All clinical trials in which Atlantic Health System personnel participate as a sponsor or investigator as part of the participating research staff adhere to the three universal principles of human research ethics:
- Respect for Persons. Individuals are treated as autonomous agents through the mechanisms of voluntary informed consent, consideration of privacy, confidentiality, and additional protections for vulnerable populations.
- Beneficence. Possible benefits of the trial are maximized and possible risks are minimized to the persons involved.
- Justice. Selection of subjects is equitable and is representative of the group that will benefit from the research.
In addition, Atlantic Health System operates in accordance with federal, state, and other applicable policies, regulations and directives pertaining to clinical research including
- Food and Drug Administration (FDA)
Regulations 21 CFR 50 and 56
- Federal Wide Assurance
Under the Department of Health and Human Services (DHHS) human subjects protection regulations at 45 CFR. 46.103, every institution engaged in human subjects research supported or conducted by DHHS must obtain an assurance of compliance approved by the Office for Human Research Protections (OHRP).
- Health Insurance Portability and Accountability Act (HIPAA)
All research must comply with HIPAA policies and regulations (45 CFR. Parts 160 and 164) pertaining to the privacy of individually identifiable health information. See in particular Atlantic Health System’s Policies HIPAA –1, 4, 12, 18, and 28.
- The Joint Commission
All research must comply with The Joint Commission standards as specified in the applicable section, “Patient Rights and Organizational Ethics Function,” R I.1.2.1, Informed Consent.