CITI Training
When must the investigator update the IRB about the progress of a trial?
During the conduct of the study and at termination
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?
Economic vulnerability
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?
Effects of findings on other family members
The National Research Act of 1974?
Established the National Commission
Institutions are required by the US Public Health Service (PHS) to do which of the following?
Evaluate whether a significant financial interest is related to an investigator's research and constitutes a financial conflict of interest
At a minimum, how often are investigators funded by the US National Institutes of Health required to receive conflict of interest training?
Every four years
Form FDA 1572, Statement of Investigator, is legally binding between the Investigator and the?
FDA
The federal regulations at 45 CFR 46 provide additional protections for subjects who are workers/employees to protect them from potential risks of harm?
False
How long is an investigator required to keep consent documents, IRB correspondence, and research records?
For a minimum of three years after completion of the study
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?
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
Identify which types of discrimination the Genetic Information Non-Discrimination Act (GINA) protects individuals from?
Health insurance and employment discrimination
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?
Honor the child's decision
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?
I waive any possibility of compensation for injuries that I may receive as a result of participation in this research
Which of the following statements in a consent form is an example of exculpatory language?
I waive any possibility of compensation for injuries that I may receive as a result of participation in this research
According to the US Public Health Service, the definition of the term "investigator"?
Includes anyone involved in the conduct or reporting of research
Which is true of inducements in research?
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
Which of the following best describes the principle of Respect for Persons as described in the Belmont Report?
Information, comprehension, voluntariness
Which of the following statements is true regarding the reporting of outside interests and the management of conflicts?
Investigators must disclose their significant financial interests related to their institutional responsibilities and not just those related to a particular project
ICH E6 describes standards that apply to?
Investigators, sponsors, and IRBs
Under HIPAA, "retrospective research" (a.k.a., data mining) on collections of PHI generally?
Is research, and so requires either an authorization or meeting one of the criteria for a waiver of authorization
A researcher's membership on an advisory board with an organization sponsoring research can create a COI because?
It may be difficult for the researcher to appear neutral, as the researcher may have an interest in the research's success
Which of the following most accurately describes the risks associated with SBR?
Less predictable, more variable, and less treatable than physical harms
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?
Medical vulnerability
A primary purpose of the ICH is to?
Minimize the need for redundant research
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?
No more than minimal risk to the child
An IRB determines a research study is greater than minimal risk with no potential direct benefit to subjects. The study includes pregnant women. Per Subpart B, can the IRB approve this study?
No, because this study presents no potential benefit and it is more than minimal risk
IRB continuing review of an approved protocol must?
Occur at least annually
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?
One member who is a prisoner or prisoner representative
Under which of the following conditions is it appropriate to re-contact the individuals who provided biological specimens?
Original signed consent documents include provisions for recontacting subjects
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?
Persons with diminished autonomy are entitled to protection
Pharmacokinetics and pharmacodynamics of a new formulation of an investigational drug most likely refers to which clinical phase of a study in humans?
Phase I
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?
Phase III
Long-term toxicology of an experimental drug in animals most likely refers to which part of drug development?
Preclinical
For a Phase I new drug study in humans, what is the primary source of the data included in the initial Investigator's Brochure?
Preclinical data
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?
Prisoners
The use of prisoners in research is a concern under the Belmont principle of Justice because?
Prisoners may be used to conduct research that only benefits the larger society
The COI management plan aims to?
Provide procedures or extra steps to be taken to minimize the risk of bias when a COI is disclosed
Which of the following was the result of the Beecher article?
Realization that ethical abuses are not limited to the Nazi regime
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?
Report the adverse drug experience in a timely manner, in keeping with the IRB's policies and procedures, using the forms or the mechanism provided by the IRB
Which of the following are the three principles discussed in the Belmont Report?
Respect for Persons, Beneficence, Justice
Which of the following are the three principles included in the Belmont Report?
Respect for Persons, Beneficence, Justice
An elderly gentleman, whose wife is his legally authorized representative 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?
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 ICH GCP guidelines?
Set standards for the design, conduct, monitoring and reporting of clinical research
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?
Significant risk device
In considering NBAC's analytic approach, an otherwise competent person who is acutely ill might be considered at especially high risk of harm for?
Situational cognitive vulnerability
Which of the following is an investigator's commitment to the sponsor?
Submit a new Form FDA 1572 to sponsor as needed
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?
Submit the research protocol to the IRB for review and submit an IND application to the FDA before conducting the research
HIPAA's protections for health information used for research purposes?
Supplement those of the Common Rule and FDA
An investigator received $4,000 of consulting income from a publicly traded drug company over the past 12 months. The investigator also owns stock in that company valued at $2,000. The investigator is submitting a grant to the National Institutes of Health that involves evaluating the effectiveness of a drug produced by the same drug company. Which of the following is true?
The aggregate of the consulting income and the stock exceeds $5,000 and therefore is a significant financial interest
Amendments involving changes to IRB approved protocols do NOT need prior IRB approval if?
The changes must be immediately implemented for the health and wellbeing of the subject
Which of the following financial conflict of interest information must be made available by institutions on a public website or within five business days upon request?
The financial conflicts of interest of senior/key personnel on PHS-funded projects
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?
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 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 for the individual's legal representative. Under the FDA regulations, which of the following describes the best course of action for the investigator?
The investigator and another physician not part of the study team agree that the situation necessitates the use of the test article and the IRB will be notified later
In order to grant a waiver or alteration of the requirements of informed consent, an IRB must find which of the following?
The research could not practicably be carried out without the waiver of consent
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?
The researcher will not be interacting/intervening with subjects and the data has no identifiers
Identify which party is responsible for reporting directly to the FDA the investigator's financial interests with the sponsor?
The sponsor
According to federal regulations, which of the following best describes when expedited review of a new, proposed study may be used by the IRB?
The study involves no more than minimal risk and meets one of the allowable categories of expedited review specified in federal regulations
Under which circumstance does the FDA allow verbal consent prior to participation in a research study?
The study is minimal risk
According to 1994 NIH Guidelines, which of the following is adequate justification for exclusion of women from NIH-funded research?
There is compelling evidence that inclusion would be inappropriate with respect to the health of the subjects
The peer review process can create conflicts of interest because the choice of who reviews a potentially publishable project may show?
There may be bias by the peer reviewer as to the area of research
The purpose of informed consent is?
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
An adult with 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?
Treat the patient with the drug based on physician's best medical judgment
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
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?
True
Which of the following is included in the Nuremberg Code?
Voluntary consent
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?
Yes - this research is permitted
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?
Yes, each of the exemptions in 45 CFR 46.104 may be applied to research subject to Subpart B
The results from research have been known to produce harms to members of the sampled population who do not actually participate in the research study. An example of the type of research that could result in group harms by stigmatizing members of the group (even for individuals who do not participate in the research) is?
A study on the types and prevalence of sexually transmitted infections (STIs) in small rural towns in a midwestern state
Which choice is the best definition of "genetic determinism"?
Genes are primarily responsible for human traits, including health, behavior, and disease
Which of the following is considered a SBR data collection method?
Interviews
When researchers plan to involve a prisoner population, which answer best describes the type of federally supported research that may be conducted?
Research that is relevant to prisoners and their conditions or situations
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?
The medical center to replace the use of paper records with electronic records for its research
Development of most new drugs, from discovery to marketing approval, usually takes?
9 years or more
Which of the following studies has the LEAST potential to create group harm?
A Phase 3 clinical trial of a new anticancer agent in middle-aged women diagnosed with breast cancer
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 breach of confidentiality
Which of the following statements most accurately describes a mitigation report?
A report to PHS of efforts that will be taken by the institution to deal with any bias that was found in research conducted while there was an unreported financial conflict of interest
An example of an individual financial COI is?
A researcher's spouse holds equity in a publicly traded pharmaceutical company that is also the sponsor of the researcher's study
Which of the following practices can be effective in minimizing group harms?
All of the above (Collaborative IRB review, ongoing consultation, planning disclosure of research results, community consultation)
When workers are asked to participate in a research study, vulnerabilities related to the subject's employment may include?
All of the above (The employer may encourage or deny participation of workers; employees may experience pressure from management to participate in the study because the employer perceives the study to be advantageous to the organization; unions may encourage employees to participate with the expectation that "entitlements" may follow from study results; the research study's finding could affect an employee's pay, benefits or promotion potential)
An investigator obtains consent and HIPAA authorization from subjects to review their medical records and HIV status. She plans to go back to the medical record, so the HIV status information is stored along with subject identifiers in a database that she keeps on her laptop computer. What are some safeguards she could use to protect subject privacy and data confidentiality?
All of the above (Using data encryption and storing data on a secure cloud environment, not on her laptop; storing her laptop in a secure, locked environment when not using it; having multi-factor authentication on her laptop to prevent others from accessing her device)
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?
All of the above (Who will have access to the data; if the study results, if any, will be included in the employee's personnel records; how the data will be collected and secured; if personal identifiers will be retained and used in the data analysis)
The FDA's regulations related to electronic records and electronic signatures (21 CFR Part 11) is intended to?
Allow the use of electronic documents and signatures in the regulatory process for drugs and devices
According to the US Public Health Service, which of the following would be considered a significant financial interest?
An equity interest valued at $5,000 owned by the investigator's spouse in a company that produces products related to the investigator's institutional responsibilities
An example of an institutional COI is?
An industry sponsor pays for the construction of a new research laboratory at the organization
If you're unsure about the particulars of HIPAA research requirements at your organization or have questions, you can usually consult with?
An organizational IRB or Privacy Board, privacy official ("Privacy Officer"), or security official ("Security Officer"), depending on the issue
Which of the following is true regarding the US Public Health Service and its approach to the disclosure of significant financial interests?
Any equity interest in a non-publicly traded company must be disclosed
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?
Assent of the child and permission of both parents are required
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?
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
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?
Breach of confidentiality from the focus group subjects (therapists)
Recruiting into research?
Can qualify as an activity "preparatory to research", at least for the initial contact, but data should not leave the covered entity
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?
Cognitive or communicative vulnerability
In completing Form FDA 1572, Statement of Investigator, the Investigator agrees to?
Conduct or supervise the investigation personally
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?
Confidentiality of the individual subject's responses
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?
De-Identified
Which of the following brought increased public attention to the problems with the IRB system?
Death of Research Subject (Jesse Gelsinger)
Which of the following is an example of how the principle of beneficence can be applied to a study employing human subjects?
Determining that the study has a maximization of benefits and a minimization of risks
Which of the following is an example of how the Principle of Beneficence can be applied to a study employing human subjects?
Determining that the study has maximized benefits and minimized risks
HIPAA includes in its definition of "research," activities related to?
Development of generalizable knowledge
The US Public Health Service (PHS) requires institutions to?
Disclose their investigators' new financial conflicts of interest to the PHS awarding component within 60 days of discovering them
A 46-year-old man is currently enrolled in a Phase III study of a drug for severe diabetic neuropathy. While the study is ongoing, a new drug becomes commercially available that may have equal or greater benefit to the subject. The investigator should do which of the following?
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