CITI Training

Which of the following most accurately describes the risks associated with SBR?

Less predictable, more variable & less treatable than physical harms

Which of the following practices can be effective in minimizing group harms?

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

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 participants

The National Research Act of 1974

Established the National Commission

IRB continuing review of a greater than minimal risk approved protocol that is currently enrolling subjects must:

Occur at least annually

The PHS regulations about financial conflict of interests require which party to disclose significant financial conflicts of interest?

Researcher

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.

An investigator proposes to study a marketed product sold to treat high blood pressure in individuals over age 12 using a liquid formulation for children under age 12. The drug sponsor hopes that the information from the research can be used to change the labeling for use of the drug in younger children. Which of the following is the investigator's most appropriate course of action?

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

A full IRB committee meeting is convened and one agenda item is a new research proposal to evaluate how mothers interact with their children with learning disabilities. The inclusion criteria require the children to be a minimum of five years of age. The protocol requires the mother of the child to look at the child without any expression and not to talk to the child for three minutes. The committee considers that the risks to the children could be more than minimal, but the proposal does not include adequate information to make a final determination regarding the risks. Which of the following best describes how the IRB should proceed?

Table the protocol and ask the investigator to provide the needed information for review by the full board at the next convened meeting.

During the course of a study, the researcher reports to the IRB that the consent form needs to be changed to reflect her new contact information. Who can approve this change?

The chair of the IRB

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.

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

A convened IRB Committee approved a protocol as a more than minimal risk study on February 15, 2019. In 2020, the study remains open to enrollment with 14 subjects currently enrolled and receiving the intervention. Which of the following best describes IRB continuation review requirements for this study?

The research must be re-reviewed by the convened IRB on or before February 14, 2020.

A researcher wants to conduct a secondary analysis using a Centers for Disease Control and Prevention (CDC) database that was collected by the agency solely for surveillance purposes from 1996-2006. The researcher did not participate in the initial collection of the data. The database is publicly available. The database does not include any identifiers. The IRB makes a determination that the individuals whose records will be reviewed do not meet the federal definition of human subjects. Which of the following considerations was relevant to the IRB's determination that this activity does not constitute research with human subjects?

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

According to current NIH Guidelines, which of the following is adequate justification for exclusion of women from NIH-funded research?

There is compelling evidence that inclusion would be inappropriate with respect to the health of the subjects

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:

all of the above

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

economic vulnerability

Identify the following groups that are protected in the federal regulations (45 CFR 46), specifically in Subparts B, C, and D with additional protections:

pregnant women, prisoners, children

Informed consent is considered an application of which Belmont principle?

respect for persons

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

respect for persons, beneficence, justice

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

significant risk device

An academic medical center is selecting a new database system for clinical research. The system needs to be "Part 11 compliant" in order to allow:

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

Which of the following is included in the Nuremberg Code:

voluntary consent

HIPAA's protections for health information used for research purposes...

Supplement those of the Common Rule and FDA.

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.

According to federal regulations, which of the following best describes when expedited review of a new, proposed study may be used by the IRB?

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

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

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.

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 judgement

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

The federal regulation, 45 CFR 46, Subpart A (the Common Rule) also includes a number of subparts (Subpart B, C, D, and E), which IRBs are required to follow. Which one of the following is not included in these subparts?

Elderly

How long is an investigator required to keep consent documents, IRB correspondence, and research records?

For a minimum of three years after completion of the study

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

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

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

Prisoners

Which of the following was the result of the Beecher article?

Realization that ethical abuses are not limited to the Nazi regime

A subject in a clinical research trial experiences a serious, unanticipated adverse drug experience. How should the investigator proceed, with respect to the IRB, after the discovery of the adverse event occurrence?

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

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

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

Vulnerable persons are those who are less able to protect themselves than other persons in a given situation. The Common Rule (45 CFR 46, Subpart A) has specific requirements for the following vulnerable populations, except:

workers

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

The Belmont Report's principle of respect for persons incorporates at least two ethical convictions: first, that individuals should be treated as autonomous agents, and second, that:

persons with diminished autonomy are entitled to protection

Which of the following studies has the LEAST potential to create group harm?

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:

A breach of confidentiality

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?

A pregnant woman and the father of the fetus

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.

If you're unsure about the particulars of HIPAA research requirements at your organization or have questions, you can usually consult with:

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

The FDA regulations governing disclosure of individual COIs require:

Applicants submitting marketing applications to disclose financial COIs of researchers who conducted clinical studies

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

Assent of the child and permission of both parents are required

The purpose of a federally supported research study is to examine the effect of scheduled cell searches on gang violence among men confined to drug treatment facilities under court order. Which of the following best describes the IRB's duties when reviewing this research?

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

A researcher is conducting a written survey about people's attitudes toward walking as an exercise option at the local shopping mall that supports a walking program. The survey is anonymous (without codes, names, or other information) and subjects may complete the survey and place it in a box at the shopping mall exits. Which of the following is the most important issue that the researcher addressed in planning the research?

Confidentiality of the individual subject's responses

Identify which types of discrimination the Genetic Information Non-Discrimination Act (GINA) protects individuals from:

Health insurance and employment discrimination

Which of the following brought increased public attention to the problems with the IRB system?

Death of Research Subject (Jesse Gelsinger)

A full IRB committee meeting is convened. The IRB committee roster consists of 15 members. However, only 8 members are in attendance for today's meeting. One of the IRB members is Principal Investigator for one of the studies being reviewed and receives a portion of her salary from the supporting grant. The IRB member who is the Principal Investigator, must recuse herself from the room during both the final deliberations and the vote on the study. Which of the following best describes the committee's action after the member leaves the IRB meeting?

Defer the proposal to the next meeting because of a loss if quorum.

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 the benefits and a minimization of risks

HIPAA includes in its definition of "research," activities related to:

Development of generalizable knowledge

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

A general requirement for the informed consent form is that it may not include any exculpatory language. Exculpatory language is that which waives or appears to waive any of the subject's legal rights or releases or appears to release those conducting the research from liability for negligence. Which of the following statements in a consent form is an example of exculpatory language?

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

HIPAA protects a category of information known as protected health information (PHI). PHI covered under HIPAA includes:

Identifiable health information that is created or held by covered entities and their business associates

Which is true of inducements in research?

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

Which of the following is considered a SBR data collection method?

Interviews

When an IRB is reviewing a research study and they are considering if a potential subject population is vulnerable, they should consider:

Is there a power differential between researchers and subjects?

A researcher calls you stating that he plans to submit a proposal to the NIH for a human subjects research study. He wants to know at what point he and his study team must submit COI disclosures to comply with the PHS regulation.

No later than the time of proposal submission

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.

A full IRB committee meeting is convened and one agenda item is a new research proposal to evaluate how mothers interact with their learning-disabled child. The inclusion criteria require the children to be a minimum of five years of age. The protocol requires the mother of the child to look at the child without any expression and not to talk to the child for three minutes. The committee determined that the mother's required task may upset the child. The IRB approved the study with appropriate language in the parental permission form regarding the possibility that children might become upset. After the start of the study, the Principal Investigator reports to the IRB that, as expected, one of the children became upset. The incident was handled according to the protocol and the child is fine. What should the IRB do with regard to this report?

Nothing

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

During an Institutional Review Board (IRB) meeting, any IRB member who may have a potential COI with a study under review should:

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

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.

The peer review process can create conflicts of interest because the choice of who reviews a potentially publishable project may show:

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

When workers are asked to participate in a research study, vulnerabilities related to the subject's employment may include:

all of the above

Recruiting into research ...

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

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

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

When required, the information provided to the data subject in a HIPAA disclosure accounting ...

must be more detailed for disclosures that involve fewer than 50 subject records.

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