CITI Training

What is the main function of the Bayh-Dole Act of 1980 as it relates to academic institutions?

It allows institutions to have control over the intellectual property from federally-funded research.

Which of the following is true about conflicts of interest?

Conflicts of interest increase the likelihood of bias.

The National Research Act of 1974

Established the National Commission.

Which of the following statements is true concerning data selection?

Establishing a data selection strategy prior to collecting data decreases the chance of a biased outcome.

The use of prisoners in research is a concern under the Belmont principle of Justice because:

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

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

Informed consent is considered an application of which Belmont principle?

Respect for Persons

According to the U.S. Federal Research Misconduct Policy, falsification involves:

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

The entity that normally is supposed to determine whether an academic researcher's conflict of interest can be managed is:

A conflict of interest committee

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.

What are the three main goals of data lifecycle management (DLM)?

Confidentiality, availability, and integrity

The two main criteria that the National Science Foundation (NSF) uses to evaluate grant proposals are:

Intellectual merit and broader impact.

Which of the following statements most accurately describes the mentoring relationship?

Mentors teach trainees about aspects of academic life that are not covered in textbooks.

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

Occur at least annually.

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 (A significant risk device presents a potential for serious risk to the health, safety, or welfare of the subject and it: (1) Is intended to be implanted into a human; (2) Is used in supporting or sustaining human life; (3) Is of substantial importance in diagnosing, curing, mitigating, or treating disease, or otherwise prevents impairment of human health; or (4) Otherwise presents serious risk to health, safety, and welfare of a subject.)

In considering NBAC's analytic approach, an otherwise competent person who is acutely ill might be considered at especially high risk of harm for:

Situational cognitive vulnerability

Which of the following is most directly related to successful mentoring?

Someone who is committed to the professional development of the trainee.

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

Which of the following is true regarding academic-industry collaborations?

The industry sponsor typically owns the data from research that it funds.

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

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

The HIPAA "minimum necessary" standard applies...

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

Which type of inappropriate practice most likely occurred if a researcher takes credit for someone else's idea and does not acknowledge the original source?

plagiarism

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 of the following most accurately describes data lifecycle management (DLM)?

It refers to the tools and processes for handling data during a research study and after it concludes.

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

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

Which of the following is true about the management of conflicts of interest?

Management plans are often created to reduce the impact of conflicts of interest.

Which of the following represents plagiarism?

Presenting someone else's ideas or words and claiming them as one's own.

Reviewers have a responsibility to promote ethical peer review by:

Preserving the confidentiality of the submission.

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.

Which of the following is a key reason why international collaborations can be challenging?

The collaborators may have different disciplinary and cultural backgrounds and practices.

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

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.

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 is unlikely to cause group harms. It is unlikely that such a study will be harmful to women with breast cancer or to women in general who do not participate in the study. The results from other hypothetical studies listed have the potential to be distressful, to stigmatize or in another way harm individual members of the Group who did not actively participate in the research.

An investigator obtains consent and HIPAA authorization from subjects to review their medical records and HIV status. He plans to go back to the medical record, so the HIV status information is stored along with subject identifiers in a database that he keeps on his laptop computer. His laptop is stolen. This incident constitutes:

A breach of confidentiality

Which of the following statements best exemplifies the importance of mentoring?

A mechanism to transmit values and standards of professional conduct.

Which of the following is most likely to create a poor relationship between a mentor and a trainee?

A mentor who recruits trainees merely for the mentor's own career advancement.

Which of the following statements is true regarding the responsibilities of a reviewer?

A reviewer's conflict of interest should be disclosed to the journal editor or grant agency.

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 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.

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?

What is the main function of a Technology Transfer Office with respect to collaborative research?

It helps collaborative researchers to commercialize their work.

A researcher's membership on an advisory board with an organization sponsoring research can create a COI because:

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

Which of the following statements is true regarding authorship practices?

Both within and between disciplines, practices differ with regard to who should be included as an author, and in what order they should be listed. (Trainees should understand the variety of authorship policies that are common to their own field and sub-fields. It is best to have these policies explained and understood when a trainee first begins a project.)

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)

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:

Cognitive or communicative 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:

Economic vulnerability

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

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

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 of the following statements most accurately describes the review process for grant proposals?

Funding agencies usually have committees, often with external reviewers, that assess the quality of the proposal.

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 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.

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:

Researchers must recognize that the primary harm in social and behavioral research is the breach of confidentiality. This risk of harm is especially significant when the data being collected involves an employee's experiences at their place of employment (for example, a situation where the employers have ongoing efforts to reduce healthcare costs by getting rid of employees who they believe will cause their healthcare insurance premiums to rise).

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

Respect for Persons, Beneficence, Justice

The defining characteristic of a mentor is someone who:

Takes a sincere interest in the growth and development of a trainee.

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

True (Genetic information has the potential to cause significant harm to research subjects if inappropriately disclosed, including harm to a subject's privacy, social standing, family obligations, employment/employability, or insurance/insurability)

Issued in 1974, 45 CFR 46 raised to regulatory status:

US Public Health Service Policy (45 CFR 46 raised to regulatory status the US Public Health Service policy of 1966 "Clinical research and investigation involving human beings".)

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.

Which of the following is included in the Nuremberg Code:

Voluntary consent (The Nuremberg Code included the requirement of the voluntary consent of subjects. While all of the choices are valid ethical concerns, none of the other choices were included in the Nuremberg Code.)

An example of an institutional COI is:

An industry sponsor pays for the construction of a new research laboratory at the organization (An institutional COI can arise when the financial interests of an organization or institutional official (acting within his or her authority on behalf of the organization) may affect or appear to affect the research conducted under the organization's auspices. This could include significant gifts received by the organization from the sponsor of human subjects research.)

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.

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.

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

Community consultation is used with the community of interest to make sure that potential harms are recognized and understood, and that the study is designed to provide benefits to the community. Collaborative IRB review with tribal IRB's will also maximize the likelihood that group harms are minimized. On-going consultation ensures that group leaders are provided with accurate information about the research as it progresses. By planning disclosure of the research, the researcher informs the community about how the research results will be disclosed early on in the process to reduce the possibility of harms to the group as the research is published or presented.

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

Which of the following is a responsibility of each author?

Confirming that data have been accurately presented in the paper (Along with other responsibilities, each author should confirm that data have been accurately presented.)

Which of the following is true regarding data acquisition?

Data acquisition should follow a detailed collection plan that is set in advance.

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:

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

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

Death of Research Subject (Jesse Gelsinger)

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.

A research collaboration can be enhanced by:

Discussing intellectual property issues while the collaboration is forming.

Which of the following is the most effective strategy for preventing research misconduct? (a) good mentoring (b) Creating hypercompetitive research environments (c) Limiting data sharing (d) Working unsupervised

Good mentoring

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. The assent of minors to participate in research is required, unless the "capability of some or all of the children is so limited that they cannot reasonably be consulted or that the intervention or procedure involved in the research holds out a prospect of direct benefit that is important to the health or well being of the children and is available only in the context of the research" (45 CFR 46.408). The IRB determined that an 8-year-old was capable of providing assent for participation in this study, and in this situation, the child's decision cannot be overruled by the permission from one or both parents.

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.

Which of the following statements is true regarding the International Committee of Medical Journal Editors (ICMJE) guidelines?

Individuals who do not meet the criteria for authorship but who have made a noteworthy contribution are normally listed in the acknowledgments section. (Authors must make significant contributions to the research. In general, contributors who do not meet the criteria for authorship should usually be listed in the acknowledgments section.)

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 (Hearing screenings, blood draws, and other physical exams are usually designed to collect physiological data, not information about attitudes and beliefs. Interviews are designed to collect information about attitudes, beliefs, and behavior and are data collection methods typically used by SBR researchers.)

Which of the following most accurately describes an institutional conflict of interest?

It occurs when an institution's financial or non-financial interests could interfere with its research activities.

Which of the following most accurately describes a conflict of commitment?

It occurs when outside activities interfere with obligations to one's primary employer.

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 (The NIH is a PHS agency. Therefore, this proposed research is subject to the PHS regulation regarding objectivity in research, which requires researchers to submit COI disclosures no later than the time a proposal is submitted to a PHS funding agency.)

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. 45 CFR 46.102(i) defines minimal risk as the "probability and magnitude of harm or discomfort anticipated in the research are not greater in and of themselves than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests." Because the risk associated with collection of a single voided urine specimen is not greater than risks encountered in the course of a routine physical examination, this research constitutes "minimal risk."

Which of the following is the most appropriate step to take if authors believe that their manuscript was reviewed unfairly?

The author can contact the editor with their concerns.

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.

Which of the following is true regarding an acknowledgments section?

The contributions of technicians and other researchers are often listed in the acknowledgments section if they do not meet all of the criteria for authorship. (Sponsors and others who were involved with a project but who do not meet all of the requirements of an author are usually recognized in the acknowledgments section in the article.)

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.

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.

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. (When the research intends to directly benefit only the fetus, the consent of both the pregnant woman and the father of the fetus must be obtained. It is important to distinguish here between experimental procedures (research) performed with the hope of providing for the health needs of the fetus, and proven therapy for the fetus. In the case of unproven (research) interventions, the mother's refusal is binding. Only in the case of fetal therapy of proven value may the objection of the mother be overruled, and then only in limited circumstances and by action of the court.)

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. (According to 46.204(d), if the purpose of the activity is to meet the health needs of the mother, then the consent of the father is NOT required.)

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.

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. (According to the 1994, NIH Guidelines, the only justification for exclusion of non-pregnant women of childbearing potential was compelling evidence that inclusion would be inappropriate with respect to the health of the subjects, or to the purpose of the research.)

What is the primary responsibility of oversight bodies (such as an IRB or IACUC)?

To determine compliance with regulatory requirements, including those relating to protecting research subjects.

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 judgment (Based on physician's best medical judgment the patient may be treated with the drug since it is a marketed drug with an approved labeled dosage. An IND is not required. There is no research being conducted for the purpose of changing the labeling of the drug or marketing a new indication.)

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

Workers who serve as research subjects at their place of employment are vulnerable to numerous kinds of pressure from their co-workers, unions, and employers. Pressure can be applied to workers in subtle ways (such as, an employer who comments that if the research concludes that the organization is spending more on healthcare than other similar organizations, there may be lay-offs).

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:

children, prisoners, and individuals with impaired decision-making capacity.

Which type of research misconduct most likely occurred if someone intentionally removes data points from the data set in order to generate a deceptive conclusion?

falsification