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) & (e) 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 (e) 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

Research Activities that don’t meet Definition of Research The revised Common Rule now identifies the following activities as not meeting the definition of research. They are the following: Scholarly and Journalistic Activities – .e.g. oral history, journalism, biography, literary criticism, legal research and historical scholarship that focuses directly on the specific individuals about whom the information is collected. Public Health Surveillance Activities Authorized by a Public Health Authority to Assess Onsets of Disease Outbreaks or Conditions of Public Health Importance Criminal Justice or Intelligence Activities collected for criminal justice purposes. Authorized operational activities for national security purposes. Additionally the following activities do not require review: 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. Quality Improvement (QI)/Quality Assessment (QA) for internal use. 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

45 CFR 46.102(e)  (e) Human subject means a living individual about whom an investigator (whether professional or student) conducting research obtains Obtains information or biospecimens through intervention or interaction with the individual and uses, studies, or analyzes the information or biospecimens; or Obtains, uses, studies, analyzes, or generates identifiable private information or identifiable biospecimens *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 information or biospecimens are gathered (e.g. 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

Breaking Down the “Human Subjects” Definition (Continued) Identifiable Biospecimens: Is a biospecimen for which the identity of the subject is or may readily be ascertained by the investigator or associated with the biospecimen. 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

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

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 Baruch HRPP Website http://www.baruch.cuny.edu/hrpp/ CUNY Templates & Resources Materials http://www.baruch.cuny.edu/hrpp/forms.htm CUNY HRPP Website http://www.cuny.edu/research/compliance/human-subjects-research-1.html 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

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