ࡱ> DFCU@ bjbj )2" P 84P G- 6 6 6 6 6 6 w&y&y&y&/&),$_.R0, $6 6 $ $, 6 6 -%%% $ 6 6 w&% $w&%%7& 7&6  P `e'$7&c&-0G-7&s1$s17& T 6 s1 7&,6 T!% ""G6 6 6 ,,P P D%P P NICHOLLS STATE UNIVERSITY HUMAN SUBJECTS INSTITUTIONAL REVIEW BOARD REQUEST FOR NON-EXEMPT REVIEW BY HUMAN SUBJECTS INSTITUTIONAL REVIEW BOARD Ӱɴý has established standards and guidelines to insure adequate protection is provided to individuals participating in a research activity. The Human Subjects Institutional Review Board (HSIRB) is charged with the responsibility of screening all research which employs human participants conducted by faculty, administrators, or students affiliated with Ӱɴý. The guidelines employed for screening are those set forth by university policy. Please fill in all requested information and return two copies of this form and any supporting documentation to the HSIRB chair or your college HSIRB representative. Procedure: 1. The primary investigator (Referred to as the "applicant") planning a research activity involving human subjects, should obtain a Request for HSIRB application form from the college HSIRB representative or HSIRB Chairperson. Research originating from other institutions should be approved by the host institution prior to applying for approval at Ӱɴý. 2. The Applicant should submit two copies of the completed forms to the college HSIRB representative. An initial review of the application will be made by the college HSIRB representative to determine if the project is considered Category I, EXEMPT, Category II, EXPEDITED REVIEW, or Category III, FULL COMMITTEE REVIEW. If the determination of the college HSIRB representative is that the application warrants an EXEMPT or EXPEDITED REVIEW determination, the Applicant may begin the research project. If the College HSIRB representative determines that the proposed research requires a FULL COMMITTEE REVIEW, the Applicant will be requested to submit ten copies of the application to the HSIRB Chairperson. The college HSIRB representative may not disapprove an application. Disapproval of proposed research involving human subjects may only be determined by the full HSIRB. 3. Applications may be submitted to the college HSIRB representative at any time, however, applications which will require a review by the full HSIRB must be submitted to the Chairperson of the HSIRB by the 20th of each month. 4. In cases where a full review of the application is required, the Applicant may be asked to discuss the proposed research at the meeting of the HSIRB. NICHOLLS STATE UNIVERSITY HUMAN SUBJECTS INSTITUTIONAL REVIEW BOARD REQUEST FOR REVIEW BY HUMAN SUBJECTS INSTITUTIONAL REVIEW BOARD Title of investigation: ____________________________________________________________ Name of primary investigator: _________________________________ Phone: ___________ Faculty supervisor (if required): ___________________________________________________ Address where HSIRB action letter is to be sent: ______________________________________ ______________________________________________________________________________ Other investigators involved in the project: ________________________ Phone: __________ _________________________ Phone: __________ _________________________ Phone: __________ Estimated starting date: _______________ Estimated completion date: _____________ Date Submitted to the NSU HSIRB: ______________ Source of project funds: __________________________________________________________ ______________________________________________________________________________ Is this project a continuation of research previously approved by the HSIRB? z Yes z No If yes, please indicate the HSIRB identification number: _______________ author, and title of the previously approved study: __________________________________________________ (Attach additional pages as necessary) 1. Brief Description of Project Goals: (Attach proposal if applicable) 2. Protocol: - Describe the proposed procedures. Provide name and description of data gathering tools (if not well known, attach examples of data gathering tools, questionnaires, etc.). Describe characteristics of proposed subjects (e.g., age range, gender, number of subjects, any other relevant subject descriptors). Describe how and where subjects will be recruited. Describe activities in which subjects will engage. Describe how long procedures will take. If other institutions are involved, describe procedures used to obtain permission(s). Indicate the nature of incentives, compensation, and/or follow-up techniques which will be used. If data collection is done in class, explain what students who do not participate will be doing. Detail any use of deception or conditions in which full disclosure of the purpose of the study will not be made available to subjects. Describe planned subject debriefing procedures. Describe how subjects may be informed of the results of the study. Note: If potential subjects are minors, detail procedures used to obtain informed parental consent and assent of minor subjects. 3. Risks: - Describe potential or known risks to subjects and precautions that will be taken to minimize them. These includes physical, psychological, and/or sociological risks. Describe how confidentiality will be maintained. Discuss the final disposition of data (what will be done with questionnaires, inventories, videotapes, and/or audio-tapes. Describe provisions to ensure that appropriate facilities and professional attention for health and safety of participants are available and will be utilized. 4. Benefits: Describe potential benefits of the research to the individual and/or mankind. 5. Consent Forms: Please attach a copy of the Regular Form or the Short Form and/or Oral Presentation as supporting documentation to this HSIRB request for review. 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