Investigator Manual: 2. Defining Human Subject Research

2.1: Research means a systematic investigation, including research development, testing, and evaluation, designed to develop or contribute to generalizable knowledge.

Systemic investigations may include data, such as the following examples:

  • Surveys and questionnaires
  • Interviews and focus groups
  • Evaluation of social or educational programs
  • Cognitive and perceptual experiments

You are developing/contributing to generalizable knowledge if you intend to share the information you produce with others (e.g., as a poster presentation, as a conference talk, or as a publication).

2.2: Human subject means a living individual about whom an investigator, including students, is conducting research:
(i) Obtains information or biospecimens through intervention or interaction with the individual, and uses, studies, or analyzes the information or biospecimens; or
(ii) Obtains, uses, studies, analyzes, or generates identifiable private information or identifiable specimens.

Intervention includes both physical procedures by which data are gathered (for example, venipuncture) and manipulation of the subject or the subject’s environment that are performed for research purposes.

Interaction includes communication or interpersonal contact between the investigator and the subject.

Investigator anyone involved in conducting the research.

Private information includes:

  • information about behavior that occurs in a context in which an individual can reasonably expect that no observations or recording is taking place
  • information that has not been provided for specific purposes by an individual and that the individual can reasonably expect will not be made public (for example, interview notes).

In general, OHRP considers identifiable private information as private information for which the subject’s identity  may readily be ascertained by the investigator associated with the information. Oftentimes, the information is retained directly or indirectly through coding systems. Coded refers to:

  • identifying information (such as name or social security number) that would enable the investigator to readily ascertain the identity of the individual to whom the private information or specimens pertain has been replaced with a number, letter, symbol, or combination thereof (i.e., the code); and
  • a key to decipher the code exists, enabling linkage of the identifying information to the private information or specimens.