section 1 - the common rule and related issues

Question 1

45 CFR Part 46 applies to

a. any research involving human subjects
b. studies sponsored by the pharmaceutical industry
c. studies under an IND or an IDE
d. studies conducted or sponsored by the DHHS

Answer 1

d. Studies conducted by or sponsored by the DHHS

Question 2

The IRB is responsible for conducting its initial and continuing review and reporting its findings to

a. the investigator only
b. the investigator and the institution
c. OHRP
d. FDA

Answer 2

b. the investigator and the institution

Question 3

The IRB should have written procedures for

a. conducting initial and continuing review including projects for which more frequent than annual review is required.
b. determining which projects need verification, from sources other than investigators, that no material changes have occurred since the previous review.
c. ensuring prompt reporting of proposal changes in approved research.
d. all of the above

Answer 3

d. all of the above

Question 4

In 45CFR Part 46 the common rule refers to

a. part A
b. part B
c. part C
d. part D

Answer 4

a. part A

Question 5

The common rule is so termed because it is

a. based on common sense.
b. based on common ethical principles.
c. meant to be followed on behalf of common people.
d. subscribed to by multiple federal departments

Answer 5

d. subscribed to by multiple federal departments

Question 6

Departments that subscribe to the common rule include

a. DHHS.
b. department of education.
c. department of defense.
d. department of agriculture.
e. all of the above

Answer 6

e. all of the above

Question 7

The IRB shall ensure that its membership is

a. not based on one gender.
b. not comprised of one profession.
c. illustrative of every nondiscriminatory effort to include qualified people of both sexes.
d. all of the above

Answer 7

d. all the above

Question 8

Continuing review of research must be conducted at

a. intervals appropriate to the risk.
b. at least once annually.
c. both A and B.
d. neither A nor B.

Answer 8

c. both A and B.

Question 9

In considering the risks of research the IRB should ensure that the study

a. ascertains that risks are minimized by using procedures consistent with sound design.
b. avoids procedures that unnecessarily expose subjects to risk.
c. uses procedures that are already being used in diagnosis and treatment.
d. all of the above.

Answer 9

d. all of the above

Question 10

Guidelines for expedited review are described in the regulations of

a. the FDA only.
b. DHHS only.
c. OHRP only.
d. DHHS and FDA.

Answer 10

d. DHHS and FDA

Question 11

The IRB in considering risk should

a. consider risks in relation to benefits.
b. consider the importance of the knowledge that may be reasonably expected but not the long-range effects of applying the knowledge.
c. consider only the research procedures and not those used in standard of care.
d. all of the above.

Answer 11

d. all of the above

Question 12

The number of basic elements of informed consent is

a. 5
b. 6
c. 7
d. 8

Answer 12

d. 8

Question 13

The number of added elements to the informed consent, to be provided when appropriate, is

a. 6
b. 5
c. 7
d. 4

Answer 13

a. 6

Question 14

An essential element of informed consent affirmed in most ethical frameworks is that

a. the research should bear fruitful results.
b. the risk of the research should always be minimal.
c. participation be voluntary, without penalty or loss of benefits.
d. compensation for research is fair.

Answer 14

c. participation be voluntary, without penalty or loss of benefits.

Question 15

An essential element of informed consent that is affirmed in most ethical frameworks is that

a. there should be compensation for medical injury.
b. there should be no deception used in the study.
c. the subject may discontinue participation at any time without penalty.
d. drugs which might diminish the quality of life not be used.

Answer 15

c. the subject may discontinue participation at any time without penalty.

Question 16

The essential basic elements of informed consent include

a. a statement that the study involves research and its purpose.
b. a description and identification of experimental procedures.
c. the duration of the study.
d. all of the above

Answer 16

d. all of the above

Question 17

The essential basic elements of informed consent include

a. statements of the risk, benefits, and alternate procedures.
b. any compensation for injury.
c. confidentiality of records and contact information regarding subject rights.
d. all of the above

Answer 17

d. all of the above

Question 18

The statement that significant new findings which may affect participation will be provided to subjects is

a. required in all consent forms.
b. an essential element of consent.
c. only required for risks, not benefits.
d. an added element included on the consent form only if the IRB deems it appropriate to do so.

Answer 18

d. an added element included on the consent form only if the IRB deems it appropriate to do so.

Question 19

Regarding the risks of pregnancy and harm to the fetus during the research study, the consent form requires that it

a. mention the procedure may involve such risks that are unforeseeable.
b. include the need for contraception.
c. provide specific instructions regarding the efficacy of specific contraceptive methods.
d. advise subjects that only women need to be aware of such risks.

Answer 19

b. include the need for contraception.

Question 20

Regarding the termination or withdrawal of a subject from a research study the consent form should

a. advise that the termination may occur without the subject’s consent.
b. advise regarding the consequences of the subject’s decision to withdraw.
c. describe the circumstances in which such termination might occur.
d. provide procedures for orderly termination.
e. all of the above

Answer 20

e. all of the above

Question 21

Regarding costs of the research to the subject, the consent form should

a. assume the subject knows that the institution will pay for all research costs.
b. disclose any additional costs as this is an additional element of consent.
c. provide detailed analysis of the study’s cost structure.
d. transfer as much of the costs to the subject as possible.

Answer 21

b. disclose any additional costs as this is an additional element of consent.

Question 22

An additional element of consent to be disclosed to subjects in the consent form if appropriate is the number of subjects involved in the study. The likely reason behind this requirement is

a. satisfy the subject’s curiosity.
b. the sponsor’s desire to impress the subject with the enrollment numbers.
c. provide the subject with an idea of how risks and burdens are being shared.
d. assure subjects that they are not alone in their decision to enroll.

Answer 22

c. provide the subject with an idea of how risks and burdens are being shared.

Question 23

An investigator is planning to submit a grant to a federal agency. Such applications need

a. notification of the IRB.
b. a budget analysis prospectively from the IRB.
c. expedited review.
d. not be reviewed by the IRB.

Answer 23

d. not be reviewed by the IRB.

Question 24

With regard to research under DHHS which is carried out in a foreign country the IRB should

a. proceed with the institution in the foreign country if it knows the institution well.
b. seek an OHRP determination that the protections offered are at least equivalent to DHHS regulations.
c. rely on a written assurance from the foreign institution’s IRB.
d. allow the substitution of foreign procedures as a form of courtesy.

Answer 24

b. seek an OHRP determination that the protections offered are at least equivalent to DHHS regulations.

Question 25

An investigator for a study approved by a US IRB wishes to carry out procedures related to a study in a foreign country. The situation requires a. that the study cannot be approved. b. a translated consent form, disclosure to the US IRB, and approval from the IRB in a foreign country. c. a review be conducted from the foreign country's IRB only. d. written approval from OHRP.

Answer 25

b. a translated consent form, disclosure to the US IRB, and approval from the IRB in a foreign country.

Question 26

Which of the following is true regarding audits of the IRB? a. OHRP does not carry out routine audits of the IRB. b. the FDA audits the IRB once every three to five years. c. the audit standards of the OHRP differ from those of the FDA. d. all of the above.

Answer 26

d. all of the above.

Question 27

Which of the following is true of OHRP audits? a. OHRP audits are usually triggered by a complaint about the IRB. b. OHRP audit may be triggered by the report of a highly significant adverse event. c. OHRP audits may be occasioned by a non-compliant IRB research practice noted in a publication. d. all of the above.

Answer 27

d. all of the above.

Question 28

OHRP and FDA penalties for non-compliance by the IRB differ in that a. OHRP can withdraw its authorization but the FDA cannot. b. the FDA can suspend all clinical trials done under FDA purview but OHRP cannot. c. the FDA but not the OHRP can impose civil penalties on the ORB's institution. d. all of the above

Answer 28

d. all of the above.

Question 29

FDA suspension of the IRB can entail a. withholding approval of new FDA studies. b. prevention of new subjects being added to existing clinical trials. c. termination of ongoing studies. d. notification to other state and federal agencies of IRB non-compliance. e. all of the above

Answer 29

d. all of the above.

Question 30

The IRB chair usually reposts to the a. Director of Research. b. Department Chair. c. Chief Financial Officer. d. Institutional Official.

Answer 30

d. Institutional Official.

Question 31

The person who signs the Federal Wide Assurance is a. IRB director. b. Director of Research Grants. c. IRB Chair. d. Institutional Official.

Answer 31

d. Institutional Official.

Question 32

When an IRB takes on an external consultant for advice on a research study, the consultant a. can count toward the quorum. b. must leave the room immediately after offering advice. c. must be free of conflict of interest d. may not vote

Answer 32

d. may not vote

Question 33

An electronic IRB a. must eliminate all manual tasks for IRB staff including printing and mailing. b. must have a statistical tool to quantitate IRB workload and performance. c. must be part 11 compliant. d. must include a conflict of interest module.

Answer 33

c. must be part 11 compliant.

Question 34

According to DHHS regulations the IRB chair a. must be a licensed physician. b. must sign the FWA. c. may break a tie vote on a motion. d. may designate an IRB member as a reviewer for expedited studies.

Answer 34

d. may designate an IRB member as a reviewer for expedited studies.

Question 35

The most significant measure of an IRB's efficiency is a. ratio of studies to staff. b. ratio of IRB members to studies. c. average length of IRB meetings. d. average turnaround time.

Answer 35

d. average turnaround time.

Question 36

The IRB may charge sponsors for the study review a. only if the study is approved. b. for initial but not continuing review. c. only if the charge falls in the range approved by OHRP. d. for study review regardless of approval or disapproval.

Answer 36

d. for study review regardless of approval or disapproval.

Question 37

DHHS regulations concerning the number of IRB staff imply that they be a. sufficient to support the IRB's review and recordkeeping duties. b. proportional to the number of expedited studies. c. proportional to the number of full committee studies. d. sufficient to meet the national benchmarks for turnaround times

Answer 37

a. sufficient to support the IRB's review and recordkeeping duties.

Question 38

Regarding audits of studies that may be performed by the IRB of its studies, DHHS regulations and OHRP affirm that such audits a. may include verification from sources other than the investigators that no material changes have occurred since the previous IRB review. b. may monitor the informed consent process c. ensure that the research plan makes adequate provision for monitoring the data collected to ensure the safety of subjects. d. all of the above

Answer 38

d. all of the above

Question 39

The choice of target studies for an IRB audit should be a. directed to Phase I studies as these represent the highest risk. b. directed only to studies where no sponsor-based monitoring is available. c. directed only to investigator initiated IND studies. d. a representative sample of all of the studies annually reviewed.

Answer 39

d. a representative sample of all of the studies annually reviewed.

Question 40

According to DHHS regulations serious and continuing noncompliance uncovered in an audit must a. lead to suspension of research privileges for the investigator. b. lead to suspension of the study but not of the investigator. c. be presented to the investigator's department chair. d. be reported promptly to the institutional official and OHRP.

Answer 40

d. be reported promptly to the institutional official and OHRP.

Question 41

A quality assurance program for clinical trials is a. defined in detail by OHRP. b. is described by ICH-GCP but not by DHHS. c. is not required by the FDA. d. is required only for Phase III trials as described by NIH.

Answer 41

b. is described by ICH-GCP but not by DHHS.

Question 42

The purpose of an IRB based post-approval monitoring programs to a. keep close scrutiny of investigators. b. ensure that IRB approved protocol procedures are being followed. c. ensure that DHHS requirements for such a program are followed. d. ensure that OHRP guidelines for post approval audits are met.

Answer 42

b. ensure that IRB approved protocol procedures are being followed.

Question 43

Which of the following statements about the IRB chair is a part of DHHS regulations? a. The name, phone number, and e-mail address of the IRB chair must be provided in the IRB registration. b. Any change in the IRB chair designationmust be updated in the IRB registration within 90 days. c. The IRB chair may designate an IRB member for expedited review. d. all of the above.

Answer 43

d. all of the above.

Question 44

Which of the following statements regarding the IRB staff are a part of DHHS regulations? a. Staff should be sufficient to support the IRB's review and recordkeeping duties. b. The approximate number of full-time equivalent positions devoted to the IRB's administrative activities must be stated in the IRB registration. c. The regulations are silent on the qualifications and reporting structure needed for IRB staff. d. all of the above.

Answer 44

d. all of the above.

Question 45

DHHS regulations comment on the volume of studies to be reviewed by the IRB include a. the number of IRB members should be proportional to the IRB volume of studies. b. the number of IRB staff should be proportional to the IRB volume of studies. c. the number of active and active DHHS protocols must be stated in the IRB registration. d. the ratio of expedited to full committee review studies must follow DHHS guidelines.

Answer 45

c. the number of active and active DHHS protocols must be stated in the IRB registration.

Question 46

Which of the following does NOT apply to the IRB administrative director? a. may or may not be an IRB member. b. may be designated as an expedited study reviewer even if the director is not an IRB member. c. may serve as an alternate member to another voting member on the IRB. d. must be the designated reviewer for exempt studies.

Answer 46

b. may be designated as an expedited study reviewer even if the director is not an IRB member.

Question 47

Which of the following is expected of the IRB chair and is NOT stated in the DHHS regulations? a. Facilitates free and vigorous discussion of studies among IRB members. b. Represents the IRB in all important institutional and regulatory matters concerning the IRB. c. Should read all protocols submitted to the IRB prior to the IRB meeting. d. all of the above

Answer 47

d. all of the above

Question 48

Which of the following is recommended for the IRB administrative director in consideration of best IRB management practices? a. Establishes compliance with federal regulations. b. Pursues accreditation with IRB accrediting agencies such as AAHRP. c. Develops and implements IRB policy. d. Serves as an authority and a resource for expertise in regulatory matters. e. all of the above

Answer 48

e. all of the above

Question 49

Which of the following is recommended for the IRB administrative director in consideration of best IRB management practices? a. Triaging research between IRB review categories. b. Supervising IRB staff. c. Overseeing IRB and researcher education programs. d. all of the above

Answer 49

d. all of the above

Question 50

According to DHHS regulations which of the following roles would be permissible for the IRB administrative director? a. Serve as a voting member of the IRB. b. Serve as an alternate member for another member on the IRB. c. Serve as reviewer for expedited studies if the director is a member of the IRB and so designated by the IRB chair. d. all of the above

Answer 50

d. all of the above

Question 51

DHHS regulations would permit which of the following roles for an attorney with respect to the IRB a. may serve as a non-scientific voting member of the IRB. b. approves the final version of an IRB-edited consent form. c. drafts or oversees all letters of approval sent to investigators. d. oversees the charges made by the IRB for study review.

Answer 51

a. may serve as a non-scientific voting member of the IRB.

Question 52

Best practices would indicate which of the following roles for an attorney associated with the IRB? a. Research as needed and provide guidance on state-related regulatory issues. b. Supervise the IRB chair's activities. c. Serve as the arbiter on all matters related to privacy and confidentiality. d. Serve as the institutional official.

Answer 52

a. Research as needed and provide guidance on state-related regulatory issues.

Question 53

Which of the following duties could be performed by a subcommittee of the IRB? a. Expedited review if all subcommittee members are members of the IRB. b. Review minor modifications to previously approved research. c. Conduct continuing review of expedited studies. d. all of the above

Answer 53

d. all of the above

Question 54

Which of the following would apply to social science research? a. Harm in social science research can affect the individual's mental and physical health can biomedical research. b. Biomedical research can include social science research and the harms associated with it. c. Harms in social science research can include loss of employment, loss of insurance, reputational harm, and social discrimination. d. Review of social and biomedical research may be carried out by separate IRBs if the volume of both studies is comparable. e. all the above

Answer 54

e. all the above

Question 55

Exempt studies cannot be carried out with which study population: a. pregnant women b. the elderly. c. prisoners. d. subjects with cognitive problems

Answer 55

c. prisoners.

Question 56

Exempt research is exempt from: a. all FDA regulations b. DHHS regulations described in Title 45 part 46 c. HIPPA regulations d. amendments of study composition changes

Answer 56

b. DHHS regulations described in Title 45 part 46

Question 57

The IRB registration is an application to the a. FDA b. CDC c. OHRP d. DHHS

Answer 57

d. DHHS

Question 58

The IRB registration must be renewed every a. 1 year b. 3 years c. 2 years d. 6 years

Answer 58

b. 3 years

Question 59

The IRB registration information should contain information on (check all that apply) a. IRB member conflict of interest information, financial disclosure, medical license numbers b. The number of total protocols including archived studies c. IRB metrics including turnaround times d. The number of active and DHHS protocols e. Full-time equivalent positions devoted to IRB administration

Answer 59

d. The number of active and DHHS protocols | e. Full-time equivalent positions devoted to IRB administration

Question 60

IRB membership roster shall include information on IRB members including a. financial disclosures and conflict of interest documents b. current list of member protocols and industry affiliations c. department job title and years of employment d. earned degrees, representative capacity, indications of experience including board certifications; the relationship between member and institution (full or part-time employment)

Answer 60

d. earned degrees, representative capacity, indications of experience including board certifications; the relationship between member and institution (full or part-time employment)

Question 61

Under DHHS staffing requirements of an IRB should have a. one administrator per 100 protocols b. at least 5 staff members c. one IRB director and 4 support staff d. sufficient staff to support the IRB's review and recordkeeping activities

Answer 61

d. sufficient staff to support the IRB's review and recordkeeping activities

Question 62

Which federal department needs a scientific review prior to the IRB review? a. DOD b. DHHS c. HUD d. EPA

Answer 62

a. DOD

Question 63

The IRB must report which of the following to OHRP: a. unanticipated problems involving risk to subject or others. b. serious or continuing noncompliance c. suspension or termination of IRB approval d. any of the above

Answer 63

d. any of the above

Question 64

The institutional official on an assurance can be the a. Vice President b. Department Chair c. Director of Research d. Legal Counsel

Answer 64

a. Vice President

Question 65

Which of the following constitutes serious non-compliance in the IRB's estimation? a. enrolling subjects without an authorized consent form b. enrolling subjects during a lapse in IRB approval c. making handwritten changes on the consent form for enrollment d. all of the above

Answer 65

d. all of the above

Question 66

When the IRB makes a risk to benefit determination it should exclude a. case report forms b. laboratory procedures c. drug accountability protocols d. procedures being performed for clinical treatment which are standard of care

Answer 66

d. procedures being performed for clinical treatment which are standard of care

Question 67

In assessing the vulnerability of research subjects the IRB should a. consider whether the subject will be in a placebo arm b. whether the benefit is significant enough given the subject's medical condition c. subject disappointment if the research study does not succeed d. whether the subjects may be subject to undue influence or coercion

Answer 67

d. whether the subjects may be subject to undue influence or coercion

Question 68

The IRB's post-approval monitoring program a. must verify that data collection is complete b. must verify that source documents are complete c. replicate the sponsor's monitoring program d. ascertain that the study is being performed as approved by the IRB

Answer 68

d. ascertain that the study is being performed as approved by the IRB

Question 69

According to DHHS regulations, the IRB has the authority to a. assess the likely future benefits to accrue from the research b. independently approve gene therapy research c. approve the budget for the study d. suspend or terminate the approval for the study

Answer 69

d. suspend or terminate the approval for the study

Question 70

The IRB has approved a study but an institutional committee's risk management unit with concerns about the study may a. change the protocol of the study without IRB approval b. determine that the IRBs conflict of interest appraisal was too sever c. disapprove the study because of liability concerns d. request that the PI be changed from one chosen by the sponsor

Answer 70

c. disapprove the study because of liability concerns

Question 71

The primary responsibility of IRB staff members is to a. track conflict of interest for all IRB members b. propose new members when older members retire c. prepare and maintain adequate documentation of IRB activities d. prepare a comprehensive investigator's manual

Answer 71

c. prepare and maintain adequate documentation of IRB activities

Question 72

According to DHHS regulations, the IRB members should a. hold postgraduate degrees b. be qualified in all the specialties reviewed by the IRB c. be full-time employees of the institution d. be sufficiently qualified through experience and expertise

Answer 72

d. be sufficiently qualified through experience and expertise

Question 73

Education on the IRB's essential regulatory requirements is essential for a. subjects b. sponsors c. IRB consultants d. principal investigators

Answer 73

d. principal investigators

Question 74

According to NIH guidelines, education on GCP and IRB issues is essential for a. study sponsors b. IRB members only c. IRB administrative staff d. key personnel conducting the research

Answer 74

d. key personnel conducting the research

Question 75

The FWA for the institution has to be renewed every a. year b. two years c. four years d. five years

Answer 75

d. five years

Question 76

Gene therapy related studies must be reviewed by a. OHRP b. FDA c. IRB only d. IRB and IBC

Answer 76

d. IRB and IBC

Question 77

The FDA has deferred the initial decision regarding the non-significant risk for devices to a. IRB b. OHRP c. the investigator d. the sponsor

Answer 77

a. IRB

Question 78

An investigator wishes to use a drug approved as a subcutaneous formulation for adults in an oral formulation in children under 15 years of age. the investigator should a. inform OHRP b. only obtain an IND c. only obtain IRB approval d. obtain an IND from the FDA and seek IRB approval

Answer 78

d. obtain an IND from the FDA and seek IRB approval

Question 79

Which of the following statements about IRB suspensions is NOT in DHHS regulations a. An IRB shall have authority to suspend or terminate approval of research that is not being conducted in accordance with the IRBs requirements b. An IRB shall have authority to suspend or terminate approval of research that has been associated with unexpected serious harm to subjects c. Any suspension or termination of approval shall include a statement of the reasons for the IRBs action d. Any suspension or termination of approval shall be reported promptly to the investigator, appropriate institutional officials, and the department or agency head e. The institution has the authority to override the IRBs disapproval of a study

Answer 79

e. The institution has the authority to override the IRBs disapproval of a study

Question 80

The FDA has the authority to audit a. IRB only b. sponsors only c. clinical investigators only d. the IRB, sponsors, and clinical investigators

Answer 80

d. the IRB, sponsors, and clinical investigators

Question 81

Regarding IRB review of cooperative research which of the following is NOT in the DHHS regulations a. each institution is responsible for safeguarding the rights and welfare of human subjects and for complying with this policy b. with OHRP/DHHS approval the IRB may enter into a joint review agreement with another IRB c. with OHRP/DHHS approval the IRB may rely upon the review of another qualified IRB, or make similar arrangements for avoiding duplication of effort d. under OHRP guidance an individual collaborative agreement with an individual from another institution is not approvable

Answer 81

d. under OHRP guidance an individual collaborative agreement with an individual from another institution is not approvable

Question 82

According to DHHS regulations continuing review of research should be performed a. as frequently as possible to address risks b. more frequently in studies involving pregnant women c. at least once annually d. every two years for minimal risk studies

Answer 82

c. at least once annually

Question 83

The IRB may review the resume of the principal investigator a. to check on whether the licensure is current b. to verify past employment of the investigator c. to assess if the publications indicate whether the investigator would truly understand the protocol d. to broadly assess whether the investigator is qualified to conduct the research

Answer 83

d. to broadly assess whether the investigator is qualified to conduct the research