CITI Program Answers

Embryonic stem cells (ESC) may be obtained from which of the following tissues: Umbilical cord blood A five-day old blastocyst Peripheral blood Bone marrow

A five-day old blastocyst

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: If personal identifiers will be retained and used in the data analysis. 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. All of the above

All of the above

The FDA's regulations related to electronic records and electronic signatures (21 CFR Part 11) are intended to: Allow the use of electronic documents and signatures in the regulatory process for drugs and devices. Require use of electronic records for all drug research. Provide specific standards for the informed consent process. Prohibit the use of paper printouts of electronic records.

Allow the use of electronic documents and signatures in the regulatory process for drugs and devices.

Issued in 1974, 45 CFR 46 raised to regulatory status: Kefauver-Harris Drug Amendments to the Federal Food, Drug & Cosmetics Act The Nuremberg Code US Public Health Service Policy The 1974 National Research Act

US Public Health Service Policy

Science communication experts recommend that written material for non-academic audiences should: Include all available mathematical formulas and graphs. Use conversational language, short sentences, and active verbs. Extensively describe the methods used in technical detail. Avoid using anecdotes or stories.

Use conversational language, short sentences, and active verbs.

A research study wants to determine the effectiveness of two prenatal care group programs as compared to individual prenatal care in reducing the risk for HIV in young women during and after pregnancy. The IRB determines the research is no greater than minimal risk for the pregnant women and the fetuses. Is this research permitted under Subpart B? Yes - this research is permitted. No - this research is not permitted because it involves fetuses. This research is only permitted if it also presents a direct benefit to the mother and the fetus. No - this research is not permitted with pregnant women.

Yes - this research is permitted.

The National Research Act of 1974 Established the National Commission. Identified the basic ethical principles of human subjects research. Required that all federal agencies have the same regulations governing human subjects research. Identified guidelines to ensure the ethical conduct of research.

Established the National Commission.

Research findings from a human clinical trial study on high blood pressure treatments in older adults were just published in a research journal. Figure 1, a box-whisker plot, reports the mean blood pressure levels of the subjects after six weeks of treatment on placebo medication, treatment A, or treatment B. What information is important to include on the box-whisker plot? Asterisk or other symbols to indicate level of statistical significance Exact p-values to indicate level of statistical significance Label to indicate the specific statistical tests performed Label to indicate the type statistical analysis performed

Exact p-values to indicate level of statistical significance

Which statement most accurately describes the "deficit model" of science communication? Science organizations can raise money by communicating better Scientists suffer from a deficit in effective communication skills The news media lacks well-informed science coverage Experts provide knowledge to a passive, poorly informed public

Experts provide knowledge to a passive, poorly informed public

Under HIPAA, "retrospective research" (a.k.a., data mining) on collections of PHI generally ... Must meet HIPAA requirements only if the data collection is in a different jurisdiction (state) than the researcher accessing it. Does not meet the definition of research, and so requires no HIPAA authorization or meeting one of the criteria for waiving authorization. Is research, and so requires either an authorization or meeting one of the criteria for a waiver of authorization. Is covered by Common Rule/FDA requirements, but not HIPAA's.

Is research, and so requires either an authorization or meeting one of the criteria for a waiver of authorization.

When an IRB is reviewing a research study and they are considering if a potential subject population is vulnerable, they should consider: Are the research procedures greater than minimal risk of harm? Has the researcher completed required training? Are there adequate resources to conduct the study? Is there a power differential between researchers and subjects?

Is there a power differential between researchers and subjects?

Which of the following most accurately describes a researcher's responsibility to communicate with the public? It is part of an implicit social contract with the public It is a kindness to the public that is unlikely to benefit the individual researcher It is a standard requirement for obtaining tenure at an academic institution It is no longer necessary because of the wealth of information available on the Internet

It is part of an implicit social contract with the public

Which of the following most accurately describes why the JPEG file format should be avoided for scientific image data? JPEG is a file format often used by consumer electronics and is therefore unscientific. JPEG is best used to make images smaller for faster loading websites. JPEG format can introduce artifacts in images that are hard for the human eye to notice. JPEG files only appear in black and white.

JPEG format can introduce artifacts in images that are hard for the human eye to notice.

Why do science communication experts recommend that speakers minimize use of jargon, the specialized vocabulary of a field, when talking to public audiences? Jargon may be harder for the speaker to pronounce. Jargon can make it harder for some in the audience to understand what is being said. Jargon generally is more acceptable in written material, than in speech. Jargon may be so concise that speakers could be left with extra time.

Jargon can make it harder for some in the audience to understand what is being said.

When workers are asked to participate in a research study, vulnerabilities related to the subject's employment may include: 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. The research study's finding could affect an employee's pay, benefits, or promotion potential. Unions may encourage employees to participate with the expectation that "entitlements" may follow from study results. All of the above

All of the above

Which of the following studies has the LEAST potential to create group harm? A study that surveys the perceptions of nurses and other health care workers about illegal drug use among cardiovascular surgeons in New York City. An anonymous survey of state high school teachers, athletic directors, and administrators that, among other things, asks for perceptions about the sexual preferences of their high school coaches. A Phase 3 clinical trial of a new anticancer agent in middle-aged women diagnosed with breast cancer. A genetic study to identify ancestral relationships between DNA obtained from a Cherokee Indian burial site and members of a Central Asian community.

A Phase 3 clinical trial of a new anticancer agent in middle-aged women diagnosed with breast cancer.

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

A breach of confidentiality

The results from research have been known to produce harms to members of the sampled population who do not actually participate in the research study. An example of the type of research that could result in group harms by stigmatizing members of the group (even for individuals who do not participate in the research) is: A study of the types and prevalence of sexually transmitted infections (STIs) in small rural towns in a midwestern state. A study of sleeping patterns and productivity in college students. A study of the efficacy of a new glucose monitoring device in middle-aged women. A study on the effects of an innovative literacy program on absenteeism in elementary schools.

A study of the types and prevalence of sexually transmitted infections (STIs) in small rural towns in a midwestern state.

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

All of the above

Techniques used to produce cells with the characteristics of embryonic stem cells include: Retroviral transduction of transcription factor genes into induced pluripotent skin cells (iPS) Parthenogenesis Somatic cell nuclear transfer (SCNT) All of the above

All of the above

Which of the following practices can be effective in minimizing group harms? Community consultation Planning disclosure of research results Collaborative IRB review Ongoing consultation All of the above

All of the above

In most cases, a U.S. researcher affiliated with an academic institution, proposing to conducted funded research outside of the U.S., must have the approval of which of the following entities: An IRB from the researcher's U.S. institution only An IRB (or equivalent entity) from the host country only U.S. Department of State An IRB from both the researcher's U.S. institution and an equivalent entity within the host country

An IRB from both the researcher's U.S. institution and an equivalent entity within the host country

An example of an institutional COI is: One of the organization's deans is the vice-chair of the organization's IRB The organization gives scholarships to some post-doctoral researchers 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 An industry sponsor pays for the construction of a new research laboratory at the organization

An industry sponsor pays for the construction of a new research laboratory at the organization

An investigator proposes a study to determine the clinical relevance of a new assay technique to measure minimal residual disease (MRD) in adolescent (age 14-16) cancer patients undergoing chemotherapy. The study requires that two additional bone marrow aspirates be performed during the course of chemotherapy. The subject's chemotherapy will not be altered based on the results of the assay technique measures. However, future patients with cancer would benefit from improved interventions based on study findings. The IRB determined that the activity was a minor increase over minimal risk. Which of the following statements best describes the IRB approval requirements for involving adolescent cancer patients in the research study? Assent of the child only is required. Assent is not required, however, one parent must give permission for the inclusion of the adolescent in this study. Assent of the child and permission of both parents are required. Assent is not required, however, both parents must give permission for the inclusion of the adolescent child.

Assent of the child and permission of both parents are required.

The purpose of a federally supported research study is to examine the effect of scheduled cell searches on gang violence among men confined to drug treatment facilities under court order. Which of the following best describes the IRB's duties when reviewing this research? Because this research does not involve individual subjects who would be considered prisoners, the IRB does not have any additional duties Even though this research involves individual subjects who would be considered prisoners and examines an alternative to incarceration, the IRB does not have any additional duties Because this research involves individual subjects who would be considered prisoners and examines the possible causes, effects, and processes of incarceration, the IRB should ensure that the additional requirements for prisoner research are met Since this research is federally supported, the IRB does not have any duty to review this research

Because this research involves individual subjects who would be considered prisoners and examines the possible causes, effects, and processes of incarceration, the IRB should ensure that the additional requirements for prisoner research are met

Tissue-specific stem cells are found most commonly in: Urine Saliva Sweat Bone marrow

Bone marrow

A researcher wants to invite therapists to participate in small focus groups to discuss their perceptions regarding "troubled" adolescent girls and the relationships they have with their parents. Specific clients of the therapists will not be discussed. Which of the following will be the most important issue for the researcher to consider when planning the research? Breach of confidentiality from the focus group subjects (therapists) Emotional distress from discussing the topic Recruiting strategies to ensure quick enrollment and completion of the research Amount of compensation for the subject's (therapist's) time

Breach of confidentiality from the focus group subjects (therapists)

Which of the following is a commonly used resource for international ethical guidelines for human subjects research? "Ethics and Clinical Research" by H.K. Beecher CIOMS International Ethical Guidelines for Health-related Research Involving Humans 45 CFR 46 - The Common Rule Health Insurance Portability and Accountability Act (HIPAA)

CIOMS International Ethical Guidelines for Health-related Research Involving Humans

Recruiting into research ... Never requires a written authorization. Always requires a written authorization for ANY contact with the patient. Is entirely at the investigator's discretion. Can qualify as an activity "preparatory to research," at least for the initial contact, but data should not leave the covered entity.

Can qualify as an activity "preparatory to research," at least for the initial contact, but data should not leave the covered entity.

A researcher is conducting a written survey about people's attitudes toward walking as an exercise option at the local shopping mall that supports a walking program. The survey is anonymous (without codes, names, or other information) and subjects may complete the survey and place it in a box at the shopping mall exits. Which of the following is the most important issue that the researcher addressed in planning the research? Recruitment of subjects to ensure varied characteristics of the sample size Confidentiality of the individual subject's responses Possibility of emotional distress for subjects from the questions themselves Data analysis from a large sample size

Confidentiality of the individual subject's responses

Which of the following would be appropriate during the process of acquiring excess blastocysts (embryos) for research purposes? The request for donation of the blastocysts directly influences the timing of the IVF procedure The physician or fertility specialist in the IVF procedure also consents the patient for the blastocyst donation The decision to dispose of the blastocysts is directly linked to the decision to donate the materials for research Consenting donors are informed that the embryo will be destroyed during the attempted derivation of embryonic stem cell lines

Consenting donors are informed that the embryo will be destroyed during the attempted derivation of embryonic stem cell lines

Which of the following is an example of how the principle of beneficence can be applied to a study employing human subjects? Ensuring that persons with diminished autonomy are protected. Ensuring that the selection of subjects includes people from all segments of the population. Determining that the study has a maximization of benefits and a minimization of risks. Providing detailed information about the study and obtaining the subject's consent to participate.

Determining that the study has a maximization of benefits and a minimization of risks.

HIPAA includes in its definition of "research," activities related to: Development of generalizable knowledge. Population health. Anything a researcher does in a federally-supported laboratory. Quality assessment and improvement.

Development of generalizable knowledge.

During an Institutional Review Board (IRB) meeting, any IRB member who may have a potential COI with a study under review should: Leave the meeting immediately Disclose their potential COI and not participate in any action Disclose their potential COI and may answer questions, but recuse themselves from voting Disclose their potential COI, but not answer any questions about the study

Disclose their potential COI and may answer questions, but recuse themselves from voting

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 Need for publication of results Long term financial impact of results Ownership of biological specimens

Effects of findings on other family members

The National Science Foundation (NSF) requires researchers that it funds to provide a non-technical description of their project in order to: Describe and analyze the history of federally funded research in the relevant field. Provide information so that researchers in other disciplines can critique the project. Explain the project's significance and provide a public justification for NSF funding. Enable the research team to more easily protect any intellectual property obtained during the research.

Explain the project's significance and provide a public justification for NSF funding.

The federal regulations at 45 CFR 46 provide additional protections for subjects who are workers/employees to protect them from potential risks of harm. True False

False. The federal regulations do not classify workers as a vulnerable population.

How long is an investigator required to keep consent documents, IRB correspondence, and research records? Until data analysis is complete As long as the investigator is at that institution For a minimum of three years after completion of the study Until the study is closed

For a minimum of three years after completion of the study

A 46-year-old man is currently enrolled in a Phase 2 study of a drug for severe diabetic neuropathy. While the study is on-going, a new drug becomes commercially available that may have equal or greater benefit to the subject. The investigator should do which of the following? Do not tell the subject about the new drug because physicians have the right to try out new treatments with their patients. 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. Tell the subject about the new drug but discourage him from switching treatments until the study is completed. Withhold this new information to avoid confusing the subject with other treatment options or alternatives.

Give the subject comprehensive information about the new drug, including its side effects. Discuss the pros and cons of both the investigational drug and the commercially available drug and then allow the subject to decide whether to withdraw from the research to take the new drug.

Identify which types of discrimination the Genetic Information Non-Discrimination Act (GINA) protects individuals from: Long-term care insurance and religious discrimination Disability insurance and mortgage insurance Health insurance and employment discrimination Gender discrimination

Health insurance and employment discrimination

Which one of these types of image alterations is considered sufficiently basic, so it may not need to be reported to a journal? Gamma adjustments Flat-field or normalization corrections Histogram stretch Software filters

Histogram stretch

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? Seek permission from one of the child's parent instead. Consent both of the child's parents instead. Honor the child's decision. Request the child reconsider assenting to the study.

Honor the child's decision.

A general requirement for the informed consent form is that it may not include any exculpatory language. Exculpatory language is that which waives or appears to waive any of the subject's legal rights or releases or appears to release those conducting the research from liability for negligence. Which of the following statements in a consent form is an example of exculpatory language? In the event of any injury you may have related to this research, you will be given medical treatment. 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. 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. 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.

Which of the following most accurately describes a case of research misconduct? Image manipulation that results in fabrication of results Image manipulation that was not archived properly Image manipulation that was not fully described in the figure legend or the methods section Image manipulation that results in a difference of opinion by the authors

Image manipulation that results in fabrication of results

Which is considered the standard way for academic researchers to first disclose new research findings? In blogs or videos posted online In press releases distributed through their employer's website In peer-reviewed journals or presentations at professional meetings In mainstream newspapers

In peer-reviewed journals or presentations at professional meetings

A journal publisher is informed that a figure published in a recent research article appears to be manipulated. The journal reviews the concern and agrees that the digital image has signs of inappropriate editing including non-linear adjustments. Which of the following most accurately describes an appropriate practice that the author(s) should have performed to avoid this situation? Include image processing protocols in the publication Manipulate the digital image to make the modifications less obvious Seek approval from all authors to show representative results Save the final version of the figure on a secure server

Include image processing protocols in the publication

Which is true of inducements in research? Inducements, like coercion, are always inappropriate, as they violate the ethical principle of respect for persons. Offering $10 for an hour long research study constitutes undue inducement. Like coercion, undue inducement is easy for IRBs to determine. 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.

Inducements constitute an "undue influence" if they alter a potential subject's decision-making processes, such that they do not appropriately weigh the risk-benefit relationship of the research.

Which of the following is considered a SBR data collection method? Interviews Blood draws Physical exams Hearing/audiological screenings

Interviews

Which of the following most accurately describes the risks associated with SBR? Less serious and more frequent than physical harms Shorter in duration and less frequent than physical harms More likely to be treatable by researchers than physical harms Less predictable, more variable, and less treatable than physical harms

Less predictable, more variable, and less treatable than physical harms

Subjects with a serious illness may be at risk for exploitation because they may be desperate for a possible cure. This is an example of: Economic vulnerability Deferential vulnerability Medical vulnerability Therapeutic misconception

Medical vulnerability

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. Not until a notice of award is received Researchers must only submit COI disclosures if they have a significant financial interest related to the research Never -- the PHS regulation does not require researchers to submit COI disclosures No later than the time of proposal submission

No later than the time of proposal submission

A federally funded research study involving children 8 to 12 years old involves collecting a single voided urine sample to assess the frequency of asymptomatic proteinuria (higher amounts of protein in the urine without any signs or symptoms of illness or infection). According to 45 CFR 46, an IRB's risk assessment would likely conclude that this study involves: More than minimal risk with no prospect of direct benefit to the child. No risk to the child and no further IRB review is required. More than minimal risk with prospect of direct benefit to the child. No more than minimal risk to the child.

No more than minimal risk to the child.

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

No, because Investigator B cannot readily ascertain the identity of the source individual and Investigator B has agreed not to attempt re-identification.

An IRB determines a research study is greater than minimal risk with no potential direct benefit to subjects. The study includes pregnant women. Per Subpart B, can the IRB approve this study? No, because this study presents no potential benefit and it is more than minimal risk. No, because greater than minimal risk research is not allowed to include pregnant women. Yes because there are appropriate safeguards in place. Yes because there is not a scientific justification to exclude pregnant women from the study.

No, because this study presents no potential benefit and it is more than minimal risk.

IRB continuing review of a greater than minimal risk approved protocol that is currently enrolling subjects must: Be conducted by an expedited review. Include copies of all signed consent forms. Occur at least annually. Occur only when the level of risk changes.

Occur at least annually.

When reviewing federally supported research involving prisoners, an IRB must have which of the following, in addition to the standard requirements for IRBs to ensure that the prisoners' perspective is represented: One member who is a health care provider at the local hospital where prisoner may be treated One member who is a prisoner or prisoner representative Two members who are currently prison guards, wardens or parole officers Two members who are employed by the federal penal system

One member who is a prisoner or prisoner representative

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 involved in research cannot financially benefit. Persons with diminished autonomy should be excluded from research. Persons with diminished autonomy should only participate in no more than minimal risk research. Persons with diminished autonomy are entitled to protection.

Persons with diminished autonomy are entitled to protection.

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, and mentally disabled Children, prisoners, and terminally ill Pregnant women, prisoners, children Prisoners, children, and elderly

Pregnant women, prisoners, children

Due to past abuses, which of the following groups of potential research subjects has specific Department of Health and Human Services (HHS) regulations to ensure additional protections when this population is being considered for research. The elderly Men Prisoners Mentally disabled persons

Prisoners

The use of prisoners in research is a concern under the Belmont principle of Justice because: Prisoners are not free to say no 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 Prisoners are not a representative sample of the general population

Prisoners may not be used to conduct research that only benefits the larger society

The COI management plan aims to: Reduce IRB review burden when a COI is disclosed Address disclosure of COIs in multi-center research when a COI is disclosed Eliminate all COIs in research when a COI is disclosed Provide procedures or extras steps to be taken to minimize the risk of bias when a COI is disclosed

Provide procedures or extras steps to be taken to minimize the risk of bias when a COI is disclosed

Researchers designing studies to be conducted in host countries outside the U.S. should: Design studies to ensure they are in compliance with U.S. federal and state policies, laws and regulations only rather than the local beliefs and practices Remember that in some populations an individual cannot make a decision about medical care without the full engagement of relatives, friends and those in authority in the community Rely only on the U.S. interpretation of the core principles from the Belmont Report Emphasize the ethical principle of respect for persons as described in the Belmont Report

Remember that in some populations an individual cannot make a decision about medical care without the full engagement of relatives, friends and those in authority in the community

A subject in a clinical research trial experiences a serious, unanticipated adverse drug experience. How should the investigator proceed, with respect to the IRB, after the discovery of the adverse event occurrence? Report the adverse drug experience in a timely manner, in keeping with the IRB's policies and procedures, using the forms or the mechanism provided by the IRB. Do not report the adverse drug experience to the IRB since it is a common adverse experience. Report the adverse drug experience as part of the continuing review report. Report the adverse drug experience to the IRB only if there are several other occurrences.

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.

When researchers plan to involve a prisoner population, which answer best describes the type of federally supported research that may be conducted? Research that is relevant to prisoners and their conditions or situations Research that involves only minimal risk to the prisoner population Research that the researcher proposes and get s funded Research that has the promise of benefit to society in general, but not necessarily the prisoner population

Research that is relevant to prisoners and their conditions or situations

Informed consent is considered an application of which Belmont principle? Justice Non-maleficence Beneficence Respect for Persons

Respect for Persons

Which of the following are the three principles discussed in the Belmont Report? Respect for Persons, Beneficence, Justice Privacy, Confidentiality, Equitable Selection of Subjects IRB Review, Federal Regulations, Declaration of Helsinki Informed Consent, Institutional Assurance, Researcher Responsibility

Respect for Persons, Beneficence, Justice

Which of the following most accurately describes what researchers are expected to do when working with bitmapped image data? Convert the data to cyan, magenta, yellow, and black (CMYK) Retain the original image file and only process a copy of the original data Only manipulate their images using ImageJ or other scientific software Back up their image data to the cloud

Retain the original image file and only process a copy of the original data

An elderly gentleman, whose wife is his legally authorized representative (LAR) since his strokes several years ago, was recently diagnosed with lung cancer. He is eligible for a clinical trial using a new investigational drug that aims to treat lung cancer. He is able to express interest, shows a basic understanding of the nature of the trial, and gives his assent to participation. The subject's wife is out of town on a business trip. Which of the following is the most appropriate action to take for the investigator? Send a copy of the informed consent via facsimile to the subject's wife. After she has had the opportunity to speak to the investigator, she can sign the informed consent and fax it back. Consult a colleague about his opinion. If the colleague agrees, enroll the man without a signed consent. Exclude the man from the study. The investigator can go ahead and enroll the man without a signed consent.

Send a copy of the informed consent via facsimile to the subject's wife. After she has had the opportunity to speak to the investigator, she can sign the informed consent and fax it back.

A sponsor proposes research to evaluate reengineering a commercially available pacemaker. It is hoped that the new pacemaker will pose fewer risks to individuals when compared to the current commercially available product. How should this device be classified? Non-significant risk device Significant risk device

Significant risk device

In considering NBAC's analytic approach, an otherwise competent person who is acutely ill might be considered at especially high risk of harm for: Economic vulnerability Situational cognitive vulnerability Capacity-related cognitive vulnerability Communicative vulnerability

Situational cognitive vulnerability

Research findings from a human clinical trial study on high blood pressure treatments in older adults were just published in a research journal. Figure 1, a box-whisker plot, reports the mean blood pressure levels of the subjects after six weeks of treatment on placebo medication, treatment A, or treatment B. What information is important to include in the legend?

Subject demographic details including age, sex, and race

An investigator proposes to study a marketed product sold to treat high blood pressure in individuals over age 12 using a liquid formulation for children under age 12. The drug sponsor hopes that the information from the research can be used to change the labeling for use of the drug in younger children. Which of the following is the investigator's most appropriate course of action? Submit the research protocol to the IRB for review, but do not submit an IND application to the FDA since the drug is already approved and marketed for this indication Submit an Investigational Device Exemption (IDE) application to the FDA Submit the research protocol to the Office for Human Research Protections (OHRP) for their review Submit the research protocol to the IRB for review and submit an IND application to the FDA before conducting the research

Submit the research protocol to the IRB for review and submit an IND application to the FDA before conducting the research

When a research project includes the collection of biological samples, all planned future uses of the samples, identifiers, and the data obtained from the samples, must be fully explained to the research subject. True False

True

A basic characteristic of stem cells is: The ability to divide and make two stem cells (self-renew) The ability to keep the number of stem cells constant The ability to produce only mature daughter cells that no longer divide A genome that is completely protected from mutation

The ability to divide and make two stem cells (self-renew)

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. The investigator keeps careful records of all changes and includes them in the final report. They are eligible for review using expedited procedures. They only involve changes to the consent form.

The changes must be immediately implemented for the health and well-being of the subject.

An investigator is confronted with a life-threatening situation that necessitates using a test article in a human subject who is unable to provide informed consent and there is no time to obtain consent from the individual's LAR and no alternative method or recognized therapy is available. Under the FDA regulations for using test articles, which of the following describes the best course of action for the investigator: The investigator and an independent physician agree that the situation necessitates the use of the test article. An exception or waiver for informed consent can be made under these circumstances. The IRB will be notified later. Use the test article without obtaining consent from the subject or the LAR then notify the IRB. Do not use the test article until either the subject or the subject's LAR can give consent. Submit a research protocol to the IRB and justify an expedited review approval of the consent document so test article can be used immediately.

The investigator and an independent physician agree that the situation necessitates the use of the test article. An exception or waiver for informed consent can be made under these circumstances. The IRB will be notified later.

An academic medical center is selecting a new database system for clinical research. The system needs to be "Part 11 compliant" in order to allow: The use of paper records meeting FDA requirements. The medical center to replace the use of paper records with electronic records for its research. The database system to assign passwords. The investigator to email subjects about the research.

The medical center to replace the use of paper records with electronic records for its research.

A research study aims to evaluate a new experimental type of fetoscopic laser surgery to correct a potentially life-threatening condition for the fetus prior to delivery. This research is to meet the health needs and directly benefit the fetus only. The pregnant woman is otherwise healthy. Per Subpart B, the investigator must obtain consent from whom? The pregnant woman and the father of the fetus (except if he is unable to consent because of unavailability, incompetence, or temporary incapacity or the pregnancy resulted from rape or incest). The pregnant woman only. The state court where the research is taking place The father of the fetus only.

The pregnant woman and the father of the fetus (except if he is unable to consent because of unavailability, incompetence, or temporary incapacity or the pregnancy resulted from rape or incest).

Investigators wish to evaluate a new treatment for eclampsia (a life-threatening condition in pregnant women) in women 30 - 50 years of age. The research is intended to directly benefit the pregnant woman who is otherwise healthy and competent. The investigator must obtain consent from whom per Subpart B? The pregnant woman only. The pregnant woman and her legally authorized representative. The pregnant woman and the father of the fetus. The father of the fetus only.

The pregnant woman only.

In order to grant a waiver or alteration of the requirements of informed consent, an IRB must find which of the following: The research plan includes a data safety monitoring board. The research could not practicably be carried out without the waiver of consent. The research involves benefit to the subjects. The research plan includes data from individuals no longer living.

The research could not practicably be carried out without the waiver of consent.

A researcher wants to conduct a secondary analysis using a Centers for Disease Control and Prevention (CDC) database that was collected by the agency solely for surveillance purposes from 1996-2006. The researcher did not participate in the initial collection of the data. The database is publicly available. The database does not include any identifiers. The IRB makes a determination that the individuals whose records will be reviewed do not meet the federal definition of human subjects. Which of the following considerations was relevant to the IRB's determination that this activity does not constitute research with human subjects? The database reflects data collected originally for surveillance purposes. The researcher will not be interacting/intervening with subjects and the data has no identifiers. The CDC is a federal agency. The data was collected between 1996-2006.

The researcher will not be interacting/intervening with subjects and the data has no identifiers.

According to federal regulations, which of the following best describes when expedited review of a new, proposed study may be used by the IRB? The study does not require informed consent or survey instruments. The study includes only research subjects that are healthy volunteers. The study is required for a student research project The study involves no more than minimal risk and meets one of the allowable categories of expedited review specified in federal regulations

The study involves no more than minimal risk and meets one of the allowable categories of expedited review specified in federal regulations

The peer review process can create conflicts of interest because the choice of who reviews a potentially publishable project may show: Their connections to the journal may yield some concern There may be bias by the peer reviewer as to the area of research The project has a limited scope They are not informed of the area of work

There may be bias by the peer reviewer as to the area of research

Journals often encourage the use of dot plots and blot-whisker plots because: These types of graphs better indicate trends in the data Funding agencies require the use of these types of graphs They are the best format to show research findings that indicate percentages of a whole These types of graphs more clearly demonstrate data variability

These types of graphs more clearly demonstrate data variability

In the context of science communication, the use of common words like "theory" and "organic" may be confusing because: They downplay the significance of scientific findings. They are words not used by the public. They are no longer used in research fields and have been replaced by more modern terms. They can mean different things in science and in everyday conversation.

They can mean different things in science and in everyday conversation.

The HIPAA "minimum necessary" standard applies... To all human subjects research. To all human subjects research that uses PHI. To all human subjects research that uses PHI without an authorization from the data subject. To all research where the data crosses state lines.

To all human subjects research that uses PHI without an authorization from the data subject.

Which choice best describes the purpose of most pharmacogenomic research? To evaluate the association between individual genotypes and the safety and efficacy of a particular drug or class of drugs To evaluate how the genomes of infectious agents impact the efficacy of certain antibiotics To evaluate whether genetic testing can reduce the cost of pharmaceuticals To evaluate how different racial and ethnic groups respond to certain drugs or classes of drugs

To evaluate the association between individual genotypes and the safety and efficacy of a particular drug or class of drugs

The purpose of informed consent is: To provide a potential subject with appropriate information in an appropriate manner and allow that person to make an informed decision about participation in research. To obtain a signature from a study subject in order to protect the investigator, the study staff and the institution. To document the investigator's participation in the consent process. To obtain a signature from a study subject in order to document his or her agreement to participate in research.

To provide a potential subject with appropriate information in an appropriate manner and allow that person to make an informed decision about participation in research.

An adult with 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? Submit an Investigational New Drug (IND) application before treating the subject Submit a research protocol for IRB review and approval before treating the patient Inform the patient that the drug cannot be prescribed Treat the patient with the drug based on physician's best medical judgment

Treat the patient with the drug based on physician's best medical judgment

Pregnant women, fetuses, and neonates are often considered vulnerable categories of subjects. Additional protections are provided through regulation, however, the protections are meant to be inclusive and not exclusive of pregnant women in research. True False

True

A HIPAA authorization has which of the following characteristics: Uses "plain language" that the data subject can understand, similar to the requirement for an informed consent document. Cannot be revoked by the data subject. Cannot be combined with any other document related to the research. Is provided at the investigator's discretion.

Uses "plain language" that the data subject can understand, similar to the requirement for an informed consent document.

Which of the following is included in the Nuremberg Code: Confidentiality of data Additional protection for vulnerable subjects Equitable selection of subjects Voluntary consent

Voluntary consent

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? No, because it would be unethical to conduct research that is not consistent with the consent form the subjects originally signed. Yes, because research with biospecimens is minimal risk. No, the original research subjects must be re-consented for the cancer research. Yes, if the biospecimens are de-identified then the research is no longer considered human subjects research.

Yes, if the biospecimens are de-identified then the research is no longer considered human subjects research.