Medical Research Exam Sample Questions

Medical Research Exam Sample Questions

1) The primary studies that provide adequate data for the product's package are done in:

a) Phase I
b) Phase II
c) Phase III
d) Phase IIIB
e) Phase IV

2) Non-clinical work focuses on establishing data showing that:

a) Humans will not be exposed to unreasonable risks in early phase clinical studies
b) Animals will not be exposed to unreasonable risks in animal studies
c) The compound is unique and patentable
d) The compound will lend itself to multiple applications

3) Chronic toxicology studies should be conducted for a period of time consistent with the:

a) Therapeutic indication
b) Results from the single dose studies
c) Expectations for efficacy
d) Earlier safety results
e) Expected life time of the animal species involved

4) If an amendment is necessary to eliminate an apparent immediate hazard to the safety of subjects in a trial, it should:

a) Be implemented before IRB review
b) Be implemented immediately after IRB review
c) Be handled by expedited review
d) Be reported to the FDA before going to the IRB
e) Be implemented within 10 days of receipt from the sponsor

5) What are the two main themes covered by the formal ICH definition of "Good Clinical Practice"?

a) Rights and well being of study subjects and compliance with regulations
b) Rights and well being of study subjects and credibility of the data
c) Compliance with regulations and credibility of the data
d) Compliance with the regulations and the formal marketing approval process
e) Credibility of the data and international consistency

6) The Belmont Report describes three basic principles relevant to the ethics of human subject research. They are:

a) Respect for persons, informed consent and IRB review
b) Justice, beneficence and special considerations for vulnerable populations
c) Respect for persons, beneficence and IRB review
d) Respect for persons, beneficence and justice
e) Beneficence, justice and IRB review

7) Under HIPAA regulations, investigators are not required to obtain signed HIPAA authorization forms from study subjects enrolled in trials prior to April 14, 2003 unless:

a) The IRB requires them to
b) The institution requires it
c) The sponsor requires it
d) The subject must be reconsented (e.g., a protocol amendment)
e) The trial continues beyond April 14, 2003

8) The purpose of the 1988 Expedited NDA regulations was to:

a) Establish procedures to expedite the development and marketing of new therapies for life-threatening illnesses
b) Establish a fee system by which pharmaceutical companies provide funds to the FDA for expedited review of new drug applications
c) Establish additional patient protections in pediatric studies
d) Establish a national database of clinical trials that can be accessed by potential trial subjects

9) Of the following, the best tool to use when preparing a study budget is the:

a) Amount the site was paid for a similar study
b) Protocol activity schedule (activities by visit)
c) Amount the investigator is paid for a typical office visit, multiplied by the number of expected study visits
d) The case report form
e) Talking with other clinical investigators in the same community

10) Any changes in financial disclosure that result in exceeding the thresholds must be reported:

a) During the course of the study
b) For one year following the study
c) During the course of the study and for one year following study completion
d) During the course of the study and for six months following study completion
e) For two years following study completion

11) Which adverse events must a sponsor report to the FDA within 15 days of becoming aware of the event?

a) All serious events
b) All serious related events
c) All serious unexpected events
d) All serious related unexpected events
e) Only serious events that result in death

12) What determines whether an adverse event in a clinical trial is expected or not expected?

a) Whether or not it has been seen regularly with the disease
b) Whether or not it is listed in the Investigator Brochure
c) Whether or not the investigator has seen the event before
d) It is an FDA decision
e) Whether or not is is listed in the protocol

13) One of the reasons adverse events are collected on marketed products is:

a) International reporting requires it
b) Events with relatively low frequency may not be seen during clinical trials
c) Consumers have input that they do not have during trials
d) The product's initial approved labeling may change after marketing
e) This is the only way IRBs can get the information

14) An adverse event that is severe in intensity:

a) Is always classified as serious
b) Is never classified as serious
c) May not meet the definition of serious
d) Should be submitted to the sponsor within 24 hours
e) Is always classified as related

15) The investigator is required by regulation to make a final study report to:

a) The sponsor
b) The institution
c) The FDA
d) The FDA and the sponsor
e) The FDA and the IRB

16) Who is required to sign a 1572 Statement of Investigator form?

a) The investigator
b) The coordinator
c) The investigator and coordinator
d) The investigator and any sub-investigators
e) Anyone substantially involved in the study

17) By signing a Statement of Investigator form, an investigator commits to all of the following except:

a) Conducting the study according to the protocol
b) Complying the the regulations
c) Personally conducting or supervising the trial
d) Obtaining informed consent from subjects
e) Submitting data to the sponsor at least quarterly

18) Who is responsible for assuring that the IRB being used for a study is properly constituted?

a) The sponsor
b) The IRB
c) The investigator
d) The hospital
e) The FDA

19) A potential investigator usually only receives a protocol to review from a sponsor:

a) After an initial visit has been made
b) After an initial telephone conversation
c) After a confidentiality agreement has been signed
d) After the protocol has been through initial IRB review
e) If the sponsor has decided to use the site

20) The process by which a subject voluntarily confirms his or her willingness to participate in a clinical trial is known as:

a) HIPAA authorization
b) IRB approval
c) Legally authorized agreement
d) Intent to treat
e) Informed consent

21) Which signatures are required by FDA regulation to be on the consent form?

a) The investigator
b) The subject
c) The investigator and the subject
d) The subject and a witness
e) The investigator, the subject and a witness

22) Which of the following is not one of the required elements of an informed consent form?

a) The purpose of the research
b) A description of benefits that may be reasonable expected from the research
c) A listing of all site personnel who will be involved in the research
d) A contact person for questions about the research
e) A statement that participation is voluntary

23) For investigational drug studies, the sponsor must provide investigators with the:

a) Investigator brochure
b) Latest package insert
c) Safety surveillance updates
d) Package inserts for all compounds in the same class of drugs
e) Full IND

24) The two main safeguards for human subjects of research are:

a) IRBs and informed consent
b) Informed consent and safety trials
c) IRBS and safety trials
d) The safety surveillance system and IRBs
e) The safety surveillance system and the Belmont Report

25) When assessing the risk/benefit relationship of a potential research study, the IRB must consider:

a) All the risks and benefits inherent in the research project
b) Only the risks and benefits the subjects that may result directly from the research, not including those that the subjects would have encountered even if they had not been in the research
c) Only the risks and benefits seen in earlier studies with the compound
d) Only the risks and benefits that are delineated in the Investigator Brochure

26) There are four main responsibilities of research sponsors. Which of the following is not one of the four?

a) Qualifying and informing investigators
b) Interacting with the IRB
c) Monitoring study conduct
d) Completing regulatory filings
e) Control of product (drug, biologic or device) shipment and disposition)

27) The Bioresearch Monitoring program (BIMO) is the inspection program of:

a) HHS
b) NIH
c) FDA
d) EU
e) ICH

28) A Federal-Wide Assurance (FWA) is only required for:

a) Research in vulnerable populations
b) Research done in teaching institutions
c) Federally sponsored research
d) Research done under FDA guidance
e) All pharmaceutical research

29) Which of the following is false? The 1938 Food, Drug and Cosmetic Act:

a) Required active approval by the FDA
b) Required pre-market approval for new drugs for safety
c) Did not define "safety"
d) Specifically exempted products marketed prior to 1938 as long as their labeling did not change

30) A good tool to use when preparing a study budget is the:

a) Amount the site was paid for a similar study
b) Protocol activity schedule (activities by visit)
c) Amount the investigator is paid for a similar visit, multiplied by the number of expected study visits
d) The case report form
e) Talking with other clinical investigators in the same community

31) If an investigator has a financial interest in a sponsor company or the investigational product:

a) The investigator may not be involved in the trial
b) All parties must be aware of the potential for conflict of interest
c) The investigator may be involved in the trial but the involvement must be approved by the FDA
d) The investigator may be involved in the trial but may not enroll more than ten percent of the total subjects
e) The investigator may be involved with no more than one study of the investigational product

32) The availability of clinical trial information for potential subjects on the Internet was impacted by which piece of legislation?

a) PDUFA
b) FDAMA
c) 1988 Expedited NDA Approval
d) Kefauver-Harris Amendments
e) IND Rewrite Regulations

33) The top five deficiency categories found in FDA audits of sites include all of the following except:

a) Problems with the informed consent form
b) Failure to receive IRB approval for the study
c) Failure to follow the protocol
d) Failure to keep adequate records
e) Failure to report adverse events

34) In general, unused investigational drugs:

a) Can be redispensed by the pharmacy
b) Can be destroyed by the investigator or pharmacy
c) Can be kept for the next study
d) Must be returned to the sponsor

35) During clinical trials, non-serious adverse events are usually:

a) Not collected
b) Collected only during the pre-drug treatment period
c) Collected and submitted to the sponsor at the end of the study
d) Collected and submitted to the sponsor periodically on the case report forms
e) Not collected unless they are severe

36) Serious adverse events that occur after a subject's study participation have to be reported to the sponsor:

a) Always
b) Never
c) Only if they occur during a 30 day period following the subject's participation
d) Only if the event is a death
e) According to the protocol instructions

37) During an audit, the FDA inspector may look at data from:

a) A sampling of the subjects
b) All the subjects
c) All the informed consents
d) a & c above
e) a, b & c above

38) The FDA compliance program covers all of the following entities except:

a) Clinical investigators
b) Institutions
c) Sponsors and sponsor monitors
d) CROs
e) IRBs

39) At the end of the audit, if there are significant findings, the inspector may issue:

a) A Form FDA-483
b) A Form FDA-482
c) An IND
d) A form FDA-157
e) a & b above

40) All study sites must be stopped/discontinued at the same time.

a) True
b) True, but only if all sites have enrolled at least one subject
c) True, but only when there is a safety problem with the investigational product
d) b or c above
e) False

41) During a trial, adverse events that require expedited reporting to the FDA by the sponsor are also required to be reported to all of the investigators working with the drug. These reports are called:

a) SAE reports
b) 1572 reports
c) Spontaneous reports
d) IND safety reports
e) Adverse experience reports

42) The purpose of source documentation is:

a) To verify that subjects exist
b) To verify that the date in the case report forms are consistent with that in the source documents
c) To verify that the protocol is being followed appropriately
d) a & b above

43) The frequency of monitoring visits will vary from site to site depending on:

a) Sponsor SOPs
b) Protocol complexity
c) The disease being evaluated
d) Investigator and staff experience
e) CRA experience and effectiveness

44) All advertising must be approved by the IRB:

a) Before the study begins
b) Before the advertising is used
c) Within 30 days of being used
d) Unless it was used for a previous, similar study
e) Unless the subjects are normal, healthy volunteers

45) Standard elements of a good protocol usually include all of the following except:

a) Title page
b) Study objectives
c) Study design
d) Blinding codes
e) Subject selection

46) Which of the following factors are taken into account when determining the sample size for a study?

a) The magnitude of the effect expected between the treatments
b) The variability of the variables to be analyzed
c) The power of the test
d) Only a & c above
e) a, b & c above

47) Under HIPAA, if a subject withdraws from a trial after the investigator has already submitted the subject's data to the sponsor:

a) The data need to be retrieved
b) The data do not have to be retrieved
c) The data may not be added to the sponsor's database
d) The data may be retrieved after the study is analyzed
e) The data must be de-identified after use

48) Under federal regulations and guidelines, institutions conducting federally funded research are required to:

a) Refer all allegations of scientific misconduct to the Office of Research Integrity (ORI)
b) Be registered with the OHRP, ORI and FDA
c) Establish a sponsored-programs office that operates the IRB
d) Provide training a research ethics to investigators and investigate reports of scientific reports of scientific misconduct

49) If a sponsor requires electronic records during a study, the investigator must be familiar with the regulations found in:

a) 21 CFR 312
b) 21 CFR 314
c) 21 CFR 56
d) 21 CFR 11
e) 21 CFR 14

50) One of the primary purposes of a Phase I study is to:

a) Determine the metabolic and pharmacologic action of the drug in humans
b) Demonstrate efficacy within the established safe dose range
c) Demonstrate long term safety and efficacy
d) Gather information on additional indications for the drug
e) Familiarize physicians with the drug

51) Before starting studies in humans with a new drug, a company must file which of the following documents with the FDA?

a) NDA
b) IND
c) IACUC
d) GLP
e) IDE

52) Who at the research site is the usual primary contact for the study sponsor?

a) Investigator
b) Co-investigator
c) Study coordinator
d) Subinvestigator
e) Office manager

53) If a site is unable to maintain study records for some reason, they should:

a) Send them to the sponsor
b) Destroy them, then let the sponsor know they are gone
c) Contact the sponsor and ask for guidance
d) Notify the sponsor that they will be destroyed after 30 days, wait for 30 days, then destroy them
e) Send them to the FDA

54) The investigator should notify the sponsor of serious adverse events:

a) As soon as possible after they occur
b) At the next sponsor monitoring visit
c) When all the information about the adverse event becomes available
d) Within seven days
e) Within fifteen days

55) When does the submission clock start for the expedited reporting of serious adverse events?

a) When the event occurs
b) When the investigator reports the event to the IRB
c) When a sponsor representative becomes aware of the event
d) When the event is recorded in the case report form
e) 48 hours after the event occurs

56) Trial-related reasons for discontinuing a study include:

a) Safety concerns
b) Business reasons
c) Investigators did not meet enrollment targets
d) a & b above
e) a, b & c above

57) Under HIPAA, an investigator may communicate directly with his or her patients to tell them about trials:

a) Only with prior patient authorization
b) Only when the patient is present for an office visit
c) Without patient authorization
d) Only if the trial is being done by the investigator him/herself
e) When the patient has signed a form saying he or she is interested in being contacted about trials

58) Under financial disclosure rules, disclosable financial arrangements include all of the following except:

a) Compensation made to the investigator in which the value of the compensation could be affected by the study outcome
b) Proprietary interest in the test product
c) Any equity interest in the company that exceeds $50,000 in value
d) Significant payments of other sorts with a cumulative value of $25,000 or more
e) Any mutual fund holdings of $100,000 or more where the funds hold stock in the company

59) The primary people who are blinded in a trial are:

a) The subjects
b) The investigator and staff
c) The study monitor and the statistician
d) Only a & b above
e) a, b & c above

60) A contract between the investigator and the sponsor will usually include all of the following except:

a) Responsibilities
b) Estimated timelines for enrollment
c) The number of subjects the investigator is expected to enroll
d) The list of all sites doing the study
e) The grant payment schedule

61) There are three basic requirements for a consent form. Which of the following is not one of the three?:

a) It must completely describe all the activities required by the protocol and the subject's participation
b) It must be signed by both the investigator and the study subject
c) It must be able to be read and understood by the study subject
d) It must contain all the required elements

62) Which of the following is not required in case histories?

a) CRFs
b) Patient charts and progress notes
c) Subject's legally authorized representative
d) Signed and dated consent forms
e) Laboratory reports

63) All of the following are good patient recruitment techniques, except:

a) Sending newsletter to study subject with updates about disease
b) Providing lavish gifts
c) Contacting the study subject between visits
d) Sending cards for special occasions and holidays

64) If there are co-investigators for a trial:

a) They are equally responsible for the trial
b) The more experienced person has primary responsibility
c) The physician has primary responsibility and the coordinator has secondary responsibility
d) Only one must be approved by the IRB
e) The one who signs the 1572

65) The investigator must maintain case histories for:

a) All trial subjects
b) Only subjects who report adverse events
c) Only subjects completing the trial
d) Trial subjects for whom the investigator is also the primary physicians
e) Only subjects denoted by the sponsor

66) Sub-investigators must be qualified by __________ and __________ to perform the duties assigned to them.

a) The FDA and the IRB
b) The sponsor and the IRB
c) Education and experience
d) The investigator and the institution
e) The investigator and the IRB

67) Which of the following is not a responsibility of the research institution?

a) Approving budget negotiations between the investigator and the sponsor
b) Complying with DHHS and FDA regulations for the performance of studies
c) Using additional safeguards for research in vulnerable populations
d) Educating researchers on issues of research ethics and scientific integrity
e) Investigating alleged cases of scientific misconduct

68) Carcinogenicity studies are required for compounds that are expected to be used for:

a) Continuously for twelve months or longer
b) Continuously for six months or longer
c) Oncology studies
d) Cardiovascular studies
e) Subjects with a life expectancy of less than two to three years

69) Which of the following phases consists of rigid, well-controlled studies in a relatively small patient population?

a) Phase I
b) Phase II
c) Phase III
d) Phase IIIB
e) Phase IV

70) Both IRBs and IECs are used to:

a) Define safety parameters for trials
b) Review proposed research before it is carried out
c) Review marketing materials for drugs
d) Determine which new drug candidates should be studied
e) Liaison between sponsors and regulatory agencies

71) An IRB must notify an investigator of its approval decision for a study:

a) After notifying the FDA
b) After notifying the sponsor
c) Orally and in writing
d) In writing
e) Within a month of making the decision

72) Which of the following contains the regulations on financial disclosure?

a) 21 CFR Part 11
b) 21 CFR Part 50
c) 21 CFR Part 54
d) 21 CFR Part 56
e) 45 CFR Part 46

73) The three geographic regions as represented in the ICH are:

a) The European Union, Japan, the Americas
b) The European Union, Japan, the United States
c) France, Germany, Great Britain
d) The United States, Canada, the European Union
e) North America, Europe, Asia

74) What is included in the official definition of scientific misconduct?

a) Negligence, errors and omissions
b) Fabrication, falsification and plagiarism
c) Incompetence, misbehavior and deviations
d) Differences in interpretations of data

75) As defined in the Belmont Report, the ethical principle of respect for person relates to the general rule:

a) Obtain consent from subjects
b) Maximize possible benefits and minimize potential risks
c) The burdens of research should be shared equally
d) Children should not be enrolled in research

76) Two key aspects of informed consent are:

a) Individual and consent
b) Voluntary and informed
c) Individual and informed
d) Legal and voluntary
e) Witness and consent

77) For exemption from consent for emergency research studies, all of the following are true except:

a) Subjects are not able to give consent prior to being treated
b) There is no time to contact the subject's legally authorized representative
c) The subject does not have a legally authorized representative
d) The intervention must be adminstered before consent can be obtained from the subject's legally authorized representative
e) There is no way to identify the individuals likely to become eligible for the study

78) Three documents (not regulations) that provide guidance to research who use human subjects in research studies are:

a) The Belmont Report, the Declaration of Helsinki, the Kennedy Report
b) The Declaration of Helsinki, the Kefauver-Harris Amendments, the Kennedy Report
c) The Nuremberg Code, the Belmont Report, the Declaration of Helsinki
d) The Kennedy Report, the Belmont Report, the Nuremberg Code

79) Which piece of regulation called for the FDA to start requiring fees from companies filing an NDA?

a) FDAMA
b) PDUFA
c) Pure Food and Drug Act
d) IND Rewrite of 1987
e) None of the above

80) A potential investigator usually only receives a protocol to review from a sponsor:

a) After an initial visit has been made
b) After an initial telephone conversation
c) After a confidientiality agreement has been signed
d) After the protocol has been through initial IRB review
e) If the sponsor has decided to use the site

81) Some of the questions an investigator should ask when assessing protocol feasibility at his or her site include all of the following except:

a) Will there be an investigator meeting?
b) Are procedures complicated, difficult and/or invasive?
c) Are any outside specialists needed?
d) Are there factors that make this protocol difficult to perform?
e) Are the case report forms easy to use?

82) The IRB approval letter verifies approval of the __________ and the __________.

a) Protocol and financial disclosure form
b) Protocol and 1572 form
c) Protocol and informed consent
d) Informed consent form and financial consent form
e) Protocol, informed consent and 1572

83) Financial disclosure must be collected:

a) At study start
b) Any time before the study is complete
c) Within one year of the study
d) At least three months before the study starts
e) Within three months of study completion

84) Under HIPAA, if an investigator is screening records that belong to another site (not his own) for possible recruits for a clinical trial, then the investigator:

a) Is allowed to contact the potential subjects
b) Is allowed to contact the potential subjects only with prior IRB approval
c) Is allowed to contact the potential subjects only with prior IRB approval
d) Is allowed to contact the potential subjects only by mail
e) Is not allowed to contact the potential subjects

85) The frequency of sponsor monitor visits may be determined by all the following except:

a) The complexity of the protocol
b) The number of subjects enrolled
c) The location of the site
d) Sponsor SOPs
e) Rate of enrollment

86) If the consent form for a study has changed, who must sign the new consent?

a) All subjects enrolled after the date the new form takes effect
b) All subjects in the study when the new form takes effect
c) All subjects who were in the study previously
d) a & b above
e) a, b & c above

87) What three conditions must be met for an adverse event to be classified as "immediately reportable" to the FDA?:

a) Serious, death, related
b) Serious, unexpected, severe
c) Serious, related, unexpected
d) Serious, related, required hospitalization
e) Severe, related, unexpected

88) Who will normally visit a study site to do an official closure visit?:

a) A CRA or other sponsor
b) An IRB member
c) An official of the institution
d) A sub-investigator
e) An independent auditor

89) At the end of the study, the Investigator Brochure should be:

a) Returned to the sponsor
b) Filed with the other study documents
c) Sent to the IRB
d) Destroyed
e) None of the above

90) A written report of the audit results from a sponsor audit:

a) Is usually given to the investigator
b) Should be placed in the investigator's study file
c) Is not available for routine access by the FDA
d) Will be sent to both the investigator and the IRB
e) Will be sent to the FDA

91) The FDA compliance program covers all of the following entities, except:

a) Clinical investigators
b) Institutions
c) Sponsors and sponsor monitors
d) CROs
e) IRBs

92) Once a compound has been identified as a potential therapeutic agent, testing proceeds as follows:

a) In vivo testing
b) In vitro testing
c) Clinical trials

93) The maximum tolerated dose of a compound is the:

a) Highest dose which produces the least toxicity
b) Highest dose
c) Highest dose which produces the best effect

94) What type of patient population is most appropriate for a Phase I investigation of a new chemotherapy for the treatment of breast cancer?

a) Patients with breast cancer who are newly diagnosed
b) Normal healthy population
c) Patients with breast cancer who have failed previous therapy

95) Pharmacokinetic studies to evaluate the effects of weight and gender are performed during this phase of investigation:

a) Phase I
b) Phase II
c) Phase III

96) After a drug has been approved for marketing by the FDA, it enters into the final phase of marketing, which will evaluate:

a) Less common side effects
b) Maximum tolerated dose
c) Bioavailability of the drug

97) The Nuremberg Code:

a) Had an immediate and profound influence on how research was conducted in the United States
b) Was not considered releavant to research practices in the United States
c) Resulted in the establishment of the National Advisory Health Council

98) In 1966, Henry K. Beecher published an article in the New England Journal of Medicine:

a) Citing 22 examples of unethical research
b) Stating that the data acquired from an unethical data should not be published
c) a & b above

99) IRBs are required to have this minimum number of members on their board:

a) At least five
b) It changes depending upon institution size
c) At least ten

100) In general, when investigators submit protocols to IRBs for review, they must demonstrate:

a) Their knowledge of the Nuremberg Code
b) How they plan to pay the support staff
c) How they plan to minimize risk

101) A researcher conducts a survey of people who were sexually abused as children, recruited through an advertisement in the local paper. The confidentiality agreement states that the signed consent forms will be kept under lock and key, but the researcher accidentally leaves the file containing the signed forms at a cyber cafe. The owner of the cafe looks through the file so he can return it to the right patron. The researcher has:

a) Breached the confidentiality agreement only
b) Violated the subjects' privacy only
c) Breached the confidentiality agreement and violated the subjects' privacy
d) None of the above

102) Which of the following statements about Certificates of Confidentiality is true?

a) Their use is limited to civil proceedings in the state in which the research took place
b) They can be used to protect information about the researchers, including income
c) They allow investigators to refuse to disclose information about individual research subjects
d) Their use is limited to research funded by the NIH

103) According to the federal regulations, private information:

a) Includes information about behavior and existing records
b) Excludes any behaviors that can be observed
c) Includes information about behavior, but not existing records
d) Can be identified in accordance with universal standards

104) Which of the following statements correctly describes covert observation?

a) Subjects must be told after the observation
b) It may place subjects at risk of harm
c) It always constitutes a violation of the subjects' privacy
d) Prior permission is secured from the individuals being observed

105) Whose expectations determine whether a proposed research setting is considered public or private?

a) The researcher's only
b) The IRB's only
c) University legal counsel
d) The individuals whose behavior is being observed and recorded

106) The following study meets the definition of research with human subjects: A researcher proposes to use customs passenger lists for ships bringing immigrants to America between 1820 and 1845 to track the restrictions immigration laws imposed on certain ethnic groups.

a) True
b) False

107) A population study examining birth rates using public birth records available at county court-houses meets the definition of research with human subjects.

a) True
b) False

108) Which of the following studies meets the definition of research with human subjects?
a) A cognitive psychologist proposes to recruit undergraduate students for a computer-based study about the effect of activating mood states on problem-solving performance.
b) A sociologist is interested in how gender roles effect the transmission of HIV/AIDS from immigrant-receiving communities in the US to immigrant-sending communities in Latin America.
c) A developmental psychologist proposes videotaping interactions between toddlers and their caregivers in a laboratory setting to determine what communication methods most effectively manage aggression.
d) All of the above

109) Which of the following studies meets the definition of research with human subjects?

a) A study in three 4th grade classrooms about the relationship between the time of day reading is taught and improved reading comprehension.
b) The collection of data about the physical dimensions of school playgrounds by a playground designer hired by the superintendent of schools.
c) An analysis of aggregate data comparing statewide high school graduation rates, provided by the State Department of Public Instruction, with county tax bases.
d) None of the above

110) According to the federal regulations for protecting research subjects, a human subject is a living individual about whom an investigator obtains:

a) Data through an intervention.
b) Identifiable private information.
c) Data through interaction.
d) All of the above

111) An investigator wishes to study lifestyle and diet influences on the risk of developing a specific cancer. The investigator chooses a case-control design with paired lifestyle interviews and a few blood and urine tests and assigns a study manager to identify patients with the diagnosis from the pathology logbook that lists names. The study manager would then ask each patient�s primary physician for permission to contact the patient. Which of the following is required before the investigator begins the study?

a) Permission from the Oncology Department.
b) Hospital accreditation.
c) A Clinical Trials Office.
d) IRB review and approval.

112) An investigator fails to inform subjects about the foreseeable risks in a study of a new drug. Which of the following best describes the ethical principle violated?

a) Access to research.
b) Research Integrity.
c) Respect for persons.
d) Justice.

113) Which of the following studies led to the establishment of the National Research Act and ultimately the Belmont Report and Federal regulations for human subject protection?

a) Obedience to authority study (Milgram study).
b) Nazi medical experiments.
c) Jewish chronic disease study.
d) The Public Health Service syphilis study.

114) Which of the following lists the three principles discussed in the Belmont Report?

a) Privacy, Confidentiality, Equitable selection of subjects.
b) Informed Consent, Institutional Assurance, Researcher responsibility.
c) Respect for Persons, Beneficence, Justice.
d) IRB review, federal regulations, Declaration of Helsinki.

115) In what way did the Beecher article impact research in the United States?

a) It resulted in the creation of the IRB.
b) It prompted congress to create an ad hoc panel to provide oversight for human research.
c) It heightened awareness of problems with unethical research.
d) It reinterpreted the Belmont principles with a focus on therapeutic medical research.

116) A student working on his dissertation plans on interviewing 15 principals in neighboring high schools. The student plans to collect data about the personal experiences the principals have had with disruptive students and what types of disciplinary actions were taken. Identifiers will be collected. This study would be categorized as which type of review?

a) Expedited Review
b) Exempt Review
c) Full Board Review
d) Not Human Subjects

117) How can faculty researchers avoid coercion of student subjects?

a) Provide extra credit to those who participate
b) Conduct research for less than 10 minutes during class so as to not take up much class time
c) Avoid using their own students in their research
d) Offer more monetary compensation

118) A student is conducting a research project that involves using a survey. The survey asks subjects about their political affiliation and their favorite politicians. No identifiable information will be collected. This study would be categorized as which type of review?

a) Expedited Review
b) Exempt Review
c) Full Board Review
d) Not Human Subjects

119) Which type of IRB review does not require an IRB approval but does require a determination by the IRB or an IRB designee?

a) Full Board
b) Expedited
c) Exempt
d) All of the above

120) A Masters degree candidate needs to conduct a research project for her Masters thesis. She is interested in the types of junk food available to the public. She plans on going to the local convenience stores and asking the owners what types of junk food they normally stock and what are their biggest sellers. Identifiers will not be collected. This study would be categorized as which type of review?

a) Expedited Review
b) Exempt Review
c) Not Human Subjects
d) Full Board Review

121) Which of the following elements must be included in an informed consent?

a) Procedures/methods involved in the research
b) The purpose of the research
c) All foreseeable risks and discomforts
d) All of the above

122) The history of ethical regulations in human subjects research began with the

a) Declaration of Helsinki
b) Common Rule
c) Nuremburg Code
d) Belmont Report

123) The Belmont Report describes all of the following EXCEPT:

a) The Belmont Report describes the concept of "Respect for Person".
b) The Belmont Report defines and delineates the differences between "Practice" and "Research".
c) The Belmont Report indicates that it is necessary to rigorously avoid conflicts of interest as an example of the Principle of Justice.
d) The Belmont Report describes the need to carefully consider how research discoveries and risks will be fairly distributed in the society.

124) Which of the following is an example of how the Principle of Beneficence can be applied to a study employing human subjects?

a) Insuring that the selection of subjects includes people from all segments of the population.
b) Insuring that confidentiality is maintained.
c) Determining that the study has a maximally favorable risk vs. benefit ratio.
d) Providing detailed information about the study and obtaining the subject's consent to participate.

125) Which of the following lists the three principles discussed in the Belmont Report?

a) Informed Consent, Institutional Assurance, Researcher responsibility.
b) IRB review, Federal regulations, Declaration of Helsinki.
c) Privacy, Confidentiality, Equitable selection of subjects.
d) Respect for Person, Beneficence, Justice.

126) Which of the following statements correctly describes covert observation?

a) It always constitutes a violation of the subjects' privacy.
b) Subjects must be told after the observation.
c) It may place subjects at risk of harm.
d) Prior permission is secured from the individuals being observed.

127) Which of the following statements about Certificates of Confidentiality is true?

a) They allow investigators to refuse to disclose information about individual research subjects.
b) Their use is limited to civil procedings in the state in which the research took place.
c) They can be used to protect information about the researchers, including income.
d) Their use is limited to research funded by the NIH.

128) A researcher conducts a survey of people who were sexually abused as children, recruited through an advertisement in the local paper. The confidentiality agreement states that the signed consent forms will be kept under lock and key, but the researcher accidentally leaves the file containing the signed forms at a cyber cafe. The owner of the cafe looks through the file so he can return it to the right patron. The researcher has:

a) Breached the confidentiality agreement and violated the subjects' privacy.
b) Violated the subjects' privacy only.
c) Breached the confidentiality agreement only.
d) None of the above

129) According to the federal regulations, private information:

a) Includes information about behavior, but not existing records.
b) Includes information about behavior and existing records.
c) Excludes any behaviors that can be observed.
d) Can be identified in accordance with universal standards.

130) Whose expectations determine whether a proposed research setting is considered public or private?

a) The IRB's only.
b) University legal counsel.
c) The researcher's only.
d) The individuals whose behavior is being observed and recorded.

131) A graduate student wants to examine the effect of print media versus televised media on individuals' position on several social issues. Her advisor�s neighbor is the superintendent of a local work release facility and will allow the graduate student access to the prison population to help her accrue subjects. She will also recruit subjects on her campus. The subjects will be asked for 15 minutes of their time. The risks appear to be no more than minimal. The IRB would most likely:

a) Not approve this project because the prisoners are merely a population of convenience.
b) Approve this project since the risk is minimal.
c) Approve this project since the superintendent is the ultimate authority on what happens in his facility.
d) Approve this project but submit it for federal review.

132) Which of the following statements about prison research is true?

a) Participation in research can be considered during parole hearings.
b) Researchers cannot pay prisoners.
c) The risks involved in the research may be higher than those that would be accepted by non-prisoners.
d) Researchers may study the effects of privilege upgrades if they are awarded by the prison.

133) An investigator is examining the quality of life for prisoners who are HIV positive. The researcher plans to use standardized survey instruments followed by an interview. Neither the survey nor the interview questions are probing about the offender�s past life but maintain a focus on current life situation in the prison. The IRB must ensure that:

a) A medical doctor serves as co-investigator.
b) The investigator is aware of the potential risks of interviewing inside a prison.
c) The survey instrument is standardized.
d) Confidentiality of the prisoners' health status is maintained.

134) An investigator is examining the relationship between family contact/visitation and depression in mothers recently admitted to a state prison. The researcher will use the data to develop support programs for prison mothers. The sample will be limited to first offenders with children under the age of five years. Research subjects will be given a basket of toys to use at their children's first visit that the children can then take home. In assessing this proposal, the IRB needs to determine that the toys are:

a) Educational.
b) Age appropriate.
c) Of high quality.
d) Not an excessive inducement.

135) Parental permission for children to participate may be waived if:

a) The children are homeless.
b) The children can read at a twelfth grade level.
c) The children are emancipated minors.
d) The parents are illiterate.

136) Which of the following methods of subject recruitment presents the LEAST potential for coercion?

a) Recruiting middle school students in the presence of their parents
b) Recruiting adolescents in the presence of their peers
c) Recruiting college freshmen on their first day on campus
d) Recruiting children to learn about ecology at a summer recreation program

137) Which of the following methods of subject recruitment presents the LEAST potential for coercion?

a) Recruiting middle school students in the presence of their parents
b) Recruiting adolescents in the presence of their peers
c) Recruiting college freshmen on their first day on campus
d) Recruiting children to learn about ecology at a summer recreation program

138) According to federal regulations, when can research with children be exempt?

a) When children are 12 or older
b) It can never be exempt
c) When parents request an exemption
d) When it falls into an eligible category of research activity

139) The absence of child dissent may be considered assent to participate in research.

a) True
b) False

140) A study of the effects of divorce on children proposes annual interviews of children, aged seven through sixteen, and their parents. Which of the following statements best describes the consent requirements for this study?

a) Parental permission is sufficient to enter a child into the study for children between the ages 7 and 14.
b) Consent must be obtained and documented for all participants using the same IRB consent form.
c) If the teacher thinks it would be helpful for a child to talk about divorce, the child may be enrolled without parental permission.
d) The assent process for the children should vary depending upon their age and maturity.

141) As part of its commitment to evidence-based medicine, Medical School Alpha wants to ensure that its students and residents will be able to understand and evaluate the results of future research. Accordingly, the school requires each student and resident to develop a research protocol, collect data on living and deceased patients, analyze the data and report the results. Many of these studies will involve medical record or chart reviews, although patients have never explicitly agreed to have their medical records used in this way. Does the Final Privacy Rule make these chart reviews improper without further IRB or Privacy Board action? Consider each of the answers and choose the most appropriate one.

a) No, because the patient information cannot be traced to anyone and therefore is �de-identified� as required by the Final Privacy Rule.
b) No. Although the patients never authorized this use of their health care data, a waiver of consent for chart review approved by the IRB would be sufficient for the research to proceed.
c) No, because patients will be given a notice of privacy practice when admitted to the Medical School Alpha which clarifies information can be collected for future use in research.
d) Yes, the IRB or Privacy Board must grant a HIPAA compliant waiver of authorization for this undertaking because the research is not authorized by a patient, not a review preparatory to research and does not solely use decedent information.

142) A consent for research under the Common Rule is the same as an authorization for disclosure of PHI under the Final Privacy Rule.

a) True
b) False

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

a) Pregnant Women
b) Prisoners
c) Children
d) Workers

144) 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.

a) True
b) False

145) 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:

a) Who will have access to the data.
b) If personal identifiers will be retained and used in the data analysis.
c) If the study results, if any, will be included in the employee's personnel records.
d) How the data will be collected and secured.
e) All of the above

146) When workers are asked to participate in a research study, vulnerabilities related to the subjects employment may include:

a) Unions may encourage employees to participate with the expectation that "entitlements" may follow from study results.
b) Employees may experience pressure from management to participate in the study because the employer perceives the study to be advantageous to the organization.
c) The employer may encourage or deny participation of workers.
d) The research study's finding could affect an employee's pay, benefits or promotion potential.
e) All of the above

147) The most important ethical concerns relating to conflicts of interest in research are (choose one answer):

a) maintaining a supply of volunteers for research studies
b) ensuring the soundness of science and the protection of human subjects
c) protecting proprietary information and fidelity to contracts with sponsors
d) All of the above

148) Current Public Health Service regulations require investigators to disclose details regarding financial conflicts of interest to:

a) subjects/participants
b) funding agency or sponsor
c) Institutional Review Boards
d) designated institutional officials
e) All of the above

149) The Case: A Full IRB Committee meeting is convened on October 18, 2006. The IRB Committee roster consists of 15 members. However, only 8 members are in attendance for today's meeting. 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. One of the IRB members, Susan, is Principal Investigator for the study and receives a portion of her salary from the supporting grant. The Question: There were a number of problems with the protocol, but the IRB eventually approved the protocol at a duly constituted Full IRB Committee Review on February 15, 2007. Accrual and treatment are planned to continue through 2008. Which of the following best describes IRB continuation review requirements for this study?

a) The continuation review may be conducted by a voting member of the IRB, delegated by the Chair.
b) The continuation review can be conducted by the IRB Chair only.
c) The IRB may extend the deadline for continuing review by 30 days. After that, the research must cease.
d) The research must be re-reviewed by the Full IRB Committee on or before February 14, 2008.

150) The Case: A Full IRB Committee meeting is convened on October 18, 2006. The IRB Committee roster consists of 15 members. However, only 8 members are in attendance for today's meeting. 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. One of the IRB members, Susan, is Principal Investigator for the study and receives a portion of her salary from the supporting grant. The Question: The proposal does not include adequate information regarding the potential risks to the minor subjects in the research study, but is otherwise approvable. The committee considers these risks to be more than minimal risk to the minor child. Which of the following best describes how the IRB should proceed?

a) Table the protocol and ask the investigator to provide the needed information for review by the full board at the next convened meeting.
b) Approve the proposal, but ask the investigator to write a letter to the IRB describing risks to the minor subjects and that might be appended to the IRB records.
c) Approve the proposal if the IRB can deduce what the risks would be.
d) Conditionally approve the research, pending receipt of additional information from the investigator, and review by the IRB staff.

151) The Case: A Full IRB Committee meeting is convened on October 18, 2006. The IRB Committee roster consists of 15 members. However, only 8 members are in attendance for today's meeting. One agenda item is a new research proposal to evaluate how mothers interact with their learning disabled child. The Question: Which of the following IRB members must be present during the IRB's discussion and vote on a proposal?

a) The Principal Investigator for the research proposal under deliberation.
b) A member who is unaffiliated with the institution.
c) The non-scientist member.
d) A social worker.

152) The Case: A Full IRB Committee meeting is convened on October 18, 2006. The IRB Committee roster consists of 15 members. However, only 8 members are in attendance for today's meeting. 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. One of the IRB members, Susan, is Principal Investigator for the study and receives a portion of her salary from the supporting grant. The Question: Susan, 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 Susan leaves the IRB meeting?

a) Trust that the study is ethical because Susan is a member of the Committee and continue with the final deliberations and vote.
b) Use an expert in child development as a consulting reviewer could help answer questions in Susan's absence.
c) Defer the proposal to the next meeting because of a loss if quorum.
d) Continue with review, discussion and vote because the minutes will note that Susan abstained from the vote.

153) The Case: A Full IRB Committee meeting is convened on October 18, 2006. The IRB Committee roster consists of 15 members. However, only 8 members are in attendance for today's meeting. 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 Question: The Committee determined that the mother's required task may upset the child. Which of the following actions best describes the most appropriate steps for the committee to take?

a) Recommend an alternate age range of disabled children between ages 7-11.
b) Check to make sure that there is an assent form for the child.
c) Evaluate the study risks and study benefits and to determine if appropriate procedures are in place to minimize study risk to participants.
d) Reject the study as too risky.

154) The Case: A Full IRB Committee meeting is convened on October 18, 2006. The IRB Committee roster consists of 15 members. However, only 8 members are in attendance for today's meeting. 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. One of the IRB members, Susan, is Principal Investigator for the study and receives a portion of her salary from the supporting grant. The Question: What is the minimum number of people required to conduct business at this Full IRB Committee meeting?

a) 10
b) 7
c) 9
d) 8

155) Which of the following lists the three principles discussed in the Belmont Report?

a) Respect for Person, Beneficence, Justice.
b) Informed Consent, Institutional Assurance, Researcher responsibility.
c) Privacy, Confidentiality, Equitable selection of subjects.
d) IRB review, federal regulations, Declaration of Helsinki.

156) In what way did the Beecher article impact research in the United States?

a) It prompted congress to create an ad hoc panel to provide oversight for human research.
b) It resulted in the creation of the IRB.
c) It heightened awareness of problems with unethical research.
d) It reinterpreted the Belmont principles with a focus on therapeutic medical research.

157) An investigator fails to inform subjects about the foreseeable risks in a study of a new drug. Which of the following best describes the ethical principle violated?

a) Access to research
b) Research Integrity
c) Respect for persons
d) Justice

158) An investigator wishes to study lifestyle and diet influences on the risk of developing a specific cancer. The investigator chooses a case-control design with paired lifestyle interviews and a few blood and urine tests and assigns a study manager to identify patients with the diagnosis from the pathology logbook that lists names. The study manager would then ask each patient's primary physician for permission to contact the patient. Which of the following is required before the investigator begins the study?

a) Permission from the Oncology Department
b) Hospital accreditation
c) A Clinical Trials Office
d) IRB review and approval

159) Which of the following studies led to the establishment of the National Research Act and ultimately the Belmont Report and Federal regulations for human subject protection?

a) The Public Health Service (PHS) syphilis study
b) Nazi medical experiments
c) Jewish chronic disease study
d) Obedience to authority study (Milgram study)

160) IRB continuing review of an approved protocol must:

a) Must occur only when the level of risk changes.
b) Occur at least annually.
c) Must be conducted by a convened IRB.
d) Include copies of all signed consent forms.

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

a) Report the adverse drug experience to the IRB only if there are several other occurrences.
b) Report the adverse drug experience as part of the continuing review report.
c) Do not report the adverse drug experience to the IRB since it is a common adverse experience.
d) Report the adverse drug experience immediately to the IRB using the forms or the mechanism provided by the institution.

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

a) As long as the investigator is at that institution
b) Until the IRB gives permission for them to be destroyed
c) Until the study is closed
d) For a minimum of three years after completion of the study

163) Amendments involving changes to IRB approved protocols do NOT need prior IRB approval if:

a) They are eligible for review using expedited procedures.
b) They only involve changes to the consent form.
c) The changes must be immediately implemented for the health and well being of the subject.
d) The investigator keeps careful records of all changes and includes them in the final report.

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

a) The study includes only research subjects that are healthy volunteers.
b) The study is required for a student research project.
c) The study does not require informed consent or survey instruments.
d) The study involves no more than minimal risk and meets one of the allowable categories of expedited review specified in federal regulations.

165) A 46-year-old man is currently enrolled in a Phase 1. 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?

a) Do not tell the subject about the new drug since physicians have the right to try out new treatments with their patients
b) 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 thes subject to decide whether to withdraw from the research to take the new drug.
c) Tell the subject about the new drug but discourage him from switching treatments until the study is completed
d) Withhold this new information to avoid confusing the subject with other treatment options or alternatives

166) An elderly man recently diagnosed with lung cancer is screened for a clinical trial using a new investigational drug. The investigator has carefully explained all of the required information about the study to the subject and the subject�s daughter. The subject demonstrates his understanding and willingness to participate, but is not able to sign the informed consent document due to paralysis from a swimming accident years before. The subject�s wife is his legally authorized representative, but she is out of town on a business trip. Which of the following is the most appropriate action to take for the investigator?

a) The investigator can go ahead and treat the man without a signed consent since he verbally agreed to participate.
b) 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 and her husband, she can sign the informed consent and fax it back.
c) Exclude the man from the study.
d) Request the IRB waive the requirement for a signed informed consent.

167) 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 for the individual's legal representative. Under the FDA regulations for using test articles, which of the following describes the best course of action for the investigator:

a) Use the test article without obtaining consent from the subject or the legal representative then notify the IRB.
b) The investigator and another 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.
c) Submit a research protocol to the IRB and justify an expedited review approval of the consent document so test article can be used immediately.
d) Do not use the test article until either the subject or the subject's legal representative can give consent.

168) A general requirement for the informed consent is that no informed consent may 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?

a) Your participation in this research is voluntary. If you choose not to participate, or change you 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.
b) In the event of any injury you may have related to this research, you will be given medical treatment.
c) 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.
d) You must provide blood samples that will be kept in a �bank� for future research. Once you have provided these blood samples, you cannot change your mind about being in the research and have the sample removed from the �bank�.

169) After beginning a records-based research project, the researcher determines that the individuals whose data is being collected need to be contacted for updated substance abuse information. This will require a change to the protocol. What level of review by the IRB is most likely?

a) Expedited
b) None
c) Review for exemption
d) Review by the convened IRB (Full Review)

170) An investigator is recording nonidentifiable information from records to study the frequency of "handedness" (left hand versus right hand) in a given population. What level of review is most appropriate?

a) Expedited review by a designated IRB member
b) None
c) Review by a convened quorum of the IRB
d) Determination of exemption

171) Under which of the following conditions is it appropriate to re-contact the individuals who provided biological specimens?

a) Subjects received financial compensation for participation in the study
b) Biological specimens need to be replenished
c) Discovery of related clinical information requires contacting subjects for follow-up
d) Original signed consent documents include provisions for recontacting subjects

172) 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?

a) Long term financial impact of results
b) Ownership of biological specimens
c) Need for publication of results
d) Effects of findings on other family members

173) An investigator planning to study behavioral changes during alcohol intoxication will pay subjects $600 for 6 hours of testing that includes drinking a moderate level of alcohol and completing several written questionnaires. He plans to recruit college students taking his courses, as well as economically disadvantaged and homeless people. Which of the following is the most important for the investigator to address before submitting the protocol to the IRB?

a) Forms of advertising for subject recruitment
b) Potential undue influence or coercion of subjects
c) Method of payment to subjects
d) Literacy of homeless subjects

174) A group of elderly men, whose government disability benefits are the sole source of income, is approached to consider an experimental research study for their current colon cancer. The study involves more than minimal risk, but offers substantial financial incentives that are equal to two months of disability benefits. The IRB will be most concerned about the possibility of:

a) Inadequacy of research design
b) Inaccuracy of data
c) Conflict of interest
d) Undue influence of the subjects

175) A faculty member wants to measure the effectiveness of a new psychological assessment instrument before including it in his new textbook. He plans to conduct a pilot test by administering both the new instrument and an established instrument to about 10 people and then compare the results. Which of the following populations would be considered potentially most vulnerable to undue influence?

a) Members of his community organization who agree to take the tests
b) Senior faculty in his department
c) Members of his professional society
d) Students taking one of his courses

176) An investigator is recruiting subjects for a study of a new antidepressant drug. The investigator has targeted a population of patients who might clearly benefit, but who are also institutionalized for a variety of psychiatric conditions. The patients are in a controlled environment and it is believed there would be little problem recruiting subjects for the study. Which of the following issues of vulnerability should be of most concern to the IRB?

a) The patients may be on other medications
b) The patients have clinical depression, which is a difficult disease to treat
c) The patients are probably illiterate
d) The patients are institutionalized

177) The purpose of a federally supported research protocol is to examine the characteristics and effectiveness of �house arrest,� a program where individuals are confined to their homes under continuous surveillance. Which of the following best describes the IRB�s duties when reviewing this research?

a) Even though this research involves individual subjects who would be considered prisoners and examines an alternative to incarceration, the IRB does not have any additional duties
b) Since this research is federally supported, the IRB does not have any duty to review this research
c) Since this research does not involve individual subjects who would be considered prisoners, the IRB does not have any additional duties
d) Since this research involves individual subjects who would be considered prisoners and examines an alternative to incarceration, the IRB should ensure that the additional requirements for prisoner research are met

178) When investigators plan to involve a prisoner population, which best describes the type of federally supported research that may be conducted?

a) research that has the promise of benefit to society in general, but not necessarily the prisoner population
b) research that involves only minimal risk to the prisoner population
c) research that is relevant to prisoners and their conditions or situations
d) research that the investigator proposes and gets funded

179) When reviewing federally supported research involving prisoners, an IRB must have at least the following member, in addition to the standard requirements for IRBs to ensure that the prisoners� perspective is represented:

a) two members who are currently prison guards, wardens or parole officers
b) two members who are employed by the federal penal system
c) one member who is a prisoner or prisoner representative
d) one member who is a health care provider at the local hospital where prisoner may be treated

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

a) mentally disabled persons
b) the elderly
c) men
d) prisoners

181) 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?

a) Assent is not required, however, one parent must give permission for the inclusion of the adolescent in this study.
b) Assent is not required, however, both parents must give permission for the inclusion of the adolescent child.
c) Assent of the child only is required.
d) Assent of the child and permission of both parents are required.

182) 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 does not assent to participate in the study described above. Which of the following procedures best describes the action to be taken by the investigator?

a) Consent one of the child�s parents instead.
b) Request the child reconsider assenting to the study.
c) Honor the child�s decision.
d) Consent both of the child�s parents instead.

183) 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:

a) More than minimal risk with prospect of direct benefit to the child.
b) No more than minimal risk to the child.
c) More than minimal risk with no prospect of direct benefit to the child.
d) No risk to the child and no further IRB review is required.

184) 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?

a) The father of the fetus only.
b) The pregnant woman only.
c) The pregnant woman and the father of the fetus.
d) The pregnant woman and her legally authorized representative.

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

a) There is compelling evidence that inclusion would be inappropriate with respect to the health of the subjects.
b) Inclusion of women would complicate analysis of the results and increase the costs of conducting the clinical trial.
c) The woman is of child-bearing potential.

186) 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) The pregnant woman only.
b) The pregnant woman and the father of the fetus.
c) The father of the fetus only.
d) The state court where the research is taking place.

187) 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 is:

a) A hair restoration study in middle aged men.
b) A study designed to investigate genetic links between DNA samples found at a prehistoric central Asian archeological site and west coast American Indian tribes.
c) A study to establish national reading standards in ten year old children.
d) A study on the efficacy of a new birth control device in middle aged women.

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

a) Planning disclosure of research results
b) Collaborative IRB review
c) Ongoing consultation
d) Community consultation
e) All of the above

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

a) A genetic study to identify ancestral relationships between DNA obtained from a Cherokee Indian burial site and members of a Central Asian community.
b) Phase 3 clinical trial of a new anticancer agent in middle-aged women diagnosed with breast cancer.
c) A study that surveys the perceptions of nurses and other health care workers about illegal drug use among cardiovascular surgeons in New York City.
d) 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.

190) An adult presents to a physician with attention deficit hyperactivity disorder (ADHD). 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?

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

191) 21 CFR Part 11 is intended to:

a) Prohibit the use of paper printouts of electronic records.
b) Provide specific standards for accuracy, reliability and consistent performance for hospital computer systems.
c) Require use of electronic records for all drug research.
d) Allow the use of electronic documents and signatures in the regulatory process for drugs and devices.

192) 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?

a) Non-significant risk device
b) Significant risk device

193) 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:

a) The database system to assign passwords.
b) The investigator to email subjects about the research.
c) The medical center to replace the use of paper records with electronic records for its research.
d) The use of paper records meeting FDA requirements.

194) 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 children. Which of the following is the investigator's most appropriate course of action?

a) 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
b) Submit an Investigational Device Exemption (IDE) application to the FDA
c) Submit the research protocol to the IRB for review and submit an IND application to the FDA before conducting the research
d) Submit the research protocol to the Office for Human Research Protections (OHRP) for their review