CITI Module questions
When a research project includes the collection of biological samples, all planned future uses of the samples, identifiers, and the data obtained from the samples, must be fully explained to the research subject. True False
true
A research collaboration can be enhanced by:
Discussing intellectual property issues while the collaboration is forming.
The PHS regulations about financial conflict of interests require which party to disclose significant financial conflicts of interest? Sponsor Applicants submitting marketing applications for drugs, biologics, or devices IRB Member Organization Researcher
Researcher
Issued in 1974, 45 CFR 46 raised to regulatory status:
US Public Health Service Policy
what 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
Which of the following is true regarding the traditional peer review process: Under single-blind review, the identity of the reviewer is revealed to the author. Under double-blind review, the identity of the author is revealed to the reviewer. Under single-blind review, the identity of the author is revealed to the reviewer. Under double-blind review, the identity of the reviewer is revealed to the author.
Under single-blind review, the identity of the author is revealed to the reviewer.
Which of the following is considered to be a Significant Financial Interest? Stock ownership of $3,000 in a publically traded company Consulting fees of $5,500 received in the last six months from a privately held company Travel reimbursed by Georgia State University Income of $7,000 received from a mutual fund for which no direct control of the investment decision is made.
Consulting fees of $5,500 received in the last six months from a privately held company
Institutions are required by the U.S. Public Health Service to do which of the following: Eliminate any and all conflicts of interest. Apply the same financial conflict of interest policy to all researchers regardless of their funding source. Update their financial conflict of interest policy every four years. Evaluate whether a significant financial interest is related to an investigator's research and constitutes a financial conflict of interest.
Evaluate whether a significant financial interest is related to an investigator's research and constitutes a financial conflict of interest.
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. Providing detailed information about the study and obtaining the subject's consent to participate. Ensuring that persons with diminished autonomy are protected. Ensuring that the selection of subjects includes people from all segments of the population.
Determining that the study has a maximization of benefits and a minimization of risks.
HIPAA includes in its definition of "research," activities related to: Quality assessment and improvement. Anything a researcher does in a federally-supported laboratory. Population health. Development of generalizable knowledge.
Development of generalizable knowledge.
The U.S. Public Health Service (PHS) requires institutions to:
Disclose their investigators' new financial conflicts of interest to the PHS awarding component within 60 days of discovering them.
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
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.
A researcher's membership on an advisory board with an organization sponsoring research can create a COI because: The organization can have policies that affect the research 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 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
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. Researchers must only submit COI disclosures if they have a significant financial interest related to the research 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
No later than the time of proposal submission
If a friendship with an applicant could interfere with a hiring decision, this is typically referred to as:
A personal conflict of interest.
Which is an example of a situation where deferential vulnerability might be a factor? An employer recruiting among persons who directly report to him A physician recruiting his patients A college professor recruiting among his students An army medical officer recruiting subjects among lower ranks
A physician recruiting his patients
According to the U.S. Public Health Service regulations, investigators are required to disclose travel sponsored or reimbursed by:
A publicly traded company.
An Investigator may be which of the following: Full- and Part-Time Faculty and Staff Staff, Students, Consultants, Collaborators and Evaluators Principal Investigator, Project Director and Co/Sub Investigators All of the above
All of the above
Which of the following practices can be effective in minimizing group harms? Ongoing consultation Planning disclosure of research results Community consultation Collaborative IRB review All of the above
All of the above
The FDA's regulations related to electronic records and electronic signatures (21 CFR Part 11) are intended to: Prohibit the use of paper printouts of electronic records. Provide specific standards for the informed consent process. Allow the use of electronic documents and signatures in the regulatory process for drugs and devices. Require use of electronic records for all drug research.
Allow the use of electronic documents and signatures in the regulatory process for drugs and devices.
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"). A designated privacy official (a.k.a., "Privacy Officer"). An organizational IRB or Privacy Board.
An organizational IRB or Privacy Board, privacy official ("Privacy Officer"), or security official ("Security Officer"), depending on the issue.
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 Economic vulnerability Social vulnerability Institutional vulnerability
Economic vulnerability
At a minimum, how often are investigators funded by the U.S. National Institutes of Health required to receive conflict of interest training?
Every four years.
What is the term for management controls that are built in to a research study (for example, independent data analysis)? Required controls Mandated controls Objective controls Inherent controls
Inherent controls
Which of following most accurately describes when investigators pursuing U.S. Public Health Service funding are required to disclose their significant financial interests to their institution? Twice per year. Within 90 days of discovering or acquiring a new significant financial interest. No later than the time of applying for funding. After they receive funding but before they start their research.
No later than the time of applying for funding.
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 researcher will not be interacting/intervening with subjects and the data has no identifiers. The database reflects data collected originally for surveillance purposes.
The researcher will not be interacting/intervening with subjects and the data has no identifiers.
In any collaboration, data ownership is typically determined by:
The type and source of funds used to support the project.
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: Who will have access to the data. If personal identifiers will be retained and used in the data analysis. How the data will be collected and secured. If the study results, if any, will be included in the employee's personnel records. All of the above
all of the above
Which of the following is a responsibility of each author? Corresponding with the journal editor. Performing the data analysis. Confirming that data have been accurately presented. Directly observing data collection.
Confirming that data have been accurately presented.
Which of the following is true about conflicts of interest? A financial dimension must be present in order for it to be a conflict of interest. A project must be funded by an external source in order for any conflicts of interest to be present. Conflicts of interest increase the likelihood of bias. Researchers are not permitted to have any conflicts of interest.
Conflicts of interest increase the likelihood of bias.
Which of the following is true regarding data acquisition? Because data acquisition is often technical, the research team does not need to be involved and it can be outsourced to external professionals. Data acquisition should follow a detailed collection plan that is set in advance. Existing data sets from other researchers can be used without restriction. A data acquisition plan is not needed because the process can be very flexible to accommodate changes that occur as the research unfolds.
Data acquisition should follow a detailed collection plan that is set in advance.
What is the main function of a Technology Transfer Office with respect to collaborative research?
It helps collaborative researchers to commercialize their work.
Which is true of inducements in research? Offering $10 for an hour long research study constitutes undue inducement. 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. Like coercion, undue inducement is easy for IRBs to determine. 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.
Which of the following is true regarding industry-sponsored research? Industry sponsors are not permitted to review data from academic projects that they sponsor. The research must take place within the industry's facilities and not at a university. Industry sponsors of research may seek to place restrictions on the disclosure of research results. Industry sponsors must give ownership of the data to the research team
Industry sponsors of research may seek to place restrictions on the disclosure of research results.
Which of the following is considered a SBR data collection method? Interviews Blood draws Physical exams Hearing/audiological screenings
Interviews
Which of the following most accurately describes the practice of ghost authorship? It is a situation where the individual who wrote the manuscript is not listed as an author. It is a situation where someone provides constructive comments on a manuscript before it is submitted. It is a situation where a high profile researcher is added as an author to improve the chance of publishing a manuscript. It is a situation where someone does not include all of the data that have been collected.
It is a situation where the individual who wrote the manuscript is not listed as an author.
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. It refers to the obligation to share data imposed by professional journals. It refers to the obligation to uphold data confidentiality imposed by federal law. It refers to the data collection requirements of a particular organization.
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? Shorter in duration and less frequent than physical harms More likely to be treatable by researchers than physical harms Less predictable, more variable, and less treatable than physical harms Less serious and more frequent than physical harms
Less predictable, more variable, and less treatable than physical harms
The use of prisoners in research is a concern under the Belmont principle of Justice because:
Prisoners may be used to conduct research that only benefits the larger society
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 database system to assign passwords. The medical center to replace the use of paper records with electronic records for its research. The use of paper records meeting FDA requirements. The investigator to email subjects about the research.
The medical center to replace the use of paper records with electronic records for its research.
Which of the following is most likely to own the data resulting from a research project? A faculty member working on a federally-funded project. A graduate student working under the direction of a faculty member. A technician who collected the data. The organization that receives federal funding for a project.
The organization that receives federal funding for a project.
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 father of the fetus only. The pregnant woman only. The pregnant woman and her legally authorized representative. The pregnant woman and the father of the fetus.
The pregnant woman and the father of the fetus.
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? Inform the patient that the drug cannot be prescribed Treat the patient with the drug based on physician's best medical judgment Submit an Investigational New Drug (IND) application before treating the subject Submit a research protocol for IRB review and approval before treating the patient
Treat the patient with the drug based on physician's best medical judgment
which of the following is considered to be research misconduct: conflict of interest harassing a co-worker plagiarism gift authorship
plagiarism
the typical first main phase in response to a research misconduct allegation is called
the inquiry
When workers are asked to participate in a research study, vulnerabilities related to the subject's employment may include: The research study's finding could affect an employee's pay, benefits, or promotion potential. The employer may encourage or deny participation of workers. Employees may experience pressure from management to participate in the study because the employer perceives the study to be advantageous to the organization. Unions may encourage employees to participate with the expectation that "entitlements" may follow from study results. All of the above
all of the above
after the inquiry if there is sufficient evidence to proceed, what is the next main phase that takes place in response to a research misconduct allegation
an investigation
which of the following is true regarding research misconduct: a central federal agency handles all cases of research misconduct funding agencies normally perform their own misconduct inquiry before the institution becomes involved the US government is required to reveal publicly the identity of any person who commits misconduct federal funding agencies typically rely on an institution to make the initial response to an allegation of research misconduct
federal funding agencies typically rely on an institution to make the initial response to an allegation of research misconduct
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: Prisoners Workers Children Individuals with Impaired Decision-Making Capacity
workers
Which of the following studies has the LEAST potential to create group harm? A genetic study to identify ancestral relationships between DNA obtained from a Cherokee Indian burial site and members of a Central Asian community. A Phase 3 clinical trial of a new anticancer agent in middle-aged women diagnosed with breast cancer. An anonymous survey of state high school teachers, athletic directors, and administrators that, among other things, asks for perceptions about the sexual preferences of their high school coaches. A study that surveys the perceptions of nurses and other health care workers about illegal drug use among cardiovascular surgeons in New York City.
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
If researchers allow their moral or other personal beliefs to influence their objectivity, this is most likely an example of:
A conflict of conscience
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
Which of the following statements most accurately describes a mitigation report? A report to the U.S. Public Health Service of efforts that will be taken by the institution to deal with any bias that was found in research conducted while there was an unreported financial conflict of interest. A report from an institution telling the U.S. Public Health Service how bias will be minimized before a research project begins. An annual report to the U.S. Public Health Service of all the significant financial interests of the institution's PHS-funded researchers. A report from the U.S. Public Health Service to an institution of what must be done to deal with financial conflicts of interest of its PHS-funded researchers.
A report to the U.S. Public Health Service of efforts that will be taken by the institution to deal with any bias that was found in research conducted while there was an unreported financial conflict of interest.
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 is not required, however, both parents must give permission for the inclusion of the adolescent child. Assent of the child only is required. Assent is not required, however, one parent must give permission for the inclusion of the adolescent in this study. Assent of the child and permission of both parents are required.
Assent of the child and permission of both parents are required.
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 Emotional distress from discussing the topic Recruiting strategies to ensure quick enrollment and completion of the research
Breach of confidentiality from the focus group subjects (therapists)
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? Possibility of emotional distress for subjects from the questions themselves Data analysis from a large sample size Recruitment of subjects to ensure varied characteristics of the sample size Confidentiality of the individual subject's responses
Confidentiality of the individual subject's responses
What are the three main goals of data lifecycle management (DLM)?
Confidentiality, availability, and integrity
Which of the following brought increased public attention to the problems with the IRB system? HHS Inspector General Report of 1998 "Shut Downs" by OHRP Death of Research Subject (Jesse Gelsinger) 1983 Presidential Commission Report
Death of Research Subject (Jesse Gelsinger)
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. Data that does not cross state lines when disclosed by the covered entity. Use of decedents' information, 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.
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? Withhold this new information to avoid confusing the subject with other treatment options or alternatives. Tell the subject about the new drug but discourage him from switching treatments until the study is completed. 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. Do not tell the subject about the new drug because physicians have the right to try out new treatments with their patients.
Give the subject comprehensive information about the new drug, including its side effects. Discuss the pros and cons of both the investigational drug and the commercially available drug and then allow the subject to decide whether to withdraw from the research to take the new drug.
Which of the following is the primary criterion for authorship? Correcting grammatical mistakes in the manuscript. Obtaining financial support for the work. Having read a draft of the manuscript before it is published. Having made a significant intellectual contribution to the work.
Having made a significant intellectual contribution to the work.
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? Request the child reconsider assenting to the study. Seek permission from one of the child's parent instead. Honor the child's decision. Consent both of the child's parents instead.
Honor the child's decision.
Which of the following statements is true regarding the reporting of outside interests and the management of conflicts? Investigators must disclose their significant financial interests related to their institutional responsibilities and not just those related to a particular project. Investigators must disclose all of their financial interests regardless of whether they are related to a research project. Investigators are responsible for developing their own management plans for significant financial interests. The institution must report identified financial conflicts of interest to the U.S. Office of Research Integrity.
Investigators must disclose their significant financial interests related to their institutional responsibilities and not just those related to a particular project.
Which of the following statements is true? Many institutions have conflict of commitment policies even though they are not strictly required to by federal agencies. Federal agencies require institutions to have policies on both conflict of commitment and conflict of conscience. Federal agencies require institutions to have a conflict of conscience policy. All institutions have conflict of conscience policies because they are required by state governments.
Many institutions have conflict of commitment policies even though they are not strictly required to by federal agencies.
Which of the following statements about mentoring is true? The mentor - trainee relationship is rarely of benefit to the mentor. Mentors can provide valuable advice to trainees regarding career decisions and contacts with leaders in their field of research. Junior faculty members need no further mentoring for their professional development. Trainees are bound to find the one individual who is the "truly complete mentor".
Mentors can provide valuable advice to trainees regarding career decisions and contacts with leaders in their field of research.
Which of the following statements most accurately describes the mentoring relationship? Mentoring relationships happen naturally and do not require work. Graduate students, but not mentors, gain from the mentoring relationship. A mentoring relationship must not turn into a friendship or else it is a failure. Mentors teach trainees about aspects of academic life that are not covered in textbooks.
Mentors teach trainees about aspects of academic life that are not covered in textbooks.
A federally funded research study involving children 8 to 12 years old involves collecting a single voided urine sample to assess the frequency of asymptomatic proteinuria (higher amounts of protein in the urine without any signs or symptoms of illness or infection). According to 45 CFR 46, an IRB's risk assessment would likely conclude that this study involves: More than minimal risk with prospect of direct benefit to the child. More than minimal risk with no prospect of direct benefit to the child. No more than minimal risk to the child. No risk to the child and no further IRB review is required.
No more than minimal risk to the child.
Which of the following is the most appropriate way to handle a conflict of conscience relating to a project? Notify relevant parties that a conflict may exist and seek advice about whether to accept or decline the project. Remain quiet about the conflict and continue with one's work. Report the issue to the institution's research misconduct office. Follow all of the federal regulations relating to conflicts of conscience.
Notify relevant parties that a conflict may exist and seek advice about whether to accept or decline the project.
IRB continuing review of a greater than minimal risk approved protocol that is currently enrolling subjects must:
Occur at least annually.
The COI management plan aims to: Address disclosure of COIs in multi-center research when a COI is disclosed Eliminate all COIs in research when a COI is disclosed Provide procedures or extras steps to be taken to minimize the risk of bias when a COI is disclosed Reduce IRB review burden when a COI is disclosed
Provide procedures or extras steps to be taken to minimize the risk of bias when a COI is disclosed
Which of the following was the result of the Beecher article? An identification of basic ethical principles Multiple Congressional hearings Realization that ethical abuses are not limited to the Nazi regime Additional FDA regulations
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.
Which of the following is true regarding data sharing and stewardship? Researchers who receive federal funding may have to adhere to a data sharing requirement. Researchers are obligated to share their data prior to a study's completion. Researchers are exempt from any national security requirements with respect to data sharing. Researchers are no longer obligated to manage data after a study concludes.
Researchers who receive federal funding may have to adhere to a data sharing requirement.
Which of the following are the three principles discussed in the Belmont Report? IRB Review, Federal Regulations, Declaration of Helsinki Informed Consent, Institutional Assurance, Researcher Responsibility Respect for Persons, Beneficence, Justice Privacy, Confidentiality, Equitable Selection of Subjects
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? Non-significant risk device Significant risk device
Significant risk device
An investigator received $4,000 of consulting income from a publicly traded drug company over the past 12 months. The investigator also owns stock in that company valued at $2,000. The investigator is submitting a grant to the National Institutes of Health that involves evaluating the effectiveness of a drug produced by the same drug company. Which of the following is true? The aggregate of the consulting income and the stock exceeds $5,000 and therefore is a significant financial interest. The value of stock is not calculated when determining significant financial interests. The investigator does not have a significant financial interest related to the grant because the consulting income is less than $5,000. The investigator does not have a significant financial interest related to the grant because the stock's value is less than $5,000.
The aggregate of the consulting income and the stock exceeds $5,000 and therefore is a significant financial interest.
Which of the following is the most appropriate step to take if authors believe that their manuscript was reviewed unfairly? Nothing; by submitting to the peer review process, authors agree to accept the outcome. The author can contact the editor with their concerns. The author should contact the reviewers directly. The author should ask the editor to reveal the identities of the reviewers.
The author can contact the editor with their concerns.
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. 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. 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.
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.
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 state court where the research is taking place The pregnant woman and the father of the fetus. The father of the fetus only. The pregnant woman only.
The pregnant woman and the father of the fetus.
What is the most appropriate process for research collaborators to use in determining which journal they should submit their work to?
The research team should discuss the issue early on and while the project is ongoing.
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 is required for a student research project The study includes only research subjects that are healthy volunteers. The study does not require informed consent or survey instruments. The study involves no more than minimal risk and meets one of the allowable categories of expedited review specified in federal regulations
The study involves no more than minimal risk and meets one of the allowable categories of expedited review specified in federal regulations
Which of the following most accurately describes the responsibilities of a trainee in the mentoring relationship? A trainee is too junior to have any responsibilities in the mentoring relationship. The trainee's primary role is to avoid seeking the mentor's advice in order to grow as a researcher. The trainee must take an active role in the relationship and clearly communicate needs and expectations. The trainee must take the lead in all aspects of the relationship.
The trainee must take an active role in the relationship and clearly communicate needs and expectations.
The main reason that grant proposal reviewers with a conflict of interest should remove themselves from the review process is because:
Their removal lessens the chance that bias will affect the review process.
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.
There is compelling evidence that inclusion would be inappropriate with respect to the health of the subjects.
A HIPAA authorization has which of the following characteristics: Cannot be combined with any other document related to the research. Is provided at the investigator's discretion. 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.
Uses "plain language" that the data subject can understand, similar to the requirement for an informed consent document.
Which of the following is included in the Nuremberg Code: Confidentiality of data Voluntary consent Equitable selection of subjects Additional protection for vulnerable subjects
Voluntary consent
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. is always the same, regardless of the number of records involved. is limited to the information elements the data subject specifically requests. is at the discretion of the organization, given its accounting policies.
Development of generalizable knowledge.
Which of the following statements is true regarding authorship practices? In scientific fields, authors have to be listed in alphabetical order. Different disciplines have different practices about who should be included as an author. In scientific fields, authors have to be listed in order of seniority. Journals do not permit a graduate student to be listed as the first author.
Different disciplines have different practices about who should be included as an author.
A general requirement for the informed consent form is that it may not include any exculpatory language. Exculpatory language is that which waives or appears to waive any of the subject's legal rights or releases or appears to release those conducting the research from liability for negligence. Which of the following statements in a consent form is an example of exculpatory language? In the event of any injury you may have related to this research, you will be given medical treatment. 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 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. I waive any possibility of compensation for injuries that I may receive as a result of participation in this research.
I waive any possibility of compensation for injuries that I may receive as a result of participation in this research.
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? Prejudice, physical control, manipulation, and coercion Physical control, coercion, undue influence, and neglect Coercion, undue influence, neglect, and disrespect Physical control, coercion, undue influence, and manipulation
Physical control, coercion, undue influence, and manipulation
Professor Smith is submitting a proposal to the NIH for a grant to support his research on a novel treatment for alcoholism. Unfortunately, the proposal deadline is 5:00pm today, and a colleague listed on the proposal, Professor Jones, has not completed a Disclosure Form. However, Professor Jones told Professor Smith over the phone that she had nothing to report, and she did not have time to fill out the Disclosure Form because she had to take her dog to the veterinarian. Which of the following could Professor Smith to do ensure the proposal is submitted on time? Professor Smith could fill out the Disclosure Forms for Professor Jones so that the Office of Sponsored Programs could submit the proposal. Professor Smith could get approval from his Department Chair to authorize the Office of Sponsored Programs to submit the proposal without Professor Jones' Disclosure Form. Professor Smith could drive to Professor Jones' veterinarian with a Disclosure Form, have her fill it out, and provide the form to the Office of Sponsored Programs in time for the Office of Sponsored Programs to submit the proposal. Professor Jones promised to submit the Disclosure Form by the end of the week.
Professor Smith could drive to Professor Jones' veterinarian with a Disclosure Form, have her fill it out, and provide the form to the Office of Sponsored Programs in time for the Office of Sponsored Programs to submit the proposal.
Which of the following financial conflict of interest information must be made available by institutions on a public website or within five business days upon request? The financial interests of all research administrators at an academic center. The financial conflicts of interest of senior/key personnel on projects funded by the U.S. Public Health Service. The financial interests of all faculty at an academic center. The conflicts of commitment of researchers funded by the U.S. Public Health Service.
The financial conflicts of interest of senior/key personnel on projects funded by the U.S. Public Health Service.
Within how many days of acquiring or discovering a significant financial interest is the investigator required to submit an updated disclosure to the institution?
30 days.
Which of the following is most likely to be considered a conflict of commitment? A senior researcher has to resolve a dispute between two junior researchers. A new graduate is deciding between job offers from two institutions. A researcher cancels laboratory meetings in order to perform consulting work. A researcher takes part in political activities during weekends.
A researcher cancels laboratory meetings in order to perform consulting work.
Which of the following statements is true regarding the responsibilities of a reviewer? A reviewer's expertise should be in a different field than that of the manuscript so the work can be evaluated from the perspective of a neutral reader. A reviewer's conflict of interest should be disclosed to the journal editor or grant agency. A reviewer should evaluate a competitor's manuscript more critically than other manuscripts. A professor can have a student complete the review without notifying the journal.
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.
The main focus of NIH's conflict of interest policy is:
Financial conflicts of interest
Which statement most accurately describes a conflict of conscience? It occurs when financial interests bias research. It occurs when an individual's personal beliefs could affect the performance or outcome of research. It occurs when a financial reward is provided for outstanding work. It occurs when researchers have two or more responsibilities to complete at the same time.
It occurs when an individual's personal beliefs could affect the performance or outcome of research.
Which statement most accurately describes a conflict of commitment? It occurs when outside activities interfere with one's responsibilities to an employer. It involves a monetary gain by one party over another party. It occurs when an institution does not follow the financial rules from a funding source. It can only occur between an institution and an outside organization.
It occurs when outside activities interfere with one's responsibilities to an employer.
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 statements is true regarding the responsibilities of reviewers? Reviewers should be an advocate for the author and to help convince the editor to publish the manuscript. Reviewers can make use of the information in a manuscript before it is published, giving them an advantage over competitors. Reviewers are not supposed to turn down opportunities to review manuscripts even if they lack the relevant expertise. Reviewers should identify the positive and negative aspects of a manuscript, and indicate where improvements are needed.
Reviewers should identify the positive and negative aspects of a manuscript, and indicate where improvements are needed.
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. Exclude the man from the study. The investigator can go ahead and enroll the man without a signed consent. Consult a colleague about his opinion. If the colleague agrees, enroll the man without a signed consent.
Send a copy of the informed consent via facsimile to the subject's wife. After she has had the opportunity to speak to the investigator, she can sign the informed consent and fax it back.
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 Communicative vulnerability Economic vulnerability Capacity-related cognitive vulnerability
Situational cognitive vulnerability
Which of the following is most directly related to successful mentoring? A passive mentoring relationship on the part of the trainee. A working relationship in which the mentor harshly criticizes the trainee's work. The absence of boundaries in the mentor-trainee relationship. Someone who is committed to the professional development of the trainee.
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 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 an Investigational Device Exemption (IDE) application to the FDA Submit the research protocol to the IRB for review and submit an IND application to the FDA before conducting the research
Submit the research protocol to the IRB for review and submit an IND application to the FDA before conducting the research
The defining characteristic of a mentor is someone who:
Takes a sincere interest in the growth and development of a trainee.
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 research does not meet the federal definition of human subject research. The study only requires IRB review if it is funded by the National Institutes of Health (NIH). The study is human subject research which must be reviewed by the full IRB. The study is human subject research which is eligible for expedited review.
The study is human subject research which is eligible for expedited review.
Which of the following is true regarding authors who seek to publish the same content in multiple papers? The research record is not affected by an author who publishes the same work multiple times. Using the same content in multiple papers is deceptive if it is not properly disclosed to journal editors or other relevant entities. Journal editors do not require authors to obtain permission for reusing the same content. Authors are never allowed to publish the same content multiple times.
Using the same content in multiple papers is deceptive if it is not properly disclosed to journal editors or other relevant entities.
