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4.6 IRB Review of Research Involving Subjects with Impaired Decision-Making Capacity
1.0 Purpose The purpose of this policy is to describe the Organization’s requirements for IRB review of research involving subjects who have impaired decision-making capacity. 2.0 Policy It is the policy of the Organization that research involving subjects wh...
4.7 Research Involving Employees of the Organization and Students as Subjects
1.0 Purpose The purpose of this policy and procedure is to describe the Organization’s requirements for IRB review and approval of research involving employees of the Organization, and/or students as subjects. These persons are considered vulnerable because o...
5.1 Obtaining Informed Consent From Research Subjects
Last Revised: 1/8/2025 1.0 Purpose The purpose of this policy is to describe the Organization’s requirements for the process and documentation of informed consent. 2.0 Policy It is the policy of the Organization that: 2.1. The process of informed consent obt...
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 requirements for granting a waiver or alteration of informed consent with or without waiver of HIPAA authorization in research. 2.0 Policy It is the policy of the ...
5.3 Use of a Remote Consent Process
Last Revised: 2/9/2024 1.0 Purpose The purpose of this policy and procedure is to describe the Organization’s requirements for use of remote informed consent process. For the purpose of this policy remote consent includes telephone, video-conferencing, or use ...
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 process for waiver of the requirement to obtain a signed Informed Consent Form (ICF). 2.0 Policy It is the policy of the Organization that: 2.1. A waiver of th...
5.5 Use of the Short Form Consent Document
Last Revised: 11/30/2022 1.0 Purpose The purpose of this policy is to describe the Organization’s requirements for use of a short form written consent document for enrollment in research. 2.0 Policy It is the policy of the Organization that: 2.1. The use of...
5.6 Exceptions from Informed Consent Requirements for Emergency Research
Last Revised: 3/5/2018 1.0 Purpose The purpose of this policy and procedure is to describe the Organization’s requirements for IRB review and approval of an exception from informed consent requirements for emergency research. 2.0 Policy 2.1. It is the polic...
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 Organization’s requirements for research involving investigational and marketed drugs. 2.0 Policy 2.1. It is the policy of the Organization that the IRB will revi...
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 Organization’s requirements for research involving investigational and marketed devices. 2.0 Policy 2.1. It is the policy of the Organization that the IRB will re...
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 Organization’s requirements for the use of a medical device that has a Humanitarian Use Device (HUD) designation. 2.0 Policy It is the policy of the Organization t...
6.4 Emergency Use of a Test Article
Last Revised: 1/22/2024 1.0 Purpose The purpose of this policy is to describe the requirements for utilization of a test article under emergency circumstances where there is not sufficient time to obtain IRB approval at a convened meeting. 2.0 Policy It is th...
7.1 Banking Human Biological Material
Last Revised: 1/25/2018 1.0 Purpose The purpose of this policy and procedure is to describe the Organization’s requirements for banking human biological material (HBM) for future research. Subsequent use of stored HBM in research is addressed in HRPP policy 7...
7.2 Use of Human Biological Material in Research
Last Revised: 1/25/2018 1.0 Purpose The purpose of this policy and procedure is to describe the Organizations requirements for the use of human biological material (HBM) in research. 2.0 Policy It is the policy of the Organization that HBM be used in research...
7.3 Data Registries
Last Revised: 3/2/2018 1.0 Purpose The purpose of this policy and procedure is to describe the Organization’s requirements for creation and operation of a data registry, and for research use of data from a registry. 2.0 Policy 2.1. It is the policy of the O...
8.1 Review of Adverse Events and Adverse Device Effects
Last Revised: 5/4/2023 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 is...
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: 5/8/2023 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 Involving the PI or Study Personnel
Last Revised: 3/6/2024 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...