ࡱ> ' bjbj !h!h<.'  4h_t~~TTT_______$ac(_-1!2"T1!1!(_U_Y$Y$Y$1!8_Y$1!_Y$Y$W\m!ZY6^k_0_Yd #dl\d\XT|Y$~dOTTT(_(_#TTT_1!1!1!1!dTTTTTTTTT X `: 91Ϣ of Health Sciences Institutional Review Board 16200 E Amber Valley Drive Whittier, CA 90604 Phone: 562 947 8755 Fax: 562 947 5724  Application to the Institutional Review Board (IRB) for Approval of Research Involving Human Subjects Statement of Policy: 91Ϣ of Health Sciences (SCU) has an approved policy for the protection of human subjects from research risk as set forth in Title 45, Part 46, of the Code of Federal Regulations (45 CFR 46). It is the policy of SCU that, except for those categories specifically exempted by 45 CFR 46 (see http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm), all research covered by this assurance will be reviewed and approved by the Institutional Review Board (IRB) established under the policy, regardless of the source of funding of the research. Instructions: Please be certain to provide all requested data. For instance, if a section lists a, b, c, it is expected that each area is included or an answer of NA is provided for that portion of the response. Instructions listed in red font indicate a need for an attachment. Please submit this document, along with the check list and any necessary attachments, electronically. In addition, please mail a signed hardcopy to the address located at the top of this form to the attention of Christine Lemke, Chair, Institutional Review Board. Section 1 Project Identification New application___ Resubmission ___ Table 1 Complete this table for all investigators, please put principal investigator first NameRole in this ProjectAcademic Degree(s)TelephoneAddressEmail AddressCompleted Human Subjects Protection Training (Date) Table 2 Submission DateTitle of Project In the space below, describe the expected duration of project through data analysis: Start Date: _________________ End Date:___________________ Table 3 Other Review Boards Involved (include copies of other IRB approvals/denials as an appendix to this application): InstitutionIRB Contact NamePhone NumberEmail (if applicable) Section 2 Description of the Project List the Hypotheses: Describe the specific aims of this research: Describe the currently available research on this subject (include evidence of a review of the literature as an appendix to this application): Summary of the research protocol/methodology (include the full research protocol as an appendix to this application): State the significance of this research to the health and welfare of the general public: List who outside of the investigators has peer-reviewed this project: State the name and location of the place where the experiment or procedures with human subjects will take place (SCUHS campus, other clinic, off-campus location): Section 3 Description of the Human Subjects of the Research Expected number of individuals to be enrolled: ____________ Provide justification for proposed sample size: Table 4 Target DemographicsDescribeAge Range: Gender: Race/Ethnicity: Health Status: Other: List the inclusion criteria and reasoning for the subjects: List the exclusion criteria and reasoning for the subjects: Are participants belonging to any of the following groups? (check all that apply) ___ Children (under 18 in US) ___ Pregnant women ___ Fetuses or neonates ___ Prisoners or detainees ___ Persons at high risk of becoming detained or imprisoned ___ Low literacy ___ Decisionally impaired ___ Economically disadvantaged ___ Persons with a stigmatized health condition ___ Patients ___ Employees ___ Students ___ Non-English speaker If you checked any of these groups, please provide rationale for their involvement and explain how the rights and privacy of these individuals will be protected in section 5 of this application Description of Informed Consent Procedures. Section 4 Description of the Recruitment Procedures Please explain recruitment procedures in detail (please note: all advertisements must be IRB approved prior to use. Please include a copy of all proposed recruitment materials (brochure, flyer, email, poster etc.) as an appendix to this application. Future and altered recruitment ads can be submitted with a modification request at a later date if needed.): Will the trial be registered with clinicaltrials.gov or any other clinical trial site? Expected dates for recruitment period: Start:_________ End:_________ Expected duration of participation of each subject: Indicate the source of subject recruitment (clinics, hospital, general public, campus): Will the subjects receive payments or other compensation (free clinic visit, course points, tied to course grade, etc) for participating? If yes, indicate amount, method of payment, payment schedule, etc): If a subject leaves the project prior to completion, will proration be made and if so, how? Section 5 Description of Informed Consent Procedures Describe how the consent/assent of the human subjects will be obtained: (include a copy of the written consent documents as an appendix to this application) Describe the circumstances under which consent will be sought and obtained (e.g. during 1st patient visit, in a classroom, etc): Describe the method of documenting consent (who will be obtaining the consent, how will it be recorded and stored, who has access to this documentation, etc): Describe what measures will be taken to ascertain that legally and morally adequate informed consent will be obtained if the subjects come from one of the special circumstances groups described in section 3.4 (e.g. involvement of parents, guardians, or next of kin in the consent process, include a copy of the consent documents specific to the inclusion of these groups as an appendix to this application): Describe the provisions for a subject to decline to participate or to withdraw consent after initiation of project. Is the investigator requesting a waiver of any required element of informed consent? If yes, please specify (you must submit a waiver of informed consent form). Is a HIPAA Waiver of Authorization being requested? If yes, please explain. (you must submit a waiver of informed consent form). Section 6 Method and Materials of the Research on Human Subjects List the treatments, interventions, examinations, and diagnostic testing, that the subjects will undergo (e.g. manipulation, soft tissue treatment, ultrasound, electrical stimulation, acupuncture, imaging, alternate teaching strategy, alternate educational environment, survey, etc) solely for the purposes of this research. For each procedure specify the investigator who will be administering the intervention/treatment the nature of the procedure(s) duration/dosage frequency of the intervention/treatment Table 5 InterventionInvestigatorNature/IngredientsDuration/DosageFrequency Will any treatments, interventions, examinations, and diagnostic testing, that human subjects will undergo as standard or customary be modified for the purposes of this research? If yes, for each procedure specify the nature the extent of the modification (e.g. detuned ultrasound) any resulting increase/decrease in the length or frequency of the procedure any change in the number of clinic visits Nature of InterventionModificationFrequency ChangeDuration ChangeVisit Change Why is this alteration necessary and how does this modification alter the risk of the intervention as compared to the usual and customary application of this intervention? Will subjects have any current medical therapies discontinued or any standard of care withheld or delayed per the study protocol? If so, under what circumstances and what is the safety plan for these subjects? Will the human subjects complete questionnaires? If yes, specify their nature, duration and frequency of their administration. (Include the questionnaire/survey as an appendix to this application.) Will investigational test articles, such as substances (including placebo) or devices, be administered or applied to the human subjects? If yes, for each test article indicate (a) name or code number, (b) type or chemical nature, (c) source, (d) presumed function or mechanism of action, (e) dosage, (f) frequency, (g) route of administration or application, (h) total duration of use and (i) whether the 30-day interval has elapsed or been waived and/or whether its use has been withheld or restricted by the U.S. Food and Drug Administration (FDA). (Please provide any investigational drug/device exemption (IDE) number and append manufacturers information on each test article). Will non-investigational (marketed) test articles as described above be administered or applied to the human subjects for the purposes of this research? If yes, for each test article indicate (a) generic and trade names, (b) source, (c) dosage, (d) frequency, (e) route of administration or application, and (f) total duration of use, and (g) purpose, if it is to be used for a purpose which is not authorized by the FDA. Will radioisotopes be administered to the human subjects? If yes, for each radioactive compound indicate (a) chemical nature, (b) amount of radioactivity to be administered, (c) frequency, (d) route, (e) total duration of administration, (f) person responsible for administration. Will radiographs or other form of ionizing radiation be used? If yes, please indicate (a) type of exposure, (b) which studies will be performed, (c) how frequently the study is to be performed, (d) total dosage to be delivered for the purposes of this research, (e) where the study will be performed, and (f) who will be performing/interpreting the study. Will non-ionizing radiation (MRI, ultrasound, lasers, ultraviolet) be used? If yes, please indicate (a) type of exposure, (b) which studies/treatments will be performed, (c) which part of the body will be exposed, (d) how frequently each will be performed, (e) how long each dose will be (f) total dosage to be delivered for the purposes of this research, (g) where the study will be performed, and (h) who will be performing/interpreting the study. Please also note if the protocol parameters are considered routine for this modality (if not, provide rational for use outside of routine application). Will the human subjects be exposed to external sources of radiation? If yes, indicate (a) type of exposure, and (b) total dosage to be delivered for the purposes of this research. Will blood or other human tissue be taken from the human subjects for purposes of this study? If yes, describe the methods and frequency for collection and use of data derived from the collection. Will deception be used in this study? If yes, describe the proposed method of deception and justify its use. Section 7 Risks and Benefits of the Research Describe the potential physical, psychological, social, legal, or other risks and inconveniences to the human subjects (e.g. injury, discomfort, extensive clinic visits, deprivation of a treatment of established efficacy, risks to confidentiality) of any aspects of this research. Itemize and describe the risks or inconveniences, (b) assess the likelihood or seriousness of the risks, and (c) assess the risks in comparison to any alternative treatments or interventions: Table 6 RiskLikelihoodSeriousnessAlternative TxRisk compared to risk of alternative  For each risk or inconvenience indicated above, (a) specify the measures to be taken to protect the subjects from it, or to minimize its impact or occurrence, (b) assess the likely effectiveness of the protective measures (if women of childbearing age are among the subjects, specify measures to be taken to avoid harm to fertility potential, undetected fetus, or breast-fed newborn/infant). Table 7 RiskMeasures to protect subjectsLikely effectiveness Describe the anticipated physical, psychological, social, legal, or other benefits to the human subjects as it relates to this research. Itemize and describe the likelihood of the benefit. Discuss why the risks to subjects are reasonable in relation to the anticipated benefits to subjects and in relation to the importance of the knowledge that may reasonably be expected to result. Describe the procedures for protecting against or minimizing potential risks, including risks to confidentiality, and assess their likely effectiveness. Describe the procedures for secondary findings. For example, what, if any secondary findings will be reported to the subject and what, if any, follow-up will be provided? Discuss provisions for ensuring necessary medical or professional intervention in the event of adverse effects to the subjects. Describe the structure/plan to report serious adverse events to the SCUHS IRB. Section 8 Data Collection, Storage, Destruction How will data be collected? Please check all that apply: ___ Interviews ___ Questionnaires/surveys ___ Focus groups ___ Public records ___ Medical records ___ Biological specimens ___ Registries ___ Other (describe) Will these data contain any personal identifiers? If data are de-identified, will study personnel have any links/keys to identifiers? Who will de-identify the data? Do they require special permissions to view the data? (please include a copy of any confidentiality agreements that may be appropriate for research personnel) If data are not de-identified, when & how will identifiers be removed from the data? Describe the provisions for monitoring the data collected to ensure the safety of subjects (Data Safety Monitoring Board (DSMB ) or individual): Describe the protocol for subject re-identification if it became necessary. For example, an unexpected diagnosis is discovered in a subject, or an adverse result is discovered during the research necessitating the contact of a subject. Section 9 Costs, Funding, and Conflicts of Interest Declarations Costs: List CostSpecifyAmount per subjectHow covered Funding: Title of Grant or Funding Application: ______________________________________________________ Number of Grant (if applicable): ___________________ Table 8 Source of fundingSpecifyAmount per YearPeriod of supportInternalFederalPrivateFellowshipCorporateOther Will patients or their health insurance carriers incur any expenses in conjunction with this research? If yes, identify each cost item, and for each indicate amounts and whether the written consent form discloses this potential liability, and justify the assignment of the burden: Do any of the investigators have an economic interest in this research external to SCUHS? If yes, please explain. 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