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Nemours Biomedical Research

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Policies & Procedures Database

Search all policies, procedures, plans and processes relating to Nemours Institutional Review Boards and the Nemours Office of Human Subjects Protection.

 
NOHSP: Organization and Administration
Policy
HSP-018 Human Subject Protection Policy and Procedure Development and Dissemination
HSP-055 Human Subject Protection Regulatory Authority
HSP-056 HSP Resource Assurance
HSP-060 Periodic IRB Capacity Assessment
HSP-095 Institutional Conflict of Interest
 
Nemours IRBs: Organization and Administration
Policy
HSP-002 Use of External Institutional Review Boards
HSP-008 IRB Member Conflict of Interest
HSP-009 IRB Organization and Membership
HSP-010 IRB Member Training
HSP-011 IRB Confidentiality
HSP-012 IRB Visitors
HSP-013 IRB Fees
HSP-015 IRB Calendar
HSP-016 IRB Jurisdiction
HSP-038 IRB Numbering System
 
IRB Review and Approval Process
Policy
HSP-001 Delegation of Signature Authority
HSP-005 Human Subjects Protection Training for Research Team Members
HSP-006 Approval Dates
HSP-007 Lapse of Continuing Review Period (Expiration of IRB Approval)
HSP-017 Blood Drawing Guidelines
HSP-020 Expedited Review
HSP-021 Approval Criteria: Privacy and Confidentiality
HSP-022 Approval Criteria: Data and Safety Monitoring
HSP-023 Equitable Selection of Participants
HSP-024 Benefit Assessment
HSP-025 Risk Assessment
HSP-027 Review of Research Involving Children
HSP-029 IRB Review: Basics
HSP-030 Initial IRB Review
HSP-031 Continuing Review
HSP-036 IRB Correspondence and Communication
HSP-037 IRB Approval of Research with Required Minor Modifications
HSP-039 Review by the Convened IRB (Full IRB Review)
HSP-042 Review of Amendments to Approved Research
HSP-044 Reciprocal Initial Approval Among Nemours Institutional Review Boards
HSP-050 Defining Human Subject Research
(Research Involving Human Participants)
HSP-063 IRB Review of Grant Applications
HSP-069 Application Following IRB Disapproval
HSP-080 Change of Principal Investigator: IRB Issues
HSP-081 Waiver or Alteration of Authorization for Use and/or Disclosure of PHI for Research
HSP-082 Research Team Conflict of Interest
HSP-087 Submission and Review of Multi-site Research Projects
HSP-093 Approval Period for Retrospective Records Research
HSP-094 Review of Human Research External Sponsor/Funder Agreements
 
Specific Research Categories
Policy
HSP-019 Research Involving Prisoners
HSP-032 Case Reports
HSP-034 Emergency Use of an Investigational Drug, Biologic or Device Without Prior IRB Approval
HSP-047 Humanitarian Use Devices
HSP-048 Planned Emergency Research
HSP-053 Research Involving the Use of Deception
HSP-061 Exempt Research
HSP-070 Research Involving Pregnant Women and Fetuses
HSP-075 Research Involving Investigational Devices
HSP-076 Research Involving Investigational Drugs or Biologics
HSP-078 Expanded Access of Investigational Drugs
HSP-086 Data and Tissue Repositories
HSP-089 Expanded Access for Investigational Devices
HSP-092 International (Transnational) Research
 
Recruitment and Enrollment
Policy
HSP-004 Enrollment of Research Participants
HSP-028 Compensating Research Participants (Reimbursement)
HSP-045 Recruitment
HSP-046 Use of the Internet for Study Listing and Records Retention and Storage
HSP-051 Enrollment of Nemours Associates
HSP-054 Enrollment of Adults with Limited Capacity
HSP-057 Advertising for Recruitment of Research Participants
HSP-064 Screening Prior to Enrollment
HSP-065 Enrollment of Non-English Speaking/Reading Participants
HSP-071 Research Involving Wards or Foster Children
HSP-074 Enrollment of Investigator's Children
HSP-090 Participant Recruitment Via Social Media
HSP-091 Enrollment of Pregnant Partners of Male Research Participants
 
Parental Permission, Assent and Informed Consent
Policy
HSP-014 Telephone and Mail Informed Consent and/or Parental Permission: Process and Documentation
HSP-033 Assent of Children to Participate in Research
HSP-043 Parental Permission
HSP-049 Waiver or Alteration of Parental Permission or Informed Consent
HSP-052 Informed Consent of Adult Subjects
HSP-072 IRB Observation of the Parental Permission or Informed Consent Process
HSP-079 Parental Permission, Informed Consents, and Research Data Stored in the Medical Record
HSP-081 Waiver or Alteration of Authorization for Use and/or Disclosure of PHI for Research
HSP-083 Research Conducted in a State Other than Delaware, Florida, New Jersey, or Pennsylvania
 
Reporting Requirements
Policy
HSP-035 Closure of a Research Study
HSP-058 Reports Initiated by the IRB
HSP-059 Managing Human Subject Protection Noncompliance
HSP-066 Management of Complaints and Inquiries
HSP-067 Prompt Reporting of Adverse Events and Unanticipated Problems
HSP-073 Principal Investigator Accountability
HSP-084 Review of Problem Reports and New Information
HSP-085 Suspension or Termination of Approved Research
HSP-088 Reporting Board Actions Under an IRB Authorization Agreement When Nemours IRB has Jurisdiction
 
Recordkeeping
Policy
HSP-003 Electronic IRB Records
HSP-040 IRB Requirements for Investigator Records
HSP-041 IRB Records


Contact Us

Please direct questions, comments, concerns, or complaints about the protection of human subjects participating in research at Nemours institutions to:

Nemours Office of Human Subjects Protection

(904) 697-4022
NOHSP@nemours.org

Resources

Nemours is proud to be fully accredited by the Association for the Accreditation of Human Research Protection Programs.

Learn More »

Nemours Office of Human Subjects Protection

Paul Garfinkel

Director
paul.garfinkel@nemours.org

Suzanne Murphy

Associate Director
suzanne.murphy@nemours.org

Robin Steinman

Executive Assistant
robin.steinman@nemours.org