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Office for Human Research Protections (OHRP) Regulations & Guidance

OHRP Homepage OHRP Homepage

red dot 45 CFR 46

45 CFR 46 consists of Sub-parts A, B, C and D. Sub part A is also known as the "Common Rule".

The text of this Rule was agreed upon by seventeen government agencies and published in the Federal Register on June 18, 1991.

45 CFR 46 Subpart a Subpart A: Common Rule
45 CFR 46 Subpart b Subpart B: Add'l Protections for Pregnant Women, Human Fetuses & Neonates
45 CFR 46 Subpart c Subpart C:
Add'l Protections for Prisoners Involved in Research
45 CFR 46 Subpart d Subpart D: Add'l Protections for Children Involved in Research

Expedited categories of research Expedited categories of research

OHRP Guidance by Topic OHRP Guidance by Topic

OHRP Commonly Used Links

Human Subjects Regulations, Decision Chart Human Subjects Regulations, Decision Chart
Research Involving Coded Private Information or Biological Specimens Research Involving Coded Private Information or Biological Specimens
Research Use of Stored Data or Tissues Research Use of Stored Data or Tissues, OHRP
Information: Special Protections for Children in Research Information: Special Protections for Children in Research
Engaged in Research', OHRP Guidance documen 'Engaged in Research', OHRP Guidance document
Reviewing and Reporting unanticipated Risks to Subjects or others Reviewing & Reporting unanticipated Risks to Subjects or others
OHRP (45 CFR 46) FAQ page OHRP (45 CFR 46) FAQ page

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