HUMAN RESEARCH PROTECTION PROGRAM (HRPP) OFFICE Developing a Satisfactory IRB Application

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 s, 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.mplia nce/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  subjects-research-1.html subjects-research-1.html  Baruch HRPP Website   CUNY Templates & Resource MaterialsMaterials  HUMAN RESEARCH PROTECTION PROGRAM (HRPP) OFFICE

HRPP Office Staff  Keisha Peterson, HRPP Coordinator ; Telephone:  Priyanka Mitra-Hahn, HRPP Liaison  Jill Douek (Psychology), HRPP Assistant 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