Developing a Satisfactory IRB Application
HUMAN RESEARCH PROTECTION PROGRAM (HRPP) OFFICE
Welcome to the Baruch HRPP Office’s video that will explain
how to develop an satisfactory IRB application
In this video we will go through the elements of developing an
IRB Application.
HUMAN RESEARCH PROTECTION PROGRAM (HRPP) OFFICE
This video will discuss:
 Differences between student thesis/grant proposals and IRB
Applications
 How to develop a research plan
 Tips for preparing an IRB Application
 Steps to be done before you submit your IRB Application
We will also be discussing additional resources that can be referenced during
the creation of your IDEATE Application.
HUMAN RESEARCH PROTECTION PROGRAM (HRPP) OFFICE
This video will not specifically discuss IDEATE Application
questions or submission procedures. If you have questions
regarding the IDEATE application please see our Step-by-Step
Series for Exempt and Expedited/Full Board Applications.
HUMAN RESEARCH PROTECTION PROGRAM (HRPP) OFFICE
Thesis/Grant Proposals vs. IRB Protocols
 PI’s new to the IRB process often confuse grant/thesis proposals with
IRB Protocols. IRB protocols often require additional details and
information that are not contained within grant or thesis proposals.
 Prior to the creation of an IRB Application a project should be fully
designed and planned. Having a fully developed research plan will
reduce the time it takes for a project to be reviewed and approved
by the HRPP/IRB. Additionally creating an IRB Application will be
much easier if your research project if the research plan has been
finalized.
HUMAN RESEARCH PROTECTION PROGRAM (HRPP) OFFICE
Research Design and Development
 PI’s prior to the creation of an IDEATE Application should develop their
research design and plan. If you are a Student PI this Research Plan should
be developed in consultation with your Faculty Advisor.
 Research Objectives
 Purpose of the Research (should be simple, clear, and written for a wide audience).
 Research Hypothesis/Goals – Provide a brief description of the theoretical and
empirical goals of this research information.
 Research Methods and Procedures
 Explain the methods and procedures to be followed. This includes any risks that may
be involved because of the study protocol.
 Explain if applicable any tests/procedures/exams that will be given to participants.
Provide a table format if the research plan is complex.
 Describe data to be collected and data analysis.
 If the study uses database or archival data, methods and procedures provided should
ONLY reflect the current study conducting the secondary data analysis.
Research Design and Development (Cont.)
 Subject Recruitment
 How will you select participants? Recruitment refers to the contact and the communication
that takes place between investigator and a potential participant.
 Include estimated number and description of types of subjects
 Describe the source and method for the recruitment of potential subjects (e.g. referral
sources, posting flyers, etc.)
 Provide eligibility criteria (inclusion and exclusion criteria). Exclusion of a population should be
justified. For further explanation of inclusion/exclusion criteria please see the IDEATE Terms
Glossary on our website.
 Benefits
 Describe any direct benefits that subjects(s) may reasonably expect to encounter. Note that
if there are no known direct benefits to the subject this must be stated in the IDEATE
Application and if applicable in the informed consent document.
 Please state and describe the anticipated benefits to society and to knowledge
development in the specific discipline.
 Do not state benefits that are unrelated to the research study. NOTE: Compensation is not
considered a benefit.
 If a study is using database or archival data there will be no direct benefit to the subjects
from which the data will be obtained. However, the anticipated benefit to society can be
stated.
Research Design and Development (Cont.)
 Risks to Subjects
 Describe in detail any immediate or long-range risks, discomforts and/or inconveniences
foreseeable to subjects associated with procedures used in the study.
 Detail the precautions you have taken to minimize these risks. For example in Internet-Based
Research there is normally risks of breach of confidentiality or privacy of subjects. A
precaution taken to mitigate or minimize these risks would be to ensure confidentiality of
participant data.
 If your research protocol involves psychological risks to subjects please describe the level of
medical or psychological care available through the study for research related risks.
 If the study uses database or archival data there are no direct risks to the subjects that
provided the data unless the data obtained contains sensitive information.
 Informed Consent
 Describe the manner in which Informed Consent will be obtained. Note that for exempt
research informed consent is not requirement. However, if you are submitting an expedited
or full board application informed consent is required unless a consent waiver is approved by
the IRB.
 Indicate what kind of consent (Child Assent/Parental Permission or Adult Consent) will be
obtained and how consent will be ascertained (documented, orally, on-line).
 If you are requesting a waiver of documented (written) consent this must be justified in the
IDEATE Application.
 Consent Templates are available to assist researchers with the development of the consent
document. These templates can be found on the Baruch HRPP Website.
Research Design and Development (Cont.)
 Confidentiality of Data
 Specify if information obtained will be recorded in a manner that human subjects can be identified,
directly or through identifiers linked to the subjects.
 Please specify what you will do to protect the confidentiality of the data. This can include storage
procedures, who will have access to the data, and if applicable de-identifying identifiable or
coded data.
 If you are planning to store sensitive identifiable information or data on a computer please
thoroughly explain how you will protect the sensitive data. If the data you will be storing will contain
information of a sensitive or illegal nature then you should indicate the level of protection subjects
will have in case of subpoena or governmental request for data. In most cases, a Certificate of
Confidentiality will have to be obtained.
 If the study uses database or archival data then please specify the kind of data you will be
obtaining (e.g. specify if data contains identifiers or will be coded or de-identified). If this is a
restricted dataset a restricted data use agreement (if required by the data holder) must be
provided for review.
 Research Compensation
 Research Compensation is defined as non-monetary (gifts, research credits, etc,) and monetary
(gift cards, money, etc.) compensation given to subjects for their time, inconvenience, and effort.
All research compensation must be described in the IDEATE Application, recruitment, and if
applicable consent documents.
 Describe any compensation to subjects. Additionally if compensation is provided specify what
action will be taken if subjects discontinue research participation before the experiment is
completed. Note: Subjects cannot be penalized for withdrawing from a research study.
IRBs take into consideration whether the type of compensation, and time and proposed method of
disbursement, are reasonable, not coercive, and do not present any undue influence.
Tips for Preparing an IRB Application
 Remember the 4 C’s (CLEAR, CONCISE, CONSISTENT, and COMPLETE)
 CLEAR – Make sure that you are responding to the IDEATE Application in a clear
manner avoiding jargon and field-specific terms. If using field-specific terms make sure
that they are clearly defined and can be understood by someone not familiar with
your field of study. More than likely your project will be reviewed by someone that is
not conversant in your field of study. Making sure that your research plan is clear and
understandable will improve your chances of an efficient approval process.
 CONCISE – Be concise with your responses in the IDEATE Application making sure
that your responses are addressing the questions being asked. Concise responses will
allow reviewers to easy understand your application and to make their
determinations. Some researchers will try the “kitchen sink” approach by providing too
much information that does not address the research questions being asked. This
approach often creates additional work for the PI and the IRB as clarifications and
revisions will be requested.
 CONSISTENT – Make sure that your application is consistent throughout by
reviewing all research materials and making sure that all research materials are
consistent with your research protocol. Note that the Informed Consent Form should
be consistent with the information provided in the IDEATE Application.
 COMPLETE
– Your application should be complete when submitted to the HRPP
Office. This means that your research design, plan, and materials should be finalized
prior to submission. Incomplete proposals will be sent back to PI’s and will not be
administratively reviewed.
Tips for Preparing an IRB Application (Cont.)
 The following items should be attached/provided in your IDEATE Application*:
 Recruitment Emails, Scripts, Flyers, Brochures, etc.
– All
communications
and recruitment instruments provided to prospective participants for research participation
must be provided to the HRPP Office
 Consent Forms – Adult Consent, Child Assent, and Parental Permission consent forms if
applicable must be submitted for review.
 Questionnaires/Survey Instruments – all questionnaire/survey instruments utilized
in research activities must be provided for review.
 Interview Questions/Protocols – Interview Questions must be provided for review. If
you are conducting an unstructured interview, sample questions and interview protocols
must be provided for review.
 Current CITI HSR Certifications – All researchers associated with research activities
must attach their CITI Training Certifications to the IDEATE Application. Applications will not
be approved until all key personnel have taken the CITI Training providing the HRPP Office
with the completion certificate.
 Grant Proposals – If a research study is funded a copy of the entire grant proposal
must be attached to the IDEATE Application.
 Research Agreements – all research agreements (Collaborative Agreements,
Restricted Data Use Agreements, IRB Reliance/Authorization Agreements, etc.) must
be attached to the IDEATE Application.
*Note that other documents such as debriefing scripts, observational protocols, etc., may be
required based on the type of research being conducted. However, the documents
described above are normally the types of research materials required for most studies.
Before You Submit Your Application…
 Review your application making sure that you’ve addressed all questions
and provided all required materials for review.
 If you are a Student PI please make sure that your Faculty Advisor has
reviewed and approved your application prior to submission to the HRPP
Office.
 Once you’ve finalized your research design/plan and have written your IRB
Application if you have any questions or would like to meet with an Baruch
HRPP Staff Member please contact either the HRPP Liaisons or Assistant.
HRPP Staff information will be provided at the end of the video
presentation.
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
 Faculty Advisor Responsibilities – This video discusses
faculty advisor responsibilities providing tips to ensure student
compliance with CUNY Policies and Procedures.
 Does My Project Require HRPP/IRB Review? - This
video discusses what constitutes research and types of
projects that don’t require HRPP/IRB Review.
 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
HRPP Resources
 CUNY HRPP Website
 http://www.cuny.edu/research/compliance/humansubjects-research-1.html
 Baruch HRPP Website
 http://www.baruch.cuny.edu/hrpp/
 CUNY Templates & Resource MaterialsMaterials
 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, 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