Research CITI

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

Under HIPAA, "retrospective research" (a.k.a., data mining) on collections of PHI generally ... -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. -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.

-Original signed consent documents include provisions for recontacting subjects

Under which of the following conditions is it appropriate to re-contact the individuals who provided biological specimens? -Subjects received financial compensation for participation in the study -Discovery of related clinical information requires contacting subjects for follow-up -Original signed consent documents include provisions for recontacting subjects -Biological specimens need to be replenished

-Is there a power differential between researchers and subjects?

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

-Effects of findings on other family members

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? -Long term financial impact of results -Ownership of biological specimens -Need for publication of results -Effects of findings on other family members

-Research that is relevant to prisoners and their conditions or situations

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

-One member who is a prisoner or prisoner representative

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

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

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

-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.

A 46-year-old man is currently enrolled in a Phase 2 study of a drug for severe diabetic neuropathy. While the study is on-going, a new drug becomes commercially available that may have equal or greater benefit to the subject. The investigator should do which of the following? -Give the subject comprehensive information about the new drug, including its side effects. Discuss the pros and cons of both the investigational drug and the commercially available drug and then allow the subject to decide whether to withdraw from the research to take the new drug. -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. -Do not tell the subject about the new drug because physicians have the right to try out new treatments with their patients.

-This is an unanticipated problem.

A Data Safety Monitoring Board report for an investigator-initiated investigational drug study indicates a significantly higher than anticipated rate of an expected adverse event. This event required revision of the informed consent form to disclose the higher rate. A change in the eligibility criteria of the protocol to reduce the risk was implemented. Current subjects would be reconsented. -Current subjects should never be reconsented. -This is not an unanticipated problem because the adverse event was acknowledged in the consent form. -This is an unanticipated problem. -This study was an investigator-initiated study. There is no need to report to the IRB or any federal agency.

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

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

-Data that does not cross state lines when disclosed by the covered entity.

A covered entity may use or disclose PHI without an authorization, or documentation of a waiver or an alteration of authorization, for all of the following EXCEPT: -Activities preparatory to research, with certain representations by the researcher. -Limited data set with an approved data use agreement. -Data that does not cross state lines when disclosed by the covered entity. -Use of decedents' information, with certain representations by the researcher.

-No more than minimal risk to the child.

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

-Honor the child's decision.

A federally funded research study involving children 8 to 12 years old involves collecting a single voided urine sample to assess the frequency of asymptomatic proteinuria (higher amounts of protein in the urine without any signs or symptoms of illness or infection). Your IRB has determined that assent of children age 8 and older is required for the study. A 10-year-old firmly declined to participate in the study described above. Which of the following procedures best describes the action to be taken by the investigator? -Honor the child's decision. -Seek permission from one of the child's parent instead. -Request the child reconsider assenting to the study. -Consent both of the child's parents instead.

-I waive any possibility of compensation for injuries that I may receive as a result of participation in this research.

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? -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. -In the event of any injury you may have related to this research, you will be given medical treatment. -I waive any possibility of compensation for injuries that I may receive as a result of participation in this research. -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.

-The pregnant woman and the father of the fetus

A research project is designed to evaluate a new experimental type of fetal surgery to correct diaphragmatic hernia in the fetus (a potentially life-threatening condition for the baby) prior to delivery. This research is directed toward the fetus as subject to meet the health needs of the fetus. The pregnant woman is otherwise healthy. The investigator must obtain consent from whom? -The pregnant woman and the father of the fetus. -The father of the fetus only. -The state court where the research is taking place -The pregnant woman only.

-No later than the time of proposal submission

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

-Confidentiality of the individual subject's responses

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

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

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

-Breach of confidentiality from the focus group subjects (therapists)

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) -Amount of compensation for the subject's (therapist's) time -Recruiting strategies to ensure quick enrollment and completion of the research -Emotional distress from discussing the topic

-It may be difficult for the researcher to appear neutral, as the researcher may have an interest in the research's success

A researcher's membership on an advisory board with an organization sponsoring research can create a COI because: -The members of the advisory board know each other -It may be difficult for the researcher to appear neutral, as the researcher may have an interest in the research's success -The research result could be flawed from missing data -The organization can have policies that affect the research

-Significant risk device

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

-This is an unanticipated problem that does not include an adverse event.

A study requires that each subject be given two study drugs. The first study drug is given on Day 1. A second study drug is given on Day 7 to counteract the toxicity of Drug 1. Subject # 4-706 is given Drug 1 on Day 1. Due to a snowstorm, Subject 4-706 is delayed for several days before returning to the site for Drug 2. Missing the administration of Drug 2 on Day 7 placed the subject at risk of significant toxicity. This event required the subject be notified of the increased risk and required close monitoring of the subject by phone. -This is an unanticipated problem that does not include an adverse event. -This is not an unanticipated problem because adverse weather is a possibility in the area where the site is located. -This is not an unanticipated problem because the subject was required to return on Day 7. -This is an adverse event, which does not require notification to the IRB.

-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.

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 to the IRB only if there are several other occurrences. -Report the adverse drug experience as part of the continuing review report.

-Economic vulnerability

A subject participates in a drug study because treatment is available at no or reduced cost, and he could not otherwise afford it. This is an example of: -Communicative vulnerability -Institutional vulnerability -Economic vulnerability -Social vulnerability

-This is an unanticipated problem, which resulted in an adverse event.

A subject received the wrong study drug resulting in severe nausea and vomiting, and a visit to the emergency room for treatment. The subject notified the study coordinator the day after the emergency room visit. The study coordinator reviewed the subject's study records and discovered the error. The coordinator notified the subject of the study drug error, which caused the nausea and vomiting. The investigator notified the IRB and the IRB approved a revision of the standard pharmacy procedure for administering investigational drugs. -The subject should have contacted the study site for authorization before going to the emergency room. -This is an adverse event that was anticipated because there is always a possibility of a pharmaceutical mistake. -This is an unanticipated problem, which resulted in an adverse event. -The IRB does not have authorization to require changes in the pharmacy procedures.

-Prisoners

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

-Inclusion of women would complicate analysis of the results and increase the costs of conducting the clinical trial.

According to current NIH Guidelines, which of the following is adequate justification for exclusion of women from NIH-funded research? -Inclusion of women would complicate analysis of the results and increase the costs of conducting the clinical trial. -The woman is of child-bearing potential. -There is compelling evidence that inclusion would be inappropriate with respect to the health of the subjects.

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

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

-Physical control, coercion, undue influence, and manipulation

According to the authors, there are four common abuses that historically are described as giving rise to vulnerability. Which response below contains the correct four? -Physical control, coercion, undue influence, and manipulation -Coercion, undue influence, neglect, and disrespect -Prejudice, physical control, manipulation, and coercion -Physical control, coercion, undue influence, and neglect

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

Amendments involving changes to IRB-approved protocols do NOT need prior IRB approval if: -The investigator keeps careful records of all changes and includes them in the final report. -The changes must be immediately implemented for the health and well-being of the subject. -They are eligible for review using expedited procedures. -They only involve changes to the consent form.

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

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

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

An adult with attention deficit hyperactivity disorder (ADHD) presents to a physician. To date, no behavioral or drug interventions have proven useful. The physician has just read several reports about a drug that is approved and marketed for another indication, but has shown some benefit for ADHD. The physician wants to prescribe this drug, in the labeled marketed dose, for the individual patient. Which of the following would be the most appropriate course of action? -Treat the patient with the drug based on physician's best medical judgment -Submit a research protocol for IRB review and approval before treating the patient -Inform the patient that the drug cannot be prescribed -Submit an Investigational New Drug (IND) application before treating the subject

-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.

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? -Consult a colleague about his opinion. If the colleague agrees, enroll the man without a signed consent. -Exclude the man from the study. -Send a copy of the informed consent via facsimile to the subject's wife. After she has had the opportunity to speak to the investigator, she can sign the informed consent and fax it back. -The investigator can go ahead and enroll the man without a signed consent.

-A researcher's spouse holds equity in a publicly traded pharmaceutical company that is also the sponsor of the researcher's study.

An example of an individual financial COI is: -A researcher's spouse holds equity in a publicly traded pharmaceutical company that is also the sponsor of the researcher's study. -A researcher's spouse works at the same university as the researcher. -A researcher's 10-year-old child wins a local science competition, the prize for which is a $5,000 scholarship to a workshop sponsored by a local company that sponsors one of the researcher's ongoing projects. -A researcher is considering buying stock in a publicly traded company that specializes in making and delivering hand tossed pizza.

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

An example of an institutional COI is: -One of the organization's deans is the vice-chair of the organization's IRB -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 -The organization gives scholarships to some post-doctoral researchers

-This is an unanticipated problem requiring notification to the IRB and FDA.

An investigational biologic administered to the first two subjects in a Phase II clinical trial was not appropriately screened for two viral contaminants, HIV and Hepatitis B, due to human error in the screening process. Follow-up testing indicated that the subjects and their partners were not infected. The subjects and others were notified of the increased risk. -There was no need to inform the IRB because this was a screening procedure. -This is an adverse event, which is also an unanticipated problem. -This is an unanticipated problem requiring notification to the IRB and FDA. -This is neither an unanticipated problem, nor an adverse event.

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

An investigator is confronted with a life-threatening situation that necessitates using a test article in a human subject who is unable to provide informed consent and there is no time to obtain consent 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: -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. -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.

-A breach of confidentiality

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 FERPA violation -A HIPAA violation -An invasion of privacy -A breach of confidentiality

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

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

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

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

-De-Identified

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: -Identifiable -From subjects over 18 years of age -From subjects under 18 years of age -De-Identified

-The study is human subject research which is eligible for expedited review.

As part of a research study, a physician plans to review medical records to explore factors related to 50 of her patients who require magnetic resonance imaging (MRI) scans for clinical treatment. The physician will review the medical records, and write down the clinical indication for the scans, any existing injuries, current prescriptions, as well as other clinical data. The clinical indication for the scans and the other clinical data will be collected in the medical records for treatment purposes as part of standard clinical care. The physician will use a coding system to be able to identify the patient's information; however, the "key" to the coding system will be stored separately from the data in a locked cabinet that only she will have access to. Which of the following is true? -The study only requires IRB review if it is funded by the National Institutes of Health (NIH). -The study is human subject research which is eligible for expedited review. -The study is human subject research which must be reviewed by the full IRB. -The research does not meet the federal definition of human subject research.

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

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, but not answer any questions about the study -Disclose their potential COI and not participate in any action -Disclose their potential COI and may answer questions, but recuse themselves from voting

-Occur at least annually.

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

-Development of generalizable knowledge.

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

-Supplement those of the Common Rule and FDA.

HIPAA's protections for health information used for research purposes... -Replace those of the Common Rule and FDA for human subjects protection. -Supplement those of the Common Rule and FDA. -Only apply to research conducted inside covered entities. -May be used at the institution's discretion instead of the Common Rule and FDA protections.

-This is an unanticipated problem and not an adverse event.

Housekeeping employees of the medical center were recruited for a federally funded study of blood pressure, blood count levels, infectious disease history, and job stress. The interviews and blood tests were conducted in a private location not affiliated with the study center. Follow-up interviews were conducted in the same location. The study coordinator stopped at the cafeteria on her way back to the study office after the second study visit for the last three study subjects and lost the three file folders. Records of one subject indicated he had a history of a sexually transmitted disease and another had recently been treated for tuberculosis. The subjects were notified of the loss. Following this event, the IRB approved a protocol change requiring that all records be transmitted electronically to the study office using the medical center's secure network. -This is an unanticipated problem and not an adverse event. -This is not an unanticipated problem because employees' medical records are on file in the medical center. -The coordinator should assume that housekeeping staff will locate the files and return them to her at the end of the day. -This is not an unanticipated problem nor an adverse event because it is not a clinical trial.

-For a minimum of three years after completion of the study

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

-Pregnant women, prisoners, children

Identify the following groups that are protected in the federal regulations (45 CFR 46), specifically in Subparts B, C, and D with additional protections: -Children, prisoners, and terminally ill -Pregnant women, prisoners, and mentally disabled -Pregnant women, prisoners, children -Prisoners, children, and elderly

-Health insurance and employment discrimination

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

-An organizational IRB or Privacy Board, privacy official ("Privacy Officer"), or security official ("Security Officer"), depending on the issue.

If you're unsure about the particulars of HIPAA research requirements at your organization or have questions, you can usually consult with: -An organizational IRB or Privacy Board, privacy official ("Privacy Officer"), or security official ("Security Officer"), depending on the issue. -A designated security official (a.k.a., "Security Officer"). -An organizational IRB or Privacy Board. -A designated privacy official (a.k.a., "Privacy Officer").

-Situational cognitive vulnerability

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 -Communicative vulnerability -Situational cognitive vulnerability -Capacity-related cognitive vulnerability

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

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

-The pregnant woman only.

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

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

Recruiting into research ... -Never requires a written authorization. -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. -Always requires a written authorization for ANY contact with the patient.

-Medical vulnerability

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

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

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

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

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

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

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

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

-Cognitive or communicative vulnerability

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: -Economic or social vulnerability -Physical vulnerability -Cognitive or communicative vulnerability -Institutional vulnerability

-Researcher

The PHS regulations about financial conflict of interests require which party to disclose significant financial conflicts of interest? -IRB Member -Sponsor -Applicants submitting marketing applications for drugs, biologics, or devices -Organization -Researcher

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

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 -They are not informed of the area of work -The project has a limited scope -There may be bias by the peer reviewer as to the area of 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

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 -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 -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 -Since this research is federally supported, the IRB does not have any duty to review this 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.

The purpose of informed consent is: -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. -To document the investigator's participation in the consent process. -To obtain a signature from a study subject in order to protect the investigator, the study staff and the institution.

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

Which choice is the best definition of "genetic determinism?" -Genetic information about an individual can foster stigma and discrimination -Genes are primarily responsible for human traits, including health, behavior, and disease -Parents determine the nature of their children through the inheritance of genes -Genetic testing can determine appropriate treatments for certain health conditions

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

-Respect for Persons, Beneficence, Justice

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

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

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

-Interviews

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

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

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

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

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 -All genetic studies should be considered greater than minimal risk -All genetic studies should be considered no more than minimal risk -Understanding the risks involved in other genetic studies is critical in determining the risk involved in a new study