Northwestern University Investigators

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Welcome Letter

Ethical Codes

• Belmont Report
  The Belmont Report sent forth the basic ethical principles underlying the acceptable conduct of research involving human subjects. Those principles, respect for persons, beneficence, and justice, are now accepted as the three quintessential requirements for the ethical conduct of research involving human subjects. This document is the foundation of human subject regulations in the United States.

• Declaration of Helsinki (PDF)
  In 1964 the World Medical Association developed the Declaration of Helsinki as a statement of ethical principles to provide guidance to physicians and other participants in medical research involving human subjects. The code of ethics has been widely adopted by medical associations in various countries. It has been revised and amended several times.

• Nuremburg Code
  The Nuremburg Code was developed from the Trials of War Criminals before the Nuremberg Military Tribunals ... and defines ethical behavior in the conduct of research using human subjects. Its development grew from the atrocities in human research conducted by the Nazis.

General IRB and Human Subjects Information

• Human Subject Regulations Decision Charts - Information on determining if your research study requires IRB review.

• Comparison of FDA and HHS Human Subject Protection Regulations

• President's Council on Bioethics - Advises the President on ethical issues related to advances in biomedical science and technology.

Federal Agencies and Guidance

• DHHS Federal Regulations Governing Human Subjects

  • Department of Health and Human Services (DHHS)
    45 CFR 46 - DHHS Regulations for the Protection of Human Subjects

  • Office for Human Research Protections (OHRP), DHHS

  • Institutional Review Board Guidebook - OHRP guidance for IRB members and investigators

• Health Insurance Portability and Accountability Act (HIPAA)
  45 CFR 46.160 and 164 - Health Insurance Portability and Accountability Act (HIPAA) Privacy Office of Civil Rights www.hhs.gov/ocr/hipaa/privacy.html and www.hhs.gov/ocr/hipaa/guidelines/research.pdf
  [45 CFR 164.501, 164.508, 164.512(i)]
  [See also 45 CFR 164.514(e), 164.528, 164.532]
  Complete text of all HIPAA Regulations

• Guidance from Federal Agencies and Other Organizations

  • Center for Disease Control
    Center for Disease Control Human Subjects Guidance: CDC Procedures for Protection of Human Research Participants (PDF document)

  • Food and Drug Administration
    FDA Regulations:

    • 21 CFR 50 - FDA regulations for Protection of Human Subjects

    • 21 CFR 56 - FDA regulations for Institutional Review Boards

    • 21 CFR 312 - FDA regulations for Investigational New Drugs

    • 21 CFR 812 - FDA regulations for Investigational Device Exemptions

    • 21 CFR 814.100 - 126 - FDA regulations for Humanitarian Use Devices

    • FDA Guidance for Institutional Review Boards and Clinical Investigators - 1998 Update
      This document provides a valuable resource for investigators regarding FDA regulations for IRB operations and procedures and clinical investigator requirements. Investigators using drugs and devices will benefit from a review of these rules.

    • Good Clinical Practice in FDA-Regulated Clinical Trials
      This site provides information concerning Good Clinical Practice (GCP) in the design and conduct of clinical trials. Compliance requirements and resources are included with links to relevant federal regulations and contact persons in the FDA.

  • Guidance for Clinical Trial Sponsors on the Establishment and Operation of Clinical Trial Data Monitoring Committees: Draft Guidance
    Though this document is only a draft, it provides reasonable suggestions on how to set up Data Monitoring Committees, what they should do, how they should operate.

  • International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH)
    This group provides guidance from a project of the regulatory authorities from Europe, Japan, and US regarding drug development to harmonize the interpretation and application of technical guidelines and requirements for product registration and to reduce the need for duplicate testing in the development of new drugs. Many sponsors require affirmation that the IRB upholds these principles.

  • Office for Research Integrity
    

    The Office for Research Integrity (ORI) promotes integrity in biomedical and behavioral research supported by the Public Health Service (PHS) at about 4,000 institutions worldwide. ORI monitors institutional investigations of research misconduct and facilitates the responsible conduct of research through educational, preventive, and regulatory activities.

  • Veterans Health Administration Office for Research Oversight (ORA)
    The Office for Research Oversight (ORO) serves as the primary Veterans Health Administration (VHA) office in advising the Under Secretary for Health on all matters of compliance and assurance regarding human subjects protections, animal welfare, research safety, and research misconduct.