ࡱ> W bbjbjll ee6+  KKKKK___8,4_*444*******$u,+/R8*K4"4448*KKM*ZZZ4LKK*Z4*ZZJ(h)1Xy()c*0*(}/X}/ )}/K)x44Z444448*8*Z444*4444}/444444444 :  Protocol #: ______________ (ACHS Use only)  SEQ CHAPTER \h \r 1Change in Protocol Review Form Primary Investigator(s), Department, Email: Researcher's Status (Check One): Undergraduate Student Graduate Student Faculty Other (Explain): Research assistants (anyone other than PI or Faculty Advisor who will have contact with participants) Faculty Advisor (if PI is a student) Department, Email: Title of Project: Desired Start Date: Length of Project: Will this research be submitted to an external agency for funding? If yes, please name agency: ____________________________________________ Does this project make use of any of the following special types of subjects and/or locations? Please mark an X on the appropriate line: Research with Children Research with Prisoners Research with Pregnant Women and Fetuses in Utero Research in Public Elementary and Secondary Schools International Research Research in VA Hospitals Research Conducted with Clinical Populations in which HIPPA Applies (e.g. Medical, Psychiatrist) Internet Research Drug Research in Human Population (FDA Regulated) INSTRUCTIONS FOR COMPLETING APPLICATION FOR REVISIONS Was the protocol approved by: ______ Խ Universitys Animal Care and Human Subjects? ______ An IRB/Human Subjects Review Board external to Խ. If approved by an outside Human Subjects Review Board please provide supporting documentation Prepare and submit to achs@muskingum.edu: Revisions, changes, additions, modifications Attachments, as necessary 1. ______Yes ______No. Have there been any changes in your subject population (numbers, geographic location, age range, gender, race, etc.,) or method of recruitment? If yes, provide complete information on changes; including copies of flyers, verbal scripts, etc. 2. ______Yes ______No. Have the procedures, policies and/or subject population changed in any way from the protocol which was last approved by the Committee? If yes, provide complete information on all changes (If you are ONLY adding project personnel please send an email to achs@muskingum.edu with the name/s being added the approved IRB number, Principal Investigator, and the title of the approved project.) 3. ______Yes ______No. Have you made any changes in project personnel including research assistants who are interacting with subjects? If yes, provide names of new project personnel (please not it is up to the researcher supervising new personnel to provide education about confidentiality and ethical research. 4. ______Yes ______No Were any complications, adverse reactions, or unexpected results encountered as a result of human subjects participating in these studies? If yes, please explain the circumstances and how the situation was handled. INVESTIGATORS ASSURANCE STATEMENT I have read Խ University's policy concerning research involving human subjects and I agree to: 1. Accept responsibility for the ethical conduct of this research study, 2. Obtain approval from the Animal Care and Human Subjects (ACHS) Committee prior to changing any procedures, 3. Report to any complications, adverse reactions or unexpected effects on subjects to the ACHS committee and/or Vice President for Academic Affairs as appropriate, 4. Submit an Application for Approval of Continuing Projects within one year, or sooner as specified in the approval letter, describing the current status of the project. PrincipalInvestigator(s): Date Date Date Faculty Review of Student Projects: I have reviewed and approved the procedures to be used in the project described in this application. 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