Related Experiment Video
Updated: Jul 16, 2026
07:48
Working with Human Tissues for Translational Cancer Research
Published on: November 26, 2015
Emergency research: only possible if consent is waived?
1Assistance Publique Hôp de Paris, Hôpital H. Mondor, Paris 12 University, Créteil, France. francois.lemaire@hmn.aphp.fr
Current Opinion in Critical Care
|March 1, 2007
Summary
Informed consent waiver for emergency research is complex. While US regulations exist, EU directives led to diverse national laws, though emergency research is gaining recognition.
Area of Science:
- Medical Ethics
- Clinical Trial Regulation
Background:
- Emergency research requires waiving informed consent.
- Recent legislative efforts in the US and Europe address this critical issue.
Purpose of the Study:
- To review the legislative landscape for emergency research informed consent waiver in the US and Europe.
- To analyze the impact of regulations on conducting clinical trials in emergency settings.
Main Methods:
- Comparative legal analysis of US and EU regulations concerning emergency research.
- Review of legislative implementation and national variations.
Main Results:
- The US enacted specific regulations in 1996, but complexity limits trial adoption.
- EU directive 2001/20/CE lacked specific emergency research rules, leading to diverse national implementations post-2004.
- Some EU countries permit consent waivers, while others prohibit them, creating regulatory heterogeneity.
Conclusions:
- Emergency and intensive care specialists' advocacy is improving the legal situation.
- National legislations increasingly recognize the unique challenges of emergency research.
- Progress is being made towards more standardized approaches to emergency research ethics and regulation.
Related Concept Videos
01:56Ethics in Research
Today, scientists agree that good research is ethical in nature and is guided by a basic respect for human dignity and safety. However, this has not always been the case. Modern researchers must demonstrate that the research they perform is ethically sound.
01:40Archival Research
Some researchers gain access to large amounts of data without interacting with a single research participant. Instead, they use existing records to answer various research questions. This type of research approach is known as archival research. Archival research relies on looking at past records or data sets to look for interesting patterns or relationships. For example, a researcher might access the academic records of all individuals who enrolled in college within the past ten years and...
02:30Naturalistic Observations
If you want to understand how behavior occurs, one of the best ways to gain information is to simply observe the behavior in its natural context. However, people might change their behavior in unexpected ways if they know they are being observed. How do researchers obtain accurate information when people tend to hide their natural behavior? As an example, imagine that your professor asks everyone in your class to raise their hand if they always wash their hands after using the restroom. Chances...
01:30Psychosurgery
Psychosurgery, the surgical alteration or permanent removal of brain tissue to alleviate severe psychological conditions, stands as one of the most radical and controversial treatments in the history of mental health care. Its development and application have evolved significantly, marked by dramatic shifts in scientific understanding and ethical perspectives.
Historical Development of Psychosurgery
In the 1930s, Portuguese neurologist Antonio Egas Moniz introduced a surgical procedure designed...
Historical Development of Psychosurgery
In the 1930s, Portuguese neurologist Antonio Egas Moniz introduced a surgical procedure designed...
01:26Types of Reports III: Telephone and Verbal Reports
Telephone and Verbal Reports in healthcare settings are two communication methods for conveying therapeutic instructions from healthcare providers to nurses or other healthcare staff.
Here's an overview of each type:
Telephone Orders
Here's an overview of each type:
Telephone Orders
01:23Ethical Standards II
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 and...
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 and...