45 CFR 46

Question 1

What is 45 CFR 46?

Answer 1

Protection of Human Subjects; referred to as “The Common Rule”and is a compliment to 21 CFR Part 50 & 56

Question 2

What does 45 CFR 46 govern?

Answer 2

It governs the protection of human subjects in research conducted by the U.S. Dept of Health and Human Services (HHS)

Question 3

Define “human subject” according to 45 CFR Part 46

Answer 3

A human subject is a living individual about whom an investigator conducting research obtains data through intervention or interaction or identifiable private information.

Question 4

What is the primary purpose of 45 CFR Part 46?

Answer 4

The primary purpose is to establish ethical standards and safeguards to protect the rights and well-being of human subjects involved in research.

Question 5

How is IRB related with 45 CFR Part 46?

Answer 5

45 CFR Part 46 mandates establishment and functioning of IRB for studies funded by HHS.

Question 6

Explain the role of Office for Human Research Protections (OHRP) in relation to 45 CFR Part 46

Answer 6

OHRP oversees the implementation and compliance of 45 CFR Part 46, providing guidance to institutions, researchers, and IRBs.

Question 7

What is a “vulnerable population” in the context of 45 CFR Part 46, and how are they protected?

Answer 7

Vulnerable populations include children, prisoners, pregnant women, and individuals with impaired decision-making capacity.

Extra safeguards are implemented to protect their rights and well-being

Question 8

What are the key elements that must be included in the informed consent form according to 45 CFR Part 46.116?

Answer 8

The informed consent form must include information about the research, risks and benefits, alternatives, confidentiality, and the right to withdraw without penalty.

Question 9

What are the 2 essentials for research on pregnant woman and fetus to be approved?

Answer 9

1) Pre-clinical studies have already been conducted
2) The absence of undue risk to the fetus and the likelihood of direct benefit to the pregnant woman or the fetus.

Question 10

Describe the consent requirements of mother and father for research per 45 CFR Part 46:

Answer 10

-Only woman consents if research benefits her and fetus
-Both mother/surrogate and father need to consent if benefit is only on the fetus. The father doesn’t have to if they are unavailable, incompetent, temp incapacitated or pregnancy was resulted by SA

Question 11

How does 45 CFR Part 46 address the requirement for additional safeguards in research involving neonates?

Answer 11

the research must present a reasonable opportunity to further the understanding, prevention, or alleviation of a serious problem affecting the health or welfare of neonates in the context of existing pre-clinical studies.

Question 12

Identify subpart B, C, and D of 45 CFR Part 46

Answer 12

B: Pregnant Women, Human Fetuses and Neonates
C: Prisoners
D: Children

Question 13

Research with uncertain or non-viable neonates can be done if: (2)

Answer 13

-Scientifically appropriate
-Consenting ppl are fully informed of foreseeable impact on neonate.

Question 14

Who needs consent for uncertain viable neonates?

Answer 14

Both parents
OR
Parent + LOR

Question 15

When can research uncertain viable neonates proceed?

Answer 15

There is a prospect of enhancing survival and improving knowledge then IRB will approve.

Question 16

Who needs consent on non-viable neonates?

Answer 16

Both or one parent give consent.

Question 17

What are the conditions for research on non-viable neonates? (4)

Answer 17

-If vitals are not artificially maintained.
-Research will not terminate heartbeat/respiration
-No additional risk
-Improving knowledge

Question 18

What are two criteria for IRB for a research involving prisoners as subjects?

Answer 18

-Majority of the board have no associations with the prison.
-One member of the board shall be a prisoner or prisoner representative.

Question 19

4 conditions for study protocol involving prisoners:

Answer 19

1. Possible advantages of participation is does not grossly outweigh their capacity to assess risks
2. Risks are comparable to non-prisoner volunteers.
3. Subject selection is fair.
4. Research participation has no effect on parole boards.

Question 20

4 conditions for study protocol involving children:

Answer 20

1. The research is an opportunity to increase understanding or prevent/alleviate a serious problem.
2. Accordance with sound ethical principles
3. Provisions are made for acquiring assent of children AND permission from parents/guardians.
4. Consultation with secretary with panel of experts approval.

Question 21

In what conditions can IRB waive the need for parental permission?

Answer 21

Neglected or abused children but must provide alternative protections.

Question 22

When can wards of State participate in research?

Answer 22

The research must be either directly related to their status as wards or conducted in settings where most participants are not wards.

Question 23

What is unique about wards of the state in research?

Answer 23

A ward that will participate in research requires an advocate, in addition to any guardian. Both will act in the child’s best interest and independent of the research.

An advocate can represent multiple children

Question 24

Criteria for IRB approval of research

Answer 24

1. Minimize Risks
2. Reasonable Risks vs Benefits
3. Equitable selection of subjects
4. Informed consent
5. Data Monitoring
6. Privacy and Confidentiality
7. Added safeguards for Vulnerable populations