Human RESEARCH Protection Program (HRPP) OFFICE

1. Principal Investigator Responsibilities Human RESEARCH Protection Program (HRPP) OFFICE

2. 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

3. 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

4. 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 UI-IRB 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.

5. 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

6. 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.

7. 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

8. 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

9. 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.

10. 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

11. HRPP Videos • Does My Project Require HRPP/IRB Review? - This video will discuss what constitutes research and what projects require HRPP/IRB Review. • What Level of Review Does My Project Require?– This video will assist researchers and advisors with determining the level of IRB Review required for IRB Applications. • Principal Investigator Responsibilities – This video discusses researcher responsibilities providing tips to ensure compliance with CUNY Policies and Procedures. • Faculty Advisor Responsibilities – This video discusses faculty advisor responsibilities providing tips to ensure student compliance with CUNY Policies and Procedures. • 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. • Step-by-Step Series – These videos will go step-by-step through the IDEATE Application by exempt and expedited/full board review types. Human RESEARCH Protection Program (HRPP) OFFICE

12. HRPP Resources • CUNY HRPP Website • http://www.cuny.edu/research/compliance/human-subjects-research-1/hrpp-policies-procedures/Researcher_Responsibilities11.21.14.pdf • http://www.cuny.edu/research/compliance/human-subjects-research-1/hrpp-policies-procedures/PI_Qualifications7-8_14.pdf • http://www.cuny.edu/research/compliance/training-education/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

13. 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

14. SATISFACTION SURVEY CLICK HERE TO TAKE OUR SATISFACTION SURVEY Human RESEARCH Protection Program (HRPP) OFFICE