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5.3 Use of a Remote Consent Process

1.0 Purpose The purpose of this policy and procedure is to describe the Organization’s requireme...

5.2 Waiver or Alteration of Informed Consent and HIPAA Authorization

1.0 Purpose The purpose of this policy and procedure is to describe the Organization’s requireme...

6.5 Expanded Access to Investigational Drugs and Devices for Treatment Use

1.0 Purpose 1.1. The purpose of this policy and procedure is to describe the requirements for ut...

6.3 Humanitarian Use Device (HUD)

1.0 Purpose The purpose of this policy and procedure is to describe the Organization’s requireme...

6.1 Research Involving Investigational and Marketed Drugs

1.0 Purpose The purpose of this policy and procedure is to describe the Organization’s requireme...

7.3 Data Registries

1.0 Purpose The purpose of this policy and procedure is to describe the Organization’s requireme...

7.2 Use of Human Biological Material in Research

1.0 Purpose The purpose of this policy and procedure is to describe the Organizations requiremen...

7.1 Banking Human Biological Material

1.0 Purpose The purpose of this policy and procedure is to describe the Organization’s requireme...

8.7 Reporting Incidents to Institutional Officials and Federal Agencies

1.0 Purpose The purpose of this policy and procedure is to describe the Organization’s requireme...

8.6 Study Hold, Suspension, and Termination

1.0 Purpose The purpose of this policy and procedure is to describe the IRB’s authority to: a) a...

8.5 Noncompliance by the IRB or Other Components of the HRPP

1.0 Purpose The purpose of this policy and procedure is to describe the: 1) definitions and clas...

8.4 Review of Noncompliance Involving the PI and Study Personnel

1.0 Purpose The purpose of this policy and procedure is to describe the: 1) definitions and clas...

8.3 IRB Review of Unanticipated Problems Involving Risk to the Subject or Others

1.0 Purpose The purpose of this policy and procedure is to describe: 1) the procedure to ensure ...

8.2 IRB Review of Study Related Complaints

1.0 Purpose The purpose of this policy and procedure is to describe the procedures for reporting...

8.1 IRB Review of Adverse Events and Adverse Device Effects

1.0 Purpose The purpose of this policy and procedure is to describe 1) the procedure to ensure p...

1.12 Sponsored Research

1.0 Purpose The purpose of this policy and procedure is to describe the Organization’s requireme...

1.11 HRPP Access to Legal Counsel

1.0 Purpose The purpose of this policy and procedure is to describe the Organization’s requireme...

1.10 Scientific and Other Committee Review of Research

1.0 Purpose The purpose of this policy and procedure is to describe the Organization’s requireme...

1.9 Resources Necessary to Protect Subjects

1.0 Purpose The purpose of this policy and procedure is to describe the Organization’s requireme...

1.7 IRB Member, Consultant, and Staff Conflict of Interest Identification and Management

1.0 Purpose The purpose of this policy and procedure is to describe the Organization’s requireme...