Is it Research?

The IRB oversees all research with human participants undertaken by faculty, staff and students of Marymount University. The MU IRB follows the federal guidelines in identifying a project as ‘research’. As per federal guidelines, “Research means a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge.” 45 CFR 46.102(d)

Projects that meet the definition of research, as described above, AND involve human subjects, must be submitted to the IRB for review prior to initiating the project.

Section 1.2 of the IRB Manual provides additional information on the definition of research.

“Systematic means an activity involving a plan that incorporates quantitative or qualitative data collection and analysis to answer a research question.” In other words a systematic investigation includes all of the following components:

  • Attempt to answer a research question (in some research, this would mean testing a hypothesis).
  • Collect data or information in an organized and consistent way.
  • Analyze the data or information in some way.

“Investigations designed to develop or contribute to generalizable knowledge are those designed to draw general conclusions, inform policy, or apply findings beyond a single individual, an instructional setting, or an internal program.” In other words, the intent of the investigation is to contribute to a field of study. Note the key here is the intention is to share the findings with other researchers, policy makers or practitioners.

The HHS Decision Charts may help you determine if your project qualifies as Research.

The IRB Manual distinguishes between Research with human participants, which always requires IRB review, and Classroom Projects, which require the instructor to complete the CITI Training and submit a Faculty Assurance Form.

There are many other kinds of activities which fall outside of IRB oversight. The IRB has developed a list of activities that do not meet the HHS definition of research. This list can be read here online. If you have suggestions for types of activities that should be added please contact the IRB Chair.

Non-Research Activities List

  • Exploratory Projects: Discussion of ideas that could later frame a research study. This information is not reported in final project (e.g., conversations designed to provide background on a topic).
  • Secondary or Archival Data Analysis: Using previously collected data to answer new questions, such as public use data sets that do not contain information about the identity of participants (e.g., US Census Bureau, National Center for Health Statistics). [Note: private access data sets or data sets with linked records may require IRB review.]
  • Observations: Observations of naturally occurring behavior in places where people have no reasonable expectation of privacy (public settings), if the observer is not changing the environment (intervention) and not talking with those who are being observed (interaction) or recording information that would be considered “private” (e.g., sitting in a shopping mall observing the types of customers who frequent stores [Exception: observations of children could require IRB review if the intent is to generalize knowledge. Refer to 45 CFR 46 Subpart D].
  • Gathering Testimonials: Collection of personal statements in support of a predetermined position, specific product or organization (e.g., collecting quotations to use in a marketing campaign, creating a video to promote a product).
  • Student Classroom Projects: Systematic investigations with human participants for instructional purposes only (e.g., project designed to teach students how to conduct interviews). [Note: Prior to engaging in classroom projects, the instructor must complete the CITI Social and Behavioral Research course and sign the Faculty Assurance Form for Classroom Projects; Students must complete the CITI Basic Student Course.
  • Non-systematic collection of information from human participants: Non-systematic gathering of information does not meet the federal definition of research.
  • Clinical or Field Experiences: A series of supervised experiences that are designed to teach students how to practice in a professional field (e.g., Education, Nursing, Counseling, Physical Therapy).
  • Needs Assessment: Collection of information from a group or population for the purpose of guiding a specific project or to improve service delivery (e.g., interviews with clients concerning design preferences).
  • Institutional Evaluation: Collection of information and ideas used to measure institutional effectiveness; e.g., MU Graduating Student Survey, MU Institutional Assessment Reports. [Exception: Projects analyzing routinely collected existing institutional data may require IRB review, unless the data are de-identified when received by the researcher. If the existing data are not de-identified, IRB approval can be sought after data collection but prior to the analysis.]
  • Learning Assessment: Collection of information and data on student acquisition of knowledge, skill or attitude for improvement of the learning process within the institutional setting; (e.g., analyzing final exams to gauge how well students mastered identified skills).
  • Instructional Assessment: Collection of information and data on the effectiveness of teaching for the purpose of improvement of the teaching process within the institutional setting (e.g., comparing student work on final exams across sections of the same course to select a more effective instructional approach to be taken in the next semester).