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Common Rule

The current U.S. system of protection for human research subjects is heavily influenced by the Belmont Report, written in 1979 by the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. The Report outlines the basic ethical principles in research involving human subjects. Pursuant to WesternU’s Federalwide Assurance for the Protection of Human Subjects, all activities related to human subjects research, regardless of the source of support, will be guided by the statement of principles contained in The Belmont Report as they pertain to protecting the rights and welfare of human subjects used in research conducted at or sponsored by WesternU.

The Federal Policy for the Protection of Human Subjects, published in 1991, is referred to as the “Common Rule”, and can be found in Subpart A of 45 CFR 46 of the Department of Health and Human Services (HHS) regulations. The Common Rule outlines the basic provisions for IRBs, informed consent and Assurances of Compliance.

Investigators may find the following videos, produced by HHS’s Office for Human Research Protections (OHRP), useful in understanding when, and to what, the Common Rule applies. Take particular note of the revisions that have been made to the Common Rule.

When does the Common Rule Apply? Review of the Basics under the Revised Rule [June 22, 2018] discusses:

  • Determining if the Common rule applies;
  • Definition of research;
  • Activities deemed not to be research;
  • Definition of human subject;
  • Definition of identifiable biospecimens and identifiable private information;
  • Determining if the research is Exempt; and
  • The exemptions in the revised Common Rule, including secondary research.

Overview of Changes to Exemptions in the Revised Common Rule [June 22, 2018] focusses on exemptions 1, 2, 3, and 5 of the Common Rule and includes a discussion of:

  • Restrictions added to Exemption 1. Educational practices;
  • Expansion of Exemption 2. Educational tests, surveys, interviews, observation of public behavior;
  • Removal and replacement of Exemption 3. Research on public officials;
  • New Exemption 3 category which includes authorized deception research;
  • Expansion of, and changes to, Exemption 5. Research conducted by a federal agency, or research funded by a federal agency, pertaining to public benefit or service programs.

Regulatory Options for Secondary Research with Private Information and Biospecimens Part 1 [June 22, 2018] discusses secondary research, i.e., research use of information or biospecimens originally collected for a) non-research purposes or b) research studies other than the original proposed one, and how it can be done under the revised Common Rule. Exemption categories 4, 7, and 8 are covered in detail. A key change to Exempt category 4 is that secondary research use of identifiable private information or identifiable biospecimens need not be already in existence prior to the start of the research. Exemption categories 7 and 8 are newly added categories and apply to the storage, maintenance and use of identifiable private information or identifiable biospecimens for secondary research.

Regulatory Options for Secondary Research with Private Information and Biospecimens Part 2 [June 22, 2018] covers options for investigators planning to do secondary research with private information or biospecimens. It is recommended that investigators watch Part 1 of this series, above, before watching part 2.