CITI Training: HSR CORE 2017

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

Understanding the purpose and context of a specific study is critical in determining the risk involved

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

Established the National Commission 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.

Assessing Risk - SBE 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: A. Experience emotional or psychological distress. B. Lose their legal status. C. Lose their employment. D. Feel that their privacy has been invaded.

A. Experience emotional or psychological distress. Some subjects may experience emotional or psychological distress. The fact that the subjects have consented to participate in the study makes it unlikely that they would feel that their privacy was being invaded. Because confidentiality procedures have been built into the protocol it is also unlikely that the subjects might lose legal status or employment.

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

Internet-Based Research - SBE Which of the following on-line research strategies raises the most concerns regarding the ethical principle of respecting the autonomy of research subjects and the corresponding federal regulations requiring informed consent? A. A researcher posts a notice on an open on-line support group for interracial adoptees asking anyone who would be interested in being interviewed for her study to contact her. B. A researcher proposes to join a moderated support group for cancer survivors posing as a survivor. She plans to insert comments to see how the members respond. C. A linguist copies portions of postings on a political blog to document the use of expletives, abbreviations, and the use of irony in the postings. D. A researcher observes the communications in an open support group without announcing her presence. She is interested in observing how long members participate and how the membership shifts over time.

B. A researcher proposes to join a moderated support group for cancer survivors posing as a survivor. She plans to insert comments to see how the members respond. The study in which the researcher pretends to be a cancer survivor involves deception and research without any informed consent process. Therefore, the study raises concerns about the ethical principle of respect for persons. Any compromise of the principle should be justified by any scientific benefit to be derived from the study. When a support group or a blog is open to any and all readers, it can be argued that the communications posted are not intended to be private and can therefore be observed and recorded without informed consent. The researcher studying interracial adoptees used the internet in a manner comparable to posting a flyer on a bulletin board.

Research Misconduct (RCR-Basic) Which of the following is true regarding research misconduct? A. A central federal agency handles all cases of research misconduct. B. Federal funding agencies typically rely on an institution to make the initial response to an allegation of research misconduct. C. Funding agencies normally perform their own misconduct inquiry before the institution becomes involved. D. The U.S. government is required to reveal publicly the identity of any person who commits misconduct.

B. Federal funding agencies typically rely on an institution to make the initial response to an allegation of research misconduct.

If a researcher creates the idea for a project and is not listed in the preferred author order position on resulting publications, is this considered to be research misconduct under federal policy? A. Yes because it involves a form of falsification. B. No; instead it is a type of authorship dispute. C. No; instead it is a type of financial conflict of interest. D. Yes because it involves a form of fabrication.

B. No; instead it is a type of authorship dispute.

Research Misconduct (RCR-Basic) According to U.S. Federal Research Misconduct Policy, which of the following is considered to be research misconduct? A. Gift authorship B. Plagiarism C. Conflict of interest D. Harassing a co-worker

B. Plagiarism Along with fabrication and falsification, plagiarism is included within the federal definition of research misconduct.

To minimize potential risks of harm, a researcher conducting an on-line survey can: A. Suggest that subjects print a copy of the informed consent form for their records. B. Comply with the survey software's Terms of Service agreement. C. Design the survey so that no direct or indirect identifiers are collected. D. Specify that all respondents must be legal adults.

C

Assessing Risk - SBE What statement about risks in social and behavioral sciences research is most accurate? A. Anonymizing data effectively manages the risk of creating emotional distress. B. There are never any risks. C. Risks are specific to time, situation, and culture. D. If a study offers potential benefits, it is not necessary to minimize risks.

C. Risks are specific to time, situation, and culture. Research in the social and behavioral sciences sometimes does pose risks to subjects. Risks can be time, situation, and context specific. What may be a socially sensitive issue or topic at a given time and/or place may not be so at another time and/or place. The risk of emotional distress cannot be managed by anonymizing data, but rather by developing a plan to respond to the distress should it occur. Risks must always be minimized to the extent possible, regardless of the potential for benefit.

The typical first main phase in response to a research misconduct allegation is called: A. The audit B. Remediation C. The inquiry D. The adjudication

C. The inquiry

Informed Consent in Clinical Trials of Drugs, Biologics, and Devices An investigator is confronted with a life-threatening situation that necessitates using a test article in a human subject who is unable to provide informed consent and there is no time to obtain consent for the individual's legal representative. Under the FDA regulations, which of the following describes the best course of action for the investigator: A. Do not use the test article until either the subject or the subject's legally authorized representative can give consent. B. Submit a research protocol to the IRB and justify an expedited review approval of the consent document so the test article can be used immediately. C. The investigator and another physician not part of the study team agree that the situation necessitates the use of the test article and the IRB will be notified later. D. Sign the consent form on behalf of the subject and use the test article.

C. The investigator and another physician not part of the study team agree that the situation necessitates the use of the test article and the IRB will be notified later. The life-threatening situation requires a timely decision so that the test article can be used. It would be unethical to withhold emergency treatment until a research protocol is submitted and approved by the IRB. Not using the test article in a situation where it might save a life is also unethical. 21 CFR 50.24 provides the option of using the test article in a life-threatening condition involving an individual subject.

Records-Based Research 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? A. Storing her laptop in a secure, locked environment when not using it B. Using data encryption and storing data on a secure cloud environment, not on her laptop C. Having multi-factor authentication on her laptop to prevent others from accessing her device D. All of the above

D. All of the above All of the listed safeguards could be employed to provide additional protections for subject privacy and data confidentiality.

Research Misconduct (RCR-Basic) According to the U.S. Federal Research Misconduct Policy, falsification involves: A. Knowingly reporting unsubstantiated allegations of research misconduct to the federal government. B. Failing to report a conflict of interest. C. Taking credit for the ideas or statements of others. D. Manipulating research materials, equipment, or processes, or changing or omitting data.

D. Manipulating research materials, equipment, or processes, or changing or omitting data. 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.

Assessing Risk - SBE The primary purpose of a Certificate of Confidentiality is to: A. Allow law enforcement to investigate abuse cases. B. Protect researchers from disclosing conflicts of interest. C. Prevent subjects from knowing the purpose of a study. D. Protect identifiable research information from compelled disclosure.

D. Protect identifiable research information from compelled disclosure. Certificates of Confidentiality protect sensitive information provided by research subjects from civil, criminal, or administrative subpoena.

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

D. Using materials from a source without proper citation. Plagiarism is the deceptive practice of using another person's ideas or words without giving appropriate credit to the original source.

As of January 2015, the NIH expects investigators to obtain the informed (valid) consent of research participants in NIH -funded genetic research for broad research use of data and data sharing, even if the cell lines or specimens are:

De-Identified

Genetic Research in Human Populations 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 cannot readily ascertain the identity of the specimen sources. B. Yes, because the specimens are from human subjects. C. Yes, because Investigator A retains the identifiers and therefore the specimens are identifiable. D. No, because Investigator B's research does not involve interaction with humans. E. No, because Investigator B cannot readily ascertain the identity of the source individual and Investigator B has agreed not to attempt re-identification.

E. No, because Investigator B cannot readily ascertain the identity of the source individual and Investigator B has agreed not to attempt re-identification. OHRP guidance stipulates that, in this scenario, Investigator B is not conducting human subjects research even though Investigator A can identify the source individuals. Investigator B must agree not to attempt re-identification of the specimens, although OHRP has not indicated that such agreements are subject to IRB oversight.

The Belmont Report 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. 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. Persons with diminished autonomy should not be excluded from participating in research, because then they would be excluded from receiving the benefits of research. The Belmont Report does not limit persons with diminished autonomy with participating in greater than minimal risk research. The Belmont Report also does not limit persons involved in research from benefiting financially.

History and Ethics of Human Subjects Research Which of the following was the result of the Beecher article? A. Additional FDA regulations B. Realization that ethical abuses are not limited to the Nazi regime C. An identification of basic ethical principles D. Multiple Congressional hearings

Realization that ethical abuses are not limited to the Nazi regime

Clinical Data Management When designing a database and data collection instruments for a study, the Data Manager should:

Use standards to reduce the time required to set up the database and to increase the consistency of the data

Clinical Data Management Typical study conduct activities performed by the data manager include all of the following EXCEPT:

defining edit checks

Populations in Research Requiring Additional Considerations and/or Protections Which is an example of a situation where deferential vulnerability might be a factor? A. An employer recruiting among persons who directly report to them B. An army medical officer recruiting subjects among lower ranks C. A physician recruiting patients to be subjects D. A college professor recruiting among their students

A physician recruiting patients to be subjects In deferential vulnerability, the authority over the prospective subject is due to informal power relationships rather than formal hierarchies. The power relationship may be based on gender, race, or class inequalities, or they can be inequalities in knowledge (such as, in the doctor-patient relationship). Like institutional vulnerability, deferential vulnerability increases the risk of harm that informed consent would be compromised because it is not fully voluntary.

Informed Consent in Clinical Trials of Drugs, Biologics, and Devices A 46-year-old man is currently enrolled in a Phase III study of a drug for severe diabetic neuropathy. While the study is ongoing, a new drug becomes commercially available that may have equal or greater benefit to the subject. The investigator should do which of the following? A. 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. B. Tell the subject about the new drug but discourage him from switching treatments until the study is completed C. Withhold this new information to avoid confusing the subject with other treatment options or alternatives D. Do not tell the subject about the new drug since physicians have the right to try out new treatments with their patients

A. 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. Informed consent is a continuing and ongoing process. 45 CFR 116(b) and 21 CFR 50.25(b) requires that the informed consent document include a statement indicating that if significant new findings are developed during research which may relate to the subject's willingness to continue they will be explained to the subject. The informed consent document must also describe the process whereby subjects will be notified of significant new findings.

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: A. Obtain a waiver of documentation of informed consent. B. Have the subject sign the consent form under an assumed name. C. Code the subjects' responses. D. Obtain a Certificate of Confidentiality.

A. Obtain a waiver of documentation of informed consent.

Internet-Based Research - SBE Researchers designing online studies should consider the following with respect to participant protections. A. Re-identification methods are unique to internet-based research. B. The prevalence of artificial intelligence (e.g., avatars, bots) make it hard to determine which online users are living humans. C. Online sites & services (e.g., social media platforms) require users to agree to their individual terms of use. D. There is no one right way to secure informed consent online.

A. Re-identification methods are unique to internet-based research. One of the biggest risk of harm to subjects taking part in social & behavioral sciences research is the inadvertent disclosure of private identifiable information that could damage their reputations, employability, insurability, or subject them to criminal or civil liability. In most internet-based research, the primary risk of harm is loss of confidentiality. Because re-identification methods are unique to internet-based researchers, researchers need to carefully consider how to best ensure participant protections when designing online studies.

Clinical Data Management At what point should a Data Manager get involved with the database development?

At study startup

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

B. The research could not practicably be carried out without the waiver of consent. In order for an IRB to grant a waiver of consent, it must ensure the following federal criteria at 45 CFR 46.116 are met: --The research involves no more than minimal risk to the subjects; --The research could not practicably be carried out without the requested waiver or alteration; --If the research involves using identifiable private information, the research could not practicably be carried out without using such information in an identifiable format; --The waiver or alteration will not adversely affect the rights and welfare of the subjects; and --Whenever appropriate, the subjects (or legally authorized representatives) will be provided with pertinent information after participation.

Records-Based Research 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 data was collected between 1996-2006. B. The researcher will not be interacting/intervening with subjects and the data has no identifiers. C. The CDC is a federal agency. D. The database reflects data collected originally for surveillance purposes.

B. The researcher will not be interacting/intervening with subjects and the data has no identifiers. Records-based research activities may not meet the federal definition of "human subjects" research. A human subject is "a living individual about whom an investigator (whether professional or student) conducting research: (i) Obtains information or biospecimens through intervention or interaction with the individual, and uses, studies, or analyzes the information or biospecimens; or (ii) Obtains, uses, studies, analyzes, or generates identifiable private information or identifiable biospecimens. (Protection of Human Subjects 2017). In this case, the investigator did not collect the data directly from the human subject and the investigator cannot readily ascertain the identity of the subject; therefore, this would not qualify as human subject research.

Informed Consent in Clinical Trials of Drugs, Biologics, and Devices Under which circumstance does the FDA allow verbal consent prior to participation in a research study? A. The subject has a legally authorized representative (LAR). B. The study is minimal risk. C. The subject is illiterate. D. The study is greater than minimal risk.

B. The study is minimal risk. In limited circumstances, the FDA regulations at 21 CFR 56.109(c)(1) allow the investigator to obtain verbal informed consent without a signature on the consent form. The FDA requires IRB approval for this anomalous consent process, and it can only occur when study participation presents minimal risk. An illiterate person can place a mark on the consent document. An impartial witness should be present during the consent discussion and should also personally sign and date the consent form. If the subject has the capacity to consent, consent should be given by the individual, not the LAR. If the subject is unable to provide consent, the LAR must personally sign and date the consent. Please note, ICH E6 Section 4.8 does not include a similar provision for waiving the requirement for a signature on the consent form.

Internet-Based Research - SBE Revelations about the Facebook Emotional Contagion study highlights what key ethical consideration to conducting research using social media? A. Participants who use social media have expectations of privacy that may be at odds with the reality that their data is available publicly. B. Users of social media sites, like Facebook, may not fully understand all of the terms to which they are agreeing to when accepting a sites' terms of use. C. Research using social media does not consider the ethical principle of justice. D. Publicly available information on social media sites are not covered in the federal regulations.

B. Users of social media sites, like Facebook, may not fully understand all of the terms to which they are agreeing to when accepting a sites' terms of use. The researchers who carried out the emotional contagion study did not secure individual consent from the 700,000 Facebook used whose news feed they manipulated. Instead, they relied on language in the terms of use Facebook users agreed to ("analysis, testing, [and] research") as a means to argue they did not need to consent each individual. Participants did not realize by agreeing to be a Facebook user, they had agreed to let Facebook use them and their information for research purposes without their consent.

Genetic Research in Human Populations 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. Under the regulations, research with de-identified specimens is not considered human subjects research. However, many commentators consider it ethically problematic to use specimens in a manner that is not consistent with the language in the informed consent document.

Records-Based Research An investigator obtains consent and HIPAA authorization from subjects to review their medical records and HIV status. He plans to go back to the medical record, so the HIV status information is stored along with subject identifiers in a database that he keeps on his laptop computer. His laptop is stolen. This incident constitutes: A. A FERPA violation B. An invasion of privacy C. A breach of confidentiality D. All of the above E. None of the above

C. A breach of confidentiality Privacy is about people and their expectations. Privacy risk pertains primarily to the methods used to obtain information about subjects. Confidentiality pertains to the actual treatment of the personal information once it is obtained. In other words, now that the researcher has obtained private information, how will it be used, stored, and reported. Clearly, this event represents a breach of confidentiality.

Internet-Based Research - SBE The internet can be used as a research tool or as the object of a study. Which of the following examples best describes an investigator using the internet as a research tool? A. An investigator designs a computer program to extract work experience information from LinkedIn profiles. B. An investigator analyzes user comments on articles posted on her university's website. C. An investigator uses his Facebook wall to post a URL link to a survey he is hosting on SurveyMonkey. D. An investigator registers an account on SecondLife to observe the way people interact with each other.

C. An investigator uses his Facebook wall to post a URL link to a survey he is hosting on SurveyMonkey. Investigators use the internet as a research tool when they actively engage, or interact, with their participants on-line. This can include distributing an instrument via email or hosting a web-based survey on an on-line survey provider, recruiting subjects from on-line panels, conducting interviews on-line, facilitating focus groups in private chat rooms, and posting on-line experiments or interventions on web-based service providers.

Assessing Risk - SBE 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: A. Neither the magnitude or probability of harm. B. Solely by the magnitude or severity of expected harm. C. Both the magnitude (or severity) and the probability (or likelihood) of harm. D. Solely by the probability of expected harm.

C. Both the magnitude (or severity) and the probability (or likelihood) of harm. Risk must be determined by assessing both the magnitude (or severity) and the probability (or likelihood) of harm. Both elements must be considered. Although the probability that an individual subject could be identified is low, the magnitude of the possible harm is high given the sensitivity of the information.

Research Misconduct (RCR-Basic) Which of the following is true regarding the U.S. Federal Research Misconduct Policy? A. Misconduct must be proven beyond a reasonable doubt. B. The standard of innocent until proven guilty does not apply in misconduct cases. C. To have a misconduct finding, the action must have been committed intentionally, knowingly, or recklessly. D. The Policy covers conflicts of interest and the misuse of grant funding.

C. To have a misconduct finding, the action must have been committed intentionally, knowingly, or recklessly.

Populations in Research Requiring Additional Considerations and/or Protections The NBAC looks at characteristics individuals might have that would prevent them from being able to provide voluntary informed consent. The traits may be thought of as falling into six broad areas: cognitive or communicative, institutional, deferential, medical, economic, and social. Prospective research subjects who are not able to comprehend information, deliberate, and make decisions about participation in a proposed research study have a: A. Institutional vulnerability B. Cognitive or communicative vulnerability C. Economic or social vulnerability D. Physical vulnerability

Cognitive or communicative vulnerability 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.

Which of the following examples of using the internet to conduct research meets the federal definition of research with human subjects? A. Downloading a publicly available dataset that includes high school students' academic achievement rates. The data are in aggregate and were derived from multiple school districts from different states. B. Gathering data to supplement an oral history project about a local civil rights activist. The activist passed away while the researcher was in the process of conducting in-person interviews with the individual's social network. C. Analyzing a website visitor report from several pro-anorexia blogs to determine the popularity of each blog. Access to the blogs is not restricted. D. Conducting an on-line focus group with cancer survivors to determine familial support systems. The researcher also invites subjects' significant others to be a part of the focus group.

Conducting an on-line focus group with cancer survivors to determine familial support systems. The researcher also invites subjects' significant others to be a part of the focus group.

Informed Consent in Clinical Trials of Drugs, Biologics, and Devices Which of the following statements in a consent form is an example of exculpatory language? A. In the event of any injury related to this research, you will be given medical treatment. B. Your participation in this research is voluntary. If you choose not to participate, or change your mind later, your decision will not affect your relationship with your doctor or your right to health care or other services that you may be eligible for. C. The investigator may stop you from participating in this research without your consent if you experience side effects that make your condition worse. If you become ill during the research, you may have to drop out. D. I waive any possibility of compensation for injuries that I may receive as a result of participation in this research.

D. I waive any possibility of compensation for injuries that I may receive as a result of participation in this research. "I waive any possibility of compensation for injuries that I may receive as a result of participation in this research." is exculpatory language. Exculpatory language is language in the consent document through which the subject is made to waive or appear to waive any of his/her legal rights, or releases or appears to release the investigator, the sponsor, the institution, or its agents from liability for negligence. Such language is specifically prohibited. The other choices provide information without asking the subject to waive any of their rights.

Assessing Risk - SBE Additional safeguards that may be included in a social and behavioral study may include: A. Frequent monitoring of the subject's heart through ECG after administration of the study drug. B. Requiring pregnancy tests before administration of the study drug. C. Requiring a legally authorized representative to provide signed consent for an incapacitated subject. D. Remove all direct identifiers from the data as soon as possible.

D. Remove all direct identifiers from the data as soon as possible. When a possible disclosure of subjects' responses is the primary source of potential harm, collecting data anonymously may provide the best protection and removing direct identifiers is an additional safeguard. The other responses are additional safeguards, but refer to studies that may involve investigational drugs or are biomedical and not social behavioral.

Internet-Based Research - SBE Which scenario best describes a researcher making thoughtful considerations in the design of their informed consent process on an online study? A. The researcher will ask for a waiver of informed consent because the prevalence of bots completing online studies means there is no certain way to secure informed consent from actual research participants. B. The researcher will ask for a waiver of informed consent because prospective participants are individuals registered in an on-line panel, thus they have already given their consent to be a research participant. C. The researcher will ask for a waiver to document informed consent because participation in the study is limited to non-playable characters (NPCs) or avatars designed and controlled by artificial intelligence. D. The researcher will ask for a waiver to document informed consent and instead will have a live button that reads, "If you agree to be in this study click below to begin."

D. The researcher will ask for a waiver to document informed consent and instead will have a live button that reads, "If you agree to be in this study click below to begin." Including a live button in on a consent process that requires subjects to actively demonstrate their consent to participate is one way of obtaining consent for online studies. While the "live button" method does not create a record that documents informed consent took place, there are other methods that day, such as using electronic informed consent (eConsent) platforms, electronic signature software, like DocuSign, and authentication systems that can track sign-on via usernames and passwords.

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

Death of Research Subject (Jesse Gelsinger) 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.

The Belmont Report 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. 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.

Genetic Research in Human Populations 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. Effects of findings on other family members B. Need for publication of results C. Long term financial impact of results D. Ownership of biological specimens

Effects of findings on other family members All of these issues are important in genetics research. However, potential effects of research findings on family members is the most important consideration.

Clinical Data Management T/F: Every member of a study team must define quality the same way in order to produce a high quality database.

False

Which choice is the best definition of "genetic determinism?"

Genes are primarily responsible for human traits, including health, behavior, and disease

Genetic Research in Human Populations Identify which types of discrimination the Genetic Information Non-Discrimination Act (GINA) protects individuals from: A. Disability insurance and mortgage insurance B. Health insurance and employment discrimination C. Long-term care insurance and religious discrimination D. Gender discrimination

Health insurance and employment discrimination GINA protects individuals against discrimination in health insurance and employment. Other forms of discrimination are not addressed by GINA.

Risk of harm in social and behavioral sciences generally fall in three categories, which are: A. Invasion of privacy, adverse reaction to study drug, and discrimination B. Breach of confidentiality, loss of autonomy, and study procedures C. Invasion of privacy, breach of confidentiality, and study procedures D. Study procedures, breach of confidentiality, and loss of employment

Invasion of privacy, breach of confidentiality, and study procedures

Populations in Research Requiring Additional Considerations and/or Protections 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

Medical Vulnerability Medical vulnerability arises when prospective subjects have serious health conditions for which there are no satisfactory standard treatments. Subjects with serious health problems may not be able to adequately weigh the risks and potential benefits of the research. Subjects are at risk of exploitation because they may overestimate potential benefit. Deferential vulnerability is similar to institutional vulnerability, but the authority over the prospective subject is due to informal power relationships rather than formal hierarchies. Economic vulnerability arises when prospective subjects are disadvantaged in the distribution of social goods and services (income, housing, or healthcare). Therapeutic misconception occurs when subjects blur the roles played by physician-researchers and fail to appreciate the difference between research and treatment.

Genetic Research in Human Populations 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 re-contacting subjects B. Subjects received financial compensation for participation in the study C. Biological specimens need to be replenished D. Discovery of related clinical information requires contacting subjects for follow-up

Original signed consent documents include provisions for recontacting subjects It is necessary to determine and document at the time of initial consent whether subjects wish to be re-contacted. It is critical to discuss with prospective subjects whether they may be re-contacted and whether they wish to receive further information, if available.

Populations in Research Requiring Additional Considerations and/or Protections 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. Prejudice, physical control, manipulation, and coercion B. Physical control, coercion, undue influence, and manipulation C. Coercion, undue influence, neglect, and disrespect D. Physical control, coercion, undue influence, and neglect

Physical control, coercion, undue influence, and manipulation There are four common abuses that historically are described as giving rise to vulnerability: 1) physical control 2) coercion 3) undue influence 4) manipulation. These exist along a continuum of severity with physical control being the most severe and undue influence and manipulation being the least. The other abuses- prejudice, neglect, and disrespect - should still be avoided in research.

Populations in Research Requiring Additional Considerations and/or Protections 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. Children, prisoners, and terminally ill C. Prisoners, children, and elderly D. Pregnant women, prisoners, and mentally disabled

Pregnant women, prisoners, children The HHS federal regulations at 45 CFR 46 includes three subparts (B, C, and D) that specifically provide additional protections to vulnerable groups. The vulnerable groups identified are: --Subpart B. Additional Protections for Pregnant Women, Human Fetuses and Neonates Involved in Research --Subpart C. Additional Protections Pertaining to Biomedical and Behavioral Research Involving Prisoners as Subjects --Subpart D. Additional Protections for Children Involved as Subjects in Research. *The regulations do not provide specific additional protections for elderly, mentally disabled or terminally ill.

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

Prisoners may not be used to conduct research that only benefits the larger society The Belmont Principle of Justice requires the equitable distribution of both the benefits and burdens of research. Prisoners should not bear the burden of participating in research that only benefits the larger society

The Belmont Report Which of the following are the three principles discussed in the Belmont Report?

Respect for Persons, Beneficence, Justice

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

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.

Clinical Data Management Which member of a study team acts as the liaison between a sponsor and site, ensuring that reported data are verifiable to source documentation?

The Clinical Research Associate

Clinical Data Management Which member of a study team is ultimately responsible for the conduct of the study at a site?

The Investigator

Which of the following methods could be considered a "best practice" in terms of informing respondents how their answers to an on-line survey about personal information will be protected? A. The investigator uses the informed consent process to explain her institution's method for guaranteeing absolute confidentiality of research data. B. The investigator uses the informed consent process to explain how respondent data will be transmitted from the website to his encrypted database without ever recording respondents' IP addresses, but explains that on the internet confidentiality cannot be absolutely guaranteed. C. Respondents are informed that investigators will try to keep their participation confidential; however, confidentiality cannot be assured. D. Respondents are informed that a research assistant will transfer all the research data to a password-protected computer that is not connected to the internet, via a USB flashdrive. The computer is located in a research team member's office.

The investigator uses the informed consent process to explain how respondent data will be transmitted from the website to his encrypted database without ever recording respondents' IP addresses, but explains that on the internet confidentiality cannot be absolutely guaranteed.

Clinical Data Management T/F: Prior to locking a database, a data manager should ensure all data have been entered and all queries are resolved.

True

History and Ethics of Human Subjects Research Which of the following is included in the Nuremberg Code? A. Voluntary consent B. Confidentiality of data C. Equitable selection of subjects D. Additional protection for vulnerable subjects

Voluntary consent 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.

Clinical Data Management In order for a quality process to work, study team members must understand all of the following EXCEPT:

how to perform the other team members' jobs

Clinical Data Management The Data Manager should review the study protocol:

to understand primary and secondary endpoints