ࡱ> 5 \bjbjl2l2 XhXh# lll8<K$3 Sg #######$;&(d#9l@3#-$###j8l#####T# dVH ##$0K$#U)!xU)#U)l#s=#tAsss##x"sssK$U)sssssssss X :  91Ϣ of Health Sciences Institutional Review Board 16200 E Amber Valley Drive Whittier, CA 90604 Phone: 562 947 8755 Fax: 562 947 5724 Modification Form Modifications may not be implemented until you have received approval. The approval of this modification does not change the original period of approval of your Human Subjects Review Committee application. If an adverse event occurs at a site covered in your approval for this study, submit an Adverse or Unanticipated Event Form. This form is available through the IRB chair. Section 1 Project Identification Table 1 Primary InvestigatorTitle & DepartmentAcademic Degree(s)TelephoneAddressEmail Address Table 2 Submission DateTitle of Project 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) __ 1. ADDING A NEW FUNDING SOURCE. Complete the information in the box below. Briefly summarize the procedures involving Human Subjects in this new funding proposal and describe any differences between the approved application and the new proposal. If there are multiple aims in this grant, please specify which aim(s) pertain to this specific Human Subjects Application, and flag or indicate the page. If this grant will modify the population, purpose or procedures, outline these changes under the appropriate heading below. (please include a copy of the funding proposal) Funding Type: __ Research Grant __ Fellowship __ Training Grant __ Contract __ Other, specify: Principal Investigator (on grant proposal): Proposal Title: Funding Agency: Agency Number (if known): Status: __New __Competing Renewal __Non-competing Renewal Start Date: End Date: __ 2. CHANGE IN STUDY PURPOSE: Describe the change/revision to the purpose of the study, and explain the reason for this change. __ 3. CHANGE IN PROCEDURES/PROTOCOLS: Briefly summarize proposed changes below. Explain why the changes are being made. Describe any changes in risks, and an assessment of whether or not any changes should be made to the consent form(s). If you believe no changes are necessary, please state. __ 4. CHANGE IN POPULATION and/or RECRUITMENT: Briefly describe proposed changes in subject population or recruitment, including the reasons for this change. Include the following for each new population, if relevant: inclusion criteria, exclusion criteria, age range, number of subjects (cases and controls), approach and recruitment methods. __ 5. SITE: Briefly describe the added/dropped site location change and submit copies of site agreement contracts related to the change. __ 6. REVISIONS TO CONSENT DOCUMENTS: Attach a copy of each revised consent/assent form or oral consent script, incorporating changes in purpose, procedures, population, investigators and risks as described elsewhere on this form. Please highlight the changes in the submitted copy. State the total number of approved consent forms in current use for this study. State if this consent form replaces a current version (and specify the approval date), or is an additional consent form. __ 7. CHANGE IN INVESTIGATORS: Provide information requested below for each new investigator; also indicate if an investigator is no longer associated with this research. If the Principal Investigator is appointing a new PI, both the current PI and new PI should sign this form. Investigator NameRole: Primary, Secondary, Clinician, Analyst, etcAdding or removingTitle & DepartmentAcademic Degree(s)TelephoneAddressEmail Address __ 8. OFF SITE ADVERSE EVENTS and SAFETY REPORTS: If an event occurs at a site covered in your approval for this study that is unexpected or more severe than anticipated, submit the SCU Adverse or Unanticipated Event Form available from the IRB chair. If an adverse event occurs that is anticipated or no more severe than expected, it must be reported on the Status Report at annual renewal or when closing the study. Otherwise, state how many events are being reported here, list the dates of occurrence and provide a brief description of each event. Also, inform us whether these adverse events are new or follow-ups of events that were already reported to us, then include the date the event was originally reported. Assess whether or not changes are required to the consent form. If you believe no changes are required, please state. Also state whether enrollment is still open for this study and whether subjects are still undergoing study procedures. __ 9. PROTOCOL AMENDMENTS: Describe what changes are being made if not described above, and assess any changes in risks to subjects. If you believe there are no changes in risks, please state. __ 10. CONFLICT OF INTEREST: If there has been a change in the financial interest for any members of the research team, provide a description of the potential conflict to include the amount of economic interest, investigators role in the study, and the mechanisms in place to manage the conflict. __11. Extension of Study DateS: Please list which phase (recruitment, data collection, data analysis, etc) of the study and include both the dates from the original request and the new, proposed, dates. __ 12. 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