Consent with Subjects Who Do Not Speak English

1. Question: A subject who does not speak English in the U.S. may indicate other areas that must be considered and addressed by researchers. Which of the following is most typically an associated concern?
2. Question: Informed consent can be facilitated in a variety of ways. Which of the below is the best way to enhance the understanding of research?
3. Question: When a researcher is conducting an interpreter-mediated consent discussion with subjects, which of the following is an appropriate action for the interpreter?
4. Question: In certain circumstances, the federal regulations permit researchers to enroll subjects without a written translation by using a "short form" written consent document, in a language the subject understands. Researchers should know that the use of a short form is conditioned upon:
5. Question: Federal regulations (21 CFR 50.20 and 45 CFR 46.116) state that the information given in the consent process must be:

Consent with Subjects Who Do Not Speak English

1. Question: When a researcher is conducting an interpreter-mediated consent discussion with subjects, which of the following is an appropriate action for the interpreter?
2. Question: One way to enhance the understanding of research through the consent process for non-English speakers is to train research assistants to use which of the following when explaining the purpose of the research study and study procedures to potential subjects.
3. Question: Researchers should engage certified interpreters to ensure the subject’s comprehension. Even so, communication and comprehension may be difficult. The best strategy for the researcher is to:
4. Question: The consent process must allow subjects to consider whether or not to participate. Which of the following would be the best way to enhance subject understanding for non-English speakers?
5. Question: When developing a research project that will enroll non-English speakers, researchers should:

History and Ethics of Human Subjects Research

1. Question: Which of the following is included in the Nuremberg Code:
2. Question: Which of the following was the result of the Beecher article?
3. Question: Which of the following brought increased public attention to the problems with the IRB system?
4. Question: Issued in 1974, 45 CFR 46 raised to regulatory status:
5. Question: The use of prisoners in research is a concern under the Belmont principle of Justice because:

Basic Institutional Review Board (IRB) Regulations and Review Process

1. Question: 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?
2. Question: How long is an investigator required to keep consent documents, IRB correspondence, and research records?
3. Question: According to federal regulations, which of the following best describes when expedited review of a new, proposed study may be used by the IRB?
4. Question: Amendments involving changes to IRB-approved protocols do NOT need prior IRB approval if:
5. Question: IRB continuing review of a greater than minimal risk approved protocol that is currently enrolling subjects must:

Informed Consent

1. Question: The purpose of informed consent is:
2. Question: 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?
3. Question: 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:
4. Question: 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?
5. Question: 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.
6. Question: Which of the following is the most appropriate action to take for the investigator?

Social and Behavioral Research (SBR) for Biomedical Researchers

1. Question: 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?
2. Question: 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?
3. Question: Which of the following most accurately describes the risks associated with SBR?
4. Question: Which of the following is considered a SBR data collection method?

Genetic Research in Human Populations

1. Question: Which of the following statements is accurate in determining subject risk involved in a genetic study:
2. Question: 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?
3. Question: Identify which types of discrimination the Genetic Information Non- Discrimination Act (GINA) protects individuals from:
4. Question: Which choice best describes the purpose of most pharmacogenomic research?
5. Question: As of January 2015, the NIH expects investigators to obtain the informed (valid) consent of research participants in NIH -funded genetic research for broad research use of data and data sharing, even if the cell lines or specimens are:

Populations in Research Requiring Additional Considerations and/or Protections

1. Question: 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:
2. Question: Which is true of inducements in research?
3. Question: Subjects with a serious illness may be at risk for exploitation because they may be desperate for a possible cure. This is an example of:
4. Question: 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:
5. Question: In considering NBAC’s analytic approach, an otherwise competent person who is acutely ill might be considered at especially high risk of harm for:

Research Involving Children

1. Question: 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?
2. Question: 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:
3. Question: 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?

FDA-Regulated Research

1. Question: 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?
2. Question: 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?
3. Question: 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?
4. Question: The FDA's regulations related to electronic records and electronic signatures (21 CFR Part 11) are intended to:
5. Question: 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:

Recognizing and Reporting Unanticipated Problems

Involving Risks to Subjects or Others in Biomedical Research

1. Question: 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.
2. The subjects and others were notified of the increased risk.
3. Question: 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.
4. Question: 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.
5. Question: A Data Safety Monitoring Board report for an investigator-initiated investigational drug study indicates a significantly higher than anticipated
6. Question: 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.

Research and HIPAA Privacy Protections

1. Question: 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:
2. Question: Under HIPAA, "retrospective research" (a.k.a., data mining) on collections of PHI generally …
3. Question: HIPAA protects a category of information known as protected health information (PHI). PHI covered under HIPAA includes:
4. Question: HIPAA’s protections for health information used for research purposes…
5. Question: HIPAA includes in its definition of “research,” activities related to:

Conflicts of Interest in Human Subjects Research

1. Question: An example of an institutional COI is:
2. Question: The FDA regulations governing disclosure of individual COIs require:
3. Question: An example of an individual financial COI is:
4. Question: The COI management plan aims to:
5. Question: What is the term for management controls that are built in to a research study (for example, independent data analysis)?

Vulnerable Subjects - Research Involving Workers/Employees

1. Question: 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:
2. Question: When workers are asked to participate in a research study, vulnerabilities related to the subject's employment may include:
3. Question: 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:
4. Question: 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.