Codes & Regulations

The Belmont Report HHS Regulations The Objectives For This Board: To identify the three principles of ethical human subjects research identified in the Belmont Report To comprehend the current HHS regulations, including: Risks associated with participation in research and appropriate protections against risks Vulnerable populations that need specific protections Situations in which research involving humans is exempt from regulatory requirements
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Subparts B, C and D define the specific categories of research in which pregnant women, human fetuses and neonates, prisoners, or children respectively may be involved. The subparts describe additional requirements for informed consent, and may specify additional responsibilities for the Institutional Review Board (IRB) when reviewing research involving these populations, and list the requirements for research that need additional levels of review and approval.
The Belmont principle of respect for persons states, in part, that individuals with diminished autonomy may need additional protections. Subparts B, C, and D describe additional protections for some of the populations that are considered particularly vulnerable: B, Additional Protections for Pregnant Women, Human Fetuses and Neonates Involved in Research, C Additional Protections Pertaining to Biomedical and Behavioral Research Involving Prisoners & D Additional Protections for Children
HHS Regulations Infographic: 5 Things YOU Need to Know About HHS Regulations. 1. What is a federal regulation? After Congressional bills become laws, federal agencies are responsible for putting those laws into action through regulations (also known as 'rules'). The public plays an extremely important role in the rulemaking process by commenting on proposed rules to help improve them. Why should I comment? We value your input. HHS must seek public review and comments before finalizing a ...
Human Subject Regulations Decision Charts |
IRBs are committees that consist of 5 or more members with varying expertise and diversity that are responsible for reviewing and approving human subjects research activities on behalf of institutions.  The Common Rule specifies:      IRB membership (45 CFR 46.107)     IRB functions & operations (45 CFR 46.108)     IRB review of research (45 CFR 46.109 and 45 CFR 46.110)     Criteria for IRB approval of research (45 CFR 46.111)
The HHS regulations (45 CFR 46.120) require that Federal Departments and Agencies that conduct or support human subjects research must evaluate all applications for research using the following criteria: Risks to the subjects, Adequacy of protection against these risks, Potential benefits of the research to the subjects and others & Importance of the knowledge gained or to be gained
The Belmont Report (Part One: Basic Ethical Principles) The Belmont Report identified three principles essential to the ethical conduct of research with humans:      Respect for persons     Beneficence     Justice  These three basic principles serve as the foundation of the current HHS regulations and guidelines for the ethical conduct of human subjects research supported by HHS.
OHRP has regulatory authority for the protection of human subjects for PHS-funded research.
Each institution that is engaged in NIH-funded human subjects research must: Obtain or hold a current Federalwide Assurance (FWA), assuring that an institution will comply with HHS regulatory requirements for the protection of human subjects (this is obtained from the HHS Office for Human Subjects Protections (OHRP)); & Certify to NIH that grant applications and contract proposals describing research involving human subjects has been reviewed and approved by an Institutional Review Board…

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The definition of justice has two parts: Fair procedures and outcomes are used to select research participants, and There is a fair distribution of benefits and burdens to populations who participate in research.
The Belmont Report (Part One: Basic Ethical Principles)
Two general rules have been articulated as complementary expressions of beneficent actions: Do no harm & Maximize possible benefits and minimize possible harms. Investigators and members of their institutions are obliged to give forethought to the maximization of benefits and the reduction of risk that might occur from the research investigation.
Human Subject Regulations Decision Charts |
The principle of respect for persons can be broken down into two basic ideas:   1. Individuals should be treated as autonomous agents 2. Persons with diminished autonomy are entitled to additional protections
Document titled with text: Code of Federal Regulations, Title 45, Public Welfare, Department of Health and Human Services, Part 46, Protection of Human Subjects.
Piece of torn paper titled with text: The Belmont Report - Ethical Principles and Guidelines for the Protection of Human Subjects of Research. Piece of paper titled with text: The Belmont Report.