FAQ: What are the subparts of the 45 CFR?

The HHS regulations, 45 CFR part 46, include four subparts: subpart A, also known as the Federal Policy or the “Common Rule”; subpart B, additional protections for pregnant women, human fetuses, and neonates; subpart C, additional protections for prisoners; and subpart D, additional protections for children.

What authority does 45 CFR 46 give an IRB?

In the United States, the Code of Federal Regulations Title 45: Public Welfare, part 46 (45 CFR 46) provides protection for human subjects in research carried out or supported by most federal departments and agencies.

What does the Common Rule apply to?

The Common Rule applies to human subjects research conducted, supported or otherwise subject to regulation by the VA. If VA investigators receive support from DHHS (NIH, CDC, etc.), additional subparts of 45 CFR Part 46 may apply.

Which portions of Code of Federal Regulations 45 CFR 46 specifically addresses vulnerable populations?

When conducting research, some populations of research participants require special considerations. The Code of Federal Regulations (CFR 45 part 46) Protection of Human Subjects includes Subparts B, C and D, that describe special protections and criteria for inclusion of pregnant women, prisoners and children.

What does 45 CFR stand for?

CFR Title 45 – Public Welfare is one of fifty titles comprising the United States Code of Federal Regulations (CFR). Title 45 is the principal set of rules and regulations issued by federal agencies of the United States regarding public welfare.

Why is 45 CFR 46 called the Common Rule?

The Federal Policy for the Protection of Human Subjects is known as the “Common Rule” because it has been adopted by a number of federal departments and agencies.

What is IEC in clinical research?

IRBs can also be called independent ethics committees (IECs). An IRB/IEC reviews the appropriateness of the clinical trial protocol as well as the risks and benefits to study participants.

Which subparts of the 45 CFR 46 is are sometimes referred to as the Common Rule?

The HHS regulations, 45 CFR part 46, include four subparts: subpart A, also known as the Federal Policy or the “Common Rule”; subpart B, additional protections for pregnant women, human fetuses, and neonates; subpart C, additional protections for prisoners; and subpart D, additional protections for children.

What are components of the Common Rule?

The main elements of the Common Rule include: Requirements for assuring compliance by research institutions. Requirements for researchers’ obtaining, waiving, and documenting informed consent. Requirements for Institutional Review Board (IRB) membership, function, operations, review of research, and record keeping.

What are the four common abuses that historically are described as giving rise to vulnerability?

There are four common abuses that historically are described as giving rise to vulnerability 1) physical control, 2) coercion, 3) undue influence, and 4) manipulation.

What are vulnerable populations?

Vulnerable populations include patients who are racial or ethnic minorities, children, elderly, socioeconomically disadvantaged, underinsured or those with certain medical conditions. Members of vulnerable populations often have health conditions that are exacerbated by unnecessarily inadequate healthcare.

What are vulnerable and protected populations?

This refers to children, prisoners, pregnant women, nonviable neonates, and neonates of uncertain viability. They are examples of vulnerable populations, which may be more susceptible to coercion or undue influence upon their decisions about whether to participate in research.

Does the research involve human subjects as defined by 45 CFR Part 46?

Part 46, Title 45 of the CFR, also known as the Common Rule, applies to all research involving human subjects conducted, supported or otherwise subject to regulation by HHS, including research conducted by federal civilian employees or military personnel, and research conducted, supported, or otherwise subject to

What does CFR stand for?

The Code of Federal Regulations (CFR) is the codification of the general and permanent rules published in the Federal Register by the executive departments and agencies of the Federal Government. It is divided into 50 titles that represent broad areas subject to Federal regulation.

What are the three ethical principles that constitute the basis for the HHS human subjects regulations 45 CFR 46?

The Belmont Report identifies three fundamental ethical principles for all human subjects research — respect for persons, beneficence, and justice.

What is the revised common rule?

The revised Common Rule requires that for any clinical trial conducted or supported by a Common Rule department or agency, one consent form must be posted on a publicly available federal website within a specific time frame. The consent form must have been used to enroll subjects in order to satisfy this new provision.

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