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Complete Overview of Regulations: 42 CFR Part 2
Special Research Protections


5.) Special Research Protections

Two federal laws, which may cover patient identifying information concurrently with the Part 2 regulations,114 protect certain researchers from being compelled to disclose any identifying characteristics about the individual research subjects.115  The first law allows the Secretary to authorize a Confidentiality Certificate for a person conducting research on mental health, including research on the use and effect of alcohol and psychoactive drugs; the second federal law allows the US Attorney General to authorize a Grant of Confidentiality for a person engaged in educational or research programs directly related to enforcement of laws under the Attorney General’s jurisdiction concerning controlled substances. Researchers granted these confidentiality protections may not be compelled to disclose identifying information about their subjects in response to a court order entered under Part 2.



  • 114. 42 CFR § 2.21(b).
  • 115. 42 CFR § 2.21(a).