45 CRF 46

Question 1

Subpart A

45 CFR 46 is often referred to as?

Answer 1

The Common Rule

Question 2

Subpart A

These regulations apply to research conducted or supported by who?

Answer 2

HHS agencies, such as the National Institutes of Health (NIH) and the Food and Drug Administration (FDA).

Question 3

Subpart A

Department or agency heads retain final judgment as to whether a particular activity is covered by this policy and this judgment shall be exercised consistent with what?

Answer 3

The ethical principles of the Belmont Report

Question 4

Subpart A

True/False: This policy does affect any state or local laws or regulations (including tribal law passed by the official governing body of an American Indian or Alaska Native tribe) that may otherwise be applicable and that provide additional protections for human subjects.

Answer 4

False; it does not.

Question 5

Subpart A

True/False: This policy does not affect any foreign laws or regulations that may otherwise be applicable and that provide additional protections to human subjects of research.

Answer 5

True.

Question 6

Subpart A

A waiver notice of this policy must include a statement that identifies?

Answer 6

The conditions under which the waiver will be applied and a justification as to why the waiver is appropriate for the research, including how the decision is consistent with the principles of the Belmont Report.

Question 7

Subpart A

The general compliance date for the 2018 Requirements is?

Answer 7

January 21, 2019

Question 8

Subpart A

The compliance date for § 46.114(b) (cooperative research) of the 2018 Requirements is

Answer 8

January 20, 2020

Question 9

Subpart A

Cooperative research projects are those projects covered by this policy that…

Each institution is responsible for?

Answer 9

involve more than one institution. Each institution is responsible for safeguarding the rights and welfare of human subjects and for complying with this policy.

Question 10

Subpart A

Any institution located in the United States that is engaged in cooperative research must rely upon approval by?

Answer 10

A single IRB for that portion of the research that is conducted in the United States

Question 11

Subpart A

The following research is not subject to § 46.114(b) (cooperative research)

Answer 11

1) Cooperative research for which more than single IRB review is required by law (including tribal law passed by the official governing body of an American Indian or Alaska Native tribe); or

2) Research for which any Federal department or agency supporting or conducting the research determines and documents that the use of a single IRB is not appropriate for the particular context.

Question 12

Subpart A

For research not subject to paragraph (b) § 46.114(b) (cooperative research), an institution participating in a cooperative project may enter into

Answer 12

A joint review arrangement, rely on the review of another IRB, or make similar arrangements for avoiding duplication of effort.

Question 13

What does 45 CFR Part 46 govern?

Answer 13

45 CFR Part 46 governs the protection of human subjects in research conducted or supported by the Department of Health and Human Services (HHS).

Question 14

What is the primary purpose of 45 CFR Part 46?

Answer 14

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

Question 15

Define “human subject” according to 45 CFR Part 46.102.

Answer 15

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

Question 16

What is the Institutional Review Board (IRB), and how is it related to 45 CFR Part 46?

Answer 16

An IRB is a committee designated to review and monitor research involving human subjects. 45 CFR Part 46 mandates the establishment and functioning of IRBs.

Question 17

Describe the criteria for IRB approval according to 45 CFR Part 46.111.

Answer 17

IRBs must determine that the research meets ethical standards, the risks are minimized, the informed consent process is adequate, and there are provisions to protect the privacy of subjects.

Question 18

What is informed consent under 45 CFR Part 46?

Answer 18

Informed consent is the process by which a subject voluntarily agrees to participate in research after being informed of the study’s purpose, risks, and benefits.

Question 19

Explain the role of the Department of Health and Human Services (HHS) Office for Human Research Protections (OHRP) in relation to 45 CFR Part 46.

Answer 19

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

Question 20

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

Answer 20

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 21

How does 45 CFR Part 46 address the use of a Data Safety Monitoring Board (DSMB) in clinical research?

Answer 21

The regulation recognizes the importance of DSMBs in monitoring the safety and efficacy of clinical trials, especially those involving vulnerable populations.

Question 22

Explain the concept of “minimal risk” under 45 CFR Part 46.102(i).

Answer 22

Minimal risk means that the probability and magnitude of harm or discomfort anticipated in research are not greater than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests.

Question 23

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

Answer 23

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

Question 24

According to 45 CFR Part 46.107, what are the responsibilities of an Institutional Review Board (IRB)?

Answer 24

IRBs are responsible for reviewing and approving, requiring modifications in, or disapproving research, and conducting continuing review of research at intervals appropriate to the degree of risk.

Question 25

Explain the criteria for IRB membership outlined in 45 CFR Part 46.107.

Answer 25

IRB membership must be diverse, including scientists, non-scientists, and at least one member not affiliated with the institution. The IRB must also have adequate expertise to review research involving vulnerable populations.

Question 26

Describe the additional elements required for informed consent when vulnerable populations are involved, as per 45 CFR Part 46.116.

Answer 26

For vulnerable populations, additional elements such as safeguards to protect their rights and well-being are required to be included in the informed consent process.

Question 27

According to 45 CFR Part 46.116, how should the informed consent process be conducted for individuals who are non-English speaking?

Answer 27

The informed consent process must be conducted in a language understandable to the subject, and a translated consent document should be provided.

Question 28

Explain the conditions under which research involving pregnant women can be conducted, as per 45 CFR Part 46.204.

Answer 28

The absence of undue risk to the fetus and the likelihood of direct benefit to the pregnant woman or the fetus.

Question 29

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

Answer 29

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.

Question 30

Under what conditions can the IRB waive or alter some or all of the elements of informed consent, according to 45 CFR Part 46.116?

Answer 30

The IRB may waive or alter elements of informed consent if it finds that the research involves no more than minimal risk to the subjects, and the waiver will not adversely affect the rights and welfare of the subjects.

Question 31

What criteria must be met for the IRB to grant a waiver of documentation of informed consent, as per 45 CFR Part 46.117?

Answer 31

The research must involve no more than minimal risk, the waiver must not adversely affect the rights and welfare of subjects, and whenever possible, subjects will be provided with additional pertinent information after participation.

Question 32

According to 45 CFR Part 46.109, when is a continuing review of research required?

Answer 32

Continuing review of research is required at least annually, and more often if the IRB determines it is necessary to ensure the ongoing protection of the rights and welfare of subjects.

Question 33

Explain the circumstances under which the IRB can suspend or terminate approval of research, as per 45 CFR Part 46.113.

Answer 33

The IRB can suspend or terminate approval of research if it believes that the rights and welfare of subjects are not adequately protected or if the research is not being conducted in accordance with the IRB’s requirements.

Question 34

What are the subparts/titles of 45 CRF Part 46?

Answer 34

Subpart A: Basic HHS Policy for Protection of Human Research Subjects
Subpart B: Additional Protections for Pregnant Women, Human Fetuses and Neonates Involved in Research
Subpart C: Additional Protections Pertaining to Biomedical and Behavioral Research Involving Prisons as Subjects
Subpart D: Additional Protections for Children Involved as Subjects in Research
Subpart E: Registration of Institutional Review Boards (IRBs)

Question 35

What IRBs must be registered?

Answer 35

Each IRB that is designated by an institution under an assurance of compliance approved for federalwide use by the Office for Human Research Protections (OHRP) under §46.103(a) and that reviews research involving human subjects conducted or supported by the Department of Health and Human Services (HHS) must be registered with HHS.

Question 36

When must an IRB be registered?

Answer 36

An IRB must be registered before it can be designated under an assurance approved for federalwide use by OHRP under §46.103(a).

IRB registration becomes effective when reviewed and accepted by OHRP.

The registration will be effective for 3 years.

Question 37

When must IRB registration information be renewed or updated?

Answer 37

(a) Each IRB must renew its registration every 3 years.

(b) The registration information for an IRB must be updated within 90 days after changes occur regarding the contact person who provided the IRB registration information or the IRB chairperson. The updated registration information must be submitted in accordance with §46.504.

(c) Any renewal or update that is submitted to, and accepted by, OHRP begins a new 3-year effective period.

(d) An institution’s or organization’s decision to disband a registered IRB which it is operating also must be reported to OHRP in writing within 30 days after permanent cessation of the IRB’s review of HHS-conducted or -supported research.