ࡱ>  Mbjbj11 ASS[:=  \\```ttt8htQz4/(8/8/N/3]8l9$ˉ}f4y`>23>>4\\8/N/\ E E E>\8/`N/ E> E ExLJ|N/ci>^z8 HQz @>p||`|D:g; E <<q:::44B:::Q>>>>::::::::: ":  IRB # Institutional Review Board Application Form San Bernardino City Unified School District (SBCUSD) Collaborative Studies RESEARCH PROTECTION PROGRAMS LOMA LINDA UNIVERSITY | Office of the Vice President of Research Affairs 24887 Taylor Street, Suite 202 Loma Linda, CA 92350 (909) 558-4531 (voice) / (909) 558-0131 (fax) Instructions: Submit a typed printout of this form. Failure to properly complete this application will delay final review of your protocol. Note that links to guidance available are in color and are underlined in blue. Ia. Principal Investigator (name, degrees)Obtaining consent?Dept./SectionExt.E-Mail  HYPERLINK "http://research.llu.edu/HSE.asp" HSE Expiration Status  FORMTEXT       FORMTEXT       FORMTEXT       FORMTEXT       FORMTEXT      Full Time FacultyIb. All persons conducting  HYPERLINK "http://www.llu.edu/pages/handbook/lluahsc_policies/H-Research%20Affairs/H-23%20Determination%20of%20Human%20Subject%20Research.pdf" Human Subjects Research who will have direct contact with students (names, degrees) FORMTEXT       FORMTEXT       FORMTEXT       FORMTEXT       FORMTEXT       FORMDROPDOWN  FORMTEXT       FORMTEXT       FORMTEXT       FORMTEXT       FORMTEXT       FORMDROPDOWN  FORMTEXT       FORMTEXT       FORMTEXT       FORMTEXT       FORMTEXT       FORMDROPDOWN  FORMTEXT       FORMTEXT       FORMTEXT       FORMTEXT       FORMTEXT       FORMDROPDOWN  FORMTEXT       FORMTEXT       FORMTEXT       FORMTEXT       FORMTEXT       FORMDROPDOWN Ic. Other personnel involved in the design, conduct, or reporting of the research study FORMTEXT       FORMTEXT       FORMTEXT       FORMTEXT       FORMTEXT       FORMDROPDOWN  FORMTEXT       FORMTEXT       FORMTEXT       FORMTEXT       FORMTEXT       FORMDROPDOWN Id. Preferred contact person:  FORMTEXT      Building - Room #  FORMTEXT      Ext.  FORMTEXT      FAX  FORMTEXT      E-mail  FORMTEXT      TITLE OF PROTOCOL  FORMTEXT      PROJECT PERIOD: From  FORMTEXT       to  FORMTEXT      IV. FUNDING SOURCE(S) (response required): If intramural, what department/LLUH entity/fund?  FORMTEXT       If extramural, what is the name of the sponsor?  FORMTEXT       LLeRA # _________________ FOR SUPPORTING SIGNATURES SEE SECTION X (ON THE LAST PAGE)  V. REQUIRED INFORMATION: Is this study initiated by:  FORMCHECKBOX  Faculty Investigator  FORMCHECKBOX  Student Investigator  FORMCHECKBOX  Community Based Partnership  FORMCHECKBOX  San Bernardino City Unified School District  FORMCHECKBOX  External sponsor/manufacturer  FORMCHECKBOX  Third part, specify:  FORMTEXT        FORMCHECKBOX  Other, specify:  FORMTEXT       Is this application associated with another IRB-approved study?  FORMCHECKBOX  No  FORMCHECKBOX  Yes: IRB# _________________ C. Will resources (including personnel such as statisticians, students, technicians, clinicians, etc.) from outside the department sponsoring the study be involved in the conduct of this study?  FORMCHECKBOX  No  FORMCHECKBOX  Yes: Letter(s) of agreement must be attached from the appropriate , MC, BMC, or HC department head. D. Is the study being submitted to Public Health Service for sponsorship?  FORMCHECKBOX  No  FORMCHECKBOX  Yes: PHS policy requires assurance that the composition of the proposed study population benefits all persons at risk of the condition under study. The gender and racial/ethnic composition, together with a rationale for inclusion/exclusion, should be described in the funding proposal and in Section VI-C and D which follows. VI. DESCRIPTION OF POPULATION: A. SubjectsNumber to be enrolled in this studyAge RangeNumber of minors FORMTEXT       FORMTEXT      Number of adults FORMTEXT        FORMTEXT      Total Number FORMTEXT      * Subjects participating at other sites, not part of this application. B. Classification of subjects (check all that apply)Vulnerable populations Special populationsOther populations FORMCHECKBOX  Developmentally disabled  FORMCHECKBOX  Diminished decision-making capacity  FORMCHECKBOX  Economically disadvantaged  FORMCHECKBOX  Educationally disadvantaged  FORMCHECKBOX  Foster system  FORMCHECKBOX  Minors/Children (under 18 years of age) Also see HYPERLINK "http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.html"45 CFR 46 Subpart D  FORMCHECKBOX  HYPERLINK "http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.html"Pregnant women  FORMCHECKBOX  HYPERLINK "http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.html"Prisoners  FORMCHECKBOX  School-based population  FORMCHECKBOX  Court-ordered treatment  FORMCHECKBOX  Elderly/aged  FORMCHECKBOX  Illiterate  FORMCHECKBOX  Institutionalized  FORMCHECKBOX  Psychotherapy:  FORMCHECKBOX  BMC or Faculty practice  FORMCHECKBOX  Private  FORMCHECKBOX  Private psychotherapist  FORMCHECKBOX  Self-referral  FORMCHECKBOX  Substance abuse treatment  FORMCHECKBOX  Terminally ill patients  FORMCHECKBOX  Traumatized  FORMCHECKBOX  Victims of abuse  FORMCHECKBOX  Other, specify:  FORMTEXT        FORMCHECKBOX  Employees  FORMCHECKBOX  Female (excludes males)  FORMCHECKBOX  Foreign (non U.S. resident)  FORMCHECKBOX  Foreign (U.S. resident)  FORMCHECKBOX  Healthy (non-patient)  FORMCHECKBOX  Male (excludes females)  FORMCHECKBOX  Minorities  FORMCHECKBOX  Non-English speaking populations  FORMCHECKBOX  Physically handicapped  FORMCHECKBOX  Seventh-day Adventist cohort  FORMCHECKBOX  Students  FORMCHECKBOX  Other, specify:  FORMTEXT       C. Criteria for inclusion of subjects:  FORMTEXT       D. Criteria for exclusion of subjects (other than those opposite the inclusion criteria):  FORMTEXT       Recruitment plan Note: In addition to providing details in the protocol, complete the questions below: 1. Source of subjects: a.  FORMCHECKBOX  PI/collaborators will recruit his/her/their own clients/students/employees. b.  FORMCHECKBOX  PI/collaborators will recruit individuals unknown to them (for example, snowball sampling, social network personal or electronic, direct approach in public situations, random digit dialing). c.  FORMCHECKBOX  Recruitment database (individuals have previously given permission to be contacted for research). d.  FORMCHECKBOX  PI will send an IRB-approved letter to colleagues asking him/her to send out IRB approved general  Dear Friend letters describing the research study. e. Other, specify:  FORMTEXT       2. Will recruitment require use of flyers, posters, hand-outs, or other forms of advertising?  FORMCHECKBOX  No  FORMCHECKBOX  Yes: Attach copy for IRB review/approval. 3. Will recruitment require verbal (including telephone) recruitment?  FORMCHECKBOX  No  FORMCHECKBOX  Yes: Attach script; See  HYPERLINK "http://research.llu.edu/forms/irb%20phone%20script%20elements.doc" Phone Script Elements 4. Will recruitment involve electronic (web or e-mail) recruiting?  FORMCHECKBOX  No  FORMCHECKBOX  Yes, describe:  FORMTEXT        FORMCHECKBOX  Organizational list  FORMCHECKBOX  Other, specify:  FORMTEXT       Describe your plan for obtaining consent:  FORMTEXT       FORMTEXT       Who will conduct consent?  FORMTEXT       FORMTEXT       What location will be used for the subject to sign the consent?  FORMTEXT       Relative to the performance of research interventions, is consent obtained  FORMCHECKBOX  in conjunction with or  FORMCHECKBOX  at a separate appointment from the performance of research interventions?  FORMTEXT       How much time will individuals be given to consider study participation?  FORMTEXT       Which consent documents are required? Check all that apply:  FORMCHECKBOX   HYPERLINK "http://research.llu.edu/HumanStudiesConsentGuidelines.asp" Informed Consent Document(s)  FORMCHECKBOX  HYPERLINK "http://research.llu.edu/SourceDocs/Consent%20Guidelines%20for%20research%20involving%20children%201-29-08.doc"Consent/Permission of Parent/Guardian  FORMCHECKBOX  Assent of Minor (13 17 yrs old; provide signature with parent on Consent Permission Form)  FORMCHECKBOX  Assent of Minor (7 12 yrs old; simplified text)  FORMCHECKBOX  HYPERLINK "http://research.llu.edu/forms/HIPAA%20Authorization%20for%20PHI%20Use%203-15-11.doc"Authorization for Use of Protected Health Information or HYPERLINK "http://research.llu.edu/Forms/%20Model%20Childs%20Authorization%203-15-11.doc"Authorization for Use of Protected Health Information (for children) when using patient information for research, including all patients receiving drug and alcohol treatment If a consent waiver is requested, select one of the following and respond to guidance:  FORMCHECKBOX  Waiver of consent (HYPERLINK "http://research.llu.edu/forms/HIPAA Waiver of ConsentAuth.doc"Waiver request form, Part A)  FORMCHECKBOX  Waiver of written consent (Provide text of verbal consent)  FORMCHECKBOX  Waiver of signed consent (Provide text for Information sheet)  FORMCHECKBOX  Waiver of HIPAA authorization (HYPERLINK "http://research.llu.edu/forms/HIPAA Waiver of ConsentAuth.doc"Waiver request form, Part B) G. Will payments/gifts be offered to the subjects?  FORMCHECKBOX  No  FORMCHECKBOX  Yes:  FORMCHECKBOX  Cash  FORMCHECKBOX  Check  FORMCHECKBOX  Other (for example, gift cards) _____________________ Describe the schedule and amount of payment, including plan for pro-rated payment, if appropriate, and total:  FORMTEXT       VII. SUBJECT-RELATED METHODS AND RISKS: What venue (location) will subject-related procedures take place?  FORMTEXT       B. Check applicable study-related procedures (only items that exceed the standard of care):Usually Minimal Risk Potentially Greater than Minimal Risk* FORMCHECKBOX  Archived data  FORMCHECKBOX  Archival data from psychotherapist s notes  FORMCHECKBOX  Blood drawing  FORMCHECKBOX  Data bank (existing data, not prospective) Date range: From  FORMTEXT       to  FORMTEXT        FORMCHECKBOX  Data collection by non-invasive means (prospective)  FORMCHECKBOX  Diet alteration  FORMCHECKBOX  ECG  FORMCHECKBOX  Focus groups  FORMCHECKBOX  Interviews  FORMCHECKBOX  Materials (data, documents, records, or specimens) to be collected solely for nonresearch purposes  FORMCHECKBOX  Medical records (existing data): Date range: From  FORMTEXT       to  FORMTEXT        FORMCHECKBOX  Observation  FORMCHECKBOX  Physical exercise or activity  FORMCHECKBOX  Physical manipulation  FORMCHECKBOX  Psychological intervention  FORMCHECKBOX  Randomization  FORMCHECKBOX  Specimens - anonymous  FORMCHECKBOX  Specimens discard  FORMCHECKBOX  Specimens prospective collection by non-invasive means  FORMCHECKBOX  Survey/questionnaire (see SBCUSD Request Packets Summary of Study Proposal and Project Activities question b.)  FORMCHECKBOX  Test, pen/pencil/computerized  FORMCHECKBOX  Tissue bank (existing, not prospective)  FORMCHECKBOX  Underwater weighing  FORMCHECKBOX  Urine or fecal sample  FORMCHECKBOX  Voice, video, digital, or image recordings  FORMCHECKBOX  Other (describe):  FORMTEXT       FORMCHECKBOX  Device - approved  FORMCHECKBOX  Device - approved, but non-approved use  FORMCHECKBOX  Placebo(s)  FORMCHECKBOX  Questions relating to disclosure of legal vulnerability (illegal activities such as illicit drug use), sexual activity and preference, and domestic violence and/or questions resulting in risks of psychological, physical, legal, social, and economic harm  FORMCHECKBOX  Mental health  FORMCHECKBOX  Radiation  FORMCHECKBOX  Randomization  FORMCHECKBOX  Substance abuse  FORMCHECKBOX  Treatment (investigational/experimental)  FORMCHECKBOX  Outpatient psychotherapy  FORMCHECKBOX  Other (describe):  FORMTEXT      *Each study greater than minimal risk MUST have a detailed description of the data safety monitoring plan in the protocol. C. Does the protocol involve deception (see Guidance on Research Involving Deception)?  FORMCHECKBOX  No  FORMCHECKBOX  Yes, Describe:  FORMTEXT       Justify:  FORMTEXT       Describe plan for debriefing: FORMTEXT       VIII. RISKS A. List the risks that might result from study-related procedures:  FORMTEXT       Do NOT say  None. State any psychological, physical, social, or legal risks and assess their likelihood and seriousness. Examples: Is there potential for emotional stress, boredom, or fatigue? If there is a potential for subjects to become upset, and thus require psychological or medical attention as a result of the research procedures, then a means of supplying this attention must be addressed. Is there potential for a loss of confidentiality about the information given by the subjects and how serious would loss of confidentiality be for the subject? Consider breach of confidentiality or privacy as a risk for all study participants. Does the research create potential social stigmatization, physical harm to subjects such as potential abuse, legal action by authorities if subject information, responses to survey questions, etc., become known outside of research? Are there potential risks to the subject related to the political, social, or economic context in which they live? When the study participants hold dual status (i.e., in addition to being research subjects, they are patients, employees, students, etc.), clearly identify the risks that would be in addition to those experienced in their pre-existing role. Does the study meet criteria for minimal risk (that the probability and magnitude of harm or discomfort anticipated in the 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)?  FORMCHECKBOX  Yes  FORMCHECKBOX  No, the study presents potentially greater than minimal risk. Consult with Research Protection Programs (909-558-4531) for a determination if Full Board review is required or submit the following form for an official determination:  HYPERLINK "http://researchaffairs.llu.edu/sites/researchaffairs.llu.edu/files/docs/irb-determination-form.doc" Request for IRB Determination of Non-human Research C. State plan for preventing or minimizing these risks (e.g., screening to assure appropriate selection of participants, identify standard of care procedures, sound research design, safety monitoring and reporting). Include provision for psychological or medical attestation, if required as a result of research procedures or means for referral for such services.  FORMTEXT       IX. BENEFIT: State the expected benefits to the subjects. (It is acceptable for subjects not to benefit individually in some studies.)  FORMTEXT       State the expected benefits to humanity.  FORMTEXT       X. CONFIDENTIALITY AND DATA SECURITY: Research data is considered proprietary and confidential. LLU/LLUMC requires that appropriate safeguards be in place for the protection of data. Electronic data -- collection & storage. Will you collect and store research data (either with identifiers or without) electronically?  FORMCHECKBOX  No, Research data will not be collected or stored electronically (i.e., via desktop computer, laptop, PDA, USB flash drive, or other computing device). OR  FORMCHECKBOX  Yes. Research data will be collected and stored electronically. All the following required protections must be in place. Confirm each:  FORMCHECKBOX  Password protection.  FORMCHECKBOX  Data saved only to a secure storage location i.e., a /MC secured server or network. Note: Saving to the c: or local drive is not secure.  FORMCHECKBOX  If a portable device is used (e.g., laptop, PDA), data will be saved only if (1) the device is encrypted, (2) the storage is temporary, and (3) the portable device is in a physically secure location. Note: Leaving a portable device in any unattended vehicle is not secure.  FORMCHECKBOX  Devices and removable media no longer needed used at one point to collect/capture, or store PHI will be forwarded to IS for proper destruction. If unable to secure the data as indicated above, briefly summarize the reason:  FORMTEXT       For guidance on creating a strong password and assistance with secure storage locations and proper encryption methods, contact the IS Help Desk. (x48611), MC (x48889). Electronic data -- transmittal & transport. Will you transmit or transport electronic research data?  FORMCHECKBOX  No. Electronic research data will not be transmitted via Internet, email, or fax system applications, and will not be transported (i.e., the carrying of a USB flashdrive, disk, CD, or removable hard drive that contains research data). OR  FORMCHECKBOX  Yes; Electronic research data will be transmitted and/or transported. Check proposed method and add the corresponding security measure to your IRB protocol:  FORMCHECKBOX  Email. /MC email system will be used only (for on/off site use).**  FORMCHECKBOX  Web interface. Only as required/provided by the research sponsor or a contracted entity, and the research sponsor or contracted entity assumes full responsibility for the security of the data collected and maintained in its systems. Note: A secure web page will have https in the address line.  FORMCHECKBOX  Fax (through system application). The system application must be an IS approved application.  FORMCHECKBOX  Portable device and/or Removable media e.g., laptop, disk, CD, back up device. Data must be encrypted using IS approved methodology. Device or medium must not be unattended during transport and must be maintained in a physically secure area (e.g., locked file, cabinet.)  FORMCHECKBOX  Other, specify:  FORMTEXT       ** Transmittal of unencrypted patient data via email sent outside of LLU/LLUMC s Outlook System is prohibited. Instant Messaging is prohibited under any condition. C. Hardcopy data -- storage. Will you store research data (either with identifiers or without) in hard copy format?  FORMCHECKBOX  No. Research data will not be stored in hard copy format. OR  FORMCHECKBOX  Yes; Research data will be stored in hard copy format. Check all security measures that will be taken and describe the details in your IRB protocol:  FORMCHECKBOX  Locked suite  FORMCHECKBOX  Locked office  FORMCHECKBOX  Locked file cabinet  FORMCHECKBOX  Data coded by PI or research team with a master list secured and kept separately  FORMCHECKBOX  Data de-identified by PI or research team  FORMCHECKBOX  Other, specify:  FORMTEXT        D. Hardcopy data -- transmittal & transport. Will any hard copy research data be transmitted (e.g., via fax) or transported?  FORMCHECKBOX  No. Hard copy research data will not be transmitted or transported. OR  FORMCHECKBOX  Yes; Hard copy research data will be transmitted and/or transported. Check proposed method and describe in your IRB protocol.  FORMCHECKBOX  Fax. Cover sheet with confidentiality statement  FORMCHECKBOX  Courier. Data in sealed envelope marked confidential  FORMCHECKBOX  Hand-delivery. Data in sealed envelope marked confidential  FORMCHECKBOX  U.S. Mail.  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I agree to meet with the student or guest investigator on a regular basis to monitor study progress. Should problems arise during the course of the study, I agree to be available, personally, to supervise the investigator in solving them. D. If I will be unavailable, as when on sabbatical leave or vacation, I will arrange for an alternate faculty sponsor to assume responsibility during my absence, and I will advise the IRB by letter of such arrangements. I certify that the information provided in this application is complete and accurate. Signed: ______________________________________________ ______________________ Principal Investigator Date DECLARATION BY STUDENT INVESTIGATOR(S): I accept my responsibilities in complying with policies and procedures for protection of human subjects in research and supporting the responsibility of my faculty sponsor, described above. Signed: _______________________________________________________________________________________ C. SIGNATURE OF DEPARTMENT CHAIR: This project has been reviewed for scientific merit and has the academic endorsement of the department. 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