21 CFR Part 50

Question 1

What does 21 CFR Part 50 cover?

Answer 1

Protection of human subjects (Informed consent & safeguards for children in clinical investigations)

Question 2

What is a clinical investigation

Answer 2

Any experiment that involves a test article and one or more human subjects that is subject to requirements for prior submission to the FDA OR that the results are intended to be submitted later or held for inspection by the FDA as part of an application for a research or marketing permit

Question 3

What is an investigator

Answer 3

An individual who actually CONDUCTS a clinical investigation

Question 4

What is a Sponsor?

Answer 4

A person (corporation or agency) who INITIATES a clinical investigation, but does NOT actually conduct the investigation

Question 5

What is a sponsor-investigator?

Answer 5

An indvidual who BOTH initiates and conducts, alone or with others, a clinical investigation

Question 6

What is a human subject?

Answer 6

An individual who is or becomes a participant in research; may be either the recipient of the test article or a control

Question 7

Define Minimal Risk

Answer 7

The probability and magnitude of harm anticipated in research are not greater than those ordinarily encountered in daily life, or during routine physical or psychological exams

Question 8

What is assent?

Answer 8

A child’s affirmative agreement to participate in a clinical investigation (lack of objection does not equal assent)

Question 9

Consent should only be sought under circumstances which _________

Answer 9

minimize the possibility of coercion or undue influence

Question 10

Informed consent may not include exculpatory language, which _____________________________

Answer 10

Waives or appears to waive the subject’s legal rights; or releases or appears to release the investigator/sponsor/institution from liability for negligence

Question 11

What are the 8 basic elements of informed consent?

Answer 11

1) A statement that the study involves research, purposes of the research, and expected duration of participation, and procedures to be followed
2) Foreseeable risks
3) Any benefits to the subject or others
4) Disclosure of appropriate alternatives
5) Statement describing the extent to which confidentiality of records will be maintained
6) Whether there is any compensation & whether medical treatments are available if injury occurs
7) Who to contact for answers to pertinent questions
8) Voluntary participation and right to discontinue participation at any time

Question 12

What are the 6 additional elements of informed consent?

Answer 12

1) Statement that treatment may involve unforeseeable risks
2) Anticipated circumstances under which participation may be terminated
3) Additional costs to the subject
4) Consequences of decision to withdraw
5) Statement that significant new findings that may effect subject’s willingness to participate will be provided
6) Approximate number of subjects in the study

Question 13

Emergency research may be excepted from informed consent requirements if it meets the following 7 criteria.

Answer 13

1) Subject is in a LIFE-THREATENING situation with unproven or unsatisfactory available treatments & collection of scientific evidence is necessary to determine the safety and effectiveness of interventions

2) Obtaining informed consent is NOT FEASIBLE d/t subjects medical condition, can’t get consent from legally authorized rep in time, and no way to prospectively identify individuals that may become eligible

3) Prospect of DIRECT BENEFIT to subject

4) Investigation could not be practically carried out without the waiver

5) Investigator commits to ATTEMPTING CONTACT w/ LAR

6) An ICF is approved and will be used when feasible

7) ADDITIONAL PROTECTIONS of rights and welfare of the subjects will be provided

Question 14

What are the additional protections of the rights and welfare of the subjects that should be provided in emergency research that is excepted from informed consent requirements?

Answer 14

1) Consultation with representatives of the community
2) Public disclosure to the community of plans for the investigation & risks/benefits
3) Public disclosure of info following completion of the investigation
4) Establishment of independent data monitoring committee
5) If a LAR is not available, investigator commits to attempt to contact a family member

Question 15

What does 21 CFR Part 50 Subpart D Cover?

Answer 15

Additional safeguards for children in clinical investigations

Question 16

In what circumstances is the assent of a child not necessary for proceeding with a clinical investigation?

Answer 16

1) The capability of some of the children is limited so that they cannot reasonably be consulted (i.e., age, maturity, psychological state)
2) The investigation holds a prospet of direct benefit important to the well-being of the child and only available in the context of the investigation

Question 17

In what circumstances is one parent’s permission sufficient for a child to participate in a clinical investigation?

Answer 17

1) Clinical investigations involving no greater than minimal risk

OR

2) Clinical investigations involving greater than minimal risk, but presenting prospect of direct benefit to the individual subjects

Question 18

Wards of the state participating in a clinical investigation must be appointed an ______________

Answer 18

Advocate, with the background and experience to act in the best interest of the child for the duration of the child’s participation in the clinical investigation.