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Federal regulations for human subject research

• Common Rule at 45 CFR 46 Code of Federal Regulations
  This is the fundamental rule for protection of human subjects in research. It details requirements for informed consent processes, IRB review, membership function, protection of vulnerable populations, and related issues.
  
  
  • The Common Rule regulates human subject research.
    
    
  • The Common Rule defines research as a systematic investigation designed to contribute to generalizable knowledge.
    
    
  • The Common Rule defines human subjects as living individuals about whom researchers obtain data either through interaction or identifiable private information and it gives the example of information as a medical record.
    
    
  • Research on excised human tissue is human subject research if the tissue or associated clinical information is identifiable.
    
    
  • Research on data that is publicly available or in which donors cannot be identified directly or by a link to their identity is exempt from the Rule. [46.101 (4)]

Key Point: Research conducted on identifiable human tissue samples is human subject research.

Key Point: Human tissue is identifiable if the individual from whom the tissue was removed can be determined.

• Federalwide Assurance for Protection of Human Subjects (OHRP)
  Section 103(a) of Common Rule extends the Rule to all human subject research at an institution with any federally funded human subject research and that has elected to extend the Common Rule to all human subject research. The Federalwide Assurance agreement does not require the extension of the Rule to all human subject research.
  
  
• Privacy Rule (HIPAA) 45 CFR 160 and 164 Standards for Privacy of Individually Identifiable Health Information requires patient authorization for electronic transmission of protected healthcare information by covered entities such as health plans, healthcare clearing houses, and health care providers. Its aim is to give patients control over the disclosure of their health information. The HIPAA Privacy Rule excludes information that is de-identified.
  

  The HIPAA Privacy Rule describes de-identified information as "health information that does not identify an individual with respect to which there is no reasonable basis to believe that the information can be used to identify an individual." De-identified samples are a major way to balance the patient's right to privacy and researchers' need for patient tissue and information. There are a few exceptions such as if the information is de-identified or obtained for a limited data set. Researchers may sign a limited data set agreement that allows them to review patient information without identifiers in order to identify potential research subjects or tissue donors. This requires approval by the IRB/Privacy Board.

  The HIPAA Privacy Rule prohibits the date of diagnoses from a Minimum Data Set, even though some critics believe the year of diagnosis is a broad designation unlikely to identify donors and should be acceptable. A de-identified Limited Data Set allows diagnoses dates but has additional restrictions and requires user agreements. Privacy violations are subject to Federal, civil and criminal penalties. In addition, the privacy of patients is protected under HIPAA even after the death of the patient.