Principal Investigator Responsibilities
HUMAN RESEARCH PROTECTION PROGRAM (HRPP) OFFICE
Welcome to the Baruch HRPP Office’s video that will explain the
responsibilities of Principal Investigators.
Note that this video also pertains to Student Investigators
serving as PI’s as well.
HUMAN RESEARCH PROTECTION PROGRAM (HRPP) OFFICE
This video will discuss:
 Principal Investigator Requirements (per CUNY Policies & Procedures)
 Researcher Responsibilities (per CUNY Policies & Procedures)
 Tips for Principal Investigators
HUMAN RESEARCH PROTECTION PROGRAM (HRPP) OFFICE
Principal Investigator Requirements
 Principal Investigators must be full-time faculty, staff, or RF-CUNY Staff. The
faculty or staff member listed as the PI on the application form is ultimately
responsible for the protection of human subjects, for compliance with
applicable regulations and CUNY policies, and for adherence with CUNY UIIRB stipulations.
 CUNY students and postdoctoral scholars may serve as PI’s on IRB
applications ONLY with the supervision and permission of their faculty
advisor or research program director.
 The faculty advisor or research program director who signs off on the given
project and the PI are both responsible for the protection of human
subjects, for compliance with applicable regulations and CUNY policies,
and for adherence with CUNY UI-IRB stipulations. See our Faculty
Responsibilities video for details.
 Adjunct Faculty may serve as Principal Investigator under certain
circumstances. As CUNY campuses may have differing administrative
policies regarding adjunct faculty conducting human subjects research
please contact your local HRPP Coordinator who can assist you with finding
out local administrative policies regarding adjuncts and research.
Researcher Responsibilities
 Protection of Human Subjects
Researchers are responsible for protecting human subjects throughout the research
process: recruiting, screening, consenting, study procedures and end of the study
considerations. Specifically researchers should:
 Develop research studies using sound research design, which minimizes risks to
subjects, does not unnecessarily expose subjects to research-related risks, and
maximizes benefits
 Planning and implementing fair and equitable recruitment practices, which
avoid the potential for coercion and undue influence
 Obtaining legally effective informed consent for subject participation
 Ensuring availability of adequate resources (including personnel, time
commitment, facilities, funding, etc.), such that the research may conducted in
a manner that protects the rights and welfare of human subject and that ensure
integrity of the research
 Responding promptly to subject complaints, concerns or request for information
and reporting any significant complains or concerns to the IRB.
HUMAN RESEARCH PROTECTION PROGRAM (HRPP) OFFICE
Researcher Responsibilities – (Cont.)
 Complying with Regulations, Policies and IRB Stipulations
To ensure compliance, researchers must:
 Seek HRPP guidance if uncertain about HRPP/IRB review requirements
 Ensure that all human subjects research that requires HRPP/IRB review receive
either HRPP exemption or IRB approval prior to its initiation (including any subject
recruitment)
 Ensure that all IRB approved protocols receive continuing review by the IRB at
least annually
 Ensure that changes to exempt or IRB approved protocols receive HRPP/IRB
review, and exemption or approval prior to their implementation.
 Promptly report any unanticipated problems involving risks to subject or others to
the IRB
 Promptly report any serious or continuing non-compliance with applicable
regulations or CUNY policies
 Accurately and thoroughly complete all relevant IRB application materials
 Comply with all applicable regulations
 Comply with all applicable CUNY policies
 Comply with all sponsor requirements, when applicable
 Comply with IRB’s determinations and stipulations
 Cooperate with the HRPP staff and IRB members during any inquiries or audits
concerning human subject research review and oversight.
Researcher Responsibilities – (Cont.)

Training and Education
 Researchers must be qualified by education, training and experience to conduct the
research they are proposing
 Researchers are required to complete the CUNY-required modules of the Collaborative
Institutional Training Initiative’s (CITI) on-line training in the protection of human subjects.
 There are alternatives for maintaining valid certifications for human subjects research
training. The HSR CITI Refresher Course (which must be taken every 3 years) can be
substituted or replaced with ongoing training obtained through the various conferences,
seminars, workshops, and brown bag lunched offered by CUNY. Please go to the CUNY HRPP
Website under Training & Education and see the CUNY Research Compliance Education
Plan for details.

Record Keeping
Researchers are required to retain research records in accordance with applicable regulations,
CUNY policies and sponsor requirements. Specifically, researchers must:
 Retain records of all IRB approved submissions including:
• All correspondence between the IRB and Researcher
• All IRB approved documents, including but not limited to IRB application, sponsor
protocol (if any), recruitment materials, screening documents, consent documents and
data collection tools.
• Documentation of subject eligibility when applicable
• Documentation of consent process for each subject, and when applicable
• All signed consent documents when applicable
Researcher Responsibilities – (Cont.)
 Record Keeping (Cont.)
 Retain all records for a minimum of three years after the end of
study; OR a minimum of six years for studies involving Protected
Health Information (HIPPA Applicable); AND with accordance
with sponsor requirements.
 Maintain confidentiality of research records in accordance with
IRB approved protocol and sponsor requirements.
HUMAN RESEARCH PROTECTION PROGRAM (HRPP) OFFICE
Tips for Principal Investigators
 In order to ensure research compliance PI’s should do the following:
 Submit your application at least 30-45 days before you intend to start your
research – This allows the HRPP/IRB time to review and approve your application.
Additionally submitting your HRPP/IRB application this far in advance will give you
time to make changes in a timely manner and still meet your research start date.
 Submit all amendments/changes prior to implementation– It is a requirement
that all changes (including key personnel additions, research method/materials
changes, etc.) being made to approved research be submitted to and
approved by the HRPP/IRB prior to research implementation.
 Make sure that all research personnel are conducting research activities as
approved by the HRPP/IRB – If PI’s have key personnel working with them to
conduct research activities, it is important that they are supervising these
personnel ensuring that they are conducting research procedures as approved
by the HRPP/IRB.
 Pay attention to project approval/expiration dates– Research activities are only
allowed during approval period of the research. Note that continuing reviews
should be submitted at least one month prior to project expiration. PI’s whose
projects expire must cease all research activities until an active approval is in
place.
 Know the levels of IRB review (Exempt, Expedited, Full, or Non-Human Subjects
Research) – PI’s must be informed and know what projects constitutes human
subjects research and must be reviewed by the CUNY HRPP/IRB.
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.
 Does My Project Require HRPP/IRB Review? - These videoa will discuss
what constitutes research and what projects 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/human-subjects-research1/hrpp-policies-procedures/Researcher_Responsibilities11.21.14.pdf
 http://www.cuny.edu/research/compliance/human-subjects-research1/hrpp-policies-procedures/PI_Qualifications7-8_14.pdf
 http://www.cuny.edu/research/compliance/trainingeducation/Education-Plan.pdf
 Baruch HRPP Website
 http://www.baruch.cuny.edu/hrpp/index.htm
 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
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