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i. Background

1.1 The Ethical Mandate to Protect Human Subjects

The Sinai Health System (SHS) Institutional Review Board (IRB) is responsible for ensuring that research on human subjects conducted at Sinai Health System (SHS) follows ethical standards. The Nuremberg Code, The Declaration of Helsinki, the Belmont Report and other research initiatives serve as guides for basic ethical principles in research.

1.1.1.	The Nuremberg Code: The Nuremberg Code was developed in 1949 by the Nuremberg Military Tribunal as a response to the atrocities committed by Nazi physicians on human research experiments. The Nuremberg Code addresses ten principles for judging the "research" practices of Nazi physicians.
1.1.2.	The Declaration of Helsinki: (www.fda.gov/oc/health/helsinki89.html) The World Medical Association published the Declaration of Helsinki: Recommendations Guiding Medical Doctors in Biomedical Research Involving Human Subjects in 1964. This document expands on the Nuremberg Code and its principles. The Declaration of Helsinki called for prior approval and ongoing monitoring of research by independent ethical review committees.
1.1.3.	The Belmont Report: (http://ohrp.osophs.dhhs.gov/ humansubjects/guidance/belmont.htm.) The Belmont Report outlines three principles concerning ethics in research. The principles are used as the framework for the protection of human subjects for biomedical and behavior research in the United States. The three principles include: Respect for Persons is found in the regulations as the need to obtain informed consent, value privacy and confidentiality and provide additional protections for vulnerable populations. Beneficence is the act of securing the well-being of research subjects by: (1) not harming human subjects, and (2) maximizing possible benefits and minimizing possible harms. Justice is applied by the equitable selection of human subjects.

1.2. The Regulatory Mandate to Protect Human Subjects:

Research on human subjects that is conducted at SHS and at its affiliated institutions must abide to the regulations listed below in addition to the Illinois Department of Public Health and laws pertaining to the protection of human subjects in research as well as Mount Sinai Hospital's Multiple Project Assurance with OHRP.

1.2.1.	Department of Health and Human Services (DHHS), 45 CFR 46: (http://ohrp.osophs.dhhs.gov/ humansubjects/guidance/45cfr46.htm) DHHS' regulation on basic human protection is named 45 CFR 46, Subpart A. It is referred to as the Common Rule. This regulation was revised in 1981, 1991 and 2001. It now includes additional protections for fetuses, pregnant women and human in vitro fertilization in 45 CFR 46 Subpart B, prisoners in 45 CFR 46 Subpart C and children in 45 CFR 46 Subpart D. These regulations are enforced by OHRP.
1.2.2.	Food and Drug Administration (FDA) Regulations at 21 CFR 50 and 21 CFR 56: (www.fda.gov/oc/health/helsinki89.html) 21 CFR 50 and 21 CFR 56 govern research funded by the Food and Drug Administration. There are additional regulations that protect human subjects including: Investigational New Drug Applications (IND) at 21 CFR 312; (www.accessdata.fda.gov /scripts/cdrh/cd) Radioactive Drugs at 21 CFR 361; (www.accessdata.fda.gov/scripts/cdrh/cfdocs/ cfcfr/showCFR.cfm?CFRPart=312) Biological Products at 21 CFR 600 (www.access.gpo.gov/nara/cfr/ waisidx_00/21cfrv7_00.html) Investigational Device Exemptions (IDE) at 21 CFR 812; (www.access.gpo.gov/nara/cfr/ waisidx_00/21cfr812_00.html) and Additional Safeguards for Children at 21 CFR 50, Subpart B (www.fda.gov/cber/ind/21cfr50sB.pdf)
1.2.3.	Additional Regulations: Federally supported human subject research for which the IRB provides review and oversight will comply with the Common Rule and the additional regulations: 7 CFR 1c - Department of Agriculture 10 CFR 745 - Department of Energy 14 CFR 1230 - National Aeronautics and Space Administration 15CFR 27 - Department of Commerce 16 CFR 1028 - Consumer Product Safety Commission 22 CFR 225 - Agency for International Development 25 CFR 60 - Department of Housing & Urban Development 28 CFR 46 - Department of Justice 28 CFR 219 - Department of Defense 34 CFR 97 - Department of Education 38 CFR 16 - Department of Veterans Affairs 40 CFR 26 - Environmental Protection Agency 45 CFR 46 - Department of Health and Human Services 45 CFR 690 - National Science Foundation 49 CFR 11 - Department of Transportation By Executive Order - Central Intelligence Agency By Statute - Social Security Administration
1.2.4.	The Assurance and IRB Registration Process. The Common Rule requires that every institution engaged in human research supported through federal dollars file an Assurance of protection for human subjects. The President of Mount Sinai Hospital is responsible for signing and ensuring compliance with all stipulations of the assurance.
1.2.5.	Good Clinical Practices (GCP) (http://www.fda.gov/oc/gcp/default.htm) The FDA has a series of regulations that establish the minimum requirements for Principal Investigators, researchers, and sponsors. These include rules about drug accountability, source documentation, adverse event reporting and safety reports, responsibilities of sponsors and monitors, monitoring of study activity, data integrity, and financial conflicts. All researchers must abide by GCP requirements without exception.
1.2.6.	Health Insurance Portability and Accountability Act of 1996 (HIPAA) 45 CFR Part 160 and Part 164 Under the HIPAA privacy regulations (effect on April 14, 2002), health care organizations are required to establish a strong infrastructure that protects patient's health care data and ensures the privacy of that data. The IRB is responsible for protecting the privacy of human subjects by requesting legal informed consent before using or disclosing protected health information in research studies. In addition, research involving medical records or registry reviews are also subject to the HIPAA requirements. Each disclosure must be documented in the medical records to ensure security and confidentiality. The Privacy Rule outlines specific limited exceptions for releasing private health information (PHI) without patient authorization through an IRB waiver that meets federal and clinical guidelines. It is the responsibility of the IRB to ensure that the use or disclosure of private health information involves no more than minimal risk to patients. HIPAA is triggered whenever PHI is created or disclosed in biomedical research or research that accompanies treatment regardless of funding source.