ࡱ> / O!bjbjNN ,bh,bh+# $$tttL z/:" .......$184/t(G@((/$$-4/" " " (.$8t." (." " -|\.bV^..J/0z/'.Z4:4$.4t.dA^" L=//4z/((((4 X : 91Ϣ of Health Sciences Institutional Review Board 16200 E Amber Valley Drive Whittier, CA 90604 Phone: 562 947 8755 Fax: 562 947 5724 Request for Waiver of Consent There are several situations in which an IRB may waive parts or the entire informed consent requirement for a study. Please indicate which exception area this study qualifies for and provide support documentation for the IRB to utilize when it deliberates your request. Categories of Waiver According to  HYPERLINK "http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm" \l "46.116" \t "_blank" 45 CFR 46.116(c), the IRB may approve a consent procedure which does not include, or which alters, some or all of the elements of informed consent, or waives the requirement to obtain consent, provided the IRB finds and documents that: The research or demonstration project is to be conducted by, or subject to, the approval of state or local government officials and is designed to study, evaluate, or otherwise examine: (i) public benefit or service programs; (ii) procedures for obtaining benefits or services under those programs; (iii) possible changes in or alternatives to those programs or procedures; or (iv) possible changes in methods or levels of payment for benefits or services under those programs; and The research could not practically be carried out without the waiver or alteration; and The research is not FDA-regulated. Additionally,  HYPERLINK "http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm" \l "46.116" \t "_blank"  46.116(d) states that an IRB may approve a consent procedure which does not include, or which alters, some or all of the elements of informed consent or waive the requirement to obtain consent all together, provided the IRB finds and documents that: The research involves no more than minimal risk to the participants; The waiver or alteration will not adversely affect the rights and welfare of the participants; The research could not practicably be carried out without the waiver or alteration; and Whenever appropriate, the participants will be provided with additional pertinent information after participation; and The research is not FDA-regulated. According to  HYPERLINK "http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm" \l "46.117" \t "_blank"  46.117(c) an IRB may waive the requirement for the Investigator to obtain a signed consent form for some or all participants if it finds either: That the only record linking the participant and the research would be the consent document and the principal risk would be potential harm resulting from a breach of confidentiality; and the research is not FDA-regulated. In each circumstance, the participant should be asked whether they want documentation linking them with the research, and their wishes will govern; or That the research presents no more than minimal risk of harm to participants and involves no procedures for which written consent is normally required outside of the research context. In cases in which the documentation requirement is waived, the IRB will consider in each case whether to require the investigator to provide participants with a written statement regarding the research. Please note that consent requirements are different in research involving children. Section 1 Project Identification Table 1 Complete this table for the PI NameTitle & DepartmentAcademic Degree(s)TelephoneAddressEmail Address Table 2 Submission DateTitle of Project In the space below, describe the expected duration of project through data analysis: Start Date: _________________ End Date:___________________ 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)Section 2 Waiver Request Description Please select the waiver type you are requesting. Request for:SelectA. Full waiver of patient informed consentB. Partial waiver or Alteration of patient informed consent: Verbal only, no signed consentC. Partial waiver or Alteration of patient informed consent: Other, please describe in box below:  Please provide a response to the two questions in the box provided. QuestionResponseDescribe why the study is of minimal risk:Describe why the study cannot be practicably conducted without this waiver or alteration of this waiver: Please complete the Yes/No columns for each set. Waiver set 1YesNoThe research or demonstration project is to be conducted by, or subject to, the approval of state or local government officials and is designed to study, evaluate, or otherwise examine: (i) public benefit or service programs; (ii) procedures for obtaining benefits or services under those programs; (iii) possible changes in or alternatives to those programs or procedures; or (iv) possible changes in methods or levels of payment for benefits or services under those programsThe research could not practically be carried out without the waiver or alterationThe research is not FDA-regulated. Waiver set 2YesNoThe research involves no more than minimal risk to the participantsThe waiver or alteration will not adversely affect the rights and welfare of the participants;The research could not practicably be carried out without the waiver or alterationWhenever appropriate, the participants will be provided with additional pertinent information after participationThe research is not FDA-regulated Waiver set 3YesNoThe only record linking the participant and the research would be the consent document and the principal risk would be potential harm resulting from a breach of confidentiality; and the research is not FDA-regulated. In each circumstance, the participant should be asked whether they want documentation linking them with the research, and their wishes will govern;The research presents no more than minimal risk of harm to participants and involves no procedures for which written consent is normally required outside of the research context. BOX FOR COMMITTEE USE ONLY! 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