ĐĎॹá>ţ˙ ˜šţ˙˙˙–—˙˙˙˙˙˙˙˙˙˙˙˙˙˙˙˙˙˙˙˙˙˙˙˙˙˙˙˙˙˙˙˙˙˙˙˙˙˙˙˙˙˙˙˙˙˙˙˙˙˙˙˙˙˙˙˙˙˙˙˙˙˙˙˙˙˙˙˙˙˙˙˙˙˙˙˙˙˙˙˙˙˙˙˙˙˙˙˙˙˙˙˙˙˙˙˙˙˙˙˙˙˙˙˙˙˙˙˙˙˙˙˙˙˙˙˙˙˙˙˙˙˙˙˙˙˙˙˙˙˙˙˙˙˙˙˙˙˙˙˙˙˙˙˙˙˙˙˙˙˙˙˙˙˙˙˙˙˙˙˙˙˙˙˙˙˙˙˙˙˙˙˙˙˙˙˙˙˙˙˙˙˙˙˙˙˙˙˙˙˙˙˙˙˙˙˙˙˙˙˙˙˙˙˙˙˙˙˙˙˙˙˙˙˙˙˙˙˙˙˙˙˙˙˙˙˙˙˙˙˙˙˙˙˙˙˙˙˙˙˙˙˙˙˙˙˙˙˙˙˙˙˙˙˙˙˙˙˙˙˙˙˙˙˙˙˙˙˙˙˙˙˙˙˙˙˙˙˙˙˙˙˙˙˙˙˙˙˙˙˙˙˙˙˙˙˙˙˙˙˙˙˙˙˙˙˙˙˙˙˙˙˙˙˙˙˙˙˙˙˙˙˙˙˙˙˙˙˙˙˙˙˙˙˙˙˙˙˙˙˙˙˙˙˙˙˙˙˙˙˙˙˙˙˙˙˙˙˙˙˙˙˙˙˙˙˙˙˙˙˙˙˙˙˙˙˙˙˙˙˙˙˙˙˙˙˙˙˙˙˙˙˙˙˙˙˙˙˙˙˙˙˙˙˙˙˙˙˙˙˙˙˙˙˙˙˙˙˙˙˙˙˙˙˙˙˙˙˙ěĽÁ3 ůż$bjbjÔÔ jLśbśb](˙˙˙˙˙˙lÖÖÖÖÖÖÖ:vvv8Ž<ęT:ž¨2Jlś"ŘŘŘłśi\Ĺ0a§c§c§c§c§c§c§$𩠬P‡§ŐÖőłłőő‡§UÖÖŘŘŰ\¨&UUUő6ÖŘÖŘa§Uőa§U(U}>–™ťÖÖýŚŘ> ŔÄđ‡ŢŒÇ:<v+*QžxýŚd‚¨<ž¨Éž4`ŹU`ŹýŚUę."ÖÖÖÖŮProtocol A complete protocol of the proposed research project that addresses all the elements listed below must be submitted. A checklist is provided at the end of this section to assure all documents are included for review. All documents must be received before the IRB will begin review of application. INTRODUCTION Describe the BACKGROUND RATIONALE for the study. Include the PUBLIC HEALTH BENEFITS to society.  FORMTEXT       List the SPECIFIC AIMS AND HYPOTHESES of the study (research questions).  FORMTEXT       METHOD Describe the EXPECTED GROUP (S) (control, experimental, geographic areas, or time periods, etc.) that will comprise the study populations. Include the number of subjects and/or records to be studied in each group. Describe the method of ASSIGNMENT to each group (randomization technique, sequential assignment, etc.)  FORMTEXT       Outline the INCLUSION and EXCLUSION CRITERIA for group membership. Justify the inclusion of records for any special groups, e.g., minors, pregnant women, etc. Justify exclusion criteria, where appropriate (e.g. women of child-bearing age).  FORMTEXT       Explain how SUBJECT RECRUITMENT is to be carried out. Provide copies of media ads, posters, announcements and clinic or hospital recruitment procedures, referrals, etc. If subject recruitment incentives are to be offered or payment to subjects is to be made, describe and justify.  FORMTEXT       Describe in detail the ROLE OF SUBJECTS in the investigation (questionnaires, observations, interviews, the use of body fluids, follow-up visits/tests, etc.)  FORMTEXT       Describe the TIME FRAMES for the phases of the study, e.g. number of months for recruitment, data collection, analysis etc.  FORMTEXT       Describe the PARAMETERS/VARIABLES TO BE MEASURED. Include how and when these measurements will be made. Attach copies of research instruments, (e.g. questionnaires) and include information supporting the validity and reliability of the instruments. If requesting data from DHSS, list name of file and the data items to be used.  FORMTEXT       Describe how DATA ANALYSIS will be performed (statistical tests, method for evaluating data) and indicate the smallest group/unit for which separate reporting will occur.  FORMTEXT       RISK/BENEFIT ASSESSMENT 10. Describe any foreseeable RISKS TO THE SUBJECTS that could arise from being in the study, particularly any risks from loss of confidentiality or anonymity. Include an assessment of each risk and indicate the steps to be taken to minimize each risk.  FORMTEXT       11. Describe the POSSIBLE BENEFITS TO SUBJECTS and POSSIBLE BENEFITS TO SOCIETY beyond those listed in response to item 1.  FORMTEXT       12. Describe any accepted ALTERNATIVE PROCEDURES/THERAPIES that are available to the participants in this research project, including the alternative of nonparticipation. If this is clinical research, include the alternative of standard therapy and describe.  FORMTEXT       13. Describe how ANONYMITY OR CONFIDENTIALITY will be maintained. Indicate measures employed to protect identity of the participants (collection of unidentifiable data or use of code numbers, master code sheet, etc.), how data will be secured and who will have access to the data (such as FDA, {named} drug company, co-investigators).  FORMTEXT       SUBJECT CONSENT 14. Explain how INFORMED CONSENT will be obtained, i.e. who will discuss risks, benefits and alternatives with the subjects and when and where the discussion will occur.  FORMTEXT       NOTE: A copy of the CONSENT FORM must be sent with this application. Consent forms should include enough information in everyday language about the purpose and procedures so that the subject will adequately comprehend of the hazards and benefits of being in the study. The statements of rights and alternatives assure the voluntariness of consent and participation. See “Informed Consent Guidelines” for more detail. 15. If there will be no consent form, or if not all elements of informed consent are to be addressed, explain/justify in detail, addressing the requirements of 45 CFR 46.116-117.  FORMTEXT       BIBLIOGRAPHY List the references that form the background/basis for the research project. 1.  FORMTEXT      2.  FORMTEXT      3.  FORMTEXT      4.  FORMTEXT      5.  FORMTEXT       PAGE  PAGE 1 Revised 04/07  346CQe‚˜ĽŚ°ą  "\˘¤¸şźĆČĘÜřźŇ\ ^ r t v € ‚ „ ž ŕ řóęčęÜęÜęÍñ͝ÍĂę“ęÍÁ͝Íę“ę“ęÍĂm͝ÍĂę“"jđ>*CJOJQJU^J>*"jx>*CJOJQJU^J5CJOJQJ^J'j>*CJOJQJU^JmHnHu"j>*CJOJQJU^J>*CJOJQJ^Jj>*CJOJQJU^J5CJOJQJ\^J>*CJOJQJ^JCJ^J5CJ\^J* 456CDĽ÷ĐĆĆÁ´h]V Ć°Ě Ć°Ě„Đ^„ĐL & F8 ưĚEƀĚ´f. $ ĆĐě°Ěa$$a$ ĆĐě°Ě&$$d%d&d'dNĆ˙OĆ˙PĆ˙QĆ˙a$ Ćő dđ ź#$ýý˘ĘĚÎÜŢł¨™™Ž|$ ư̄Є0ý^„Đ`„0ýa$  Ć ő °Ědđ ư̄v„Šţ^„v`„Šţ ư̄Đ^„ĐL & F8 ưĚEƀĚ´f.Ţ\ „ † f Ž  ł¨ĄU¨ĄL & F8 ưĚEƀĚ´f. 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