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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 requireme...
4.5 Local 407 Panel Review of Pediatric Research
1.0 Purpose The purpose of this policy and procedure is to describe the Organization’s requireme...
4.3 Research Involving Prisoners
1.0 Purpose The purpose of this policy and procedure is to describe the Organization’s requireme...
4.1 Additional Protections for Vulnerable Populations
1.0 Purpose The purpose of this policy and procedure is to describe the Organization’s requireme...
5.6 Exceptions from Informed Consent Requirements for Emergency Research
1.0 Purpose The purpose of this policy and procedure is to describe the Organization’s requireme...
5.4 Waiver of Requirement to Obtain Signed Consent Form
1.0 Purpose The purpose of this policy and procedure is to describe the Organization’s process f...
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...
8.6 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...