Table

Ethical principles of the Belmont Report and their applications to human subjects research (data from The Belmant Report, 1979 and Cohen, J.)

Principles Applications

Respect for Persons

Beneficence

Justice

Informed consent

Protection of vulnerable research subjects (e.g., persons with impaired decisionmaking capacity and institutionalized persons)

Proxy consent and subject assent for persons with impaired decision-making capacity

Maintenance of subject confidentiality Scientifically valid study design Research question worth answering Study minimizes harms and maximizes benefits

Equitable distribution of benefits and burdens of research (i.e., fair recruitment and selection of subjects)

Today, the Office for Human Research Protections (OHRP), which is part of the DHHS, oversees matters related to protecting human research subjects participating in studies conducted or supported by the DHHS. The OHRP (a) establishes criteria for and approves assurances of compliance for protecting human subjects with institutions engaged in research conducted or sponsored by the DHHS; (b) provides clarification and guidance on involving human subjects in research; (c) develops and implements educational programs and resource materials; and (d) promotes the development of approaches to enhance human subject protections. Under the direction of the OHRP, more than 10,000 research institutions have agreed to comply with the regulations for protecting human subjects found in the Common Rule (Office for Human Protections).

In addition to designing and conducting research studies that adhere to the ethical principles of the Belmont Report and comply with federal regulations, investigators engaged in human subjects research have a number of specific responsibilities regarding their local IRBs. These responsibilities are listed in Table 7.3.

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