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8.7 Reporting Incidents to Institutional Officials and Federal Agencies
Last Revised: 8/1/2023 1.0 Purpose The purpose of this policy is to describe the Organization’s r...
8.3 Review of Unanticipated Problems Involving Risk to the Subject or Others
Last Revised: 8/6/2025 1.0 Purpose The purpose of this policy is to describe the process for repo...
8.1 Review of Adverse Events and Adverse Device Effects
Last Revised: 10/2/2024 1.0 Purpose The purpose of this policy is to describe the process for rep...
7.3 Data Registries
Last Revised: 4/16/2025 1.0. Purpose The purpose of this policy is to describe the Organization’...
7.2 Collection, Storage and Use of Human Biological Material in Research
Last Revised: 9/24/2025 1.0 Purpose The purpose of this policy is to describe the Organizations r...
6.3 Humanitarian Use Device (HUD)
Last Revised: 5/26/2021 1.0 Purpose The purpose of this policy and procedure is to describe the O...
6.2 Research Involving Investigational and Marketed Devices
Last Revised: 1/23/2024 1.0 Purpose The purpose of this policy and procedure is to describe the O...
6.1 Research Involving Investigational and Marketed Drugs
Last Revised: 1/24/2024 1.0 Purpose The purpose of this policy and procedure is to describe the O...
5.4 Waiver of Requirement to Obtain Signed Consent Form
Last Revised: 12/11/2024 1.0 Purpose The purpose of this policy is to describe the Organization’s...
5.2 Waiver or Alteration of Informed Consent and HIPAA Authorization
Last Revised: 2/7/2024 1.0 Purpose The purpose of this policy is to describe the Organization’s r...
4.7 Research Involving Employees of the Organization and Students as Subjects
Last Revised: 1/29/2018 1.0 Purpose The purpose of this policy and procedure is to describe the O...
4.6 IRB Review of Research Involving Subjects with Impaired Decision-Making Capacity
Last Revised: 11/27/2024 1.0 Purpose The purpose of this policy is to describe the Organization’s...
4.3 Research Involving Prisoners
Last Revised: 01/17/2024 1.0 Purpose The purpose of this policy and procedure is to describe the ...
4.2 Research Involving Pregnant Women, Human Fetuses, and Neonates (Nonviable or of Uncertain Viability)
Last Revised: 9/25/2024 1.0 Purpose The purpose of this policy is to describe the Organization’s ...
3.12 Ethical Access
Last Revised: 3/5/2025 1.0 Purpose The purpose of this policy is to define ethical access and to ...
3.6 Subject Recruitment Through Direct Invitation
Last Revised: 3/12/2025 1.0 Purpose The purpose of this policy is to describe the Organization’s ...
3.5 Subject Recruitment Through Advertisements
Last Revised 12/11/2024 For an abbreviated version intended for investigators, coordinators, and ...
3.4 Use of Protected Health Information in Research
Last Revised: 4/9/2018 1.0 Purpose The purpose of this policy and procedure is to describe the Or...
3.3 Privacy Interests and Confidentiality of Research Data
Last Revised 1/21/2024 1.0 Purpose The purpose of this policy is to describe the Organization’s r...
2.9 Closure of On-Going Research
Last Revised: 08/10/2023 1.0 Purpose The purpose of this policy is to describe the criteria for, ...