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Ž H F2 ÿÿÿÿ ÞÓ1 Â8 \2 * 0 Œ2 û/ Ø h 2 2 ÿ ÿÿÿÿ ÿÿÿÿ h ÿÿÿÿ ÿÿÿÿ Â8 h Œ2 ÿÿÿÿ ÿÿÿÿ h ÿÿÿÿ ÿÿÿÿ h h - 7/ Ä ÿÿÿÿ h h Â8 h h h ÿÿÿÿ ÀÆl- h h Ò! h ð" ð" û/ ¦ôÐ Ö '/ Â8 û/ ð" h ÿÿÿÿ ÿÿÿÿ h ´ ð" h hÿÿÿÿ ÿÿÿÿ h- ÿÿÿÿ ÿÿÿÿ h h Ð h- h ÿÿÿ ÿÿÿÿ h- ð : NEW PROJECTS ONLY FORDHAM UNIVERSITY PROTOCOL FOR HUMAN SUBJECTS RESEARCH PLEASE BE SURE TO COMPLETE ALL SECTIONS As of January 1, 2013, all investigators, faculty sponsors, or any research team members involved with a study that involves human subjects research must complete the online required CITI training at HYPERLINK "http://www.citiprogram.org" www.citiprogram.org . I. NATURE OF THE RESEARCH Type of Review being applied for: Review Type: _____exempt category_____ (Choose 1 of 6 categories) _____ expedited category ______ (Choose 1 or more of 9 categories) ______ Full Board Title of Research: ____________________________________________________________ Principal Investigator: _________________________________________________________ Department/School_______________________ Room # where mail can be sent ______________ Phone ______________ E-mail _______________________ Other Investigator: _________________________________________________________ Department/School_______________________ Room # where mail can be sent ______________ Phone ______________ E-mail ________________________ **Faculty Sponsor (for Student Research): ____________________________________ Department/School_______________________ Room # where mail can be sent ______________ Phone ______________ E-mail _______________ Student Street Address ________________________________________ City ________________________State_________ Zip _______________ Type of Research: __ Faculty Research __Nonthesis related Graduate Research __Dissertation ** __Undergraduate Research __ Masters Thesis __Staff Research __Other (Please specify)_____________________ **Please note: IRB review of dissertation research requires prior successful proposal defense. PhD Defense Date:_________________________ Dates Human Subjects Portion of Research Scheduled: _______. Site(s) of Human Subject Data Collection: ______________________________________________ from: _______ to List the information requested for each agency or organization where data will be collected. Status of IRB application and site permission/support letters Name of agency or organization: Agency address: Contact person: Does the site have an IRB? ____Yes ___No If yes, will this IRB defer to the Fordham IRB? ____Yes ____No Had IRB approval been obtained? ___Yes___No If yes, date of approval: Include approval letter as an attachment. ____In Progress Site permission/support letter obtained? ___Yes ____No ____In Progress Include letter from site as an attachment (Add more rows to above table if necessary) Funding: (Please check one) ___Externally Funded Sponsor and Sponsor ID:________________________________________ ____Seeking Funding Sponsor:________________________________________ Is IRB approval of this application required f o r a g r a n t s u b m i s s i o n ? &Y e s &N o &N / A _ _ _ _ I n t e r n a l l y F u n d e d S p o n s o r : _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ N o t S e e k i n g F u n d i n g I I . P U R P O S E B r i e f l y t h e r e s e d e s c r i p t description will O F R E S E A R C H d e s c r i b e t h e o b j e c t i v e ( s ) o f a r c h ( p l e a s e k e e p i o n j argon free and use 100 words or less; this be included as the description on the monthly meeting agenda). III. METHODS SUBJECTS: Approximate number of subjects: _____________________________ Describe in detail the participant population(s) including gender and age range. Vulnerable Subject Groups Check all that apply: ___Minors ___Involuntarily institutionalized (including Prisoners) ___Pregnant Women/Neonates ___Cognitively Impaired ___Economically/Educationally Disadvantaged ___Students enrolled in a class in which the instructor is the investigator ___Other vulnerability specify:______________________ If above checked, rationale for use of vulnerable population whose ability to give voluntary informed consent may be in question. (Must be fully explained and justified). Eligibility/Screening Describe in detail the inclusion/exclusion criteria (e.g. age, health status, language, occupation etc…) How will eligibility be determined and by whom? Please be sure to attach all screening forms. Recruitment Describe in detail how the subjects will be selected and recruited: Explain how, where and by whom prospective subjects will be identified, selected, and invited to participate in the study. Be sure to explain what precautions will be taken to minimize potential coercion or undue influence to participate. STUDY PROCEDURES: Describe how the research will be conducted, providing information on all study procedures, methods of data collection, the chronological sequence of study procedures, who will conduct the procedures, where and when they will take place, frequency and duration of subject involvement and time commitment for the study. Is there deception involved in this study? ____Yes ___No If yes, please describe what the deception is and why it is necessary. Will subjects be offered compensation/incentives for participation? ___Yes ___No If yes, please explain in detail the amount, methods/terms of payment, lottery information, rationale etc... Will there be?: Audio taping ____ Yes____ ____Yes___ No No Videotaping IV. RISKS/BENEFITS TO PARTICIPANTS Identify possible risks and inconveniences to subjects: (NOTE: These may be of a physical, psychological, social, employment, financial or legal nature.)Describe steps taken to minimize risk and assess the likelihood of occurrence. Identify the anticipated benefits to subjects: If individual participants may not benefit directly, state so here. Describe anticipated benefits to society or specific class of indviduals. Do benefits outweigh risks in your opinion? Please explain: V. Yes No _______ INFORMED CONSENT Consent Setting Describe the consent process including who will obtain consent, where and when it will be obtained, and how much time participants will have to make a decision. Describe how the privacy of participants will be maintained throughout the consent process. State whether an assessment of consent materials will be conducted to assure that participants understand the information (may be warranted in studies with complicated study procedures, those that require extensive time commitments or those that expose participants to greater than minimal risk). Capacity to Consent Describe how the capacity to consent will be assessed for participants with limited decision-making capacity, language barriers or hearing difficulty. If a participant is incapable of providing consent, you will need to obtain consent from the participant’s legal guardian. Documentation of Consent Specify the forms that will be used for each participant population, i.e. adult consent form, surrogate consent form child assent form (written form or oral script) or an information sheet. Copies of all forms should be submitted with this application in the same format that they will be given to participants (templates and instructions are available on the IRB website). Parent/Guardian Permission and Assent (if applicable) If enrolling children, state how parents/guardians will provide permission, whether the child’s assent will be obtained, will parent/guardian be present during obtaining assent and if assent will be written or oral. Provide a copy of the script to be used if oral assent will be obtained. ONLY COMPLETE THE NEXT SECTION IF APPLICABLE: Waiver or Alteration of Consent The IRB may waive or alter the elements of consent in some minimal risk studies. If you plan to request either a waiver of consent (i.e. participants will not be asked to give consent), an alteration of consent (e.g., deception) or a waiver of sign consent (i.e. participants will give consent after reading an information sheet), please answer the following questions using specific information from the study: Waiver (i.e.) participants will not be asked to give consent) or alteration of consent (e.g. use of deception in research, online research). Please answer the following four questions: Why is the study considered to be minimal risk? How will the waiver affect the participants’ rights and welfare? The IRB must find that participants’ rights are not adversely affected. For example, participants may choose not to answer any questions they do not want to answer and they may stop their participation in the research at any time. Why would the research be impracticable without the waiver? For studies that involve deception, explain how the research could not be done if participants know the full purpose of the study. How will important information be returned to the participants, if appropriate? For studies that involve deception, indicate that participants will be debriefed and that the researchers will be available in case participants have questions. Waiver of signed consent (i.e. participants give consent only after reading an information sheet). Please answer the following four questions: Why is the study considered to be minimal risk? Does a breach of confidentiality constitute the principal risk to participants? Relate this to the risks associated with breach of confidentiality and indicate how risks will be minimized because of the waiver of signed consent. Would the signed consent form be the only record linking the participant to the research? Relate this to the procedures to protect privacy/confidentiality. Does the research include any activities that would require signed consent in a non-research setting? For example, in non-research setting, normally there is no requirement for written consent for completion of questionnaires. VI. PRIVACY/CONFIDENTIALITY Please explain how subject’s privacy will be maintained during the study. If existing records are to be examined, has appropriate permission been sought i.e. from institutions, subjects physicians? What specific provisions have been made to protect the confidentiality of sensitive information about individuals? Describe the plans for storage and security of the data during and after the study? Who will have access to the data? (Explain for digital data as well.) Who will the data or final results be shared with? E.g. organization, sites, presentations, etc… VII. INVESTIGATOR ASSURANCE I agree: To comply with all IRB policies, decisions, conditions and requirements. This this study has been designed, to the best of my knowledge, to protect human participants engaged in research in accordance with the applicable principles, policies, regulations, and laws governing the protection of human subjects in research. To obtain prior approval from the IRB before amending the research protocol or the approved consent/assent form. To report to the IRB any adverse event(s) and/or unanticipated problem(s) involving risks to participants. To submit the Annual Review Form as needed. That each individual listed as study personnel in this application has complete the required CITI training and are knowledgeable of study procedures described in the protocol. That each individual listed as study personnel in this application possesses the necessary training and experience for conducting research activities in the role described for them in this research study. By completing and submitting this application to the IRB, you indicate you have read the Investigator Assurance and agree with each of the statements above: Please be sure to include the following attachments if applicable: CITI Completion Reports HYPERLINK "http://www.citiprogram.org" www.citiprogram.org (REQUIRED for all studies) See instruction page. Consent/Assent Forms (All parental/guardian consent forms, Information Sheets for Waiver of Consent, Internet Consents, Verbal Consent Scripts, etc…) Site Permission/Support Letters Screening Materials (Demographic questionnaires or measures used in screening subjects for inclusion or exclusion) Recruitment Materials (Flyers, verbal scripts of what will be said to potential participants, advertisements, postings, etc…) Data Collection Instruments ) O v w @ A i j } ~ € • „ › • À Á Ï Ô Ú ' 0 8 @ G J ‹ — ˜ üïåáÔáÈ¹á±á±¨±á¡™‘‘uiuiuiuiuiu\ hy P 5 •CJ OJ QJ \ • h¤| 5 •OJ QJ \ •h hy P 5 •OJ QJ \ •h hN * 5 •OJ QJ \ •h hy P hy P CJ aJ h= e CJ aJ h¤| h¤| hz Ò h¤| 0J j h¤| U h¤| hj!r 5 •6 •CJ \ • ] • hj!r 5 •6 •CJ \ •] • h /b h¤| CJ, OJ QJ h¤| h¤| 6 •> * CJ$ ] • hj!r 5 •CJ OJ QJ \ • hj!r ! 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