Skip to main content
 

Find lower cost health insurance and savings now through August 15, 2021 at HealthCare.gov.

This is archived HHS content.
HHS.gov Office for Human Research Protections
Search
U.S. Department of Health & Human Services
Close
A-Z Index
  • About OHRP
  • Regulations, Policy & Guidance
  • Education & Outreach
  • Compliance & Reporting
  • News
  • Register IRBs & Obtain FWAs
  • SACHRP Committee
  • International

Breadcrumb

HHS > OHRP > Regulations, Policy & Guidance > Guidance > Biological Materials and Data

  • Text Resize A A A
  • Print Print
  • Share Facebook Twitter Email

Left Nav: /ohrp/regulations-and-policy

  • Belmont Report
  • Regulations has sub items, about Regulations
    • 45 CFR 46
      • 2018 Requirements (2018 Common Rule)
      • Exemptions (2018 Requirements)
      • Subpart B
      • Subpart C
      • Subpart D
      • Subpart E
      • List of Expedited Categories (1998)
      • Annotated version of 2018 Requirements
      • Pre-2018 Common Rule
      • Exemptions (Pre-2018 Requirements)
    • Revision of the Common Rule
      • Preamble to the Revised Common Rule (2018 Requirements)
      • Path to Revising the Common Rule (2011–2018)
      • Explanation of Terminology
  • Decision Charts has sub items, about Decision Charts
    • Pre-2018 Requirements Decision Charts
    • 2018 Requirements Decision Charts
  • Guidance has sub items, about Guidance
    • OHRP Guidance on COVID-19
    • OHRP Guidance on Elimination of IRB Review of Research Applications and Proposals
    • OHRP Guidance on Maintaining Consistency Regarding the Applicability of the 2018 or Pre-2018 Requirements
    • Frequently Asked Questions
      • 2018 Requirements FAQs
      • 45 CFR 46 FAQs
      • Assurance Process FAQs
      • Children: Research with Children FAQs
      • Exempt Research Determination FAQs
      • Informed Consent FAQs
      • Investigator Responsibilities FAQs
      • IRB Registration Process FAQs
      • Prisoner Research FAQs
      • Quality Improvement Activities FAQs
    • Informed Consent
    • Institutional Issues
    • For Investigators
    • Vulnerable Populations
    • Protocol Review
    • Biological Materials & Data
    • Correspondence
    • Alphabetical List
  • Requests for Comments
  • Informed Consent Posting
  • Single IRB Exception Determinations has sub items, about Single IRB Exception Determinations
    • Background
    • November 2019 Exception Determination
    • October 2020 Exception Determination
  • Subpart C Certification Request to OHRP
  • Regulations & Policy Archived Materials

Biological Materials and Data

Clinical Data Registries - OHRP Correspondence (2015)
Coded Private Information or Biospecimens Used in Research
Coded Private Information or Specimens Use in Research, Guidance (2008)
Fetal Tissue Transplantation Research Guidance (2003)
Genetic Information Nondiscrimination Act (GINA): OHRP Guidance (2009)
Human Embryonic Stem Cells, Germ Cells, and Cell-Derived Test Articles: OHRP Guidance (2002)
Issues to Consider in the Research Use of Stored Data or Tissues (1996, 1997)
National Health Registry Activities and 45 CFR part 46 (2011)
Statute on Fetal Tissue Transplantation Research (1993)

Connect With Us

Visit the HHS Facebook account Visit the HHS Twitter account Visit the HHS Instagram account

Visit the HHS YouTube account Visit the HHS Flickr account

Sign Up for Email Updates

To sign up for updates or to access your subscriber preferences, please enter your contact information below.

Sign Up
OHRP Headquarters

Office for Human Research Protections
1101 Wootton Parkway, Suite 200
Rockville, MD 20852

  • Contact HHS
  • Careers
  • HHS FAQs
  • Nondiscrimination Notice
  • HHS Archive
  • Accessibility
  • Privacy Policy
  • Viewers & Players
  • Budget/Performance
  • Guidance Portal
  • Inspector General
  • EEO/No Fear Act
  • FOIA
  • The White House
  • USA.gov
  • Vulnerability Disclosure Policy
Back to Top
This is archived HHS content.