Does My Project Require
HRPP/IRB Review?
Engagement
Human Subject
Research
HUMAN RESEARCH PROTECTION PROGRAM (HRPP) OFFICE
This four-part video will discuss what constitutes
human subjects research and the types of
research activities that require HRPP/IRB
Review.
HUMAN RESEARCH PROTECTION PROGRAM (HRPP) OFFICE
This video will go through three components that
make up human subjects research providing
researchers with information on how to determine
whether or not a project requires HRPP/IRB Review.
To assist researchers with applying these concepts,
quizzes have been included in this video. Please
note that quiz results may be used in aggregate
form for HRPP program evaluation purposes.
HUMAN RESEARCH PROTECTIONS PROGRAM (HRPP) OFFICE
Not Human Subjects Research vs.
Exempt Research
• Many Researchers confuse non-human subjects
determinations with project exemptions.
• Projects that are determined not be human subjects
research are projects that don’t meet the human subjects
or research definitions and thus don’t require HRPP/IRB
Review.
• Exemptions is a review type for projects that meet the
human subjects and research definitions but don’t require
IRB Review as the project meets one or more of the
exemption categories. CUNY requires that all exempt
projects be reviewed/determined by the campus HRPP
Office.
HUMAN RESEARCH PROTECTION PROGRAM (HRPP) OFFICE
Federal Human Subject Regulations –
45 CFR 46.102 (d) & (f)
• There are two parts of the federal regulations
that define human subjects research.
• The concepts of “research” and “human
subject” are defined separately.
• Both 45 CFR 46.102(d) and (f) must be
applicable to a particular research study in
order for a project to be determined “human
subjects research”.
HUMAN RESEARCH PROTECTION PROGRAM (HRPP) OFFICE
45 CFR 46.102(d)*
• (d) Research means a systematic
investigation, including research
development, testing and evaluation,
designed to develop or contribute to
generalizable knowledge.
*Parts of this definition are bolded for emphasis.
HUMAN RESEARCH PROTECTION PROGRAM (HRPP) OFFICE
Breaking Down the “Research”
Definition
Systematic Investigation
• Attempt to answer research questions (in some
research, this would be an hypothesis)
• Is methodologically driven, that is it collects data
or information in an organized and consistent way.
• The data or information is analyzed in some way,
be it quantitative or qualitative data.
• Conclusions are drawn from the results
HUMAN RESEARCH PROTECTION PROGRAM (HRPP) OFFICE
Breaking Down the “Research”
Definition (continued)
Generalizable Knowledge
• The intent of the research is to add information to your field of
study.
• The results are expected to be generalized to a larger population
beyond the subject population and site of study.
• The data or information is analyzed in some way, be it quantitative
or qualitative data.
• Publication, presentation or other distribution of the results is
intended to inform the field of study.*
*Publication or dissemination of results isn’t the sole determinate of
whether or not HRPP/IRB Review is required. If your research activity is
designed with the aim of discovering information that can be applied in
other settings, it can be considered research whether or not a project
results are published or disseminated.
HUMAN RESEARCH PROTECTION PROGRAM (HRPP) OFFICE
Quiz – Part I
Thank you for taking Quiz 1 please use the
link below to go to Part Two of this Video.
HUMAN RESEARCH PROTECTION PROGRAM (HRPP) OFFICE
45 CFR 46.102(f)*
• (f) Human subject means a living individual
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.
*Parts of this definition are bolded for emphasis.
HUMAN RESEARCH PROTECTION PROGRAM (HRPP) OFFICE
Breaking Down the “Human Subjects”
Definition
Intervention or interaction with the individual:
• Intervention - includes both physical procedures
by which data are gathered (for example,
venipuncture) and manipulations of the subject or
the subject's environment that are performed for
research purposes.
• Interaction - includes communication or
interpersonal contact between investigator and
subject. Interactions include but are not limited to
surveys, interviews, and questionnaires.
HUMAN RESEARCH PROTECTION PROGRAM (HRPP) OFFICE
Breaking Down the “Human Subjects”
Definition (Continued)
Identifiable 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 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.
HUMAN RESEARCH PROTECTION PROGRAM (HRPP) OFFICE
Additional Information Regarding
Human Subjects Definition
• Information obtained from subjects must be about those
living individuals themselves to meet the HSR Definition.
• It may not be necessary to get HRPP/IRB approval if
interview questions are about a particular policy, agency,
program, technology, technique, or best practice. Especially
if there isn’t a plan to universalize the interviewees
experiences or quantify the results of interviews in some
way.
• De-Identified Data is not considered “human subjects” data
as the data can not be linked to individual subjects. Projects
solely analyzing de-identified datasets or data obtained
from publicly available websites will not require HRPP/IRB
review.
HUMAN RESEARCH PROTECTION PROGRAM (HRPP) OFFICE
Types of Research that may not need
HRPP/IRB Review*
• Open-ended interviews, that ONLY document a specific historical event or
experiences of individuals without intent to draw conclusions or generalize
findings (i.e. Oral History Projects).
• a supervised internship or field practicum/field study
• Program Evaluation/Quality Improvement activities designed for local CUNY
improvement efforts (i.e. Course/Program Improvement) limited to
dissemination or implementation within CUNY.
• Activities designed for educational purposes ONLY (such as classroom
projects, research practica, etc.). Results will NOT contribute to generalizable
knowledge.
• Interviews with content experts or consultants about factual issues only, in
which no personal information is obtained from the interviewees.
*There are some circumstances where these types of research may be considered
“Human Subjects Research”. If you are unsure whether or not a project requires
HRPP/IRB review please contact the Baruch HRPP Office.
HUMAN RESEARCH PROTECTIONS PROGRAM (HRPP) OFFICE
Quiz – Part II
Thank you for taking Quiz 2 please use the
link below to go to Part Three of this Video.
HUMAN RESEARCH PROTECTION PROGRAM (HRPP) OFFICE
CUNY Research Engagement*
• Once a project has been determined to be human subjects
research, the HRPP Office must determine whether or not
CUNY is “engaged” in human subjects research.
• Engagement – CUNY is considered engaged in a particular
human subjects research project when CUNY employees or
agents obtain for the purposes of the research project (1)
data about the subjects of the research through
intervention or interaction with them; (2) identifiable
private information about the subjects of the research; or
(3) the informed consent of human subjects for research.
*Note with the exception of item 3, this definition is similar
to the “Human Subjects” Definition.
HUMAN RESEARCH PROTECTION PROGRAM (HRPP) OFFICE
CUNY Research Engagement
(Continued)
• CUNY employees or agents can include staff,
students, contractors, and volunteers. These are
persons that act on behalf of CUNY.
• Normally complications regarding the issue of
research engagement occur during Collaborative
Research with other Institutions where a
determination must be made as to the activities
of CUNY Researchers for a particular study and
whether or not review is required.
• Also if CUNY is receiving funding this may also
engage CUNY in research.
HUMAN RESEARCH PROTECTION PROGRAM (HRPP) OFFICE
Quiz 3
Conclusion
• The “Not Research” or “Not Human Subjects Research”
determinations are made by researcher and the HRPP Office.
• Simply put if a research project is determined “Not Research” or
“Not Human Subjects Research” PI’s are not required to submit this
project for review.
• This determination differs from Exemptions which are considered
human subjects research that does not require IRB review. All
exempt projects still must be reviewed by the HRPP Office.
• Whether or not research activities occur at Baruch/CUNY an CUNY
employee, faculty, or student can be considered engaged in
research activities if they are conducting the engagement activities
mentioned using their CUNY Affiliation for publication or
dissemination purposes.
• If you have any questions as to whether or not a project requires
HRPP/IRB review then please contact the Baruch HRPP Coordinator.
HUMAN RESEARCH PROTECTION PROGRAM (HRPP) OFFICE
HRPP Services
• Application Assistance – This includes assistance with the development
and submission of an IRB Application on IDEATE our on-line system. HRPP
Liaisons and Assistant are available to assist researchers with the
development of their proposals. Please go to our website and click on the
Investigators Assistance link for further details.
• Departmental/Classroom Presentations – The HRPP Office will conduct
department/classroom presentations in consultation with departmental
chairs , faculty members, and instructors. Please contact the HRPP
Coordinator, who will assist with setting up a presentation.
• Guidance regarding HRPP Policy and Procedures – The HRPP Coordinator
will assist researchers with interpreting CUNY policies and procedures to
ensure compliance. This includes but is not limited to assisting
investigators with determining whether or not their project requires
HRPP/IRB Review, assessing the level of review, or navigating researchers
through the CUNY IRB process.
HUMAN RESEARCH PROTECTION PROGRAM (HRPP) OFFICE
HRPP Videos
• Step-by-Step Series – These videos will go step-by-step
through the IDEATE Application by exempt and expedited/full
board review types.mpliance/human--research-1.html
• Creating a Satisfactory IRB Application – This video
discusses the elements of creating an IRB Application providing
tips to assist researchers in developing and submitting a
satisfactory IRB Application.
• Faculty Advisor Responsibilities – This video discusses
faculty advisor responsibilities providing tips to ensure student
compliance with CUNY Policies and Procedures.
• Assessing the Level of IRB Review Series (Upcoming) –
These videos will help faculty advisors and researchers with
determining the level of IRB Review required for IRB
Applications.
HUMAN RESEARCH PROTECTION PROGRAM (HRPP) OFFICE
Useful Links
• CUNY HRPP Website
― http://www.cuny.edu/research/compliance/human-subjects-research1.html
• Baruch HRPP Website
– http://www.baruch.cuny.edu/hrpp/
• CUNY Templates & Resources Materials
– http://www.baruch.cuny.edu/hrpp/forms.htm
HUMAN RESEARCH PROTECTION PROGRAM (HRPP) OFFICE
HRPP Office Staff
• Keisha Peterson, HRPP Coordinator
Email: Keisha.Peterson@baruch.cuny.edu Telephone: 646-312-2217
• Priyanka Mitra-Hahn (Psychology), HRPP Liaison
Email: priyankamitra718@gmail.com
• Jill Douek (Psychology), HRPP Assistant
Email: hrppassistant@baruch.cuny.edu
To view HRPP Staff office hours please go to the Baruch HRPP
Office website and click on the Investigators Assistance Link.
HUMAN RESEARCH PROTECTION PROGRAM (HRPP) OFFICE
Satisfaction Survey