ORI Introduction to RCR: Chapter 3. The Protection of Human Subjects

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Researchers are responsible for obtaining appropriate approval before conducting research involving human subjects. The need for approval rests on three seemingly obvious but not always easy-to-interpret considerations: 1) whether the work qualifies as research, 2) whether it involves human subjects, and 3) whether it is exempt. All three considerations are discussed in the Common Rule and guide decision making about the use of human subjects in research. The authority to make decisions about the need for approval rests with the Institutional Review Board (IRB, discussed below) or other appropriate institutional officials.

Research. The Common Rule defines research as “systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge” (§ 46.102(d), see box, next page, for full definition). This means that a project or study is research if it:

  • is conducted with the intention of drawing conclusions that have some general applicability and
  • uses a commonly accepted scientific method.

The random collection of information about individuals that has no general applicability is not research. Scientific investigation that leads to generalizable knowledge is.

Human subjects. Human subjects are “living individual(s) about whom an investigator conducting research obtains: (1) data through intervention or interaction with the individual; or (2) identifiable private information” (§ 46.102(f), see box, next page, for full definition). Humans are considered subjects and covered by Federal regulations if the researcher:

  • interacts or intervenes directly with them, or
  • collects identifiable private information.

If one of these two conditions applies and if the project or study qualifies as research, then institutional approval is needed before any work is undertaken.

Exempt research. Some studies that involve humans may be exempt from the requirements in the Federal regulations. Studies that fall into the following categories could qualify for exemptions, including:

  • research conducted in established or commonly accepted educational settings;
  • research involving the use of educational tests;
  • research involving the collection or study of existing data, documents, records, pathological specimens, or diagnostic specimens, if unidentifiable or publicly available;
  • research and demonstration projects which are conducted by or subject to the approval of department or agency heads; or
  • taste and food quality evaluation and consumer acceptance studies.

It is critically important to note, however, that decisions about whether studies are exempt from the requirements of the Common Rule must be made by an IRB or an appropriate institutional official and not by the investigator.

45 CFR 46.102


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