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1.0 Purpose The purpose of this policy and procedure is to describe the Organization’s requirements for convening a local 407 Panel to consider pediatric research which is not federally funded or FDA regulated. 2.0 Policy It is the policy of the Organizatio...

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 ...

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 ...

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 obtained from subjects, ...

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 Organization that: 2...

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 of desktop, mobile or ...

1.0 Purpose The purpose of this policy and procedure is to describe the Organization’s process for IRB waiver of the requirement to obtain a signed ICF. 2.0 Policy 2.1. It is the policy of the Organization that a waiver of the requirement to obtain a signed...

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 a short form written co...

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 policy of the Organization t...

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 review all research involvi...

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 review all research invol...

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 that all uses of an HUD...

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 the policy of the Organi...

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 7.2 (Use of Human Biolog...

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 in accordance to HHS ...

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 Organization that intern...

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 the policy of the Or...

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 problems, concerns, or q...

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 the organization that: ...

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 in HRPP 8.5 (Noncomplia...