption (HDE).

A. IRB approval and an Investigational Device Exemption (IDE).

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.
B. Takes a sincere interest in the growth and development of a trainee.
C. Pays for a trainee's research projects.
D. Advises a trainee on how to complete paperwork for graduation.

B. Takes a sincere interest in the growth and development of a trainee.

Which of the following statements about mentoring is true?
A. Junior faculty members need no further mentoring for their professional development.
B. Mentors can provide valuable advice to trainees regarding career decisions and contacts with leaders in their field of research.
C. Trainees are bound to find the one individual who is the "truly complete mentor".
D. The mentor - trainee relationship is rarely of benefit to the mentor.

B. Mentors can provide valuable advice to trainees regarding career decisions and contacts with leaders in their field of research.

Which of the following statements most accurately describes the mentoring relationship?
A. Graduate students, but not mentors, gain from the mentoring relationship.
B. Mentors teach trainees about aspects of academic life that are not covered in textbooks.
C. A mentoring relationship must not turn into a friendship or else it is a failure.
D. Mentoring relationships happen naturally and do not require work.

B. Mentors teach trainees about aspects of academic life that are not covered in textbooks.

Which of the following is most likely to be considered plagiarism?
A. Using materials from a source without proper citation.
B. Tampering with research equipment.
C. Adding extra data points without proper justification.
D. Intentionally reporting the results of inaccurate statistical tests.

A. Using materials from a source without proper citation.

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?
A. Falsification
B. Fabrication
C. Unauthorized access
D. Plagiarism

A. Falsification