21 CFR Part 50

Question 1

According to 21 CFR Part 50, documentation that supports the use of a test article on a subject when obtaining informed consent was NOT feasible is due to the IRB within how many working days?

a) 1
b) 3
c) 4
d) 5

Answer 1

d) 5

50. 23(c)

Question 2

What is a sponsor-investigator?

Answer 2

An individual who both initiates and conducts, alone or with others, a clinical investigation.

50.3(f)

Question 3

An informed consent should never include:

a) disclosure of alternative treatments/procedures
b) exculpatory language through which a subject’s legal rights are waived
c) the agencies that can potentially review the subject’s research record
d) benefits that may result due to the subject’s participation

Answer 3

b) exculpatory language through which a subject’s legal rights are waived
50. 20

Question 4

According to 21 CFR Part 50, if a short form is used there must be a witness to the oral presentation of the consent document.

true
false

Answer 4

true

Question 5

In seeking informed consent, the following information shall be provided to each subject:

a) a statement that the study involves research, an explanation of the purposes of the research and the expected duration of the subject’s participation, a description of the procedures to be followed, and identification of any procedures which are experimental.
b) a description of any reasonably foreseeable risks or discomforts to the subject.
c) a description of any benefits to the subject or to others which may reasonably be expected from the research.
d) all the above

Answer 5

d) all the above

Question 6

Informed consent shall be documented by the use of a written consent form approved by the IRB and signed and dated by the subject or the subject’s legally authorized representative at the time of consent with no exceptions.

true
false

Answer 6

false

IRB may waive requirement if:

1) no more than minimal risk and involves no procedures where written consent if normally required outside the research context; or
2) requirements for emergency research are met

Question 7

No investigator may involve a human being as a subject in research covered by these regulations unless the investigator has obtained the legally effective informed consent of the subject or the subject’s legally authorized representative (with some exceptions).

true
false

Answer 7

true

Question 8

Sponsor-investigator means:

a) a corporation or agency who both initiates and actually conducts, alone or with others, a clinical investigation.
b) a person who initiates a clinical investigation, but who does not actually conduct the investigation.
c) an individual who both initiates and actually conducts, alone or with others, a clinical investigation.
d) an individual who actually conducts a clinical investigation.

Answer 8

c) an individual who both initiates and actually conducts, alone or with others, a clinical investigation.

Question 9

Institution is defined in 21 CFR Part 50 as:

a) foundation, society
b) public or private entity or agency (including Federal, State, and other agencies)
c) organization or establishment
d) none of the above

Answer 9

b) public or private entity or agency (including Federal, State, and other agencies)

Question 10

What is 21 CFR 50.23?

a) documentation of Informed Consent
b) exception from Informed Consent
c) exception from General Requirements
d) General Requirements for Informed Consent

Answer 10

c) exception from General Requirements

Question 11

The FDA allows exceptions from general requirements for informed consent for the following:

a) clinical investigations involving military personnel
b) clinical investigations involving in vitro diagnostic devices
c) emergency research
d) all of the above

Answer 11

d) all of the above

Question 12

Informed consent shall be documented by the use of a written consent form approved by the IRB and signed and dated by the subject or the subject’s legally authorized representative at the time of consent with no exceptions.

true
false

Answer 12

False (there are some allowable exceptions)

see 50.24 exceptions for emergency research

Question 13

What information (basic elements) must be provided when seeking informed consent? (n=8)

Answer 13

1. A statement that the study involves research.
2. Known risks.
3. Expected benefits.
4. Identification or which procedures are experimental and alternatives to those procedures (standard of care).
5. Extent records kept confidential
6. If more than minimal risk…compensation, treatment
7. Contact information
8. Statement about voluntary participation

50.25

Question 14

Test article categories (n=6)

Answer 14

• any drug (including biological product for human use)
• medical device for human use
• human food additive
• color additive
• electronic product
• any other article subject to regulation under the act or under sections 351 and 354-360F of the Public Health Service Act (42 U.S.C. 262 and 263b-263n)

Question 15

21 CFR Part 50 pertains to:

a) electronic records; electronic signatures
b) protection of human subjects
c) Institutional Review boards

Answer 15

b) protection of human subjects

Question 16

Exceptions from general requirements of informed consent of human subjects include (n=4):

Answer 16

1) human subject confronted by life-threatening situation necessitating use of test article
2) informed consent cannot be obtained because of inability to communicate with, or obtain legally effective consent from subject
3) time is not sufficient to obtain consent from subject’s legal representative
4) no alternative method of approved or generally recognized therapy that provides an equal or greater likelihood of saving the life of the subject

Question 17

The President may waive the prior consent requirement for the administration of an investigational new drug to a member of the armed forces in connection with the member’s participation in a particular military operation.

true
false

Answer 17

true

Question 18

What is 21 CFR 50.24?

Answer 18

Exception from informed consent requirements for emergency research

Question 19

When seeking informed consent for applicable clinical trials, as defined in 42 U.S.C. 282(j)(1)(A), the following statement shall be provided to each clinical trial subject in informed consent documents and processes.

“A description of this clinical trial will be available on http://www.ClinicalTrials.gov, as required by U.S. Law. This website will not include information that can identify you. At most, the Web site will include a summary of the results. You can search this Web site at any time.”

true
false

Answer 19

true

Question 20

21 CFR Part 50, subpart D pertains to:

a) additional safeguards for prisoners in clinical investigations
b) additional safeguards for military in clinical investigations
c) additional safeguards for children in clinical investigations
d) additional safeguards for minority races in clinical investigations

Answer 20

c) additional safeguards for children in clinical investigations

Question 21

In determining whether children are capable of providing assent, the IRB must take into account what 3 things?

Answer 21

1) ages
2) maturity
3) psychological state

Question 22

Informed consent must be presented in the English language.

true
false

Answer 22

False - The information that is given to the subject or the representative shall be in language
understandable to the subject or the representative.

Question 23

If Informed consent cannot be obtained from the subject prior to intervention, the IRB must be informed within how many working days after said intervention?

a) 2 days
b) 3 days
c) 4 days
d) 5 days
e) 10 days

Answer 23

d) 5 days

Question 24

When the President requests an IND consent waiver for military members, what materials must the IRB approve?

a) The information sheet that subjects are required to receive
b) All known adverse events associated with the investigational agent
c) The plan to disseminate information on the IND to recipients AND health care providers
d) Informed consent form (if circumstances allow some or all members to be consented)

Answer 24

a, c and d

Question 25

If a minor does not object to participation in study, this is considered assent to participate.

true
false

Answer 25

False. Assent requires affirmative agreement to participate in a study.

Question 26

In the event that obtaining informed consent for use of an investigational test article is deemed not feasible, which of the the following must the investigator verify (in writing)?

a) the human subject has a life-threatening situation necessitating use of the test article
b) consent may not be obtained due to an inability to communicate with, or obtain consent from, the subject
c) the subject will not be charged for the test article
d) there is not sufficient time to obtain consent from a legally authorized representative
e) there is no available alternative method of approved treatment that provides an equal or greater likelihood of saving the subject’s life than the test article

Answer 26

a, b, d and e.

These must be verified by an independent physician not associated with the clinical investigation. This documentation must be submitted for IRB review within 5 days of use of the test article.

Question 27

IRB approval for conducting emergency research without obtaining prior informed consent must be granted for each individual subject.

true
false

Answer 27

False.

This may be approved in general for a clinical investigation under the following conditions:

• life-threatening condition without proven effective and available treatments AND collection of evidence is necessary to prove safety and efficacy
• Consent not feasible due to lack of ability d/t medical condition AND intervention must be administered before consent from LAR is feasible AND no reasonable way to prospectively identify subjects who will be eligible to participate
• There is prospect for direct benefit (life-threatening, based on animal data, reasonable risks)
• Investigation could not be carried out without consent waiver
• Investigator will attempt to contact LAR for consent within a potential therapeutic window (defined in protocol) rather than proceeding without consent. Summary of these efforts to IRB at continuing rev.
• IRB has reviewed and approved consent plan and document for use when feasible
• Additional protections of rights and welfare of subjects (consult community representatives, public disclosure (to community where it will be done) of protocol prior to initiation and of results when completed, use of independent data monitoring committee for oversight, attempts are made to contact non-LAR family member of subject to ask if they object to participation (summary of efforts reported to IRB at cont. rev)

50.24(a)

Question 28

For what period of time must the governing IRB retain records regarding their review of waiver of consent for emergency research?

a) 1 year after completion of the investigation
b) 3 years after completion of the investigation
c) 5 years after completion of the investigation
d) 7 years after completion of the investigation

Answer 28

b. This applies to determination that conditions for waiver of consent for emergency research have been met as well as written documentation of any situations where the IRB determines that these conditions have NOT been met (the investigation is not approved). In cases where the IRB does not agree that conditions for consent waiver have been met, the (IND) sponsor must promptly notify:
- the FDA
- any clinical investigators participating/asked to participate in this or a similar investigation
- other IRBs that have been asked to review this or a substantially equivalent investigation

Question 29

There may be a protocol requiring prior consent and a protocol allowing a consent waiver (for emergency research), both operated under a single IND or IDE.

true
false

Answer 29

False.

Protocols with a consent waiver for emergency research must be operated under an IND or IDE separate from that under which a protocol requiring prior consent operates, even if the two protocols use the same test article and in the same disease population. Applications for a protocol utilizing a consent waiver for emergency research may not be submitted under an existing IND or IDE.

50.24(d)

Question 30

What is 21 CFR Part 50.25?

Answer 30

Elements of informed consent.

Question 31

Additional elements of informed consent. When appropriate, one or more of the following elements of information shall also be provided to each subject: (n=5)

Answer 31

1) risks to subject (or embryo/fetus) which are currently unforeseeable
2) participation may be terminated by investigator without regard to subject’s consent
3) additional costs to subject resulting from participation
4) consequences of subject’s decision to withdraw
5) significant new findings relating to subject’s willingness to continue participation will be provided
6) approximate number of subjects involved

50.25(b)