For researchers (students and professionals) at CSUMB to use in determining whether or not to submit a full application for CPHS review of human subjects research.

1. 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 (45CFR46), and Title 21, Parts 50, 56, 312 and
812 (21CFR50, 56, 312 & 812).
Where to Start: 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”?
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2. First you need to figure out if your research design meets the criteria set forth by
OHRP requiring review of: A systematic investigation, including research
development, testing and evaluation, designed to develop or contribute
to generalizable knowledge.
Let’s break that down. A “systematic investigation” includes development, testing
and evaluation of what? It is widely accepted that this refers to the components of
a research design including your procedures, methods and instruments. In other
words: Do you intend to develop, test and evaluate the procedures, methods and
instruments used in your research design?
Something to consider with respect to “systematic investigation”: Are you using an
existing, valid and tested, instrument or are you developing your own? If you’re
developing your own instrument (e.g.: questionnaire) do you intend to test it,
evaluate it, improve it and repeat the data collection? If not, then your research
probably doesn’t meet the criteria for a “systematic investigation”.
What does OHRP mean by “contributing to generalizable knowledge”? Again, it is
widely accepted that this means making the components of a 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.
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3. Traditionally this occurs when publishing or presenting at a professionally refereed
venue, conference or competition but it may also occur through new‐media methods
of professional discourse.
Something to consider with respect to “contributing to generalizable knowledge”: Do
you intend to present your research strictly in class, at the Capstone Festival, and/or
within the confines of the campus? If you (or your faculty adviser) never intend to
share your research design and findings with other professionals to peer review,
replicate and utilize, your research probably doesn’t meet the criteria for
“contributing to generalizable knowledge”.
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4. The criteria for "Human Subjects" is defined by OHRP as: 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.
So "Human Subjects" must be living individuals that you "Intervene" with, "Interact"
with, or analyze "Identifiable Private Information" about. What does that mean?
Common forms of data collection that involve "Intervention" with "Human
Subjects" include: Physical procedures (e.g.: fatigue stress tests) and manipulations
of the subject of the subject's environment that are performed for research
purposes (e.g.: response induction techniques).
Common forms of data collection that involve "Interaction" with "Human Subjects"
include: Observing, surveying, and interviewing.
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.
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5. But data from deceased individuals, irrevocably de‐identified data made publically
available (e.g.: public health data), and even some coded data made available by
authorized institutions (when the researcher has no way of ascertaining any
individual’s identity) is not involving "Human Subjects" because you are not
"Intervening" with, "Interacting" with, or analyzing "Identifiable Private Information"
about living individuals.
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6. Were you able to answer confidently “NO” to any of the questions? If so, download
and complete the worksheet “Does My Project Need CPHS Review?”. Keep it in your
research files, or if you're a student turn it in to the faculty advising your research to
double‐check that your project does not require CPHS review.
Note: On the worksheet, pay attention to the Additional Precautions questions
related to “Special Risk” posed by research which involves protected or vulnerable
populations, or may cause participants harm (e.g.: psychological, physical, legal,
social and/or economic) during data collection or if it’s ever revealed. Also, if the
research activities pose a risk to you as the researcher, you (or your faculty adviser)
must contact the university’s Risk Management Department regarding "Special
Risk" assessment.
If you answered “YES” or “NOT SURE” to both questions then you need learn more
by reading the "Human Subjects in Research" tabs at: spo.csumb.edu/human‐subjects‐
research. If you're a student, start a conversation with the faculty advising your
research project by completing and discussing the worksheet “Does My Project
Need CPHS Review?”. If you (and/or your faculty adviser) are still not sure if you
need to submit your project to the CPHS for review, you can always contact a CPHS
member or administrative support for the CPHS (see below).
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