The Common Rule and Related Issues

Question 1

45 CFR Part 46 applies

Answer 1

to studies conducted or sponsored by the Department of Health and Human Services

Question 2

IRB is responsible for conducting its initial and CR and reporting the findings to

Answer 2

the investigator and institution

Question 3

IRB should have written procedures for

Answer 3

conducting initial and CR including projects for which more frequent than annual review is required

determining which projects need verification from sources other than investigators that n material changes have occurred since previous review

for ensuring prompt reporting of proposed changes in approved research

Question 4

In 45 Part 46, the common rule refers to?

Answer 4

Part A

Question 5

the common rule is termed because..

Answer 5

it is subscribed by multiple federal department

Question 6

departments subscribed to the common rule include

Answer 6

department of health and human services
department of education
department of defense
department of agriculture

Question 7

IRB shall ensure that its membership is

Answer 7

not based on gender
not comprised of one profession
illustrative of every nondiscriminatory effort to include qualified people of both sexes

Question 8

CR of research must be conducted at

Answer 8

intervals appropriate to the risk/at least once annually

Question 9

In considering risk of research, the IRB should ensure that the study

Answer 9

ascertain that risks are minimized using procedures consistent with sound design

avoid procedures which unnecessarily expose subjects to risk

uses procedures that are already being used in diagnosis and treatment

Question 10

guidelines for expedited review are described in the regulations of

Answer 10

DHHS and FDA

Question 11

IRB considering risk should

Answer 11

consider risk in relationship to benefits

consider the importance of knowledge that may be reasonably expected but not the long range effects of applying the knowledge

consider only the research procedures and not those used in standard of care

Question 12

an essential element of informed consent affirmed in most ethical framework is that

Answer 12

the participation be voluntary, without penalty or loss of benefits

Question 12

The number of basic elements of informed consent?

Answer 12

8

Question 12

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

Answer 12

6

Question 13

an essential element of consent that is affirmed in most ethical frameworks is that

Answer 13

the subject may discontinue participation at any time without penalty

Question 14

essential basic elements of consent include

Answer 14

statement that the study involves research and its purpose

description and identification of experimental procedures

duration of study

statements of the risk, benefit, and alternate procedures

any compensation for injury

confidentiality of records and contact information regarding subject rights

Question 15

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

Answer 15

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

Question 16

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

Answer 16

include the need for contraception

Question 17

regarding the termination or withdrawal of a subject from a research study, the consent should

Answer 17

provide procedures for orderly termination

describe circumstances in which termination should occur

advise regarding consequences of the subject’s decision to withdraw

advise that termination may occur without the subject’s consent

Question 18

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

Answer 18

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

Question 19

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?

Answer 19

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

Question 20

an investigator is planning to submit a grant to a federal agency. such applications need?

Answer 20

do not need to be reviewed by IRB

Question 21

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

Answer 21

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

Question 22

an investigator for the study approved by a US IRB wishes to carry out procedures related to a study in a foreign country. this situation requires?

Answer 22

a translated consent form, disclosure to the US IRB, an approval from the IRB in a foreign country

Question 23

regarding audits of the IRB, which of the following is true
1.the OHRP does not carry out routine audits of the IRB
2.the FDA audits the IRB once every 3 to 5 years
3.the audit standards of the OHRP differ from those of the FDA

Answer 23

1.true
2.true
3.true

Question 24

which of the following is true of OHRP audits?
1.OHRP audits are usually triggered by a complaint about the IRB?
2.OHRP audit may be triggered by the report of a highly adverse event
3.OHRP audits may be occasioned by a noncompliant IRB research practice as noted in a publication

Answer 24

1.true
2.true
3.true

Question 25

OHRP and FDA penalties for non-compliance by the IRB differ in that
1.OHRP can withdraw its authorization but the FDA cannot
2.The FDA an suspend all clinical trials done under FDA purview but the OHRP cannot
3.the FDA, but not OHRP, can impose civil penalties on the IRB’s institution

Answer 25

1.true
2.true
3.true

Question 26

FDA suspension of the IRB can entail

Answer 26

withholding approval of new FDA studies
prevention of new subjects being added to existing clinical trials
termination of ongoing studies
notification to other state and federal agencies of IRB noncompliance

Question 27

the IRB chair usually reports to

Answer 27

institutional official

Question 28

the person who signs the Federal Wide Assurance is?

Answer 28

institutional official

Question 29

when an IRB takes on an external consultant advise on a research study, the consultant

Answer 29

may not vote

Question 30

an electronic IRB

Answer 30

must be part 11 compliant

Question 31

according to the DHHS regulations, the IRB chair

Answer 31

may designate an IRB member as a review for expedited studies

Question 32

the most significant measure of an IRB’s efficiency is

Answer 32

average turnaround time

Question 33

the IRB may charge sponsors for the study review?

Answer 33

yes, can charge for study review regardless of approval or disapproval

Question 34

DHHS regulations concerning the number of IRB staff imply that they be

Answer 34

sufficient to support the IRB’s review and recordkeeping duties

Question 35

what is true regarding audits of studies that may be performed by the IRB of its studies, DHHS regulations and OHRP affirm that such audits

1.may include verification from sources other than the investigator that no material changes have occurred since previous IRB review
2.may monitor the informed consent process
3.ensure that research plan makes adequate provision for monitoring data collected to ensure safety of subjects

Answer 35

1. true
   2.true
   3.true

Question 36

the choice target of studies for an IRB should

Answer 36

be representative sample of all the studies annually reviewed

Question 37

according to DHHS regulations, serious and continuing noncompliance uncovered in an audit

Answer 37

must be reported promptly to the institutional official and OHRP

Question 38

a quality assurance program for clinical trials is

Answer 38

described by ICH/GCP but not by DHHS

Question 39

the purpose of an IRB based post approval monitoring program is to

Answer 39

ensure that IRB approved protocol procedures are being followed

Question 40

what is true regarding the IRB chair is part of DHHS regulations?

1.name, phone number and email address of the IRB chair must be provided in IRB registration

2.any change in the IRB chair designation must be updated within 90 days

3.IRB chair may designate an IRB member for expedited review

Answer 40

1.true
2.true
3.true

Question 41

what is true regarding the IRB staff is part of the DHHS regulations?
1. staff should be sufficient to support the IRB’s review and record keeping duties
2.the approximate number of full time positions devoted to IRB admin activities must be stated in the IRB registration
3. regulation are silent on the qualifications and reporting structure

Answer 41

1.true
2.true
3.true