CITI training responsible conduct
According to the federal regulations, which of the following studies meets the definition of research with human subjects?
A study of twenty 4th grade classrooms in which researchers ask the schools to systematically vary the time of day reading is taught, and collect weekly assessments of reading comprehension for each child over a three-month period.
The PHS regulations about financial conflict of interests require which party to disclose significant financial conflicts of interest?
Researcher
Which of the following are the three principles discussed in the Belmont Report?
Respect for Persons, Beneficence, Justice
What statement about risks in social and behavioral sciences research is most accurate:
Risks are specific to time, situation, and culture.
According to the federal regulations, which of the following studies meets the definition of research with human subjects?
An experiment is proposed on the relationship between gender-related stereotypes in math and the subsequent performance by males and females on math tests.
Identify the example of when situation and time are key to assessing risk of harm in a research study:
Asking women if they have had an abortion
Under HIPAA, a "disclosure accounting" is required:
For all human subjects research that uses PHI without an authorization from the data subject, except for limited data sets.
If disclosure of a subject's involvement in a specific research study can be potentially harmful to the subject, and the consent form is the only record linking the subject to the research, which of the following would be most helpful:
If the only identifier collected in the course of a study would be the signature on the consent document and the principal source of harm would be a breach of confidentiality disclosing one's participation in the study, a waiver of documentation of informed consent should be sought. With such a waiver, the informed consent process could be conducted verbally with no written evidence of the subject's participation in the 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.
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?
Yes - research with neonates of uncertain viability may be involved because there is no additional risk
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?
Yes, if the biospecimens are de-identified then the research is no longer considered human subjects research.
When required, the information provided to the data subject in a HIPAA disclosure accounting ...
must be more detailed for disclosures that involve fewer than 50 subject records.
Census data (the final report as published by the Census Bureau) is an example of:
public information
ICH E6 describes standards that apply to:
Investigators, sponsors, and Institutional Review Boards (IRBs) / Independent Ethics Committees (IECs) / Research Ethics Boards (REBs). The ICH standards apply to clinical research. Sponsors, Institutional Review Boards (IRBs) / Independent Ethics Committees (IECs) / Research Ethics Boards (REBs), and investigators are each involved in aspects of clinical research.
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?
Falsification
According to the U.S. Federal Research Misconduct Policy, falsification involves:
Falsification involves purposefully manipulating research materials, equipment, or processes, or changing or omitting data or results such that the research is not accurately represented in the research record.
Which of the following is true regarding research misconduct?
Federal funding agencies typically rely on an institution to make the initial response to an allegation of research misconduct.
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
The ICH E6 guideline should be followed when:
Generating clinical trial data that are intended to be submitted to regulatory authorities
Identify which types of discrimination the Genetic Information Non-Discrimination Act (GINA) protects individuals from:
Health insurance and employment discrimination
Amendments involving changes to IRB-approved protocols do NOT need prior IRB approval if:
The changes must be immediately implemented for the health and well-being of the subject
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.
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?
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).
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?
The pregnant woman only. Comment According to 46.204(d), if the purpose of the activity is to meet the health needs of the mother, then the consent of the father is NOT required.
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.
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
The two important goals of the ICH E6 standard are:
To assure that the rights, well-being, and confidentiality of trial subjects are protected; to assure that trial data are credible.
Which of the following is true regarding the U.S. Federal Research Misconduct Policy?
To have a misconduct finding, the action must have been committed intentionally, knowingly, or recklessly.
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.
The FDA's regulations related to electronic records and electronic signatures (21 CFR Part 11) are intended to:
Allow the use of electronic documents and signatures in the regulatory process for drugs and devices.
Which of the following brought increased public attention to the problems with the IRB system?
Although all of these are related to the problems with the IRB system, the death of a research subject (Jesse Gelsinger) was what received public attention.
In a longitudinal study that will follow children from kindergarten through high school and will collect information about illegal activities, which of the following confidentiality procedures would protect against compelled disclosure of individually identifiable information?
Although data encryption, using pseudonyms, and waiving documentation of consent, provide data protection, the researcher can link individuals to their responses. Therefore, the data are vulnerable to subpoena in civil, criminal, and administrative court proceedings. Unless the researcher has a Certificate of Confidentiality, he or she may be compelled to release individually identifiable information about research subjects. The Certificate provides the highest level of protection.
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 research, as described presents greater than minimal risk and no prospect of direct benefit to individual subjects, but is likely to yield generalizable knowledge about the subject's disorder or condition. It is therefore potentially approvable under 45.406, provided: (1) the risk represents a minor increase over minimal risk; (2) the intervention or procedure presents experiences to subjects that are reasonably commensurate with those inherent in their actual or expected medical, dental, psychological, social, or educational situations; (3) the intervention or procedure is likely to yield generalizable knowledge about the subjects' disorder or condition which is of vital importance for the understanding or amelioration of the subjects' disorder or condition; and (4) adequate provisions are made for soliciting assent of the children and permission of their parents or guardians.
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 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?
Breach of confidentiality from the focus group subjects (therapists)
Which of the following is a commonly used resource for international ethical guidelines for human subjects research?
CIOMS International Ethical Guidelines for Health-related Research Involving Human Many people have questioned the practice of institutions from Western countries sponsoring and/or conducting research with humans in developing countries. CIOMS was formulated specifically for use in the international community. These guidelines were prepared under the auspices of the World Health Organization. Research funded by U.S. agencies also must comply with the appropriate U.S. regulations such as 45 CFR 46 or 21 CFR 50, 56. For studies subject to the 45 CFR 46, U.S. regulations require that a study must be reviewed and approved by an IRB in the area where the study will be conducted. It is not enough that a U.S.-based IRB approve a study; it must also be approved by a board made up of members of the community in which the study will be performed. This requirement is in addition to complying with host country national guidelines or regulations.
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. Comment It is still permissible under HIPAA to discuss recruitment into research with patients for whom such involvement might be appropriate. This common practice is considered to fall within the definition of treatment, at least when the conversation is undertaken by one of the patient's healthcare providers. If the contact will be made by someone other than the patient's healthcare provider, permission will be required.
Which of the following most accurately describes the risks associated with SBR?
Less predictable, more variable, and less treatable than physical harms
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
According to the U.S. Federal Research Misconduct Policy, fabrication involves:
Fabrication involves making up data or results, recording the data in a permanent record, sharing fake data informally or in a written report.
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.
Which of the following most accurately describes the practice of ghost authorship?
It is a situation where the individual who wrote the manuscript is not listed as an author.
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
The use of prisoners in research is a concern under the Belmont principle of Justice because
Prisoners may not be used to conduct research that only benefits the larger society
A general requirement for informed consent is that no informed consent may include any exculpatory language. Exculpatory language is that which waives or appears to waive any of the subject's legal rights or releases or appears to release those conducting the research from liability for negligence. Which of the following statements in a consent form is an example of exculpatory language?
Taking part in the research is voluntary, but if you choose to take part, you waive the right to legal redress for any research-related injuries
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
The HHS regulations require at least one IRB member who is a prisoner or prisoner representative. Individuals employed by the federal penal system, prison guards, wardens, parole officers, or health care providers at the local hospital where prisoners may be treated do not satisfy the regulatory requirements for prisoner representation on the IRB.
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.
Which of the following constitutes both a breach of confidentiality (the research data have been disclosed, counter to the agreement between researcher and subjects) and a violation of subjects' privacy (the right of the individuals to be protected against intrusion into their personal lives or affairs)?
A faculty member makes identifiable data about sexual behavior available to graduate students, although the subjects were assured that the data would be de-identified.
Which is an example of a situation where deferential vulnerability might be a factor?
A physician recruiting patients to be subjects
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.
The FDA regulations governing disclosure of individual COIs require:
Applicants submitting marketing applications to disclose financial COIs of researchers who conducted clinical studies
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
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:
Data that does not cross state lines when disclosed by the covered entity.
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.
HIPAA protects a category of information known as protected health information (PHI). PHI covered under HIPAA include
Identifiable health information that is created or held by covered entities and their business associates.
Which of the following is considered a SBR data collection method?
Interviews Hearing screenings, blood draws, and other physical exams are usually designed to collect physiological data, not information about attitudes and beliefs. Interviews are designed to collect information about attitudes, beliefs, and behavior and are data collection methods typically used by SBR researchers.
Risk of harm in social and behavioral sciences generally fall in three categories, which are:
Invasion of privacy, breach of confidentiality, and study procedures
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.
When an IRB is reviewing a research study and they are considering if a potential subject population is vulnerable, they should consider:
Is there a power differential between researchers and subjects?
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 E6 guideline is to:
Minimize the need for redundant research.
A researcher calls you stating that he plans to submit a proposal to the NIH for a human subjects research study. He wants to know at what point he and his study team must submit COI disclosures to comply with the PHS regulation.
No later than the time of proposal submission
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. 45 CFR 46.102(i) defines minimal risk as the "probability and magnitude of harm or discomfort anticipated in the research are not greater in and of themselves than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests." Because the risk associated with collection of a single voided urine specimen is not greater than risks encountered in the course of a routine physical examination, this research constitutes "minimal risk."
IRB continuing review of a greater than minimal risk approved protocol that is currently enrolling subjects must:
Occur at least annually.
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.
Only the mother would provide consent per Subpart B.
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.
According to the authors, there are four common abuses that historically are described as giving rise to vulnerability. Which response below contains the correct four?
Physical control, coercion, undue influence, and manipulation Comment There are four common abuses that historically are described as giving rise to vulnerability 1) physical control, 2) coercion, 3) undue influence, and 4) manipulation. These exist along a continuum of severity with physical control being the most severe and undue influence and manipulation being the least (Nelson and Merz 2002, V69-80). The other abuses- prejudice, neglect, and disrespect - should still be avoided in research.
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 are a population afforded additional protections under the HHS regulations: 45 CFR 46.301 - 306 - Subpart C - Additional Protections for Prisoners. Although the HHS regulations do not have specific additional protections for the elderly, mentally disabled person and men involved in research, investigators should consider and the IRB may require additional projections, precautions or safeguards for these populations.
The primary purpose of a Certificate of Confidentiality is to:
Protect identifiable research information from compelled disclosure.
As part of the consent process, the federal regulations require researchers to:
Provide potential subjects with information at the appropriate reading comprehension level.
Which of the following is included in the Nuremberg Code:
The Nuremberg Code included the requirement of the voluntary consent of subjects. While all of the choices are valid ethical concerns, none of the other choices were included in the Nuremberg Code.
ICH topics and guidelines fall into four main categories:
Quality, Safety, Efficacy, Multidisciplinary The ICH guidelines fall into four main categories: Quality: Harmonisation achievements in the quality area include pivotal milestones such as the conduct of stability studies, defining relevant thresholds for impurities testing and a more flexible approach to pharmaceutical quality based on good manufacturing practice (GMP) risk management. Safety: ICH has produced a comprehensive set of safety guidelines to uncover potential risks like carcinogenicity, genotoxicity, and reprotoxicity. A recent breakthrough has been a non-clinical testing strategy for assessing the QT interval prolongation liability: the single most important cause of drug withdrawals in recent years. Efficacy: The work carried out by ICH under the efficacy heading is concerned with the design, conduct, safety, and reporting of clinical trials. It also covers novel types of medicines derived from biotechnological processes and the use of pharmacogenetics/genomics techniques to produce better targeted medicines. Multidisciplinary: Those are the cross-cutting topics which do not fit uniquely into one of the quality, safety, and efficacy categories. It includes the ICH medical terminology (MedDRA), the Common Technical Document (CTD), and the development of Electronic Standards for the Transfer of Regulatory Information (ESTRI).
Researchers designing studies to be conducted in host countries outside the U.S. should:
Remember that in some populations an individual cannot make a decision about medical care without the full engagement of relatives, friends and those in authority in the community
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. Comment The most appropriate action for the investigator to take is to report the adverse drug experience in a timely manner using the forms provided by the institution.
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?
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.
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
HIPAA's protections for health information used for research purposes...
Supplement those of the Common Rule and FDA.
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?
- Storing her laptop in a secure, locked environment when not using it - Using data encryption and storing data on a secure cloud environment, not on her laptop - Having multi-factor authentication on her laptop to prevent others from accessing her device
Issued in 1974, 45 CFR 46 raised to regulatory status:
45 CFR 46 raised to regulatory status the US Public Health Service policy of 1966 "Clinical research and investigation involving human beings".
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 is the most effective strategy for preventing research misconduct?
Among the options mentioned, good mentoring is the most effective strategy for preventing research misconduct.
In most cases, a U.S. researcher affiliated with an academic institution, proposing to conducted funded research outside of the U.S., must have the approval of which of the following entities:
An IRB from both the researcher's U.S. institution and an equivalent entity within the host country
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. The assent of minors to participate in research is required, unless the "capability of some or all of the children is so limited that they cannot reasonably be consulted or that the intervention or procedure involved in the research holds out a prospect of direct benefit that is important to the health or well being of the children and is available only in the context of the research" (45 CFR 46.408). The IRB determined that an 8-year-old was capable of providing assent for participation in this study, and in this situation, the child's decision cannot be overruled by the permission from one or both parents.
According to the federal regulations, research is eligible for exemption, if:
Research is only eligible for exemption if all the activities associated with the research fall into one of eight categories of activities described in the federal regulations. The regulations do allow some research with children to be exempt (although institutional policy may not). The duration of the study and the experience of the researcher are not criteria for determining eligibility for exemption.
Which choice best describes the purpose of most pharmacogenomic research?
To evaluate the association between individual genotypes and the safety and efficacy of a particular drug or class of drugs
Which of the following is true about the management of conflicts of interest?
Management plans are often created to reduce the impact of conflicts of interest. Organizations often create management plans to reduce the impact of conflicts of interest rather than completely eliminating them. However, in some cases, it will be necessary to eliminate a conflict of interest.
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 Research must first be relevant to the prisoner population although it may also be relevant to the general population; funding does not eliminate the regulatory requirements for protection of prisoner subjects; and there are circumstances where research involving more than minimal risk to the prisoner subjects may be conducted.
Informed consent is considered an application of which Belmont principle?
Respect for Persons
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
The National Research Act of 1974
The National Research Act of 1974 established the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. The identification of guidelines, ethical principles and regulations came as a result of the deliberations of the National Commission. Established the National Commission.
The two main criteria that the National Science Foundation (NSF) uses to evaluate grant proposals are:
The two main criteria used by NSF to evaluate a grant proposal are the intellectual merit and broader impacts of the proposal.
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
A researcher leaves a research file in her car while she attends a concert and her car is stolen. The file contains charts of aggregated numerical data from a research study with human subjects, but no other documents. The consent form said that no identifying information would be retained, and the researcher adhered to that component. Which of the following statements best characterizes what occurred?
There was neither a violation of privacy nor a breach of confidentiality
The HIPAA "minimum necessary" standard applies...
To all human subjects research that uses PHI without an authorization from the data subject.
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?
Treat the patient with the drug based on physician's best medical judgment Based on physician's best medical judgment the patient may be treated with the drug since it is a marketed drug with an approved labeled dosage. An IND is not required. There is no research being conducted for the purpose of changing the labeling of the drug or marketing a new indication.
Which of the following is an example of how the principle of beneficence can be applied to a study employing human subjects?
Your AnswerDetermining that the study has a maximization of benefits and a minimization of risks.ResultCorrectComment The principle of beneficence includes the obligation of researchers to strive to do no harm and to maximize benefits and minimize harms. "Persons are treated in an ethical manner not only by respecting their decisions and protecting them from harm, but also by making efforts to secure their well-being" (The National Commission 1979). The principle of beneficence can be applied to a study employing human subjects by determining that the study has a maximization of benefits and a minimization of risks. Providing detailed information during consent and ensuring persons with diminished autonomy are protected would be examples of applying the principle of respect for persons. Ensuring the selection of subjects is equitable is an example of applying the principle of justice.
