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4.6 IRB Review of Research Involving Subjects with Impaired Decision-Making Capacity
Last Revised: 11/27/2024 For an abbreviated version intended for investigators, coordinators, and study teams - please visit here: Research Involving Decisionally Impaired Persons 1.0 Purpose The purpose of this policy is to describe the Organization’s require...
4.7 Research Involving Employees of the Organization and Students as Subjects
Last Revised: 1/29/2018 For an abbreviated version intended for investigators, coordinators, and study teams - please visit here: Employees as Subjects For an abbreviated version intended for investigators, coordinators, and study teams - please visit here: St...
5.1 Obtaining Informed Consent From Research Subjects
Last Revised: 1/8/2025 For an abbreviated version intended for investigators, coordinators, and study teams - please visit here: Informed Consent 1.0 Purpose The purpose of this policy is to describe the Organization’s requirements for the process and document...
5.2 Waiver or Alteration of Informed Consent and HIPAA Authorization
Last Revised: 2/7/2024 For an abbreviated version intended for investigators, coordinators, and study teams - please visit here: Waiving Consent Process 1.0 Purpose The purpose of this policy is to describe the Organization’s requirements for granting a waiver...
5.3 Use of a Remote Consent Process
Last Revised: 2/9/2024 For an abbreviated version intended for investigators, coordinators, and study teams - please visit here: Remote Consent 1.0 Purpose The purpose of this policy and procedure is to describe the Organization’s requirements for use of remot...
5.4 Waiver of Requirement to Obtain Signed Consent Form
Last Revised: 12/11/2024 For an abbreviated version intended for investigators, coordinators, and study teams - please visit here: Waiving Signed Consent 1.0 Purpose The purpose of this policy is to describe the Organization’s process for waiver of the require...
5.5 Use of the Short Form Consent Document
Last Revised: 11/30/2022 For an abbreviated version intended for investigators, coordinators, and study teams - please visit here: Short Form Consent 1.0 Purpose The purpose of this policy is to describe the Organization’s requirements for use of a short form ...
5.6 Exceptions from Informed Consent Requirements for Emergency Research
Last Revised: 3/5/2018 For an abbreviated version intended for investigators, coordinators, and study teams - please visit here: Emergency Research - Waiving Consent 1.0 Purpose The purpose of this policy and procedure is to describe the Organization’s require...
6.1 Research Involving Investigational and Marketed Drugs
Last Revised: 1/24/2024 For an abbreviated version intended for investigators, coordinators, and study teams - please visit here: Investigational and Marketed Drugs 1.0 Purpose The purpose of this policy and procedure is to describe the Organization’s requirem...
6.2 Research Involving Investigational and Marketed Devices
Last Revised: 1/23/2024 For an abbreviated version intended for investigators, coordinators, and study teams - please visit here: Investigational and Marketed Devices 1.0 Purpose The purpose of this policy and procedure is to describe the Organization’s requir...
6.3 Humanitarian Use Device (HUD)
Last Revised: 5/26/2021 For an abbreviated version intended for investigators, coordinators, and study teams - please visit here: Humanitarian Use Devices (HUD) 1.0 Purpose The purpose of this policy and procedure is to describe the Organization’s requirements...
6.4 Emergency Use of a Test Article
Last Revised: 1/22/2024 For an abbreviated version intended for investigators, coordinators, and study teams - please visit here: Emergency Use of a Test Article 1.0 Purpose The purpose of this policy is to describe the requirements for utilization of a test a...
7.1 Banking Human Biological Material
Last Revised: 10/7/2025 HRPP Policy 7.1 has been merged with HRPP policy 7.2 Please refer to HRPP 7.2 Collection, Storage and Use of Human Biological Material in Research
7.2 Collection, Storage and Use of Human Biological Material in Research
Last Revised: 9/24/2025 For an abbreviated version intended for investigators, coordinators, and study teams - please visit here: Collection, Storage, and Use of HBM in Research 1.0 Purpose The purpose of this policy is to describe the Organizations requiremen...
7.3 Data Registries
Last Revised: 4/16/2025 For an abbreviated version intended for investigators, coordinators, and study teams - please visit here: Data Registries 1.0. Purpose The purpose of this policy is to describe the Organization’s requirements for creation and operation...
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 reporting research related Adverse Events (AEs) and Adverse Device Effects (ADEs) to the ORA and the IRB, and the process for review of AEs and ADEs. 2.0 Policy It i...
8.2 Review of Study Related Complaints
Last Revised: 5/8/2023 1.0 Purpose The purpose of this policy is to describe the process for reporting research related complaints to the ORA and the IRB, and the process for review of complaints. 1.1. For the purposes of this policy “complaints” includes pr...
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 reporting potential unanticipated problems (UPs) involving risk to the ORA and the IRB, and the process for review of potential UPs. 2.0 Policy It is the policy of th...
8.4 Review of Noncompliance by the PI, Study Team, and/or Subjects
Last Revised: 8/6/2025 1.0 Purpose The purpose of this policy is to describe the process for reviewing and reporting incidents of noncompliance by the PI, study team, and/or subjects. Noncompliance by the IRB and/or Other Components of the HRPP is addressed i...
8.5 Noncompliance by the IRB or Other Components of the HRPP
Last Revised: 5/9/2023 1.0 Purpose The purpose of this policy is to describe the process for reviewing and reporting incidents of noncompliance by the IRB and/or other components of the HRPP. 2.0 Policy It is the policy of the Organization that: 2.1. Report...