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3.11 Collecting Data from Pregnant Partners of Research Subjects
Last Revised: 9/9/2019 1.0 Purpose The purpose of this policy is to describe the Organization’s requirements for obtaining informed consent, and collecting data from pregnant partners of research subjects and from their infants. 2.0 Policy 2.1. It is the po...
3.12 Ethical Access
Last Revised: 3/5/2025 For an abbreviated version intended for investigators, coordinators, and study teams - please visit here: Ethical Access 1.0 Purpose The purpose of this policy is to define ethical access and to describe the Organization’s requirements t...
3.13 Use of Placebo or Wash-Out of Effective Therapy in Clinical Trials
Last Revised: 2/7/2018 For an abbreviated version intended for investigators, coordinators, and study teams - please visit here: Placebos For an abbreviated version intended for investigators, coordinators, and study teams - please visit here: Wash-Out 1.0 Pur...
3.14 Phase I and First-in-Human Studies
Last Revised: 2/5/2018 1.0 Purpose The purpose of this policy and procedure is to describe the Organization’s requirements for IRB review and approval of Phase I and First in Human Studies. 2.0 Policy 2.1. It is the policy of the Organization that, except i...
3.15 Managing Radiographic Incidental Findings in Human Subjects Research
Last Revised: 2/28/2018 For an abbreviated version intended for investigators, coordinators, and study teams - please visit here: Incidental Findings 1.0 Purpose The purpose of this policy and procedure is to describe the Organization’s requirements for disclo...
4.1 Additional Protections for Vulnerable Persons
Last Revised: 4/16/2025 For an abbreviated version intended for investigators, coordinators, and study teams - please visit here: Vulnerable Populations - Additional Protections 1.0 Purpose The purpose of this policy is to describe the Organization’s requireme...
4.2 Research Involving Pregnant Women, Human Fetuses, and Neonates (Nonviable or of Uncertain Viability)
Last Revised: 9/25/2024 For an abbreviated version intended for investigators, coordinators, and study teams - please visit here: Research Involving Neonates For an abbreviated version intended for investigators, coordinators, and study teams - please visit he...
4.3 Research Involving Prisoners
Last Revised: 01/17/2024 For an abbreviated version intended for investigators, coordinators, and study teams - please visit here: Research Involving Prisoners 1.0 Purpose The purpose of this policy and procedure is to describe the Organization’s requirements ...
4.4 Research Involving Children
Last revised: 9/3/2025 For an abbreviated version intended for investigators, coordinators, and study teams - please visit here: Research Involving Children 1.0 Purpose The purpose of this policy is to describe the Organization’s requirements for research invo...
4.5 Local 407 Panel Review of Pediatric Research
Last revised: 2/19/2018 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 pol...
4.6 IRB Review of Research Involving Subjects with Impaired Decision-Making Capacity
Last Revised: 11/27/2024 For an abbreviated version intended for investigators, coordinators, and study teams - please visit here: Research Involving Decisionally Impaired Persons 1.0 Purpose The purpose of this policy is to describe the Organization’s require...
4.7 Research Involving Employees of the Organization and Students as Subjects
Last Revised: 1/29/2018 For an abbreviated version intended for investigators, coordinators, and study teams - please visit here: Employees as Subjects For an abbreviated version intended for investigators, coordinators, and study teams - please visit here: St...
5.1 Obtaining Informed Consent From Research Subjects
Last Revised: 5/13/2026 For an abbreviated version intended for investigators, coordinators, and study teams - please visit here: Informed Consent 1.0 Purpose The purpose of this policy is to describe the Organization’s requirements for the process and documen...
5.2 Waiver or Alteration of Informed Consent and HIPAA Authorization
Last Revised: 2/7/2024 For an abbreviated version intended for investigators, coordinators, and study teams - please visit here: Waiving Consent Process 1.0 Purpose The purpose of this policy is to describe the Organization’s requirements for granting a waiver...
5.3 Use of a Remote Consent Process
Last Revised: 1/14/2026 For an abbreviated version intended for investigators, coordinators, and study teams - please visit here: Remote Consent 1.0 Purpose The purpose of this policy is to describe the Organization’s requirements for use of remote informed co...
5.4 Waiver of Requirement to Obtain Signed Consent Form
Last Revised: 12/11/2024 For an abbreviated version intended for investigators, coordinators, and study teams - please visit here: Waiving Signed Consent 1.0 Purpose The purpose of this policy is to describe the Organization’s process for waiver of the require...
5.5 Use of the Short Form Consent Document
Last Revised: 11/30/2022 For an abbreviated version intended for investigators, coordinators, and study teams - please visit here: Short Form Consent 1.0 Purpose The purpose of this policy is to describe the Organization’s requirements for use of a short form ...
5.6 Exceptions from Informed Consent Requirements for Emergency Research
Last Revised: 3/5/2018 For an abbreviated version intended for investigators, coordinators, and study teams - please visit here: Emergency Research - Waiving Consent 1.0 Purpose The purpose of this policy and procedure is to describe the Organization’s require...