Defining Research with Human Subjects

HHS regulations for the protection of human subjects involved in research apply to projects determined to be research involving human subjects.

Revised Common Rule (2018 Requirements): Research and Human Subject Definitions

• Research

  Research means a systematic investigation, including research development, testing, and evaluation, designed to develop or contribute to generalizable knowledge. Activities that meet this definition constitute research for purposes of this policy, whether or not they are conducted or supported under a program that is considered research for other purposes. For example, some demonstration and service programs may include research activities.

  For purposes of the revised Common Rule regulations for the protection of human subjects, the following activities are deemed not to be research:

  (1) Scholarly and journalistic activities (e.g., oral history, journalism, biography, literary criticism, legal research, and historical scholarship), including the collection and use of information, that focus directly on the specific individuals about whom the information is collected.

  (2) Public health surveillance activities, including the collection and testing of information or biospecimens, conducted, supported, requested, ordered, required, or authorized by a public health authority. Such activities are limited to those necessary to allow a public health authority to identify, monitor, assess, or investigate potential public health signals, onsets of disease outbreaks, or conditions of public health importance (including trends, signals, risk factors, patterns in diseases, or increases in injuries from using consumer products). Such activities include those associated with providing timely situational awareness and priority setting during the course of an event or crisis that threatens public health (including natural or man-made disasters).

  (3) Collection and analysis of information, biospecimens, or records by or for a criminal justice agency for activities authorized by law or court order solely for criminal justice or criminal investigative purposes.

  (4) Authorized operational activities (as determined by each agency) in support of intelligence, homeland security, defense, or other national security missions.

  MSU Requirements

  If the activity meets this definition, even if the activity is conducted under a demonstration, service, or other program, the activity is considered research. Presently, MSU master's theses and Ph.D. dissertations are considered to be designed to develop or contribute to generalizable knowledge.

  However, in some MSU courses, students collect data from humans by using professional research methods, even though the student's work is not expected to contribute to generalizable knowledge. For those student classroom activities that do not meet the federal definition of research because they are not designed to develop or contribute to generalizable knowledge, IRB review is not required. In these instances, the instructors are responsible for assuring that human subjects are protected. However, if such activities meet the definition of human subject research or a clinical investigation, the activity must be reviewed and approved by the IRB prior to initiation of the activity. Visit HRPP Manual Section 6-9-A, Special Considerations: Student Classroom Research, for more information.

• Human Subject

  Human subject means a living individual about whom an investigator (whether professional or student) conducting research:

  • Obtains information or biospecimens through intervention or interaction with the individual, and uses, studies, or analyzes the information or biospecimens; or

  • Obtains, uses, studies, analyzes, or generates identifiable private information or identifiable biospecimens.

  Intervention includes both physical procedures by which information or biospecimens are gathered (e.g., venipuncture) and manipulations of the subject or the subject's environment that are performed for research purposes.

  Interaction includes communication or interpersonal contact between investigator and subject.

  Private information includes information about behavior that occurs in a context in which an individual can reasonably expect that no observation or recording is taking place, and information that has been provided for specific purposes by an individual and that the individual can reasonably expect will not be made public (e.g., a medical record).

  Identifiable private information is private information for which the identity of the subject is or may readily be ascertained by the investigator or associated with the information.

  An identifiable biospecimen is a biospecimen for which the identity of the subject is or may readily be ascertained by the investigator or associated with the biospecimen.

Pre-2018 Common Rule: Research and Human Subject Definitions

• Research

  Research means a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge. Activities which meet this definition constitute research for purposes of this policy, whether or not they are conducted or supported under a program which is considered research for other purposes. For example, some demonstration and service programs may include research activities.

  MSU Requirements

  If the activity meets this definition, even if the activity is conducted under a demonstration, service, or other program, the activity is considered research. Presently, MSU master's theses and Ph.D. dissertations are considered to be designed to develop or contribute to generalizable knowledge.

  However, in some MSU courses, students collect data from humans by using professional research methods, even though the student's work is not expected to contribute to generalizable knowledge. For those student classroom activities that do not meet the federal definition of research because they are not designed to develop or contribute to generalizable knowledge, IRB review is not required. In these instances, the instructors are responsible for assuring that human subjects are protected. However, if such activities meet the definition of human subject research or a clinical investigation, the activity must be reviewed and approved by the IRB prior to initiation of the activity. Visit HRPP Manual Section 6-9-A, Special Considerations: Student Classroom Research, for more information.

• Human Subject

  Human subject means a living individual about whom an investigator (whether professional or student) conducting research obtains

  • Data through intervention or interaction with the individual, or

  • Identifiable private information.

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

  Interaction includes communication or interpersonal contact between investigator and subject.

  Private information includes information about behavior that occurs in a context in which an individual can reasonably expect that no observation or recording is taking place, and information which has been provided for specific purposes by an individual and which the individual can reasonably expect will not be made public (for example, a medical record). Private information must be individually identifiable (i.e., the identity of the subject is or may readily be ascertained by the investigator or associated with the information) in order for obtaining the information to constitute research involving human subjects.

Contact the MSU IRB with Any Questions

Application of the definitions for research involving human subjects to certain activities is not always straightforward. Contact the MSU IRB office with any questions.