Human Subjects Research (IRB)

Do I need to submit a CPHS Application?

Are you planning a research project involving people or their personally identifiable information as the basis of your analysis? If you answered "YES" then you need to figure out if your project has to be written up for review by the Committee for Protection of Human Subjects (CPHS), CSU Monterey Bay's Institutional Review Board (IRB) before you commence research activities.

Research in any field of study can be designed in such a way that it meets the criteria for "research involving human subjects", or not. Research that is involving human subjects requires review by an IRB before research commences.

Some research designs do not require IRB review so you must first determine if your project is or is not "research involving human subjects" per the Code of Federal Regulations Title 45, Part 46 — Protection of Human Subjects (45 CFR 46).

Download the worksheet (Google Doc or PDF) and continue reading to learn if your project needs CPHS review.

Elements of Human Subjects Research

There are two critical elements to figuring out if your research project meets the criteria for requiring review:

  1. Does your research design require an IRB to review it? AND
  2. Does your research involve "Human Subjects"?

Research Designs Requiring CPHS Review

The Code of Federal Regulations 45 CFR 46 require IRB review of projects which are:

A systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge.

But what does that actually mean? Let's break out the parts:

  • Indicators

    • Your project is designed to explore cause-and-effect relationships among a set of factors (e.g.: independent variables) and your topic (dependent variable); or
    • Your project is systematically organized in such a way that you can test your hypothesis/research question.

    If your project doesn't do either of the above, then your research probably doesn't meet the criteria for a systematic investigation.

  • Indicators

    • You are using an existing, valid and tested, instrument; or
    • If you’re developing your own instrument (e.g.: questionnaire), you intend to test it, evaluate it, improve it and repeat the data collection.

    If your project doesn't do either of the above, then your research probably doesn't meet the criteria for development, testing and evaluation.

  • Indicators

    • Drawing conclusions from your findings which if applied to another/larger/equivalent population elsewhere and replication of your study will result in the same/similar findings; and/or
    • Making the components of your research design (procedures, methods, and instruments) as well as your analyzed findings available for other professionals and/or academics to peer review, replicate and utilize.

    Note: Publication in, or presentation at, a peer-reviewed venue (digital and/or traditional) is often how research is disseminated. Although it's commonly considered an indicator of the researcher's intention to "develop or contribute to generalizable knowledge" it is NOT a key factor in determining if the research requires CPHS review.

    Quality Improvement Activities

    Planning to publish an account of a quality improvement project does not necessarily mean that the project fits the definition of research; people seek to publish descriptions of non-research activities for a variety of reasons, if they believe others may be interested in learning about those activities. Conversely, a quality improvement project may involve research even if there is no intent to publish the results.
    OHRP's FAQs on Quality Improvement Activities

    If you think your research might be Quality Improvement Activities check out our guidance Teacher Efficacy, Program Evaluation and Service Assessments designed in collaboration with CSUMB faculty in the College of Education (who conduct a lot of QIA).


    If you intend to present your research strictly in class, at the Capstone Festival, and/or within the confines of the campus, your research probably doesn’t meet the criteria for contributing to generalizable knowledge.

    However: If you're intending to present your research at a peer-reviewed venue, including student research competitions, or publish in a peer-reviewed journal, your activities may be crossing the threshold of "within the confines of the campus" and very well may require CPHS review.

The Code of Federal Regulations (45 CFR 46) defines a "Human Subject" as:

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
  • Uses, studies, analyzes or generates identifiable private information or identifiable biospecimens.

But what does that actually mean? Let's break out the parts:

  • Common forms of data collection that involve intervention with human subjects include:

    • Physical procedures (e.g.: fatigue stress tests, biospecimen sampling)
    • Manipulations of the subject's environment that are performed for research purposes (e.g.: response induction techniques)
  • Common forms of interaction with human subjects include:

    • Performing consent procedures (informing subjects of the risks and benefits during enrollment) in person
    • Surveying (by instrument or questionnaire) in person
    • Interviewing (systematically across all participants) in person
    • Inter rating (scoring or measuring performance or behavior of subjects) in person
  • 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, or 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).

    Individually Identifiable (information or biospecimens)

    Individually identifiable means the identity of the subject is or may readily be ascertained by the researcher (including anyone on the research team) or is associated with the information or biospecimen.

    Common forms of data with identifiable private information involving human subjects include:

    • Student or health records with identifiers
    • Immigration status records with identifiers
    • New media forms of individual disclosure which are not made public but you have access to by privilege or accident
    • Data from deceased individuals
    • Irrevocably de-identified data made publicly available (e.g.: public health data)
    • Coded data made available by authorized institutions and the researchers have no way of ascertaining any individual subject’s identity

    Quality Improvement Activities

    Many activities are not designed with the objective of "generalizability". They're designed to measure and report on performance data for clinical, practical, or administrative uses. To learn more about Quality Improvement Activities, check out OHRP's FAQs and CPHS' guidance Teacher Efficacy, Program Evaluation and Service Assessments.

    Excluded Activities (per Revised Common Rule)

    As of 1/21/19, the Revised Common Rule identifies the following disciplines rarely conduct activities meeting the definition of Human Subjects Research: Oral History, Journalism, Public Health Surveillance, Criminal Justice, and investigative activities in support of intelligence, homeland security, defense, or national security missions.

    That said, if a researcher seeks to aggregate data from multiple sources (archives or repositories), and draw conclusions which apply to general/similar/other populations, that project may constitute Human Subjects Research. The CPHS recommends submitting a "trimmed down" protocol for Not HSR verification review in these cases.

Special Risk

Even if your project doesn't require CPHS review, some research (whether Human Subject Research or not) may pose a special risk if it:

  • Involves protected or vulnerable populations;
  • May cause participants harm (e.g.: psychological, physical, legal, social and/or economic) during data collection or if it’s ever revealed;
  • If the research activities pose a risk to you as the researcher.

In these circumstances, you must contact the university’s Risk Management Department regarding "Special Risk" assessment.