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3.1 Assessing the Need for Increased Monitoring, Interim Continuing Review, and Verification from Sources Other than the PI
Last Revised: 1/2/2018 1.0 Purpose The purpose of this policy and procedure is to describe the Organization’s requirements for determining the need for: 1) IRB review more often than annually, 2) increased monitoring, and 3) verification from sources other tha...
3.2 Data and Safety Monitoring
Last Revised 12/22/2022 For an abbreviated version intended for investigators, coordinators, and study teams - please visit here: Data and Safety Monitoring 1.0 Purpose The purpose of this policy is to describe the Organization’s requirements for data and safe...
3.3 Privacy Interests and Confidentiality of Research Data
Last Revised 1/21/2024 For an abbreviated version intended for investigators, coordinators, and study teams - please visit here: Confidentiality For an abbreviated version intended for investigators, coordinators, and study teams - please visit here: Privacy 1...
3.4 Use of Protected Health Information in Research
Last Revised: 4/9/2018 For an abbreviated version intended for investigators, coordinators, and study teams - please visit here: Using PHI in Research 1.0 Purpose The purpose of this policy and procedure is to describe the Organization’s requirements for ensur...
3.5 Subject Recruitment Through Advertisements
Last Revised 12/11/2024 For an abbreviated version intended for investigators, coordinators, and study teams - please visit here: Advertisements 1.0 Purpose The purpose of this policy is to describe the Organization’s requirements for recruitment of subjects t...
3.6 Subject Recruitment Through Direct Invitation
Last Revised: 3/12/2025 For an abbreviated version intended for investigators, coordinators, and study teams - please visit here: Recruitment 1.0 Purpose The purpose of this policy is to describe the Organization’s requirements for subject recruitment through ...
3.7 Finder’s Fees and Recruitment Bonuses
Last Revised: 1/26/2018 1.0 Purpose The purpose of this policy and procedure is to describe the Organization’s requirements related to finder’s fees and recruitment bonuses. 2.0 Policy HHS regulations at 45 CFR 46.116 and FDA regulations at 21 CFR 56.116 requ...
3.8 Research Subject Compensation and Reimbursement
Last Revised: 7/3/2024 For an abbreviated version intended for investigators, coordinators, and study teams - please visit here: Compensation For an abbreviated version intended for investigators, coordinators, and study teams - please visit here: Reimbursemen...
3.9 Contraception Requirements
Last Revised: 5/5/2025 1.0 Purpose The purpose of this policy is to describe the contraception requirements for subjects participating in research involving drugs, devices or biologics. 2.0 Policy It is the policy of the Organization that subjects must utiliz...
3.10 Pregnancy Testing
Last Revised: 7/9/2025 For an abbreviated version intended for investigators, coordinators, and study teams - please visit here: Pregnancy Testing 1.0 Purpose The purpose of this policy is to describe the Organization’s requirements for determining how and whe...
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...