Home > SEK Education S... > SEKESC-IRB Regulations

SEKESC-IRB Regulations

Ethical Principles

SEKESC is committed to the ethical principles for the protection of human subjects in research. Information about the ethical codes that serve as the foundation for the conduct of research with human participants may be found here:

  • Nuremberg Code – Modern human subjects protections begin with the Nuremberg Code. The Code (1949) was developed following the Nuremberg Military Tribunal as a standard by which to judge human experimentation conducted by the Nazis. It addresses many of the basic principles governing the ethical conduct of human subjects research, including the voluntary consent of human subjects.
  • Declaration of Helsinki – The World Medical Association adopted the Declaration of Helskinki (1964) as guidance for medical doctors undertaking biomedical research involving human subjects. The Declaration has been continuously revised (most recently in 2008). It addresses important issues including the principle of risk to benefit ratio in research, human studies based on laboratory and animal studies, review of research by independent committees and informed consent.
  • Belmont Report – The U.S. Congress commissioned the Belmont Report (1979) in response to public outrage over the Tuskegee syphilis study conducted by the U.S. Public Health Service. The report addresses three ethical principles of respect for persons, beneficence, and justice.

Professional Ethics Codes

In addition to complying with the federal regulations governing human subjects, researchers should also follow codes of ethics and regulations within their profession and area of research:

Federal Regulations

  • Human Subjects Research Guidance – This guidance provides in-depth information to SEKESC investigators who may be uncertain if their study meets the definitions of human subjects research stated in the federal regulations (45 CFR 46.102).
  • Children’s Online Privacy Protection Act (COPPA) – The COPPA rule gives parents control over what information websites can collect from their children, as well as establishes additional protections and procedures that companies covered by the rule need to follow. Though the rule was designed to protect those under 13, it applies to operators of commercial websites and online services aimed at general audiences that collect, use, or disclose personal information from children, or on whose behalf such information is collected or maintained.
  • FERPA – The Family Educational Rights and Privacy Act (FERPA) is a Federal law that protects the privacy of student education records. The law applies to all schools that receive funds under an applicable program of the U.S. Department of Education.
  • Office for Human Research Protections Policy and Guidance – The Office for Human Research Protections (OHRP) provides leadership in the protection of the rights, welfare, and wellbeing of subjects involved in research conducted or supported by HHS. OHRP has published a variety of policy and regulatory guidance materials to assist the research community in conducting ethical research that is in compliance with the HHS regulations.
  • HIPAA – The Health Insurance Portability and Accountability Act (HIPAA) Privacy Rule protects personal health information and gives patients a variety of rights. The HIPAA Privacy Rule establishes the conditions under which protected health information may be used or disclosed by coveted entities for research purposes. For more information in the requirements of HIPAA and the de-identification of data, please click HERE.
  • Food and Drug Administration (FDA) Regulations – The Food and Drug Administration (FDA) is an HHS agency that regulates clinical investigations of products under its jurisdiction, such as drugs, biological products, and medical devices. FDA regulations are published as part of Chapter 21 of the CFR, and FDA’s human subject protection regulations are in parts 50, 56, 312, and 812. For FAQs drafted by FDA please click HERE.
  • Code of Federal Regulations – The U.S. Department of Health and Human Services (HHS) issues and enforces rules pertaining to the protection of human subjects in research. All regulations issued by federal agencies under the statutory authority established by Congress are published in the Code of Federal Regulations (CFR). Regulations pertaining to the protection of human subjects can be found in Title 45 Part 46 (45 CFR 46) and is divided into four subparts: A, B, C, and D.