IRB Full or Expedited Review Appl

Rutgers, The State University of New Jersey INSTITUTIONAL REVIEW BOARD FOR THE PROTECTION OF HUMAN SUBJECTS IN RESEARCH ORSP Form Version 5.12 APPLICATION FORM TO REQUEST FULL / EXPEDITED REVIEW OF A RESEARCH PROTOCOL INVOLVING HUMAN SUBJECTS This form is to be used for requesting Expedited or Full IRB review of any new project IRB approval is required before any research involving human subjects may be initiated Full details must be given and all necessary documentation submitted If you are unable to provide certain information at the time of submission, please indicate this in a cover letter It is vital that all information be submitted at the time of review in order to ensure appropriate review and timely processing of the protocol Please read the attached instructions before completing this form Handwritten and/or incomplete forms will be returned to the investigator(s) without review IRB REVIEW TYPE REQUESTED: (specify only one of the following) Full IRB panel review Refer to “Categories of IRB Review” in the Expedited IRB panel review - specify category(s): instructions De Novo Application (i.e Rewrite of a previously approved protocol), provide the protocol number: _ For exemptions submit instead the Request for Exemption from IRB Review form If unsure after reviewing the “Categories of IRB Review” for Exemptions, you may fill out this form or call the IRB office for assistance TITLE OF PROJECT: Projected Study Dates: Begin Recruitment: End Analysis: PRINCIPAL INVESTIGATOR (type name here): _ Please note that undergraduate student investigators may not be named as the principal investigator on protocols and must instead name their faculty advisor Graduate students may serve as a Principal Investigator, with their advisor serving as CO-Principal Investigator CHECK ONE: Faculty Title: Staff Title: Graduate Student Ph.D Graduate Student Masters Department/Unit: (DO NOT ABBREVIATE): Mailing Address: Cell Phone (optional): Office Phone: E-Mail: Dr Mr. Ms. Home phone (optional): Fax: I certify that the statements made in this request are accurate and complete, and that I will conduct this study in accordance with the recommendations of the Institutional Review Board for the Protection of Human Subjects in Research (IRB) I will not begin work on this project until I receive a Notice of Approval from the IRB I understand that I am responsible for reporting any serious adverse events or emergent problems to the IRB, for obtaining IRB approval before implementing modifications, and for requesting continuing review and approval I have read the Federal Wide Assurance (FWA), which is available at < http://orsp.rutgers.edu/Human.asp>, and understand my responsibilities as a Principal Investigator If work will be done by an undergraduate student, I will properly mentor them Signature of Principal Investigator: _ Date _ Name of Undergraduate Investigator: _ E-Mail: _ Signature of Student: _Date: _ Indicate the date that the undergraduate successfully completed the Human Subjects Certification Program: If this project is being performed as part of an honors program, please check here  and specify the program: Copyright 2008, Rutgers University All rights reserved Page of 24 Print Date: 10/20/2022 Version 5.12 In lay language, briefly state the hypothesis, objectives, or purpose of the proposed research, in the space provided below This must be no more than sentences, understandable by a person not familiar with your research Attach a complete research protocol, marked ‘Attachment 1' Faculty Advisor as Co-Principal Investigator for Graduate Student Principal Investigator: Faculty Advisor must serve as the Co-Principal Investigator if their graduate student serves as the Principal Investigator: As faculty advisor for the graduate student named as Principal Investigator for the this protocol, I certify that I am familiar with Rutgers University policies and federal regulations as they apply to research involving human subjects I have advised and/or assisted the student in the preparation of this application and have reviewed it for completeness and accuracy I endorse the study and certify that it fulfills all the guidelines and requirements for IRB review I agree to serve as the Co-Principal Investigator for this project Name: (printed) Title: Cell Phone (optional): E-Mail: Signature: Date: _ Department: Home Phone (optional): Office Phone: Fax: Human Subjects Certification Completion Date: _ Graduate Program Director: The graduate program director will be contacted if problems arise from the protocol Provide program director‘s information below: Name: (printed) Title: Cell Phone (optional): E-Mail: Department: Home Phone (optional): Office Phone: Fax: Complete this section if someone in addition to the PI is designated to receive and respond to correspondence CONTACT PERSON: Title: Department/Unit: Mailing Address: Phone: Fax: E-Mail: REQUESTS RECEIVED WITHOUT THE APPROPRIATE SIGNATURE(S) WILL NOT RECEIVE REVIEW FUNDING STATUS: Funded by: (Agency or Organization): Funding proposal submitted to: (Agency or Organization): If #1 and/or #2 above is applicable, please complete and sign the following: Anticipated Start Date: Projected End Date: I certify that the grant application or contract listed above describes no research involving human subjects other than that which is included in this protocol Name (printed): Signature: _ Funding not applied for at this time (check here): (PI must sign even if not funded) Copyright 2008, Rutgers University All rights reserved Version 5.12 Page of 24 Print Date: 10/20/2022 EDUCATION Effective January 1, 2001, successful completion of the web-based Human Subjects Certification Program by the principal investigator and all other key personnel will be required prior to the Notice of Approval being issued for a protocol Indicate the date that the Principal Investigator successfully completed the Human Subjects Certification Program: Date of Completion: List below other key personnel including undergraduate investigators, who are responsible for the design OR conduct of the study Attach additional sheets if necessary, marked ‘Attachment 2' Name: Title: Department: Mailing Address: Phone: Fax: Email: Date of successful completion of Human Subjects Certification Program: Name: Title: Department: Mailing Address: Phone: Fax: Email: Date of successful completion of Human Subjects Certification Program: Name: Title: Department: Mailing Address: Phone: Fax: Email: Date of successful completion of Human Subjects Certification Program: Name: Title: Department: Mailing Address: Phone: Fax: Email: Date of successful completion of Human Subjects Certification Program: Name: Title: Department: Mailing Address: Phone: Fax: Email: Date of successful completion of Human Subjects Certification Program: Name: Title: Department: Mailing Address: Phone: Fax: Email: Date of successful completion of Human Subjects Certification Program: RATIONALE FOR EXPEDITED REVIEW: (if applicable) If you are requesting EXPEDITED review, please provide your rationale here: Copyright 2008, Rutgers University All rights reserved Version 5.12 Page of 24 Print Date: 10/20/2022 PROTOCOL DESCRIPTION: THE HUMAN SUBJECTS INVOLVED IN THIS RESEARCH: a) Who are the subjects? b) How many subjects will be involved in the project? c) Specify your plans for including women and minorities, if appropriate d) List all inclusion and exclusion criteria e) Do your subjects include any of the following: _Yes _No Pregnant Women or Human Fetuses or Neonates? Indicate only if specifically needed for the research _Yes _No Children and Minors ages seven through seventeen? _Yes _No Infants or Children younger than seven years of age? _Yes _No Cognitively Impaired Persons? _Yes _No Inmates/Prisoners? _Yes _No Elderly/Aged Persons? _Yes _No Non-English Speaking Persons? NOTE: These subjects, by virtue of their age or status, may not be competent or free to give their own consent and may be particularly vulnerable to coercion and undue influence Investigators must incorporate additional safeguards into the research plan and document fully the informed consent of these individuals and/or that of their legal representatives Guidelines for inclusion of vulnerable populations are available from the IRB office via the web site: f) Are your subjects students? _Yes _No If YES, name the institution(s) in which they are enrolled: g) Are you including students who are enrolled in your own class or in a "subject pool" at Rutgers? _Yes _No Read and sign Appendix A, entitled "Use of Rutgers Students as Experimental Subjects in Research" regardless of your response h) Are there prospective subjects who, if selected for this project, would be especially vulnerable to risk because of the procedures you will be using? _Yes _No If YES, describe the process you will use to screen such subjects: RECRUITMENT: a) Specify how you will gain access to, recruit, and select your subjects b) Are you advertising or posting a notice for subjects/volunteers? _Yes _No If YES, submit a copy of the advertisement or notice, marked ‘Attachment 3' c) Will the subjects be recruited from your place of employment? Copyright 2008, Rutgers University All rights reserved Version 5.12 Page of 24 Print Date: 10/20/2022 _Yes _No If YES, explain how this research relates to your job role and provide any other information pertinent to your relationship with the subjects (e.g., how will you ensure against the possibility of coercion?): DURATION OF PARTICIPATION: a) Indicate the length of each session (e.g minutes, hours) and the number of sessions in which each subject will participate: b) What is the total duration of an individual subject’s involvement (e.g days, weeks, months)? COST/PAYMENT: a) Are you paying your subjects? _Yes _No If YES, indicate the amount of payment and describe if (and how) you will pro-rate the payments to subjects who withdraw before they complete their participation: b) Will participation in the study involve any cost to the subject? _Yes _No If YES, indicate the anticipated costs to the subject INFORMED CONSENT: a) Does your protocol involve the use of an informed consent form? _Yes _No If YES, enclose a copy of the form, marked ‘Attachment 4' Informed consent must be obtained from the subjects and/or, in the case of minors under the age of 18, the parent or legal guardian Review the instructions regarding the use of written vs oral consent The document must include all of the relevant elements mentioned in the instructions b) Does your protocol involve the use of assent or oral consent? _Yes _No If YES, provide an approximate script that will be communicated to the subjects, or the assent statement, marked ‘Attachment 5' Assent is agreement by an individual not competent to give legally valid informed consent to participate in research (e.g A child or cognitively impaired person) See the instructions for the use of assent and oral consent c) If you not intend to use a consent form, please provide your rationale here: DOMESTIC / INTERNATIONAL SITE(S): a) Domestic Sites: Specify the site(s) within the United States where you will perform your study (e.g on Rutgers campus, in local schools, hospital, prison) Copyright 2008, Rutgers University All rights reserved Version 5.12 Page of 24 Print Date: 10/20/2022 b) International Sites: Will any of the research under this protocol be conducted outside of the United States? _ Yes No If YES, Complete Appendix C found at http://orsp.rutgers.edu/Humans/internationalproceduresdoc.asp c) Is one or more of the sites a non-Rutgers institution? _Yes _No If YES, list the institutions and provide letters from appropriate institutional official(s) (e.g school principal, director of institution, IRB), marked ‘Attachment 6' THE RESEARCH PROCEDURES: a) Describe in lay language exactly what you will be doing to, or with, your subjects: b) Will you be carrying out procedures or asking questions that might disturb your subjects emotionally or produce stress or anxiety? _Yes _No If YES, describe your plans and criteria for counseling such subjects: c) Are you using a questionnaire, survey, and/or an interview as part of your procedure? _Yes _No If YES, submit a copy of the questionnaire(s) and/or interview questions, marked ‘Attachment 7' d) Are you using focus group discussions as a part of your procedure? _Yes _No If YES, submit a copy of the focus group guide, marked ‘Attachment 8' e) Does your study involve deception of your subjects? _Yes _No If YES, describe the deception, justify its need, and describe the procedure you will use to debrief your subjects Submit a copy of the debriefing statement, marked ‘Attachment 9', which should include a statement of your willingness to allow subjects to withdraw from your study after debriefing and to remove from your files all records of their involvement f) Will this study involve the use of existing data, documents, records, pathological specimens, or diagnostic specimens? _Yes _No If YES, include authorization to access the data if not publicly available, marked ‘Attachment 10' DATA COLLECTION: Copyright 2008, Rutgers University All rights reserved Version 5.12 Page of 24 Print Date: 10/20/2022 a) Are you obtaining from your subjects information about their private behavior, economic status, sexual preferences, religious beliefs, or other matters which, if made public, might impair their self-esteem or reputation, or could reasonably place the subjects at risk of criminal or civil liability or be damaging to their financial standing or employability? _Yes _No If YES, please explain: b) Indicate below the types of demographic data that will be recorded _Names of people _Ethnicity _Addresses _Marital status _Phone numbers _Income _Age _Social security number _Gender _Job title (Check all that apply.) _Names of employers _Types of employers _Other unique information (Specify) _ c) Do you plan to use a code to link a subject to his/her response? _Yes _No If YES, indicate where and by whom the code is held DATA STORAGE/DISPOSITION: a) Describe how you will keep your data secure and maintain confidentiality during the course of your project: b) Describe how you will ultimately dispose of your data (notes, drafts, lists of subjects, photographic records, tapes, computer disks, etc.) after you have completed your research (e.g shredding, burning) (please note that all research records must be maintained for at least three years after the completion of the research, including consent forms, flyers, etc.) If you not plan to destroy research data, please provide a justification for maintaining the data for an indefinite period of time and how you will ensure confidentiality: 10 RISK/BENEFIT: In three or four sentences, summarize the risk/benefit ratio of the proposed research, with regard to the human subjects, the risks to them, and the potential benefits to knowledge or society: Copyright 2008, Rutgers University All rights reserved Version 5.12 Page of 24 Print Date: 10/20/2022 11 INTERNAL REVIEW: Does your department, unit, or school have an ethics or research review committee? _Yes _No If YES, state the name of the committee and the date it reviewed and approved your project: 12 COLLABORATION: Does this research project involve the IRB approval of one or more participating institutions or organizations other than that of Rutgers? _Yes _No If YES, list the institutions and submit copies of the related IRB approval notices, marked ‘Attachment 11' 13 ADDITIONAL INFORMATION (OPTIONAL) • If you are unable to provide certain information at the time of submission, please indicate this in a cover letter It is vital that all information be submitted at the time of review in order to ensure appropriate review and timely processing of the protocol Copyright 2008, Rutgers University All rights reserved Version 5.12 Page of 24 Print Date: 10/20/2022 • All subjects must be informed by the investigator that they are free to terminate their participation in the study at any time without penalty • Be sure to completely fill out and include the checklist, Appendix B, with your application All entries should be marked with X (= yes) or NA (= no) • Review the application before submission to verify that all required signatures are included Requests received without the appropriate signature(s) will be returned without review • Submit the complete application packet by the 12th of the month for review consideration at the upcoming IRB meeting Do not submit instructions • All relevant attachments should be marked and attached to the protocol form in the following order: Appendix A Appendix B Appendix C Attachment Attachment Attachment Attachment Attachment Attachment Attachment Attachment Attachment Attachment 10 Attachment 11 Use of Rutgers Students as Experimental Subjects in Research Investigator and Reviewer Checklist Full/Expedited Studies Involving International Research Research Protocol (e.g grant application, dissertation proposal) Additional Key Personnel Information Advertisement or Recruitment Notice Consent Form(s) Assent or Script for Oral Consent Authorization from Non-Rutgers Research Sites Questionnaire(s), Survey(s), Interview Questions Focus Group Guide Debriefing Statement Authorization to Use Data IRB Approval Notices from Participating Institutions APPENDIX A RUTGERS - THE STATE UNIVERSITY OF NEW JERSEY USE OF RUTGERS STUDENTS AS EXPERIMENTAL SUBJECTS IN RESEARCH Copyright 2008, Rutgers University All rights reserved Version 5.12 Page of 24 Print Date: 10/20/2022 The procedures outlined in this statement are designed to reduce the element of coercion or influence in any use of Rutgers students as subjects the research projects conducted by faculty or instructional staff These procedures DO NOT apply to students studying research techniques in courses that require them to perform experiments; rather, they apply to experimentation that uses students not as investigators, but as subjects The ethical principles of professional societies insist that all consent to participate in research must be voluntary, and that all potential subjects must be treated as autonomous agents, with the right to choose or not to choose to take part in experiments Federal regulations (e.g., 45 CFR 46.116) are explicit: "An investigator shall seek such consent only under circumstances that provide the prospective subject or the representative sufficient opportunity to consider whether or not to participate and that minimize the possibility of coercion or undue influence." By action of the Rutgers Board of Governors, all research in this university that involves human subjects is required to conform with federal regulations Consequently, individual faculty members and instructional staff, students, and departments that use students as experimental subjects, or that maintain "subject pools" of students from which investigators may draw research participants, are asked to adopt procedures that meet the following conditions: Before they enroll in a course, students must be informed of the possibility that they may be asked to serve as research subjects in experiments under direction of the faculty If there is a course requirement that students serve as research subjects in such experiments, then alternative ways must be provided for students to meet this requirement During the first week of classes, students should receive a written description of the various ways of meeting the requirement Each department that regularly requires students to act as research subjects should establish a committee composed of faculty and students to review the research projects involved This committee should be responsible for hearing and acting on any student complaints in connection with the research-participation requirement All members of the faculty who invite students to act as subjects in their research must be acquainted with the ethical standards that govern such activities, such as those promulgated by the American Psychological Association or other discipline-related professional organization, or those in the so-called Belmont Report of the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research A copy of the latter report is obtainable from ORSP (Website: ) Please check one box below, sign your name, and include this form with your application [ ] [ ] I have read the above statement and agree to follow the procedures recommended OR I will not be using Rutgers students as subjects in this protocol Name (Printed): Signature: Date: Copyright 2008, Rutgers University All rights reserved Version 5.12 Page 10 of 24 Print Date: 10/20/2022 APPENDIX B Rutgers, The State University of New Jersey INSTITUTIONAL REVIEW BOARD FOR THE PROTECTION OF HUMAN SUBJECTS IN RESEARCH INVESTIGATOR CHECKLIST This checklist is to be completed by the PI and submitted with the IRB application Principal Investigator: _ Date: _ Type of IRB review requested: full panel expedited exempt APPLICATION: (use X if "yes" and NA if "not applicable") _Justification provided for expedited review or exemption, if requested _Application typed or computer-generated, not hand written _Summary in non-technical terms (2 sentence maximum) _Risks specified _Benefits specified _Informed Consent Form appended _All instruments appended (e.g questionnaires, standardized tests, interview schedules) _Form: "Use of Rutgers Students as Experimental Subjects " signed, appended _Advertisement for recruitment of participants appended, if relevant _Performance site(s) specified _Principal Investigator's signature on application _Names of all investigators specified _Study dates specified (beginning, ending) _Funding source(s), if any, specified _Approval letter(s) from ALL relevant off-campus site(s) (e.g school principal, other IRB's) appended _FINAL disposal of data (and time) specified _If applicant is a STUDENT, advisor signature on page _Inclusion/exclusion criteria specified _Inclusion of women and/or minorities addressed in text _ Appendix C: FULL / EXPEDITED Studies Involving International Research, attached _ Appendix D: EXEMPT Studies Involving International Research, attached Investigator: check ONLY ONE of the following: Participants' identity will be: _anonymous _confidential neither INFORMED CONSENT FORM (must be written in non-technical terms for participants) _Study description and goals _Clear description of what will be done to the participant (e.g withdraw _ amount of blood) _Clear description of what will be required of participant (e.g physical exertion) _Risks (e.g side effects, toxicities, radiation) to participant specified _Benefits to participant specified _Duration of participation (e.g minutes, days, months, number of sessions, etc.) _Provision and procedure for accessing counseling specified, if participants may be affected adversely _Alternatives to participation, if applicable _Payment to participant specified, including reimbursement for expenses, if applicable _Freedom to withdraw from study at any time without penalty: STATED PROMINENTLY _Pro-rating specified, if participant withdraws early from study _Costs to participant specified (i.e those not reimbursed, if any) _Conditions under which INVESTIGATOR may terminate subject's participation, if relevant _Number of participants in overall study _Line for participant to initial EACH page of informed consent form _Rutgers Disclaimer / Coverage for adverse effects specified Copyright 2008, Rutgers University All rights reserved Version 6.08 Page 11 of 24 Print Date: 10/20/2022 _Names, phone numbers, addresses of contact persons (investigators AND IRB) _Signature lines for participant AND investigator; witness signature line if appropriate _Video, audio, and/or photographic consent, if applicable _Consent for the use of subjects’ genetic material, if applicable _Translation into appropriate foreign language, if applicable _Pregnancy waiver, if applicable _Specification of any groups to be excluded from the study (e.g women, minorities) _Specification of whether research results (individual, group) will be provided to participant _Explicit assurance of participant's confidentiality/anonymity in investigator's reports of findings _Consistent use of "I / you" in the text ****NOTE THAT YOU MUST SUBMIT ONE ORIGINAL AND TWO COPIES OF THE APPLICATION AND ALL RELEVANT MATERIALS**** Investigator Comments (optional): Copyright 2008, Rutgers University All rights reserved Version 6.08 Page 12 of 24 Print Date: 10/20/2022 IRB PROTOCOL FORM INSTRUCTIONS DO NOT SUBMIT THIS SECTION WITH YOUR APPLICATION!!! IT IS PROVIDED FOR YOUR INFORMATION ONLY This application should be submitted to the Institutional Review Board for The Protection of Human Subjects in Research (IRB) in the Office of Research and Sponsored Programs (ORSP) to request Review and Approval, or Exemption, of any Research Protocol Involving Human Subjects IRB APPROVAL IS REQUIRED BEFORE ANY RESEARCH INVOLVING HUMAN SUBJECTS CAN BE INITIATED REQUIREMENT OF IRB REVIEW AND APPROVAL PRIOR TO PERFORMING RESEARCH ON HUMAN SUBJECTS: In accordance with action taken by the University's Board of Governors, all full-time and part-time members of the university faculty, staff, and student body who propose to undertake any research studies that involve human participants and/or the use of existing data collected from human beings are obliged to conform with procedures prescribed by the US Department of Health and Human Services (DHHS) and set forth most recently as a Common Federal Policy for the Protection of Human Subjects The procedures apply to externally funded, internally funded, and non-funded studies, including course-related research projects at the undergraduate and graduate level, honors projects, masters theses, and dissertations All applicable research projects must be reviewed and approved by the University's IRB before the research begins Additionally, projects covered under one of the six allowable "exemption" categories require review and approval by a subcommittee of the IRB before the research begins Definition of Research: A systematic investigation (i.e., the gathering and analysis of information) designed to develop or contribute to generalizable knowledge [Federal Policy 45 CFR 46.102(d)] Definition of Human Subject: Living individual(s) about whom an investigator conducting research obtains: (1) data through intervention or interaction with the individual; or (2) identifiable private information [Federal Policy 45 CFR 46.102(f)] SUBMISSION DATES for Full and Expedited Review: The IRB meets monthly, except during August All Requests for Full and Expedited Review must be received in the IRB office by the 12th of the month in order to be considered at the imminent meeting (e.g received by January 12th for review at the February meeting) Requests received later than the 12th will be held until the subsequent month’s meeting (e.g received on January 13th for review at the March meeting) SUBMISSION DATES for Exempt Review: Exempt Reviews are on conducted on a weekly basis All Requests for Exemption Review must be received in the IRB Office on Wednesdays Requests for Exemption are sent out for review the following week However, if you are unsure whether your project qualifies for an exemption, you are advised to adhere to the deadline schedule listed above and submit the Full / Expedited form, or contact the IRB unit Then, if an exemption request is denied by the subcommittee, the case can be referred to the imminent IRB meeting Copyright 2008, Rutgers University All rights reserved Version 6.08 Page 13 of 24 Print Date: 10/20/2022 SUBMISSIONS SHOULD BE SENT TO: Institutional Review Board (IRB) Office of Research and Sponsored Programs Rutgers, the State University of New Jersey ASB III, Rutgers Plaza New Brunswick, NJ 08901 Phone: (848) 932-0150 Fax: (732) 932-0163 Inquiries should be directed to: Margaret Cooper, IRB Administrator Phone: (848) 932-4018 Email: margaret.cooper@rutgers.edu Michelle Gibel, IRB Administrator Phone: (848) 932-4058 Email: gibel@grants.rutgers.edu Erik Schneebeck, IRB Administrator Phone: (848) 932-4054 Email: erik.schneebeck@rutgers.edu PROCEDURE TO REQUEST IRB REVIEW: To request IRB review, copy for Full and Expedited Reviews and original for Exemption Reviews are required of each of the following items must be submitted to the IRB office, assembled in the following order: The attached IRB Protocol Form, which may be downloaded from the Rutgers ORSP website: and is available at the Office of Research and Sponsored Programs Appendix A, “Use of Rutgers Students as Experimental Subjects in Research” This form describes the procedures designed to reduce the risk of coercion or undue influence on Rutgers students who are participating in research, and must be signed and returned If you are NOT using Rutgers students, check the appropriate box on the form, sign and return the Appendix B, “Investigator and Reviewer Checklist” This checklist is designed to assist the investigator in ensuring the completeness of the IRB Protocol Form It must be filled out completely and submitted with application (i.e “X” or “NA” for each item) by Appendix C, Full/Expedited Studies Involving International Review This form should only be completed investigators who intend on doing human subjects research with people in foreign countries Appendix D, Exempt Studies Involving International Research This form should only be completed by investigators who intend on doing human subjects research with people in foreign countries the plan Attachment - A complete copy of the research proposal, plan or protocol, that sets forth the objectives of research and describes the procedures designed to reach that objective, OR A copy of the proposal or for a dissertation leading to an advanced degree Copyright 2008, Rutgers University All rights reserved Version 6.08 Page 14 of 24 Print Date: 10/20/2022 One original copy for Full and Expedited Review and one original for Exempt Review of the following items must also be submitted, IF APPLICABLE TO YOUR PROPOSAL, in the following order: Attachment - Information for additional key personnel, if more than five individuals are involved Attachment - All advertisements or other recruitment material, which must include a contact name and number, a brief description of the research, inclusion criteria, and payment to the subject, if any their is Attachment - The informed consent form that the subjects will sign and that can be used to document informed consent (Note: If exemption from review is requested and approved, an informed consent form not required, but may still be desirable) For subjects who are unable to sign for themselves (e.g infants, children ages six and below, adults who are cognitively impaired, and the mentally disabled), written informed consent must be obtained from the subject's legally authorized representative Investigators using minor subjects, (ages to 17), must obtain not only the consent of their legal representative (e.g parent or guardian), but also the assent of the subject – Attachment Definition of Assent: Agreement by an individual not competent to give legally valid informed consent (e.g A child or cognitively impaired person) to participate in research In these cases, the informed consent form should provide for a signature of a witness for the subject's signature, in addition to that of the legally authorized representative 10 Attachment - Authorization letters from research sites that are not affiliated with Rutgers University (e.g schools) 11 Attachment - All questionnaires, surveys, interview schedules, tests, and any other test instruments proposed to be used, and Attachment - focus group guides 12 Attachment - The debriefing statement that will be used if deception is involved in the study 13 Attachment - Authorization to use data if it is not publicly available 14 than Attachment 10 - Letters of collaboration and IRB approval notices from institutions or organizations other Rutgers that are participating in the research MANDATORY EDUCATION IN HUMAN SUBJECTS RESEARCH: Effective January 1, 2001, successful completion of the web-based Human Subjects Certification Program by the principal investigator and all other key personnel will be required prior to the Notice of Approval being issued for a protocol Definition of Key Personnel: All individuals who are responsible for the design or conduct of the study Information about the program is available on the website for the Office of Research and Sponsored Programs at or you may contact the IRB Administrator at the address above It is strongly recommended that all principal investigators and key personnel (including Faculty Advisor if appropriate) named on protocols involving human subjects complete the program as soon as possible Copyright 2008, Rutgers University All rights reserved Version 6.08 Page 15 of 24 Print Date: 10/20/2022 THE BASIC IRB REVIEW CRITERIA: In order to approve research covered by the Common Rule (45 CFR 46), the IRB shall determine whether all of the following requirements have been satisfied, as applicable: and Risks to subjects are minimized, a) by using procedures that are consistent with sound research design that not unnecessarily expose the subjects to risk, and (b) whenever appropriate, by using procedures already being performed on the subjects for diagnostic or treatment purposes Risks to subjects are reasonable in relation to anticipated benefits, if any, to the subjects, and the importance of the knowledge that may reasonably be expected to result are Selection of subjects is equitable, and the special problems of research involving vulnerable populations adequately addressed Informed consent will be sought from each prospective subject or the subject's legally authorized representative Informed consent will be appropriately documented The research plan makes adequate provision for monitoring the data to ensure the safety of the subjects Adequate provisions are made to protect the privacy of the subjects and to maintain the confidentiality or anonymity of data Appropriate additional safeguards have been included in the research plan when some or all of the subjects are likely to be vulnerable to coercion or undue influence This includes children, prisoners, pregnant women, cognitively impaired persons, or economically or educationally disadvantaged persons The purpose of the research is consistent with the environmental setting in which it will be conducted 10 If the subjects may be expected to require mental health counseling as a result of the research procedure (e.g an interview that raises emotionally-distressing issues), specification must be provided regarding whether counseling will be provided by the investigator, or another qualified individual In addition, it must specified who will bear financial responsibility for the counseling be THE INFORMED CONSENT FORM BASIC ELEMENTS: The following information is to be provided to each subject in the informed consent form: of A statement that the study involves research, an explanation (in non-technical language) of the purposes the research, a description of the procedures to be followed, and identification of any procedures that are experimental A description of any reasonably foreseeable risks or discomforts to the subject Copyright 2008, Rutgers University All rights reserved Version 6.08 Page 16 of 24 Print Date: 10/20/2022 from A description of any benefits to the subjects or other persons, that may reasonably be expected to result the research A disclosure of appropriate alternative procedures or treatments that might be beneficial to the subject A statement describing the extent, if any, to which confidentiality of records identifying the subject will be maintained Your proposal must specify precisely whether the identity of your subjects will be: a) Anonymous; b) Confidential; or c) Neither Note: Your subjects’ responses may be recorded and maintained as confidential or anonymous, but not both Definition of Anonymous: Data are recorded such that no identifier whatsoever exists to link a subject's identity to that subject's response Examples: (1) subject fills out and mails back to the investigator a questionnaire that does not provide subject's name, social security number, phone number, or any other identifier; (2) investigator interviews subject by phone and notes responses, but does not have any record connecting any response to any phone number Definition of Confidential: There exists a documented linkage between a subject's identity and his/her response in the research, and the investigator provides assurance in the protocol and in the informed consent form that the identity of any individual subject will not be revealed in any report of the study Example: a subject's data record is assigned a code, and a "master list" that links the code to the subject's identity is maintained in a secure location Cautionary Note: Even research records that are obtained via a "confidential" protocol may be subject to subpoena If the investigator and/or the IRB deem(s) it necessary to prevent the possibility of such compelled disclosure of the research records (e.g in the case of potential revelation of criminal activity), the investigator may, in advance of initiating the research, apply to any of several government agencies (e.g NIH) for a "Certificate of Confidentiality," which legally prevents any governmental agency from obtaining the investigator's records Contact the Sponsored Programs Administrator for instructions on how to apply for this document For research involving more than minimal risk, a statement that Rutgers will not provide compensation or medical treatment in the event of a research-related injury of A statement specifying the amount of time required for participation in the study (e.g a realistic estimate the number of minutes required to complete a questionnaire, the number of separate sessions, the overall duration [days, weeks, months] that the subject will be involved in the study) A statement that participation is voluntary, that refusal to participate will involve no penalty or loss of benefits to which the subject is otherwise entitled, and that the subject may discontinue participation at any time without penalty or loss of benefits to which the subject is otherwise entitled Specify the consequences, if any, to the subject of his/her decision to withdraw from the research before completing the protocol (e.g loss of pro-rated compensation for participation in the study) and procedures for orderly termination of participation by the subject (e.g exit interview) Statement regarding financial or other compensation, if any, to the subjects, giving precise amounts and providing for prorating of payment if a subject withdraws before completing the study Also, specify any uncompensated costs to the subject that may result from participation in the research (e.g travel costs, absence from the workplace) 10 A statement regarding accessibility of the investigator to the subjects for questions related to the research (e.g phone number, email address, institutional address) 11 The following statement regarding subjects’ rights: If you have any questions about your rights as a research subject, you may contact the IRB Administrator at Rutgers University at: Copyright 2008, Rutgers University All rights reserved Version 6.08 Page 17 of 24 Print Date: 10/20/2022 Rutgers University Institutional Review Board for the Protection of Human Subjects Office of Research and Sponsored Programs Rutgers Plaza New Brunswick, NJ 08901-8559 Tel: 848 932-4058 Email: humansubjects@orsp.rutgers.edu ADDITIONAL ELEMENTS OF INFORMED CONSENT: When appropriate, one or more of the following elements of information should be provided to each subject: 12 or A statement that the particular treatment or procedure may involve risks to the subject (or to the embryo fetus, if the subject is, or may become, pregnant) which are currently unforeseeable 13 Anticipated circumstances under which the subject's participation may be terminated by the investigator without regard to the subject's consent 14 the A statement that significant new findings developed during the course of the research, which may relate to subject's willingness to continue participation, will be provided to the subject 15 The approximate number of subjects involved in the study FORMAT OF THE INFORMED CONSENT FORM: Text should be written in non-technical terms, at a sixth-grade reading level, with non-technical explanation of any specialized terms If the consent form is more than one page, include a notation, “Subject’s Initials ”, at the bottom of each page except the signature page If non-English speaking subjects will be involved, a consent form that has been translated into the relevant language is required Signature lines for the Principal Investigator and the subject, with corresponding lines for the date of each signature, are required Signature lines for a legally authorized representative or minor subject may also be necessary, depending upon the categories of subjects that are involved A witness signature is not required in most cases; exceptions are oral consent verification (below) and situations in which a legally authorized representative signs for the subject If the protocol involves videotaping, audiotaping, or photographing of subjects, the consent form must include either a separate statement of agreement for these procedures within the consent document, with signature line, or an addendum to the consent form describing the recording procedure with a statement of agreement and signature line The purpose of the distinct signature for these procedures is to ensure that the subject is aware of their inclusion, and if the study design permits, to allow the subject to participate in the study without being recorded Provide either: a) a detailed written form that incorporates the elements of informed consent, OR b) a brief written document stating that the elements of informed consent will be presented orally to the subject or the subject's legally authorized representative and witnessed by a third party In either case, a copy of the document should be given to the person signing the form A written summary of the oral presentation should be included in your Request for Review Copyright 2008, Rutgers University All rights reserved Version 6.08 Page 18 of 24 Print Date: 10/20/2022 THE THREE CATEGORIES OF IRB REVIEW: Based on the criteria provided below, investigators should request, on the IRB application and on the checklist provided, one and only one of the following three possible types of review: 1) full IRB panel review, 2) expedited IRB review, 3) exemption from IRB panel review FULL IRB PANEL REVIEW: All proposals that not qualify for expedited review or exemption (criteria specified below) shall be reviewed by the full IRB Panel EXPEDITED REVIEW: a Research activities that: 1) present no more than minimal risk to human subjects, AND 2) involve only procedures listed in one or more of the following categories, may be reviewed by the IRB through the expedited review procedure authorized in 45 CFR 46.110 and 21 CFR 56.110 (dated November 1998) Definition of Minimal Risk: A risk is minimal where the probability and magnitude of harm or discomfort anticipated in the proposed research are not greater, in and of themselves, than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests [Federal Policy 45 CFR 46.102(i)] b General Criteria: 1) The activities listed should not be deemed to be of minimal risk simply because they are included on this list Inclusion on this list merely means that the activity is eligible for review through the expedited review procedure when the specific circumstances of the proposed research involve no more than minimal risk to human subjects 2) The categories in this list apply regardless of the age of subjects, except as noted 3) The expedited review procedure may not be used where identification of the subjects and/or their responses would reasonably place them at risk of criminal or civil liability or be damaging to the subjects' financial standing, employability, insurability, reputation, or be stigmatizing, unless reasonable and appropriate protections will be implemented so that risks related to invasion of privacy and breach of confidentiality are no greater than minimal 4) The expedited review procedure may not be used for classified research involving human subjects 5) The standard requirements for informed consent (or its waiver, alteration, or exception) apply regardless of the type of review - expedited or convened - utilized by the IRB 6) Categories 1-7 pertain to both initial and continuing IRB review c Specific research areas that qualify for expedited review: Specify one or more categories that pertain to your proposal: 1) Clinical studies of drugs and medical devices only when condition a) or b) is met: a) research on drugs for which an investigational new drug application (21 CFR Part 312) is not required.² b) research on medical devices which (1) not require an investigational device exemption application (21 CFR Part 812); OR (2) are cleared/approved for marketing and are being used in accordance with their cleared/approved labeling 2) Collection of blood samples by finger stick, heel stick, ear stick, or venipuncture as follows: a) from healthy, non-pregnant adults who weigh at least 110 pounds For these subjects, the amounts drawn may not exceed 550 ml in an eight-week period and collection may not occur more frequently than twice per week; OR Copyright 2008, Rutgers University All rights reserved Version 6.08 Page 19 of 24 Print Date: 10/20/2022 b) from other adults and children, considering the age, weight, and health of the subjects, the collection procedure, the amount of blood to be collected, and the frequency with which it will be collected For these subjects, the amount drawn may not exceed the lesser of 50 ml or 3ml/kg in an eight-week period and collection may not occur more frequently than twice per week 3) Prospective collection of biological specimens for research purposes by non-invasive means For example: a) hair and nail clippings in a non-disfiguring manner; b) deciduous teeth at time of exfoliation or if routine patient care indicates a need for extraction; c) permanent teeth if routine patient care indicated a need for extraction; d) excreta and external secretions [including sweat]; e) uncannulated saliva collected either in an unstimulated fashion or stimulated by chewing gumbase or wax or by applying a diluted citric solution to the tongue; f) placenta removed at delivery; g) amniotic fluid obtained at the time of rupture of the membrane prior to or during labor; h) supra- and subgingival dental plaque and calculus, provided the collection procedure is not more invasive than routine prophylactic techniques; i) mucosal and skin cells collected by buccal scraping or swab, skin swab, or mouth washings; j) sputum collected after saline mist nebulization 4) Collection of data through non-invasive procedures [not involving general anesthesia or sedation] routinely employed in clinical practice, excluding procedures involving x-rays or microwaves Where medical devices are employed, they must be cleared/approved for marketing For example: a) physical sensors that are applied either to the surface of the body or at a distance and not involve input of significant amounts of energy into the subject or an invasion of the subject's privacy; b) weighing or testing sensory acuity; c) magnetic resonance imaging; d) electrocardiography, electroencephalography, thermography, detection of naturally occurring radioactivity, electroretinography, ultrasound, diagnostic infrared imaging, doppler blood flow, and echocardiography; e) moderate exercise, muscular strength testing body composition assessment, and flexibility testing where appropriate given the age, weight, and health of the individual 5) Research involving materials [data, documents, records, or specimens] that have been collected or will be collected solely for non-research purposes, such as medical treatment or diagnosis 6) Collection of data from voice, video, digital, or image recordings made for research purposes 7) Research on individual or group characteristics or behavior [including but not limited to research on perception, cognition, motivation, identity, language, communication, cultural beliefs or practices, and social behavior] or research employing survey, interview, oral history, focus group, program evaluation, human factors evaluation, or quality assurance methodologies 8) Continuing review of research previously approved by the convened IRB as follows: a) where: the research is permanently closed to the enrollment of new subjects; all subjects have completed all research-related interventions; and the research remains active only for long-term follow-up of subjects; OR b) where no subjects have been enrolled and no additional risks have been identified; OR c) where the remaining research activities are limited to data analysis Copyright 2008, Rutgers University All rights reserved Version 6.08 Page 20 of 24 Print Date: 10/20/2022 9) Continuing review of research, not conducted under an investigational new drug application or investigational device exemption where categories though not apply but the IRB has determined and documented at a convened meeting that the research involves no greater than minimal risk and no additional risks have been identified Footnotes: An expedited review procedure consists of a review of research involving human subjects by the IRB chair or by one or more experienced reviewers designated by the chair from among member of the IRB in accordance with the requirements set forth in 45 CFR 46.110 and 21 CFR 56.110 (November 1998) Research on marketed drugs that significantly increases the risks or decreases the acceptability of the risks associated with the use of the product is not eligible for expedited review Children are defined in the HHS regulations as "persons who have not attained the legal age for consent to treatments or procedures involved in this research, under the applicable law of the jurisdiction in which the research will be conducted." [45 CFR 46.402 (a)] Studies intended to evaluate the safety and effectiveness of the medical device are generally not eligible for expedited review, including studies of cleared medical devices for new indications Some research in this category may be exempt from the HHS regulations for the protection of human subjects, according to 45 CFR 46.101(b)(4) This listing refers only to research that is not exempt Some research in this category may be exempt from the HHS regulations for the protection of human subjects, according to 45 CFR 46.101(b)(2) and (b)(3) This listing refers only to research that is not exempt EXEMPT REVIEW (effective August 19, 1991) a Research activities that: 1) Present less than minimal risk to human subjects, AND 2) Involve only procedures listed in one or more of the following categories, may receive exemption from IRB review as authorized in 45 CFR 46.101(b), unless otherwise required by Federal department or agency heads Definition of Minimal Risk: A risk is minimal where the probability and magnitude of harm or discomfort anticipated in the proposed research are not greater, in and of themselves, than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests [Federal Policy 45 CFR 46.102(i)] b Specific research areas that are exempt from IRB review: Specify one or more categories that pertain to your proposal: 1) Research conducted in established or commonly accepted educational settings, involving normal educational practices, such as (i) research on regular and special education instructional strategies, or (ii) research on the effectiveness of, or the comparison among, instructional techniques, curricula, or classroom management methods 2) Research involving the use of educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures or observation of public behavior, unless: (i) information obtained is recorded in such a manner that subjects can be identified, directly or through identifiers linked to the subjects; and (ii) any disclosure of the human subjects' responses outside the research could reasonably place the subjects at risk of criminal or civil liability or be damaging to the subjects' financial standing, employability, or reputation 3) Research involving the use of educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures or observation of public behavior that is not exempt under paragraph (2) if: (i) the human subjects are elected or appointed public officials or candidates for public office; or (ii) federal statute(s) require(s) without exception that the confidentiality of the personally identifiable information will be maintained throughout the research and thereafter Copyright 2008, Rutgers University All rights reserved Version 6.08 Page 21 of 24 Print Date: 10/20/2022 4) Research involving the collection or study of existing data, documents, records, pathological specimens, or diagnostic specimens, if these sources are publicly available or if the information is recorded by the investigator in such a manner that subjects cannot be identified, directly or through identifiers linked to the subjects 5) Research and demonstration projects which are conducted by or subject to the approval of Federal department or agency heads, and which are designed to study, evaluate, or otherwise examine: (i) public benefit or service programs; (ii) procedures for obtaining benefits or services under those programs; (iii) possible changes in or alternatives to those programs or procedures; or (iv) possible changes in methods or levels of payment for benefits or services under those programs 6) Taste and food quality evaluation and consumer acceptance studies, (i) if wholesome foods without additives are consumed or (ii) if a food is consumed that contains a food ingredient at or below the level and for a use found to be safe, or agricultural chemical or environmental contaminant at or below the level found to be safe, by the Food and Drug Administration or approved by the Environmental Protection Agency or the Food Safety and Inspection Service of the U.S Department of Agriculture Footnotes: These exemptions not apply to research involving prisoners, fetuses, pregnant women, or human in vitro fertilization This exemption does not apply to research with children except for research involving observations of public behavior when the investigator(s) not participate in the activities being observed If the records involved are those of Rutgers students, the project is not exempt and must be reviewed by the IRB Such research must conform with the Family Education Rights and Privacy Act of 1974, also known as the Buckley Amendment COURSE-RELATED STUDENT RESEARCH PROJECTS: (Rutgers University Guidelines) Student projects that not require IRB review: "Classroom exercises" not qualify for IRB review if the projects: a) b) take place in a Rutgers University classroom, departmental, dormitory, or other (Rutgers University) campus setting, or in a public setting with generally unlimited access to the public, such as a shopping center, park or street, AND involve only the learning of research techniques Such projects should not put the subjects at more than minimal risk, the data must be recorded anonymously by the student researchers (i.e., with no names, social security numbers, or any other codes that can be linked to a list of names of the research subjects), and the findings are not to be published Student projects that not qualify under number above, but that qualify as exempt from IRB full panel review under the federally-allowed categories defined in Section above: If student proposals are submitted to the IRB under this category, all the included student projects must be aggregated by the course instructor as "one classroom project," such that only one, inclusive, IRB exemption request form is submitted by the course instructor who asserts, in a signed cover letter, that s/he has reviewed each of the proposals, that EACH is in COMPLETE accordance with the IRB guidelines, and a separate IRB Checklist for EACH student's proposal has been filled out completely and accurately and attached to each student's proposal These proposals will be reviewed by the IRB exemption subcommittee If any forms are incomplete, the entire package will be returned to the course instructor without review Timetable: Requests for a "one classroom project" IRB exemption must be received at the office of the IRB not later than September 12 for the fall term or February 12 for the spring term In the case of a two- Copyright 2008, Rutgers University All rights reserved Version 6.08 Page 22 of 24 Print Date: 10/20/2022 semester course, the request for exemption should be submitted at least one month before the students will begin their projects Student research projects that not qualify under number or above, but that qualify for: a) expedited IRB review, or b) IRB full-panel review (i.e they use an informed consent form): If student proposals are submitted to the IRB under either or both of these two categories, a) the course instructor must sign the cover page of each proposal, assuring that s/he has reviewed each of the individual proposals and EACH is in COMPLETE accordance with all the relevant IRB requirements, b) if expedited review is requested, the rationale for the request, based on the relevant expeditable category (defined in Section 2, page 17) must be specified for each proposal, AND c) an IRB Proposal Checklist is required to be fully and accurately completed and attached to each student's proposal If any forms are incomplete, the entire package will be returned to the course instructor without review Timetable: All requests for review of non-exempt projects that are to be completed during the fall semester must be submitted by September 12 for consideration at the October IRB meeting For nonexempt projects to be completed during the spring semester, the requests for review must be submitted by February 12 for consideration at the March IRB meeting In the case of a two-semester course, the students should submit their requests for review at least a month before they wish to start their data collection Faculty and their student research advisees should be cognizant that if approval of student projects is not obtained according to the above schedule, it may not be possible for the projects to be completed in a timely manner IRB REVIEW FREQUENT CONCERNS: Research protocols involving children in school: sensitivity issue: If not all children in a classroom will be participants in your study, be sure to specify in the protocol how you will ensure that the non-participating children are not made to feel "left out." Specify in the protocol what provision will be made for the non-participants while the subjects are participating in the study Permission from an institutional representative: If the research site will be a school, corporate office, factory, house of worship, or other non-Rutgers institution, you must provide in your IRB application a letter of permission from a responsible representative of that institution to perform your project on those premises Revisions after IRB review: If you submit a revised protocol following recommendations in the IRB review, please indicate any revisions(s) distinctively, e.g CAPITALIZED, boldface, underlined, and/or [bracketed] in the margins Do not use a colored highlighting pen, because the highlighting either does not show up, or it obscures the text in photocopies In addition, submit an entire “clean” copy of the revised version that is devoid of the markings that identify the revisions MISCELLANY Continuing review: For all non-exempt studies, continuing review by the IRB is required at least annually Approximately two months before the expiration date of the protocol, the IRB office will mail a form entitled "Request for Continuing Review" to principal investigators, which must be completed and returned promptly If the form is not returned by the end of the approval period, the protocol will be administratively inactivated, in which case the research using human subjects must be terminated immediately Change in protocol or principal investigator: Copyright 2008, Rutgers University All rights reserved Version 6.08 Page 23 of 24 Print Date: 10/20/2022 Whenever an ongoing project acquires a new principal investigator, or whenever there is a change in the protocol or the subject population, the IRB must be notified in writing Upon approval of the modification, the IRB will issue a revised notice of approval Adverse Events: All adverse and/or unexpected events experienced by participants in research studies must be reported immediately to the IRB on the Adverse/Unexpected Event Report form, which may be downloaded from the ORSP website: < In addition, a copy of the form will be mailed to the Principal Investigator with each Notice of Approval Federal grant applications: If the project is being submitted to a Federal agency that requires IRB review, please inform the Office of Research and Sponsored Programs of this fact, and provide the address of the person in the Federal agency who is to be notified once the project has received IRB approval IRB decisions: All IRB decisions will be communicated to investigators in writing On occasion, an investigator may be invited to appear before the IRB to provide information about matters not covered in the request for review In the unlikely event of an unresolvable conflict between the IRB and an investigator, the case will be referred to the Vice President of Research and the Graduate and Professional Education for further review In the event of non-compliance: In accordance with the Rutgers University Federalwide Assurance #FWA00003913 “ensuring prompt reporting to the IRB, appropriate institutional officials, the relevant Department or Agency Head, any applicable regulatory body, and OHRP of any: (i) unanticipated problems involving risks to subjects or others, (ii) serious or continuing noncompliance with the Federal Regulations or IRB requirements, and (iii) suspension or termination of IRB approval” The Federal Office of Human Research Protections (OHRP) may also be informed of non-compliance FOR FURTHER REFERENCE: The review criteria, and the other rules and regulations under which the IRB operates, are set forth in the Federal Register, Vol 56, No 117, for Tuesday, June 18, 1991, (revised November, 1998) and are encompassed in Rutgers University's Assurance of Compliance as approved by the Division of Compliance, OPRR, U.S Department of Health and Human Services The ethical principles to which the IRB subscribes are set forth in the Belmont Report, printed in the Federal Register, Vol 44, No 76, for Wednesday, April 18, 1979 These documents are available at the Rutgers University IRB Office, ASB III, Rutgers Plaza, New Brunswick, NJ 08901 IRB webpage on the Rutgers University ORSP website: < http://orsp.rutgers.edu/Human.asp > Copyright 2008, Rutgers University All rights reserved Version 6.08 Page 24 of 24 Print Date: 10/20/2022 ... possible types of review: 1) full IRB panel review, 2) expedited IRB review, 3) exemption from IRB panel review FULL IRB PANEL REVIEW: All proposals that not qualify for expedited review or exemption... Administrator Phone: (848) 932-4054 Email: erik.schneebeck@rutgers.edu PROCEDURE TO REQUEST IRB REVIEW: To request IRB review, copy for Full and Expedited Reviews and original for Exemption Reviews... of IRB review requested: full panel expedited exempt APPLICATION: (use X if "yes" and NA if "not applicable") _Justification provided for expedited review or exemption, if requested _Application