Related Experiment Video
Updated: Jun 4, 2025
08:01
Biobank for Translational Medicine: Standard Operating Procedures for Optimal Sample Management
Published on: November 30, 2022
4.1K
Sharing Data and Transferring Samples Within Pediatric Clinical Studies: How to Overcome Challenges and Make Them a
Annalisa Landi1, Federica D'Ambrosio2, Silvia Faggion2
1Fondazione per la Ricerca Farmacologica Gianni Benzi Onlus, 70124 Bari, Italy.
Healthcare (Basel, Switzerland)
|December 17, 2024
Summary
The EPIICAL consortium developed practical solutions for ethical and regulatory challenges in international pediatric HIV research. This involved creating standardized agreements for data and biological sample transfer, aiding multi-national studies.
Area of Science:
- Pediatric infectious diseases
- Clinical trial management
- Bioethics and regulatory science
Background:
- The EPIICAL consortium aimed to establish a platform for novel therapeutic strategies in pediatric Human Immunodeficiency Virus (HIV) infection.
- Pediatric clinical studies within EPIICAL required complex cross-border transfer of biological samples and data.
- Academic partners often lack resources for managing multinational studies' ethical and regulatory aspects.
Purpose of the Study:
- To guide the EPIICAL consortium through ethical and regulatory complexities of international pediatric clinical studies.
- To support the design and preparation of multi-center, multinational pediatric studies.
- To develop practical solutions for data and sample transfer hurdles in pediatric HIV research.
Main Methods:
- Established a dedicated expert Working Group focusing on ethical and regulatory compliance.
- Developed structured informed consent and assent templates for pediatric participants.
- Implemented data sharing and material transfer agreements to govern sample and data exchange.
Main Results:
- Provided guidance on ethical and regulatory aspects throughout the project lifecycle.
- Facilitated the design and preparation of prospective and retrospective multi-center studies.
- Established robust agreements for regulating the transfer of biological samples and associated data.
Conclusions:
- Dedicated expert support and ad hoc agreements are effective in overcoming ethical and regulatory hurdles in international pediatric clinical research.
- Standardized protocols and agreements streamline the transfer of data and samples, crucial for advancing pediatric HIV research.
- The EPIICAL model offers practical solutions for multinational collaborations involving vulnerable pediatric populations.
Related Concept Videos
01:23Ethical Standards II
646
Ethical standards are the backbone of nursing practice, guiding nurses as they interact with patients, families, and colleagues. These standards are crucial for providing safe, empathetic care centered on the patient's needs.
Nurses are entrusted with upholding various ethical principles and standards. Nurses forge solid therapeutic relationships using trust, empathy, autonomy, confidentiality, and professional competence.
Confidentiality is crucial, embodying respect for individual privacy...
Nurses are entrusted with upholding various ethical principles and standards. Nurses forge solid therapeutic relationships using trust, empathy, autonomy, confidentiality, and professional competence.
Confidentiality is crucial, embodying respect for individual privacy...
646
01:02Sample Handling
87
Transportation of samples from the collection point to the laboratory, as well as storage and preservation techniques, are crucial for maintaining sample integrity and ensuring accurate and reliable test results.
Samples should be transported carefully from collection points to the laboratory. They should be properly sealed and clearly labeled to prevent cross-contamination. To preserve the sample integrity, optimal temperature conditions during transport are essential. This could involve using...
Samples should be transported carefully from collection points to the laboratory. They should be properly sealed and clearly labeled to prevent cross-contamination. To preserve the sample integrity, optimal temperature conditions during transport are essential. This could involve using...
87
01:25Ethical Standards I
773
The American Nurses Association (ANA) created and implemented the first nationally accepted Code of Ethics for Nurses with Interpretive Statements. The Code of Ethics is a living document regularly updated by the ANA and establishes an ethical standard that is non-negotiable for nurses in all roles and settings.
The Code of Ethics provisions outline the nurse's duty to the patient, the healthcare team, the profession, and society. The Code's fundamental principles include advocacy,...
The Code of Ethics provisions outline the nurse's duty to the patient, the healthcare team, the profession, and society. The Code's fundamental principles include advocacy,...
773
01:23Types of Biopharmaceutical Studies: Controlled and Non-Controlled Approaches
120
Biopharmaceutical studies constitute a vital field aiming to enhance drug delivery methods and refine therapeutic approaches, drawing upon diverse interdisciplinary knowledge. In research methodologies, the choice between controlled and non-controlled studies significantly influences the study's reliability and accuracy.
Non-controlled studies, commonly employed for initial exploration, lack a control group, rendering them susceptible to biases and external influences. In contrast,...
Non-controlled studies, commonly employed for initial exploration, lack a control group, rendering them susceptible to biases and external influences. In contrast,...
120
01:16Clinical Trials
6.6K
Clinical trials are prospective experimental studies conducted on humans to determine the safety and efficacy of treatments, drugs, diet methods, and medical devices. Using statistics in clinical trials enables researchers to derive reasonable and accurate conclusions from the collected data, allowing them to make wise decisions in uncertain situations. In medical research, statistical methods are crucial for preventing errors and bias.
There are four phases in a clinical trial. A phase one...
There are four phases in a clinical trial. A phase one...
6.6K