What Level of Review Does my
Project Require?
CONVENED/FULL BOARD
EXEMPT
EXPEDITED
HUMAN RESEARCH PROTECTION PROGRAM (HRPP) OFFICE
This video will discuss how to determine what
level of review is required for applications
submitted to the HRPP/IRB.
HUMAN RESEARCH PROTECTION PROGRAM (HRPP) OFFICE
This video will go through the three levels of
review. Providing information as to the types of
research that would require exempt, expedited,
or full board review.
To assist researchers with applying these review
types, 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 PROTECTION PROGRAM (HRPP) OFFICE
This video will not go into detail regarding the
review categories for each review type. Instead
categories for each review type will be summarized.
If you have any questions about a specific review
category please go to the CUNY HRPP Website and
see policies regarding Exempt, Expedited, and Full
Board review.
Additionally as this video will be referring to and
building on our video “Does My Project Require
HRPP/IRB Review?” it is recommended that you
view this video first.
HUMAN RESEARCH PROTECTION PROGRAM (HRPP) OFFICE
Levels of Risk for Exempt, Expedited, and
Convened/Full Board Research*
• Minimal Risk – A risk is considered minimal where the
probability and magnitude of harm or discomfort
anticipated in the proposed research are not greater, in
and of themselves, than those ordinarily encountered in
daily life or during the performance of routine physical or
psychological examinations or tests. The HRPP/IRB must
determine that a research study is minimal risk in order for
that project to meet exempt or expedited review criteria.
• Greater Than Minimal Risk – Are research procedures that
may include risks beyond that ordinarily encountered by
subjects. Greater than minimal risk studies require
Convened/Full Board Review.
*Parts of these definitions are bolded for emphasis
HUMAN RESEARCH PROTECTION PROGRAM (HRPP) OFFICE
What does Exempt Review Mean?
• Exemption is a review type for projects that meet the human subjects and
research definitions but can be “exempt” from the regulations that govern
projects requiring IRB Review (45 CFR 46.110) such as expedited and
convened/full board projects.
• Exempt Projects are considered minimal or low risk studies that will not
cause more than minimal harm or discomfort to study participants.
• Exemptions do not apply to research involving prisoners, or children
except where research involves only observations where the investigator
does not participate in or manipulate the activities being observed.
• To qualify for exempt status research procedures must fall within the six
exemption categories set forth in 45 CFR 46.101(b).
• Per CUNY Policy, Researchers can not make an exempt determination.
Exempt Applications must be sent to and approved by the HRPP Office.
HRPP Staff will also apply the ethical guidelines set forth in the Belmont
Report to exempt projects as these projects are not exempt from these
guidelines.
HUMAN RESEARCH PROTECTION PROGRAM (HRPP) OFFICE
Exemption Categories*
(1) Research Conducted in Established or Commonly accepted educational
settings, involving normal procedures including regular and special
education instructional strategies and effectiveness/comparison of
instructional techniques, curricula, or classroom management
techniques.
(2) Research using anonymous or minimal/low risk educational tests,
surveys, interviews, or observation of public behavior. Note that Children
can only be observed with no interaction or intervention from the
researcher.
(3) Same as Category 2 however this category refers to Public Officials or
Candidates (elected or appointed)
(4) Research involving the collection or study of existing data if it is
publically available or if subjects can not be identified.
(5) Research examining public service programs.
(6) Taste and Food Quality and Consumer Acceptance studies
*The categories listed above have been summarized to see full exempt
category descriptions please go to the CUNY HRPP Website.
HUMAN RESEARCH PROTECTION PROGRAM (HRPP) OFFICE
Types of Exempt Research*
1.
2.
3.
4.
Research involving existing data or specimens recorded anonymously or
publically available. Note that studies that exclusively are analyzing deidentified/publically available datasets are not considered “human
subjects” research and do not require review.
Surveys, interviews, and public observation research that are anonymous or
do not have risks to subjects of criminal/civil liability or could be damaging to
subjects financial standing, employability or reputation.
Research designed to study or examine public benefit or service programs.
Research conducted in commonly accepted educational settings regarding
normal educational practices.
* Exemptions do not apply to research that involves or collects sensitive
identifiable information from subjects such as sexual history or illegal behavior. If
your project involves the collection of sensitive information then it will likely not
meet exemption criteria. Additionally those projects that involve deception will
likely not meet exemption criteria.
HUMAN RESEARCH PROTECTION PROGRAM (HRPP) OFFICE
What Does Expedited Review Mean?
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Expedited Review does not mean “fast” but is a review type for minimal risk
studies that don’t meet exemption criteria.
Like Exemptions, Expedited is a review type for projects that meet both the
research and human subjects definitions. However, Expedited Projects must
receive IRB Review and are subject to the regulations set forth in 45 CFR 46.110.
There are nine Expedited Review Categories that include research utilizing medical
devices or clinical drug studies, research involving materials (data, documents,
records or specimens) that have been collected or will be collected for nonresearch purposes or data from voice, video, digital, or image recordings. Expedited
Review categories apply regardless of the age of subjects except as noted in the
category descriptions.
Per CUNY Policy, Expedited Projects require IRB Review and Approval. Expedited
Applications are usually sent to one IRB Member for review.
Projects that were initially reviewed by Convened/Full Board can be determined by
the IRB to be expedited (Categories 8 and 9) when certain conditions are met. See
CUNY Expedited Policies and Procedures for details.
HUMAN RESEARCH PROTECTION PROGRAM (HRPP) OFFICE
Expedited Review Categories*
(1)
(2)
Clinical studies of drugs and devices when certain conditions are met
Collection of blood samples by finger stick, heel stick, ear stick, or venipuncture in certain
populations and within certain amounts.
(3)
Prospective Collection of Biological Specimens for Research Purposes by Non-Invasive
Means
(4)
Collection of data through non-invasive procedures (not involving general anesthesia or
sedation) routinely employed in clinical practice, excluding procedures involving x-rays or
microwaves.
(5)
Research involving materials (data, documents, records, or specimens) that have been
collected, or will be collected solely for non-research purposes
(6)
Collection of data from voice, video, digital, or image recordings made for research
purposes.
(7)
Research on individual or group characteristics or behavior or research employing survey,
interview, oral history, focus group, program evaluation, human factors evaluation, or
quality assurance methodologies.
(8)
Continuing Review for initial review was conducted by convened IRB if certain conditions
are met.
(9)
Research not conducted under an investigational new drug application or investigational
device exemption where categories two through 8 do not apply but IRB has determined
and documented that the research involves no greater than minimal risk and no additional
risks have been identified.
*The categories listed above have been summarized to see full expedited category descriptions
please go to the CUNY HRPP Website.
HUMAN RESEARCH PROTECTION PROGRAM (HRPP) OFFICE
Examples of Expedited Research
• Projects collecting data, voice, video and scans (For
example utilizing EEG or fMRI scans).
• Minimal Risk Research that utilizes deception by either
withholding information regarding purpose of research or
by intentionally providing misleading or false information.
• The analysis of identifiable data collected for non-research
purposes such as academic data, medical records, or
specimens.
• Observational Studies in which the PI interacts or
intervenes with human subjects.
HUMAN RESEARCH PROTECTION PROGRAM (HRPP) OFFICE
What does Convened/Full Board Review Mean?
There are three main reasons why a project may require
Convened/Full Board Review:
1. Project procedures that may pose greater than minimal risk
to subjects.
2. Projects that may pose no greater than minimal risk to
subjects but does not appear in any of the categories of
research that can be reviewed under Expedited Review
Procedures. CUNY UI IRB would initially review these types
of projects but can determine that projects may undergo
expedited review procedures during continuing review.
3. The convened board may also review and take action on
unanticipated problems, allegations of serious or
continuing non-compliance, and subject complaints.
HUMAN RESEARCH PROTECTION PROGRAM (HRPP) OFFICE
Types of Studies that could necessitate
Convened Board Review
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Research studies that can result in emotional stress such as asking questions
related to subjects’ personal experiences such as sexual or physical abuse,
divorce, etc.
Studies that have risks due to breach of confidentiality such as a research
study that collects identifying information and asks subjects about illegal
activities such as drug use, or crimes committed.
Studies that seek to recruit/enroll Prisoners may be subject to CUNY UI IRB
Review.
Studies that may contain procedures that subject participants to pain,
discomfort, or injury.
Studies where sensitive data and subject identifiers have been collected.
Transcranial direct current stimulation (tDCS) and Transcranial magnetic
stimulation (TMS) studies.
FDA Regulated Studies such as those studies that are Investigational Device,
Investigational Drug, or Biologics Studies.
HUMAN RESEARCH PROTECTION PROGRAM (HRPP) OFFICE
Mitigating Risks in Research
There are many ways that a PI can mitigate risks in studies:
• Psychological Risk – a research activity or experimental condition could result an emotional
stress which depending on the amount or level of emotional stress cold be considered more
than minimal risk. Researchers should try to reduce potential emotional distress. One way to
reduce emotional distress would be by having information on hand such as directing study
participants to counseling centers. If there is a greater than minimal risk of emotional distress
to study participants having an counselor on site to assist study participants.
• Invasion of Privacy & Breach of Confidentiality – This is a common risk especially with those
who conduct research online. Reducing this risk by appropriately protecting confidentiality or
using data collection procedures that would make it impossible to link any identifying
information with subjects’ responses or data. Additionally if you are obtaining documented
(signed) consent, assent, and/or parental permission the forms should always be kept in a
secure location separate from data.
• Vulnerable Populations – Risk Groups such as the elderly, mentally disabled persons,
economically or educationally disadvantaged persons, or persons with diseases and psychiatric
disorders should be given special consideration depending on the type of the study being
conducted. Special Vulnerable Groups that are covered by the federal regulations (e.g.
children/minors, prisoners, pregnant women, etc). It is important that the researcher ensure
that any vulnerable person participating in a research study is appropriate for inclusion in the
study. The vulnerable person and/or their surrogate must make an informed decisions about
whether or not the individual wants to participate.
HUMAN RESEARCH PROTECTION PROGRAM (HRPP) OFFICE
Conclusion
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The determination of the level of review required is made by the HRPP/ IRB not by
researcher. However, being knowledgeable about the review types will decrease
the workload of researchers.
Research activities described in either the exempt and expedited categories are
merely eligible for these review types/categories. The HRPP/IRB will make
determinations as to whether or not the proposed research involves no more than
minimal risks to human subjects and meet the exempt or expedited criteria.
Convened Review are for projects that don’t meet either exempt or expedited
criteria. Additionally, unanticipated problems, allegations of serious or continuing
non-compliance, and subject complaints are reviewed by the Convened IRB as
well.
PI’s should always try to mitigate risks to subjects by ensuring that they are
collecting the data needed for their studies, storing and protecting data in a secure
way making sure to limit access to only research personnel, and making sure that
risks to subjects are minimized. Collecting minimal (or no) demographic or
identifiable information that could directly or indirectly identify participants is an
additional way of minimizing risk.
If you have any questions as to the level of HRPP/IRB review required 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 – 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