SNMMI Clinical Trials Network Research Series for Technologists: Ethical Issues and Regulations in the Medical Workplace

Article Figures & Data

TABLE 1

Regulatory Policies and Governing Bodies

Name	Responsibilities
U.S. FDA	Protects public health by ensuring safety, efficacy, and security of human and veterinary drugs, biologic products, and medical devices
CFR	Organizes rules published by U.S. federal government departments and agencies; is divided into 50 titles
NRC	Ensures safe use of radioactive materials
Joint Commission	Sets standards and accredits health-care organizations in United States
HIPAA	Provides data privacy and security for safeguarding medical information
OSHA	Sets and enforces workplace safety
OHRP	Protects human subjects and provides leadership in biomedical and behavioral research
WHO	Promotes healthy lives and well-being for all people
ICH	Promotes public health safety through international harmonization

TABLE 2

Research Ethical Standards

Standard	Description
Nuremberg Code	Set of research ethical principles for human experimentation from Nuremberg trials
Declaration of Helsinki	General guiding principles for researchers when working with human subjects
Belmont Report	Basic ethical guidelines on human subject research (respect for persons, beneficence, and justice)
GCP	Description of clinical trial design and responsibilities of investigator, sponsor, and institution
Common Rule (title 45 of CFR, part 46, subpart A)	Rule for creating uniform regulations across U.S. agencies involved in human subject research