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institutional review board

 

Human Subjects Research

Research

Research is defined by federal regulations as "a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge" 45 CFR §46.102 (d).  

The St. Ambrose University IRB requires submission of all activities involving human subjects, whether the activity is regarded as research by the federal definition or if the activity involves the collection of any sensitive information, including but not limited to implications for criminal or civil liability, employability, damage to the subject's financial standing or reputation, or gender identity or sexual preference.  

Human subjects

Human subjects are defined by federal regulations as living individuals about whom an investigator (whether faculty, staff, or student) conducting research obtains either 1) data through intervention or interaction with the individual, or 2) identifiable private information 45 CFR §46.102 (f).

Definitions

Intervention: both physical procedures by which data are gathered and manipulations of the subject or the subject's environment that are performed for research purposes.
Interaction: communication or interpersonal contact between investigator and subject. 
Private information: 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.
Investigation: A searching inquiry for facts, or detailed or careful examination.
Systematic: Having or involving a prospectively identified approach to the investigation, based on a system, methods, or plans.
Designed: The activity has a predetermined purpose and intent.
Develop: To form the basis for a future contribution.
Contribute: To result in.
Knowledge: Truths, facts, information.
Generalizable: The data and/or conclusions are intended to apply more broadly beyond the individuals studied or beyond a specific time and/or location, such as to other settings, circumstances, or categories.

Research FAQ

But is it actually research?

Examples of research:

• A survey of college students' television watching preferences.
• Teaching a different variation of phonics for learning reading, and gathering data to assess the success of the technique.
• Testing whether relaxation training reduces pain for individuals with chronic back pain.

Examples of projects which are probably not "research" as defined above:

• Reviewing and compiling information from published sources, as in a term paper.
• A subjective comparison of two PowerPoint presentations.
• Classroom demonstrations of use of a memory technique.
• Shadowing a professional through a day.

What Is Considered Research Involving Human Subjects?

If your project is:

• Research
• Your source of data is Human Beings, and
• Collecting information about the person

Then your project falls under the requirement of submission to the Institutional Review Board for Protection of Human Subjects at St. Ambrose University.  

Examples:

• Surveys
• Interviews
• Answers to tests, entries in journals
• Observation of human behavior or physiology (progression of a disease, for instance)
• Information from clients' files at an agency, school, or medical setting.


Examples of research which probably is not defined as "human subject":

• Questions on a survey that are not about the person or their opinions.
• Recording and analyzing the content of television shows, magazine articles, published books, or published music.
• Use of publicly available, compiled, anonymous data sources, such as U.S. census data or stock market prices.
• Use of data sources involving elected officials.
• Quality assurance or program improvement information