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Regulations and Ethics for Protection of Human Subjects in Research

While scientific research involving human subjects can produce substantial benefits, it also has the potential for troubling ethical questions. Past abuses of the violations of the rights and welfare of human subjects have resulted in various codes and regulations at the Federal level. State and local regulations, as well as institutional policies, provide additional protection for research subjects.

Regulations are built on three ethical principles: respect for persons, beneficence, and justice. The principles govern much of the research with human subjects in the United States, as well as all research involving these subjects at South Piedmont Community College. SPCC will voluntarily adhere to the Common Rule of 45 CFR 46, which is the federal regulation administering research falling under the regulation of Department of Health and Human Services (DHHS).

The DHHS requires research institutions receiving federal funds to conduct research to assure compliance with federal regulations governing research with human subjects. A component of this protection is an established IRB that maintains responsibility for reviewing all research activities involving human subjects within the given institution, and for ensuring proper training in research ethics. South Piedmont Community College will voluntarily enforce 45 CFR 46 as the minimum standard for all studies across the entire institution, whether or not the study is receiving governmental or external funding.

Federal Regulations

45 CFR 46- The National Research Act
The first federal regulation that became effective in 1974 and established the IRB system for work with human subjects

The Belmont Report
The cornerstone statement of ethical principles for human subjects’ protection. The three ethical principles of the Belmont report are: respect for persons, beneficence, and justice.

  1. Respect for persons- pragmatically expressed through informed consent and through establishing protections for those with diminished autonomy. This also includes the right to confidentiality and the right to withdraw consent without consequence.
  2. Beneficence- the act of securing the well-being of research subjects. The researcher must do no harm and maximize possible benefits while minimizing potential harm.
  3. Justice- fairness in the distribution of the burdens and benefits of research. This is reflected in the regulations through review criteria requiring equitable selection of subjects.

21 CFR 50 and 21 CFR 56
These regulations require researchers seek approval from an IRB for investigational use of drugs, devices, and biologics.

The Common Rule
Though it has now been integrated into 45 CFR 46, The Common Rule provides the basis for regulations covering the protection of human subjects in research.