ࡱ> Y vbjbj[[ l9 \9 \ hJPP8p|{Z\!!!YYYYYYY$\_ Z! @!!! ZPP5Z!#!#!#!P8Y!#!Y!#!#NdOSFv!j Q0YKZ0{Z : Office use only: Office Use ONLY Protocol #: _____________ Date: _______ Appendix B IRB Request for Research Involving Minors (Children) MINORS: In Washington State, minor (child) refers to non-emancipated persons under the legal age of 18. Minors are a special group of research participants, classified as a vulnerable population and protected under the Common Rule 45 CFR 46 Subpart D and 21 CFR 50 Subpart D. Read the  HYPERLINK "/irb/policies-and-procedures/policies-for-protocol-submissions/research-involving-minors/" SU IRB Policy on Research Involving Minors prior to completing this appendix. Email this typed form with your initial protocol application as a separate file titled: LASTNAME.Appendix B.Minors.DATE to  HYPERLINK "mailto:irb@seattleu.edu" irb@seattleu.edu. Be sure to include appropriate Assent and Parental Permission forms and/or  HYPERLINK "/irb/protocol-forms/" Appendix A -- Waiver or Alteration of Consent Process request form, if applicable. [Include with application as separate files with corresponding titles.] Section 1: Information Principal Investigator (Last name, First)Project TitleIRB Protocol # Section 2: Population Ages of minors in research (check all that apply): FORMCHECKBOX  4 years and under  FORMCHECKBOX  5 to 8 years FORMCHECKBOX  9 to 12 years  FORMCHECKBOX  13 to 17 yearsIf procedures vary for different age groups, explain below. If the risk/benefit ratio is not the same for all minor participants, explain why. Identify the category of research involving minors: (For more information, see  HYPERLINK "http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.html" \l "subpartd" OHRP Guidance on Children in Research Subpart D)  FORMCHECKBOX  a) No greater than minimal risk (46.404)  FORMCHECKBOX  b) Greater than minimal risk with prospect of direct benefits (46.405)  FORMCHECKBOX  c) Greater than minimal risk with no direct benefits but yielding generalizable research (46.406)  FORMCHECKBOX  d) Research not otherwise approvable which presents an opportunity to understand, prevent, or alleviate a serious problem affecting the health or welfare of children. (46.407) If the research falls into Question 4 category c) or d) above, explain below whether any of the children are considered wards of the state. Section 3: Parental Permission If you are requesting a waiver of two-parent permission, where only one parent provides permission to participate in the research study, select the applicable conditions: FORMCHECKBOX  The research falls into Question 4 categories a) or b) above, AND/OR The waiver is requested only for those minors:  FORMCHECKBOX  for whom one parent is deceased, unknown, incompetent, or not reasonably available, OR  FORMCHECKBOX  who have a guardian or belong to a single-parent family, where only one person has legal responsibility for the care and custody of the child.If you requesting a waiver of both parents permission, where neither parent provides permission for the minor to participate in the study, you must complete and submit Appendix A: Waiver or Alteration of Informed Consent Process.     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