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3.1 Assessing the Need for Increased Monitoring, Interim Continuing Review, and Verification from Sources Other than the PI
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 than the PI that no mater...
3.2 Data and Safety Monitoring
1.0 Purpose The purpose of this policy is to describe the Organization’s requirements for data and safety monitoring for non-exempt research. 2.0 Policy It is the policy of the Organization that all non-exempt research must have an appropriate plan for data...
3.3 Privacy Interests and Confidentiality of Research Data
1.0 Purpose The purpose of this policy is to describe the Organization’s requirements for 1) protection of privacy interests of research subjects, and 2) maintenance of confidentiality of data. For the purposes of this policy “subjects” and “participants” are...
3.4 Use of Protected Health Information in Research
1.0 Purpose The purpose of this policy and procedure is to describe the Organization’s requirements for ensuring the appropriate protections for use of Protected Health Information (PHI) in research. 2.0 Policy 2.1. It is the policy of the Organization tha...
3.5 Subject Recruitment Through Advertisements
1.0 Purpose The purpose of this policy is to describe the Organization’s requirements for recruitment of subjects through advertisements. For the purpose of this policy, “advertisements” refer to printed advertisements (including bulletins, newsletters, poste...
3.6 Subject Recruitment Through Direct Invitation
1.0 Purpose The purpose of this policy is to describe the Organization’s requirements for subject recruitment through direct invitations to participate. Subject recruitment through advertisements is described in HRPP policy 3.5. 2.0 Policy 2.1. It is the ...
3.7 Finder’s Fees and Recruitment Bonuses
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 require minimization of th...
3.8 Research Subject Compensation and Reimbursement
1.0 Purpose The purpose of this policy is to describe the Organization’s requirements and limitations regarding compensation and reimbursement of research subjects. 2.0 Policy It is the policy of the Organization that 2.1. Compensation for research subjec...
3.9 Contraception Requirements
1.0 Purpose The purpose of this policy and procedure is to describe the contraception requirements for subjects participating in research. 2.0 Policy It is the policy of the Organization that subjects must utilize appropriate contraception methods while par...
3.10 Pregnancy Testing
1.0 Purpose The purpose of this policy and procedure is to describe the Organization’s requirements for determining how and when pregnancy testing should be performed on subjects who are of childbearing potential enrolled in protocols that describe pregnancy ...
3.11 Collecting Data from Pregnant Partners of Research Subjects
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 policy of the organizatio...
3.12 Ethical Access
1.0 Purpose The purpose of this policy is to define ethical access and to describe the Organization’s requirements to protect the privacy of patients in the context of recruitment for participation in research, or for identification of subjects for review of ...
3.13 Use of Placebo or Wash-Out of Effective Therapy in Clinical Trials
1.0 Purpose The purpose of this policy and procedure is to describe the Organization’s requirements for IRB review and approval of clinical trials that utilize placebos or wash-out of effective therapy. 2.0 Policy 2.1. It is the policy of the Organization t...
3.14 Phase I and First-in-Human Studies
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 in limited circumstances...
3.15 Managing Radiographic Incidental Findings in Human Subjects Research
1.0 Purpose The purpose of this policy and procedure is to describe the Organization’s requirements for disclosure, or nondisclosure, of radiographic incidental findings that may affect the management of a subject’s current or future health or welfare. 2.0 P...
4.1 Additional Protections for Vulnerable Populations
1.0 Purpose The purpose of this policy and procedure is to describe the Organization’s requirements for additional protections for vulnerable populations. 2.0 Policy 2.1. It is the policy of the Organization that vulnerable populations will be afforded addi...
4.2 Research Involving Pregnant Women, Human Fetuses, and Neonates (Nonviable or of Uncertain Viability)
1.0 Purpose The purpose of this policy is to describe the Organization’s requirements for IRB review and approval of research involving pregnant women, fetuses, and neonates (nonviable or of uncertain viability). 2.0 Policy It is the policy of the Organizat...
4.3 Research Involving Prisoners
1.0 Purpose The purpose of this policy and procedure is to describe the Organization’s requirements for review and approval of research involving prisoners. 2.0 Policy 2.1. It is the policy of the Organization that federally funded research involving prison...
4.4 Research Involving Children
1.0 Purpose The purpose of this policy is to describe the Organization’s requirements for research involving children. 2.0 Policy It is the policy of the Organization that: 2.1. Federally funded non-exempt research involving children will be reviewed and...
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 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...