CITI Training, RM: Citi Modules, CITI Modules 9-17, CITI Certification, CITI quiz
Amendments involving changes to IRB approved protocols do not need prior IRB approval if:
The changes must be immediately implemented for the health & well being of the subject.
The purpose of informed consent is:
To provide a potential subject with appropriate information in an appropriate manner & allow that person to make an informed decision about participation in research.
Which of the following is included in the Nuremberg Code?
Voluntary Consent
research that is relevant to prisoners and their conditions or situations
When researchers plan to involve a prisoner population, which best describes the type of federally supported research that may be conducted?
Issued in 1974, 45 CFR 46 raised to regulatory status:
US Public Health Service Policy (45 CFR 46 raised to regulatory status the US Public Health Service policy of 1966 "Clinical research and investigation involving human beings".)
IRB continuing review of an approved protocol must:
Occur at least annually.
No more than minimal risk to the child
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:
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). 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?
According to the federal regulations, which of the following studies meets the definition of research with human subjects? A. A cognitive psychologist enrolls undergraduate students for a computer-based study about the effect of mood on problem solving behaviors. B. Undergraduate students in a field methods class are assigned a research question and asked to interview another classmate, to be followed by a class discussion on interview techniques. C. A researcher conducts a comparison of the comments made in a publicly available blog and the blogger's comments on a similar topic in a weekly magazine. D. A researcher sets up a meeting with the superintendent of a large and diverse public school system to get data about the ethnic composition of the school system and the number of students receiving free lunches.
A. A cognitive psychologist enrolls undergraduate students for a computer-based study about the effect of mood on problem solving behaviors.
According to the federal regulations, which of the following studies meets the definition of research with human subjects? A. A developmental psychologist videotapes interactions between groups of toddlers and their care givers to determine which intervention methods most effectively manage aggression. B. A researcher asks the director of a local free clinic about the number of patients in the last two years with newly diagnosed HIV/AIDS. C. A researcher uses the Customs Office's passenger lists for ships bringing immigrants to the US between1820-1845 to track the numbers of immigrants from certain ethnic groups. D. A researcher conducts a linguistic study of comments posted on a local public blog.
A. A developmental psychologist videotapes interactions between groups of toddlers and their care givers to determine which intervention methods most effectively manage aggression.
An example of an institutional COI is: A. An industry sponsor pays for the construction of a new research laboratory at the organization B. One of the organization's deans is the vice-chair of the organization's IRB C. The organization gives scholarships to some post-doctoral researchers D. The organization's president is a member of the board of trustees for a local non-profit organization that does not sponsor research at the organization
A. An industry sponsor pays for the construction of a new research laboratory at the organization
According to the federal regulations, human subjects are living human beings about whom an investigator obtains data through interaction or intervention with the individual or: A. Identifiable private information. B. De-identified private information. C. Observations of public behavior. D. Identifiable public information.
A. Identifiable private information.
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. Subjects received financial compensation for participation in the study D. Discovery of related clinical information requires contacting subjects for follow-up
A. Original signed consent documents include provisions for recontacting subjects
When a focus group deals with a potentially sensitive topic, which of the following statements about providing confidentiality to focus group participants is correct? A. Using pseudonyms in reports removes the concern about any confidences shared in the group. B. If group participants sign confidentiality agreements, the researcher can guarantee confidentiality. C. If group members know each other confidentiality is not an issue. D. The researcher cannot control what participants repeat about others outside the group.
D. The researcher cannot control what participants repeat about others outside the group.
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
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.
Under which of the following conditions is it appropriate to recontact the individuals who provided biological specimens?
Original signed consent documents inclue provisions for recontacting subjects
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
A man in his early 50s, who was recently diagnosed with lung cancer, is screened for a clinical trial using a new investigational drug. The investigator has carefully explained all of the required information about the study to the subject and the subject's daughter. The subject demonstrates his understanding and willingness to participate, but is not able to sign or mark the informed consent document due to a recent accident where he burned both hands. The subject's wife is his legally authorized representative, but she 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 and her husband, she can sign the informed consent and fax it back.
Which choice best describes the purpose of most pharmacogenomic research? A. 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 C. To evaluate whether genetic testing can reduce the cost of pharmaceuticals D. To evaluate how the genomes of infectious agents impact the efficacy of certain antibiotics
B. To evaluate the association between individual genotypes and the safety and efficacy of a particular drug or class of drugs
must be more detailed for disclosures that involve fewer than 50 subject records
When required, the information provided to the data subject in a HIPAA disclosure accounting ...
one member who is a prisoner or prisoner representative
When reviewing federally supported research involving prisoners, an IRB must have at least the following member, in addition to the standard requirements for IRBs to ensure that the prisoners' perspective is represented:
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. Yes, because research with biospecimens is minimal risk. B. Yes, if the biospecimens are de-identified then the research is no longer considered human subjects research. C. No, because it would be unethical to conduct research that is not consistent with the consent form the subjects originally signed. 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.
Phase 3 clinical trial of a new anticancer agent in middle-aged women diagnosed with breast cancer
Which of the following studies has the LEAST potential to create group harm?
What is the term for management controls that are built in to a research study (for example, independent data analysis)? A.Objective controls B.Inherent controls C.Mandated controls D.Required controls
B.Inherent controls
Which of the following concerns is related to the Belmont Principle of Justice: A. Prisoners are not free to say no B. Privacy and confidentiality concerns when research occurs in prisons C. Prisoners participating in research that only benefits the larger society D. Prisoners are not a representative sample of the general population
C. Prisoners participating in research that only benefits the larger society
A medical record is an example of: A. Public behavior. B. Public information. C. Private information. D. Private behavior.
C. Private information.
Which of the following was the result of the Beecher article? A. An identification of basic ethical principles B. Additional FDA regulations C. Realization that ethical abuses are not limited to the Nazi regime D. Multiple Congressional hearings
C. 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? A. Do not report the adverse drug experience to the IRB since it is a common adverse experience. B. Report the adverse drug experience to the IRB only if there are several other occurrences. C. 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. D. Report the adverse drug experience as part of the continuing review report.
C. 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.
The PHS regulations about financial conflict of interests require which party to disclose significant financial conflicts of interest? A. Organization B. IRB Member C. Researcher D. Sponsor E. Applicants submitting marketing applications for drugs, biologics, or devices
C. Researcher
Informed consent is considered an application of which Belmont principle? A. Non-maleficence B. Beneficence C. Respect for Persons D. Justice
C. Respect for Persons
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? A. Waiving documentation of consent. B. Using pseudonyms in research reports. C. Securing a Certificate of Confidentiality. D. Using data encryption for stored files.
C. Securing a Certificate of Confidentiality.
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. Communicative vulnerability C. Situational cognitive vulnerability D. Capacity-related cognitive vulnerability
C. Situational cognitive vulnerability
A professor at Big State University is writing a biography about Bill Gates and conducting oral histories with all of Bill Gates' friends, family members and business acquaintances. The researcher submits the research proposal to the institution's IRB. What action can he expect by the IRB? A. The IRB will not review this study because it does not involve an investigational new device. B. The IRB will not review this study because it does not include human subjects as defined by the federal regulations. C. The IRB will not review this study because it is not research as defined by the federal regulations. D. The IRB will review this study because it includes human subjects and is considered research.
C. The IRB will not review this study because it is not research as defined by the federal regulations.
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 volunteers 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
A situation in which financial or other personal considerations have the potential to compromise or bias professional judgment and objectivity is an example of:
Conflict of Interest
An organizational IRB or Privacy Board, privacy officer ("Privacy Officer"), or privacy official ("Privacy Official"), depending on the issue.
If you're unsure about the particulars of HIPAA research requirements at your organization or have questions, you can usually consult with:
Census data (the final report as published by the Census Bureau) is an example of: A. Private behavior. B. Public behavior. C. Private information. D. Public information.
D. Public information.
Amendments involving changes to IRB approved protocols do NOT need prior IRB approval if: A. The investigator keeps careful records of all changes and includes them in the final report. B. They are eligible for review using expedited procedures. C. They only involve changes to the consent form. D. The changes must be immediately implemented for the health and well being of the subject.
D. The changes must be immediately implemented for the health and well being of the subject.
Issued in 1974, 45 CFR 46 raised which of the following to regulatory status? A. The 1974 National Research Act B. The Nuremberg Code C. Kefauver-Harris Drug Amendments to the Federal Food, Drug & Cosmetics Act D. US Public Health Service Policy
D. US Public Health Service Policy
Which of the following statements is accurate in determining subject risk involved in a genetic study: A. All genetic studies should be considered greater than minimal risk B. Understanding the risks involved in other genetic studies is critical in determining the risk involved in a new study 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
Which of the following brought increased public attention to the problems with the IRB system?
Death of Jesse Gelsinger (Although all of these are related to the problems with the IRB system, the death of Jesse Gelsinger was what received public attention.)
Current NIH rules require investigators to disclose details regarding financial conflicts of interest to:
Designated institutional officials
Data are made anonymous by
Destroying all identifiers connected to the data.
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 a maximization of benefits and a minimization of risks.
prisoners
Due to past abuses, which of the following groups of potential research subjects has specific Department of Health and Human Services (DHHS) regulations to ensure additional protections when this population is being considered for research.
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
Which of the following is an example of how the principle of beneficence is applied to a study involving human subjects?
Ensuring that risks are reasonable in relationship to anticipated benefits.
The most important ethical concerns related to conflicts of interest in research are:
Ensuring the objectivity of research and the protection of human subjects
A researcher wishes to study generational differences in coping mechanisms among adults who experienced abuse as children. Adequate measures will be instituted to obtain informed consent and ensure that there is no breach of confidentiality. The most likely additional risk is that some subjects may:
Experience emotional or psychological distress.
How long is an investigator required to keep consent documents, IRB correspondence & research records?
For a *minimum of three years* after completion of the study. (May be required to keep them longer than 3 years)
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
development of generalizable knowledge.
HIPAA includes in its definition of "research," activities related to ...
identifiable health information that is created or held by covered entities and their business associates
HIPAA protects a category of information known as protected health information (PHI). PHI includes:
supplement those of the Common Rule and FDA.
HIPAA's protections for health information used for research purposes...
The researcher's failure to protect research subjects from deductive disclosure is the primary ethical violation in which of the following studies?
Harvard "Tastes, Ties, and Time (T3)" study (2006-2009)" study
NBAC proposed a concept of vulnerability in research based on features of potential subjects or of their situation. Which of the following was NOT included as possibly leading to vulnerability?
High potential for individual benefit from participating in research
A general requirement for the 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?
I waive any possibility of compensation for injuries that I may receive as a result of participation in this research.
According to the Belmont Report, the moral requirement that there be fair outcomes in the selection of research subjects, expresses the principle of:
justice
Allow the use of electronic documents and signatures in the regulatory process for drugs and devices.
The FDA's regulations related to electronic records and electronic signatures (21 CFR Part 11) is intended to:
to all human subjects research that uses PHI without an authorization from the data subject.
The HIPAA "minimum necessary" standard applies...
Which of the following studies is linked most directly to the establishment of the National Research Act in 1974 and ultimately to the Belmont Report and Federal regulations for human subject protection?
The Public Health Service Tuskegee Study of Untreated Syphilis in the Negro Male.
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 legal representative 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.
According to the federal regulations, research is eligible for exemption, if
The research falls into one of six categories of research activity described in the regulations.
When a focus group deals with a potentially sensitive topic, which of the following statements about providing confidentiality to focus group participants is correct?
The researcher cannot control what participants repeat about others outside the group.
Significant financial interest, as defined by the 2011 final rule that amended Public Health Service (PHS) regulations on Responsibility of Applicants for Promoting Objectivity in Research for which PHS Funding is Sought (42 C.F.R. Part 50, Subpart F) and Responsible Prospective Contractors (45 C.F.R. Part 94), include(s) (Check all that apply):
- Equity/stock interests (regardless of value) in a non-publicly traded company. - Intellectual property rights upon receipt of income related to such rights. - Consulting payments in excess of $5,000.
Uses "plain language" that the data subject can understand, similar to the requirement for an informed consent document.
A HIPAA authorization has which of the following characteristics:
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. 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. B. A researcher, who is a guest, audio-records conversations at a series of private dinner parties to assess gender roles, without informing participants. C. A researcher asks cocaine users to provide names and contact information of other cocaine users D. In order to eliminate the effect of observation on behavior, a researcher attends a support group and records interactions without informing the attendees.
A. 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.
Significant risk device
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 criterion for waiving informed consent is that, when appropriate, subjects are provided additional pertinent information after the study. In which of the following studies would it NOT be appropriate to provide subjects with information about missing elements of consent:
A study in which subjects were assigned to study activities based on an undesirable or unflattering physical characteristic as assessed by members of the research team.
An investigator obtains consent 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 patient identifiers in a database that he keeps on his laptop computer. His laptop is stolen. This incident constitutes: A. A breach of confidentiality. B. An invasion of privacy.
A. A breach of confidentiality.
In a longitudinal study that will follow children from kindergarten through high school and will collect information about illegal activities, which of the following confidentiality procedures would protect against compelled disclosure of individually identifiable information? A. Securing a Certificate of Confidentiality. B. Using pseudonyms in research reports. C. Using data encryption for stored files. D. Waiving documentation of consent.
A. Securing a Certificate 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 database reflects data collected originally for surveillance purposes. C. The CDC is a federal agency. D. The data was collected between 1996-2006.
A. The researcher will not be interacting/intervening with subjects and the data has no identifiers.
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.
The peer review process can create conflicts of interest because the choice of who reviews a potentially publishable project may show: A. Their connections to the journal may yield some concern B. There may be bias by the peer reviewer as to the area of research C. The project has a limited scope D. They are not informed of the area of work
B. 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? A. The subjects' privacy has been violated. B. There was neither a violation of privacy nor a breach of confidentiality. C. Confidentiality of the data has been breached. D. There was both a violation of privacy and a breach of confidentiality.
B. There was neither a violation of privacy nor a breach of confidentiality.
The pregnant woman and the father of the fetus.
A research project is designed to evaluate a new experimental type of fetal surgery to correct diaphragmatic hernia in the fetus (a potentially life-threatening condition for the baby) prior to delivery. This research is directed toward the fetus as subject to meet the health needs of the fetus. The pregnant woman is otherwise healthy. The investigator must obtain consent from whom?
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, children B. Prisoners, children, and older adults C. Pregnant women, prisoners, and individuals who are economically disadvantaged D. Children, prisoners, and individuals who are critically ill
A. Pregnant women, prisoners, children
Which of the following is included in the Nuremberg Code: A. Voluntary consent B. Equitable selection of subjects C. Additional Protection for vulnerable subjects D. Confidentiality of data
A. Voluntary consent
Which of the following is not considered an SBR data collections method?
Hearing/augiological screenings
Which of the following most accurately describes the risks associated with SBR?
Less predictable, more variable & less treatable than physical harms
the potential for bias
A conflict of interest implies:
Data that does not cross state lines when disclosed by the covered entity.
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:
- Activities preparatory to research, with certain representations by the researcher. - Limited data set with an approved data use agreement. - Use of decedents' information, with certain representations by the researcher.
A covered entity may use or disclose PHI without an authorization, or documentation of a waiver or an alteration of authorization, for:
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.
Receiving stock in a company funding your research
A financial conflict of interest could involve:
conflict of interest
A situation in which financial or other personal considerations have the potential to compromise or bias professional judgment and objectivity is an example of:
Which is an example of a situation where deferential vulnerability might be a factor?
A physician recruiting his patients
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: A. De-Identified B. From subjects under 18 years of age C. From subjects over 18 years of age D. Identifiable
A. De-Identified
Which choice is the best definition of "genetic determinism?" A. Genes are primarily responsible for human traits, including health, behavior, and disease B. Genetic testing can determine appropriate treatments for certain health conditions C. Genetic information about an individual can foster stigma and discrimination D. Parents determine the nature of their children through the inheritance of genes
A. Genes are primarily responsible for human traits, including health, behavior, and disease
A general requirement for the 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? A. I waive any possibility of compensation for injuries that I may receive as a result of participation in this research. B. 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. C. 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. D. In the event of any injury you may have related to this research, you will be given medical treatment.
A. I waive any possibility of compensation for injuries that I may receive as a result of participation in this research.
As part of a research study, a physician plans to review medical records of the next 50 of her patients who require magnetic resonance imaging (MRI) scans for clinical treatment to explore factors related to patients requiring MRI scans. The physician will review the medical records, and write down the clinical indication for the scans, any existing injuries, current prescriptions, as well as other clinical data. The clinical indication for the scans and the other clinical data will be collected in the medical records for treatment purposes as part of standard clinical care. The physician will use a coding system to be able to identify the patient's information; however, the "key" to the coding system will be stored separately from the data in a locked cabinet that only she will have access to. Which of the following is true? A. The study is human subject research which is eligible for expedited review. B. The research does not meet the federal definition of human subject C. The study is human subject research which must be reviewed by the full IRB. D. The study is human subject research which is eligible for exemption.
A. The study is human subject research which is eligible for expedited review.
There is compelling evidence that inclusion would be inappropriate with respect to the health of the subjects
According to current NIH Guidelines, which of the following is adequate justification for exclusion of women from NIH funded research?
Greater than $5,000 of ownership in any single public entity/public company.
According to the DHHS 2011 updated of the PHS federal regulations, the threshold amount for reporting a significant financial interest (investigator and his/her spouse and dependents) is:
The medical center to replace the use of paper records with electronic records for its research.
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:
Treat the patient with the drug based on physician's best medical judgment
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?
Assent of the child and permission of both parents are required.
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?
Submit the research protocol to the IRB for review and submit an IND application to the FDA before conducting the research
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?
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?
Securing a Certificate of Confidentiality.
The 1998 FDA regulations for requiring disclosure of significant financial interest reflect which threshold:
Any equity interest in a publicly held company that exceeds $50,000
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
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. Withhold this new information to avoid confusing the subject with other treatment options or alternatives B. 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. C. Do not tell the subject about the new drug since physicians have the right to try out new treatments with their patients D. Tell the subject about the new drug but discourage him from switching treatments until the study is completed
B. 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.
An example of an individual financial COI is: A. A researcher's 10-year-old son 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. B. A researcher's wife holds equity in a publicly traded pharmaceutical company that is also the sponsor of the researcher's study. C. A researcher's wife works at the same university as the researcher. D. A researcher is considering buying stock in a publicly traded company that specializes in making and delivering hand tossed pizza.
B. A researcher's wife holds equity in a publicly traded pharmaceutical company that is also the sponsor of the researcher's study.
The FDA regulations governing disclosure of individual COIs require: A. Organizations to disclose financial COIs to the FDA no later than the time of submission of the IND application B. Applicants submitting marketing applications to disclose financial COIs of researchers who conducted clinical studies C. Researchers to annually self-disclose financial COIs to the FDA D. Sponsors to annually disclose to the FDA financial COIs of researchers who conducted clinical studies
B. Applicants submitting marketing applications to disclose financial COIs of researchers who conducted clinical studies
How long is an investigator required to keep consent documents, IRB correspondence, and research records? A. Until data analysis is complete B. For a minimum of three years after completion of the study C. As long as the investigator is at that institution D. Until the study is closed
B. For a minimum of three years after completion of the study
Multiple Choice/Single Answer - Select only one answer 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 includes only research subjects that are healthy volunteers. B. The study involves no more than minimal risk and meets one of the allowable categories of expedited review specified in federal regulations C. The study does not require informed consent or survey instruments. D. The study is required for a student research project
B. The study involves no more than minimal risk and meets one of the allowable categories of expedited review specified in federal regulations
Identify which types of discrimination the Genetic Information Non-Discrimination Act (GINA) protects individuals from: A. Long-term care insurance and religious discrimination B. Health insurance and employment discrimination C. Disability insurance and mortgage insurance D. Gender discrimination
B. Health insurance and employment discrimination
NBAC proposed a concept of vulnerability in research based on features of potential subjects or of their situation. Which of the following was NOT included as possibly leading to vulnerability? A. High risk for exploitation B. High potential for individual benefit from participating in research C. Difficulty providing voluntary, informed consent arising from limitations in decision-making capacity D. Difficulty providing voluntary, informed consent arising from or situational circumstances
B. High potential for individual benefit from participating in research
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. Are the research procedures greater than minimal risk of harm? D. Has the researcher completed required training?
B. Is there a power differential between researchers and subjects?
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? A. Coercion, undue influence, neglect and disrespect B. Physical control, coercion, undue influence, and manipulation C. Prejudice, physical control, manipulation and coercion D. Physical control, coercion, undue influence and neglect
B. Physical control, coercion, undue influence, and manipulation
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? A. Exclude the man from the study. B. 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. C. The investigator can go ahead and enroll the man without a signed consent. D. Request the IRB meet and waive the requirement for a signed informed consent.
B. 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 researcher wants to do a web-based survey of college students to collect information about their sexual behavior and drug use. Direct identifiers will not be collected; however, IP addresses may be present in the data set. Risk of harm should be evaluated by:
Both the magnitude (or severity) and the probability (or likelihood) of harm.
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 partcipants
Which is an example of a situation where deferential vulnerability might be a factor? A. A college professor recruiting among his students B. An army medical officer recruiting subjects among lower ranks C. A physician recruiting his patients D. An employer recruiting among persons who directly report to him
C. A physician recruiting his patients
According to the federal regulations, which of the following studies meets the definition of research with human subjects? A. An organization for women academics in engineering asks a federal agency to provide the number of women investigators funded by that agency to include in a report for its membership. B. A university designs an in-house study to improve the mentoring of women students in its engineering department with the proposed outcome consisting of a report of recommendations for the department. C. An experiment is proposed on the relationship between gender-related stereotypes in math and the subsequent performance by males and females on math tests. D. A researcher receives anonymized data for secondary analysis from a survey about gender-related differences in stress levels conducted by a colleague at another university.
C. An experiment is proposed on the relationship between gender-related stereotypes in math and the subsequent performance by males and females on math tests.
Data are made anonymous by A. Keeping the key linking names to responses in a secure location. B. Reporting data in aggregate form in publications resulting from the research. C. Destroying all identifiers connected to the data. D. Requiring all members of the research team to sign confidentiality agreements.
C. Destroying all identifiers connected to the data.
During an Institutional Review Board (IRB) meeting, any IRB member who may have a potential COI with a study under review should: A. Disclose their potential COI, but not answer any questions about the study B. Disclose their potential COI and not participate in any action C. Disclose their potential COI and may answer questions, but recuse themselves from voting D. Leave the meeting immediately
C. Disclose their potential COI and may answer questions, but recuse themselves from voting
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 A. Institutional vulnerability B. Communicative vulnerability C. Economic vulnerability D. Social vulnerability
C. Economic vulnerability
A researcher's membership on an advisory board with an organization sponsoring research can create a COI because: A. The research result could be flawed from missing data B. The organization can have policies that affect the research C. It may be difficult for the researcher to appear neutral, as the researcher may have an interest in the research's success D. The members of the advisory board know each other
C. It may be difficult for the researcher to appear neutral, as the researcher may have an interest in the research's success
Subjects with a serious illness may be at risk for exploitation since they may be desperate for a possible cure. This is an example of A. Deferential vulnerability B. Therapeutic misconception C. Medical Vulnerability D. Economic vulnerability
C. Medical Vulnerability
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. No, because Investigator B's research does not involve interaction with humans. B. Yes, because the specimens are from human subjects. C. No, because Investigator B cannot readily ascertain the identity of the source individual and Investigator B has agreed not to attempt re-identification. D. No, because Investigator B cannot readily ascertain the identity of the specimen sources. E. Yes, because Investigator A retains the identifiers and therefore the specimens are identifiable.
C. No, because Investigator B cannot readily ascertain the identity of the source individual and Investigator B has agreed not to attempt re-identification.
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 legal representative 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. Do not use the test article until either the subject or the subject's legal representative can give consent. B. Use the test article without obtaining consent from the subject or the legal representative 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. Submit a research protocol to the IRB and justify an expedited review approval of the consent document so test article can be used immediately.
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.
The purpose of informed consent is: A. To obtain a signature from a study subject in order to protect the investigator, the study staff and the institution. B. To obtain a signature from a study subject in order to document his or her agreement to participate in research. C. 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. D. To document the investigator's participation in the consent process.
C. 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.
Designated institutional officials
Current NIH rules require investigators to disclose details regarding financial conflicts of interest to:
According to the federal regulations, which of the following studies meets the definition of research with human subjects? A. The collection of data, by a playground designer hired by the superintendent of schools, about the physical dimensions of school playgrounds, presence of fencing, and the kinds of equipment currently provided. B. An analysis of aggregate data comparing statewide high school graduation rates provided by the State Department of Public Instruction, using county tax information. C. A feasibility study for implementing a year-round school program, focusing on economic issues such a facilities utilization and transportation costs. D. 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.
D. 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.
Which of the following brought increased public attention to the problems with the IRB system? A. HHS Inspector General Report of 1998 B. 1983 Presidential Commission Report C. "Shut Downs" by OHRP D. Death of Jesse Gelsinger
D. Death of Jesse Gelsinger
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. Ownership of biological specimens B. Need for publication of results C. Long term financial impact of results D. Effects of findings on other family members
D. Effects of findings on other family members
The National Research Act of 1974 A. Identified the basic ethical principles of human subjects research B. Identified guidelines to ensure the ethical conduct of research. C. Required that all federal agencies have the same regulations governing human subjects research. D. Established the National Commission.
D. Established the National Commission.
Which is true of inducements in research? A. Like coercion, undue inducement is easy for IRBs to determine. B. Offering $10 for an hour long research study constitutes undue inducement. C. Inducements, like coercion, are always inappropriate, as they violate the ethical principle of respect for persons. D. 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.
D. 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 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. A. Researchers must only submit COI disclosures if they have a significant financial interest related to the research B. Not until a notice of award is received C. Never -- the PHS regulation does not require researchers to submit COI disclosures D. No later than the time of proposal submission
D. No later than the time of proposal submission
IRB continuing review of an approved protocol must: A. Be conducted by a convened IRB. B. Occur only when the level of risk changes. C. Include copies of all signed consent forms. D. Occur at least annually.
D. Occur at least annually.
The COI management plan aims to: A. Address disclosure of COIs in multi-center research when a COI is disclosed B. Reduce IRB review burden when a COI is disclosed C. Eliminate all COIs in research when a COI is disclosed D. Provide procedures or extras steps to be taken to minimize the risk of bias when a COI is disclosed
D. Provide procedures or extras steps to be taken to minimize the risk of bias when a COI is disclosed
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.
Risk of harm in social and behavioral sciences generally fall in three categories, which are:
Invasion of privacy, breach of confidentiality, and study procedures
The pregnant woman only.
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?
According to the Belmont Report, the moral requirement that there be fair outcomes in the selection of research subjects, expresses the principle of:
Justice.
Subjects with a serious illness may be at risk for exploitation since they may be desperate for a possible cure. This is an example of
Medical Vulnerability
Continuing review of an approved and ongoing protocol
Must occur within 12 months of the approval date.
According to federal regulations, the expedited review process may be used when the study procedures pose:
No more than minimal risk and the research activities fall within regulatory categories identified as eligible.
IRB continuing review of an approved protocol must:
Occur at least annually
Which of the following statements about the relationship between an institution and the institution's IRB(s) is correct?
Officials of the institution may overrule an IRB approval.
The Belmont Principle of beneficence requires that
Potential benefits justify the risks of harm.
The Belmont principle of beneficence requires that:
Potential benefits justify the risks of harm.
Identify the following groups that are protected in the federal regulations (45 CFR 46), specifically in Subparts B, C and D with additional protections:
Pregnant women, prisoners, children
In addition to pregnant women, fetuses, and neonates, another subpart of the HHS regulations provides additional protections for which of the following vulnerable populations?
Prisoners.
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 was the result of the Beecher article?
Realization that ethical abuses are not limited to the Nazi regime
A financial conflict of interest could involve:
Receiving stock in a company funding your research.
can qualify as an activity "preparatory to research," at least for the initial contact, but data should not leave the covered entity.
Recruiting into research ...
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.
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.
- 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.
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:
Informed consent is considered an application of which Belmont principle? ****
Respect for Persons (Respect for persons involves respecting individual autonomy in the decision to participate in research. That respect is implemented through the process of informed consent)
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 discussed in the Belmont Report?
Respect for Persons, Beneficence, Justice.
Humphreys collecting data for the Tearoom Trade study under the pretense that he was a lookout is an example of a violation of the principle of:
Respect for persons.
What statement about risks in social and behavioral sciences research is most accurate:
Risks are specific to time, situation, and culture.
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
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.
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 you, you waive the right to legal redress for any research-related injuries
Any equity interest in a publicly held company that exceeds $50,000
The 1998 FDA regulations for requiring disclosure of significant financial interest reflect which threshold:
All of the following are true regarding the Belmont Report, EXCEPT:
The Belmont Report indicates that it is necessary to rigorously avoid conflicts of 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 well being of the subject.
Ensuring the objectivity of research and the protection of human subjects
The most important ethical concerns related to conflicts of interest in research are:
A waiver of the requirement for documentation of informed consent may be granted when:
The only record linking the subject and the research is the consent document and the principal risk is a breach of confidentiality.
A therapist at a free university clinic treats elementary school children with behavior problems who are referred by a social service agency. She is also a doctoral candidate who proposes using data she has and will collect about the children for a case-based research project. Which of the following statements about parental permission is correct?
The parents of the children might feel pressure to give permission to the therapist to use their children's data so that she will continue to provide services to their children.
Since 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
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?
- Collaborative IRB review - Ongoing consultation - Planning disclosure of research results - Community consultation
Which of the following practices can be effective in minimizing group harms?
A study of the genetic links between DNA samples found at a prehistoric central Asian archeological site and west coast Native American tribes.
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 is:
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 & meets one of the allowable categories of expedited review specified in federal regulations.
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
As part of a research study, a physician plans to review medical records of the next 50 of her patients who require magnetic resonance imaging (MRI) scans for clinical treatment. The physician will review the medical records, and write down the clinical indication for the scans, any existing injuries, current prescriptions, as well as other clinical data. The clinical indication for the scans and the other clinical data will be collected in the medical records for treatment purposes as part of standard clinical care. The physician will use a coding system to be able to identify the patient's information; however, the "key" to the coding system will be stored separately from the data in a locked cabinet that only she will have access to. Which of the following is true?
The study is human subject research which is eligible for expedited review
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.
true
True or False: 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.
is research, and so requires either an authorization or meeting one of the criteria for a waiver of authorization
Under HIPAA, "retrospective research" (a.k.a., data mining) on collections of PHI generally ...
for all human subjects research that uses PHI without an authorization from the data subject, except for limited data sets.
Under HIPAA, a "disclosure accounting" is required:
Workers
Vulnerable persons are those who are less able to protect themselves than other persons in a given situation. The Common Rule (45 CFR 46) has specific requirements for the following vulnerable populations, EXCEPT:
- Pregnant Women - Human Fetuses and Neonates - Prisoners - Children
What are the vulnerable populations?
- 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.
When workers are asked to participate in a research study, vulnerabilities related to the subject's employment may include:
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
