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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 re...
6.4 Emergency Use of a Test Article
1.0 Purpose The purpose of this policy is to describe the requirements for utilization of a test...
8.4 Review of Noncompliance Involving the PI or Study Personnel
1.0 Purpose The purpose of this policy is to describe the process for reviewing and reporting in...
8.3 Review of Unanticipated Problems Involving Risk to the Subject or Others
1.0 Purpose The purpose of this policy is to describe the process for reporting potential unanti...
8.2 Review of Study Related Complaints
1.0 Purpose The purpose of this policy is to describe the process for reporting research related...
8.1 Review of Adverse Events and Adverse Device Effects
1.0 Purpose The purpose of this policy is to describe the process for reporting research related...
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...
6.3 Humanitarian Use Device (HUD)
1.0 Purpose The purpose of this policy and procedure is to describe the Organization’s requireme...
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...
6.2 Research Involving Investigational and Marketed Devices
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...
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...
5.5 Use of the Short Form Consent Document
1.0 Purpose The purpose of this policy is to describe the Organization’s requirements for use of...
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 is to describe the Organization’s requirements for granti...
5.1 Obtaining Informed Consent From Research Subjects
1.0 Purpose The purpose of this policy is to describe the Organization’s requirements for the pr...
8.5 Noncompliance by the IRB or Other Components of the HRPP
1.0 Purpose The purpose of this policy is to describe the process for reviewing and reporting in...