№ files_lp_4_process_3_104431
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Structured procedural checklist detailing regulatory requirements and documentation steps for IRB review of research studies involving neonates of uncertain viability, including consent, risk assessment, and review pathways.
Year:
2026
Type of Document:
Regulatory guidance / procedural checklist
Institution:
Institutional Review Board (IRB) / Human Subjects Research Office (HSRO)
Target Audience:
IRB members and Designated Reviewers
Scope:
Research involving neonates of uncertain viability
Regulatory Reference:
HRP-314 - WORKSHEET - Criteria for Approval
Application:
Initial review, continuing review, modification, expedited review, convened IRB review
Consent Requirements:
Legally effective informed consent of parent or legally authorized representative required
Risk Level:
Minimal to moderate, protocol-specific determination required
Funding Source:
Federal (if indicated)
Documentation Retention:
HSRO protocol file
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The product description is provided for reference. Actual content and formatting may differ slightly.
Year:
2026
Note:
Region / City
Period of Action:
February 18 (Ash Wednesday) – April 5, 2026
Year:
1960
Region / City:
Ohio
Theme:
Personal narrative, childhood experiences
Document Type:
Memoir excerpt
Author:
Unknown
Target Audience:
General
Period of Action:
1960s
Date of Approval:
N/A
Date of Changes:
N/A
Year:
2025
Region / City:
Nationwide, USA
Topic:
Faculty Salaries, Inflation, Economic Impact
Document Type:
Report
Organization:
ASA Research
Author:
Abby Miller, Sue Clery
Target Audience:
Academics, Researchers, Policy Makers
Period of Application:
2023-2024
Approval Date:
February 2025
Date of Last Change:
February 2025
Year:
2021
Region / City:
ASEAN, EU
Theme:
Supply Chain Resilience
Document Type:
Article
Institution:
European Union, ASEAN
Author:
Angela Pennisi di Floristella, Xuechen Chen
Target Audience:
Policymakers, Academics, Industry Professionals
Period of Application:
2021-present
Approval Date:
Not specified
Date of Modifications:
Not specified
Year:
2026
Region / city:
Not specified
Topic:
Healthcare communication
Document type:
Guidance / Protocol
Institution:
Healthcare facility
Author:
Medical education team
Target audience:
Healthcare professionals
Period of application:
During patient care discussions
Key concepts:
Patient communication, family support, medical planning, informed consent
Procedure stages:
Preparation, starting the conversation, communication principles, patient assessment, outlining plan, warning about uncertainty, future plans, closing conversation
Confidentiality:
Must record discussions in patient healthcare record
Authors:
Brendan J. McMullan; Anita J. Campbell; Christopher C. Blyth; Jonathan C. McNeil; Christopher P. Montgomery; Steven Y. C. Tong; Asha C. Bowen
Type of document:
Narrative review article
Topic:
Pediatric Staphylococcus aureus bacteremia
Population:
Neonates, children and adolescents
Medical specialty:
Infectious Diseases
Methods:
Systematic appraisal of published literature
Data sources:
PubMed and Medline
Search period:
January 1960 – 31 December 2018
Geographic context:
High-income countries
Funding source:
No funding received
Conflict of interest:
None declared
Clinical scope:
Community-acquired and healthcare-associated bacteremia
Year:
2026
Organization:
Canberra Health Services
Department:
Neonatology
Document Type:
Procedure
Target Audience:
Medical Officers, Registered Nurses, Midwives, Student Nurses under supervision
Scope:
Neonates from birth to 44 weeks corrected gestational age
Related Policies:
Neonatal Intensive Care Drug Manual, ANMF guidelines
Definitions Included:
Blood Glucose Levels, Hyperglycaemia, Significant Hyperglycaemia
Treatment Recommendations:
Insulin infusion, glucose monitoring, TPN and enteral feeding guidance
Risks Addressed:
Hypoglycaemia, glucose delivery variability, insulin-plastic binding
Year:
2023
Region / City:
Canberra
Topic:
Healthcare Procedure
Document Type:
Procedure Manual
Organization:
Canberra Health Services
Author:
Not specified
Target Audience:
Healthcare professionals (nurses, doctors, allied health staff)
Period of validity:
Ongoing
Approval Date:
Not specified
Date of Amendments:
Not specified
Year:
2023
Region / city:
Canberra
Theme:
Medical Procedure
Document type:
Procedure
Organization:
Canberra Health Services
Author:
Unknown
Target audience:
Medical professionals, including Medical Officers, Nurses, and Midwives
Effective period:
Ongoing
Approval date:
Unknown
Date of amendments:
Unknown
Note:
Year
Topic:
Infection control, Acute Respiratory Infection
Document type:
Procedure
Organ / institution:
Canberra Health Services
Target audience:
Healthcare staff, students, trainees, and contracted agents working in CHS Network
Year:
2024
Region / city:
Canberra
Topic:
Immunology, Blood Products
Document Type:
Procedure
Organization / Institution:
Canberra Health Services
Author:
Not specified
Target Audience:
Medical Officers, Nurses, Midwives, Students under direct supervision
Period of validity:
Not specified
Approval Date:
Not specified
Date of Changes:
Not specified
Year:
2026
Region / city:
Canberra
Topic:
Clinical Procedures, Healthcare, Intravenous Access
Document Type:
Procedure
Organization / institution:
Canberra Health Services
Author:
Not specified
Target audience:
Healthcare professionals at Canberra Health Services
Effective period:
Ongoing
Approval date:
Not specified
Revision date:
Not specified
Year:
2023
Region / city:
Canberra
Topic:
Medical Procedure, Bleeding Disorders
Document Type:
Procedure
Organization / Institution:
Canberra Health Services
Author:
Canberra Health Services
Target Audience:
Medical and nursing staff involved in desmopressin administration
Period of validity:
Ongoing
Approval Date:
2023
Date of changes:
N/A
Note:
Year
Region / City:
Canberra
Subject:
Stoma care, Post-operative care
Document Type:
Procedure
Organization / Institution:
Canberra Health Services
Target Audience:
Healthcare professionals involved in stoma care
Description:
Procedure document for the management of patients with a stoma in Canberra Health Services, including pre-operative education, post-operative care, and various stoma-related issues across different patient groups.
Year:
2023
Region / city:
Canberra
Subject:
Neonatal respiratory support
Document type:
Clinical guideline
Author:
Canberra Health Services
Target audience:
Medical officers, nurses, midwives, physiotherapists, students under supervision
Date of approval:
Not specified
Date of changes:
Not specified
Clinical areas:
Neonatology, pediatric intensive care, respiratory therapy
Treatment procedures:
Invasive and non-invasive respiratory support, oxygen therapy, mechanical ventilation, physiotherapy
Medical equipment:
Ventilators, oxygen therapy devices, transcutaneous and end-tidal CO2 monitors, NAVA ventilators
Document type:
IRB review checklist
Subject:
Human subjects research involving non-viable neonates
Regulatory framework:
45 CFR §46.205
Intended users:
IRB members and Designated Reviewers
Review stages covered:
Initial review, continuing review, modifications, expedited review, convened IRB review
Responsible body:
Institutional Review Board (IRB)
Purpose:
Documentation of regulatory determinations and protocol-specific findings
Consent requirements:
Parental informed consent conditions
Record retention:
IRB protocol file
Live Attenuated Vaccines: Avoid Use In Those Who Are Clinically Immunosuppressed, Including Neonates
Year:
2016
Region / City:
Wales
Topic:
Vaccination, Immunosuppression
Document Type:
Medical/Health Advisory
Organization:
NHS Wales
Author:
Dr Chris Jones
Target Audience:
Healthcare professionals, General practitioners, Paediatricians, Oncologists, Rheumatologists, Immunologists, Nurses, Pharmacists, Medical Directors
Period of Validity:
Not specified
Approval Date:
4 May 2016
Modification Date:
Not specified
Contextual Description:
Medical advisory document warning healthcare professionals about the risks of live attenuated vaccines for immunosuppressed individuals, especially neonates and elderly patients.
Year:
2023
Region / City:
United Kingdom
Topic:
Clinical Trials, Neonatology, Supplementation
Document Type:
Research Protocol
Institution:
University of Oxford
Author:
Julie-Clare Becher, David Quine, Magda Rudnicka, Colette Jacobs, Hilary Cruickshank, Fiona McKeown, Anne Marshall, Alison Wood
Target Audience:
Healthcare professionals, Researchers
Period of Validity:
From study start to 12 months post EDD
Approval Date:
Not specified
Date of Changes:
Not specified
Context:
A research protocol for a clinical trial studying the impact of long-term feed supplementation on developmental outcomes of neonates with hypoxic-ischemic encephalopathy.
Year:
2021
Region / City:
Charleston, SC
Subject:
Hepatitis B vaccination, neonatal healthcare
Document Type:
Research article
Institution:
MUSC Health, Shawn Jenkins Children’s Hospital
Author:
Anna Dugovich, Sandra Garner, Erin R. Weeda, Toby Cox
Target Audience:
Healthcare professionals, researchers, public health officials
Period of Effect:
November 1, 2018 – June 30, 2021
Date of Approval:
N/A
Date of Changes:
N/A
Year:
2011-2013
Region / city:
United Kingdom
Topic:
Neonatal care, environmental management
Document type:
Clinical guideline
Organization / institution:
NHS Staffordshire, Shropshire and Black Country Newborn Network
Author:
Multiple healthcare contributors (NHS network)
Target audience:
Neonatal healthcare professionals
Period of validity:
2011-2013
Approval date:
2011
Sources:
BAPM (2005), Gardner et al (2010), McCall et al (2010), Lyon and Freer (2011), Turnbull and Petty (2013 a and b)