What does the IRB consider as research and a human subject?

What is research?

What is a human subject?

 

Question

What is research?

Answer

Research is defined in the federal regulations about Institutional Review Board (IRB) oversight as “a systematic investigation, including research development, testing, and evaluation, designed to develop or contribute to generalizable knowledge” [45 CFR 46.102 (d)]. It can be qualitative or quantitative in nature or employ mixed research methods. Several categories of projects are generally considered non-research and would ordinarily be exempt from IRB oversight, including: (1) quality assurance studies, (2) evidence-based practice improvement, (3) marketing studies, (4) project implementations, (5) product or program evaluation studies, and (6) institutional research. Most capstone models at WGU fall into these categories and are exempt. However, when these projects employ atypical methodology, deal with vulnerable populations or relations, investigate sensitive topics, or put subjects at risk, IRB oversight may be required (see Student Handbook IRB Policy).

 

Question

What is a human subject?

Answer

Federal regulations (45 CFR 46) provide the following definitions related to human subjects and related topics:

 

Human subjects: "Living individual(s) about whom an investigator (whether professional or student) conducting research obtains: (1) data through intervention or interaction with the individual, or (2) identifiable private information."

 

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 or academic 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.”

 

Therefore, all activities involving prospective collection of information about individuals by means of intervention/interaction are considered using human subjects and may require WGU Institutional Review Board (IRB) approval before initiation of the study methods including data collection.

 

When studies involve the use of secondary/existing data (data/information that exist(s) at the time the research project begins [e.g., previously collected survey data, school records, medical records]), WGU IRB approval is not needed to use such data for research purposes if the secondary/existing data do not contain private information. Some common examples of secondary/existing data that are not considered private information include:

 

Certain information on the Internet - content of public tweets and blogs; information on public Facebook pages; census information; freely-available sets of data; identifiable information about individuals in a public archive. Additionally, many hospitals, healthcare systems, federal and state departments and agencies make available data to the public that may be used as secondary data research.

 

Realize that not all information on the Internet is considered publicly available and not all datasets that are characterized as anonymous actually are. Examples include, but are not limited to: Comments on a non-public chatroom or listserv; restricted-access datasets; or privately held datasets where individuals may be identified, either directly, through a code associated with a name, or through a combination of variables. The WGU IRB does not give automatic approval for the use of secondary data, just because the data may be classified as such. Researchers must be certain that the secondary/existing data do not contain private information before use.

 

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