21 CFR Part 50

Question 1

What must an investigator do for emergency research?

Answer 1

Investigator must submit written certification of determinations and INDEPENDENT physician to IRB and FDA within 5 working days

Question 2

What are 3 possible reasons for emergency research?

Answer 2

1. Subject requires the test article to preserve life.
2. Inability to consent secondary to inability to commuicate or capability to execute effective consent.
3. Insufficient time.

Question 3

When can a waiver of consent occur?

Answer 3

Research is deemed to be minimal risk and/or will not adversely affect the rights and welfare of the subjects.

Ex: Taste and food quality evaluations and consumer acceptance studies.

Question 4

What are 2 things that a short form require?

Answer 4

1. Witness to attest to the oral presentation of ICF
2. Written summary of short form approved by IRB

Question 5

How do short forms of ICF need to be signed?

Answer 5

Subject only needs to sign the short form. Witness will sign short form and written summary. Subject will receive a copy of both.

Question 6

What is the botom line for safeguards for children in clinical investigations?

Answer 6

Adequate provisions are made for soliciting the assent of the children and the permission of their parents or guardians.

Question 7

With regulator bodies, what does a research that aim to understand, prevent, or alleviate a serious problem affecting children require?

Answer 7

Approval of both IRB and FDA.

Question 8

Assent from children- IRB must ensure there are provisions for obtaining assent from children if they are capable of providing it based on what?

Answer 8

based on
- age
-maturity
-psychological state

Question 9

Assent may not be required if

Answer 9

1. child’s ability to understand is too limited
2. Clinical investigations offers direct benefit to the child that is only available through the study

Question 10

IRB may waive the assent requirement if :

Answer 10

1. study involves minimal risk
2. waiver will not negatively affect the child’s rights or welfare
3. study couldn’t be done without waiver
4. If appropriate, children will be given additional relevant information after participating

Question 11

Parental permission

Answer 11

obtained from child’s parents or guardians, for some studies the permission of one parent may be sufficient.

For higher risk studies, both parents must provide permission unless they are deceased or unavailable.

Question 12

Parental permission must be documented, what about child’s assent?

Answer 12

IRB must determine whether and how to document the child’s assent