WAIVER OF INFORMED CONSENT REQUIREMENTS IRB Number: Project Title: Principal Investigator: Please the applicable category of waiver(s) requested: Waiver of Informed Consent (waiver of the entire process of informed consent) -complete Section 1. Waiver of Required Elements of Informed Consent - complete Section 1 & 2. Waiver of Documentation of Informed Consent (waiver of signatures) -complete Section 3. Section 1: If there is more than one study population (or groups/study arms) in the study, please describe the population(s) (or groups/study arms) for which this wavier pertains: N/A applies to all research participants. – Describe why the research cannot practicably be carried out without the waiver: Please check either box 1 or box 2 below: (1) The following criteria are met: The research involves no more than minimal risk to the research participants; The research could not practicably be carried out without the requested waiver or alteration; If the research is federally supported or conducted and involves the use of identifiable private information or identifiable biospecimens, the research could not practicably be carried out without using such information or biospecimens in an identifiable format; The waiver or alteration will not adversely affect the rights and welfare of the participants; Whenever appropriate, the research participants or LARs will be provided with additional pertinent information participation (e.g., debriefing research participants involved in deception research). If box (1) is checked, when applicable, describe how the research participants will be provided with additional pertinent information participation: N/A (2) The research cannot practicably be carried out without the waiver or alteration and 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: public benefit or service programs; procedures for obtaining benefits or services under those programs; possible changes in or alternatives to those programs or procedures; or possible changes in methods or levels of payment for benefits or services under those programs Section 2: If there is more than one study population (or groups/study arms) in the study, please describe the population(s) (or groups/study arms) for which this wavier pertains: N/A applies to all research participants. –
WAIVER OF INFORMED CONSENT REQUIREMENTS IRB Number: Project Title: Principal Investigator: Please the applicable category of waiver(s) requested: Waiver of Informed Consent (waiver of the entire process of informed consent) -complete Section 1. Waiver of Required Elements of Informed Consent - complete Section 1 & 2. Waiver of Documentation of Informed Consent (waiver of signatures) -complete Section 3. Section 1: If there is more than one study population (or groups/study arms) in the study, please describe the population(s) (or groups/study arms) for which this wavier pertains: N/A – applies to all research participants. Describe why the research cannot practicably be carried out without the waiver: Please check either box 1 or box 2 below: (1) The following criteria are met: The research involves no more than minimal risk to the research participants; The research could not practicably be carried out without the requested waiver or alteration; If the research is federally supported or conducted and involves the use of identifiable private information or identifiable biospecimens, the research could not practicably be carried out without using such information or biospecimens in an identifiable format; The waiver or alteration will not adversely affect the rights and welfare of the participants; Whenever appropriate, the research participants or LARs will be provided with additional pertinent information participation (e.g., debriefing research participants involved in deception research). If box (1) is checked, when applicable, describe how the research participants will be provided with additional pertinent information participation: N/A (2) The research cannot practicably be carried out without the waiver or alteration and 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: public benefit or service programs; procedures for obtaining benefits or services under those programs; possible changes in or alternatives to those programs or procedures; or possible changes in methods or levels of payment for benefits or services under those programs Section 2: If there is more than one study population (or groups/study arms) in the study, please describe the population(s) (or groups/study arms) for which this wavier pertains: N/A – applies to all research participants.
ApplicationforWaiverofInformedConsentRequirements12.22.2017.docx