№ lp_1_2_24278
File format: docx
Character count: 3535
File size: 62 KB
A regulatory review source defining criteria and documentation requirements for Institutional Review Board determinations on research involving non-viable neonates under U.S. human subjects protections.
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
Price: 8 / 10 USD
The file will be delivered to the email address provided at checkout within 12 hours.
The file will be delivered to the email address provided at checkout within 12 hours.
Don’t have cryptocurrency yet?
You can still complete your purchase in a few minutes:- Buy Crypto in a trusted app (Coinbase, Kraken, Cash App or any similar service).
- In the app, tap Send.
- Select network, paste our wallet address.
- Send the exact amount shown above.
The final amount may vary slightly depending on the payment method.
The file will be sent to the email address provided at checkout within 24 hours.
The product description is provided for reference. Actual content and formatting may differ slightly.
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
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)
Year:
2023
Region / City:
United States
Topic:
Health Economics, Neonatal Care
Document Type:
Supplemental Material / Research Table and Figure
Institution:
Academic Medical Center / Research Group
Authors:
Not specified
Target Audience:
Health economists, neonatologists, researchers
Analysis Period:
Short-term (hospital stay) and long-term (childhood)
Data Currency:
US Dollars
Health Conditions Covered:
Intestinal failure-associated liver disease (IFALD), necrotizing enterocolitis, sepsis
Outcomes Measured:
Hospital costs, long-term disability, chronic liver disease, QALY
Methodology:
Cost-effectiveness analysis, transition probabilities, incremental cost-effectiveness ratio (ICER)
Model Population:
Surgical neonates at risk of IFALD and related complications
Year:
2022
Region / City:
Cheshire and Merseyside
Subject:
Child Protection, Family Law
Document Type:
Practice Note
Issuing Authority:
His Honour Judge Steven Parker, Designated Family Judge for Cheshire and Merseyside
Period of Application:
2022-2023 (pilot phase)
Approval Date:
9th March 2022
Amendment Date:
None
Year:
2025
Region / City:
Northern Territory
Theme:
Research Ethics, Mental Health
Document Type:
Protocol
Organization / Institution:
Charles Darwin University
Author:
Claire Burke Draucker, Donna S. Martsolf, Candice Poole
Target Audience:
Researchers, Indigenous Communities, Mental Health Professionals
Period of Validity:
Ongoing
Approval Date:
October 2009
Date of Last Revision:
2025
Note:
Year
Topic:
Research Ethics
Document Type:
Form
Target Audience:
Research participants
Note:
Year
Institution:
Bath Spa University
Target Audience:
Staff, students, and event organizers
Note:
Year
Topic:
Incident Reporting
Document Type:
Report Form
Organization:
NHS
Target Audience:
NHS Staff, Contractors