Related Experiment Video
Updated: Apr 18, 2026
06:28
E-Patient Counseling Trial E-PACO: Computer Based Education versus Nurse Counseling for Patients to Prepare for Colonoscopy
Published on: August 1, 2019
9.4K
"Targeted" consent for pragmatic clinical trials
1Department of Bioethics, NIH Clinical Center, Building 10, Room 1C118, Bethesda, MD, 20892-1156, USA, dwendler@nih.gov.
Journal of General Internal Medicine
|January 15, 2015
Summary
Pragmatic clinical trials require a balanced consent process. Research consent should supplement standard care consent only for deviations, ensuring ethical approval without bias.
Area of Science:
- Clinical Trials
- Bioethics
- Regulatory Science
Background:
- Interventions within standard of care offer potential but pose ethical and regulatory challenges.
- Determining appropriate consent for pragmatic clinical trials is a key issue.
- Current approaches to consent in pragmatic trials present trade-offs between informed consent and trial integrity.
Purpose of the Study:
- To propose a novel consent model for pragmatic clinical trials.
- To balance ethical considerations, regulatory compliance, and research integrity.
- To minimize selection bias and clinical disruption in pragmatic trials.
Main Methods:
- The manuscript proposes a tiered consent approach.
- Consent supplements standard care consent based on research deviations.
- Focuses on trials where interventions align with standard clinical practice.
Main Results:
- The proposed model suggests minimal additions to standard care consent for many pragmatic trials.
- This approach aims to satisfy ethical and regulatory requirements.
- It seeks to avoid significant selection bias and disruption to clinical care.
Conclusions:
- A nuanced consent process can be achieved for pragmatic clinical trials.
- Ethically appropriate and regulatory-compliant consent is feasible.
- This model supports the integrity and efficiency of pragmatic research.
Related Concept Videos
01:16Clinical Trials
11.2K
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...
11.2K
01:11Clinical Trials: Overview
5.5K
Clinical development focuses on how the drug will interact with the human body and encompasses four key phases of clinical trials, each serving a specific purpose in assessing the safety and effectiveness of new drugs. These phases overlap and build upon one another. Phase I involves a small group of healthy volunteers (typically 20-80 individuals) or, in cases where significant toxicity is expected, patients with the targeted disease, such as cancer or AIDS. The volunteers are tested for...
5.5K
01:11Blinding
4.2K
Blinding is a commonly used method of not telling participants which treatment a subject is receiving. Blinding is a critical part of a randomized control trial or RCT. It reduces the bias that affects the results. In an RCT, blinding is used in the form of a placebo. A placebo effect occurs when untreated subjects falsely believe they have received the treatment and report improved symptoms. A placebo or a dummy treatment is administered to subjects to negate the bias caused by such an effect.
4.2K
01:23Types of Biopharmaceutical Studies: Controlled and Non-Controlled Approaches
582
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,...
582
01:15Bioavailability Study Design: Healthy Subjects Versus Patients
229
Bioavailability studies are essential for evaluating a drug's therapeutic efficacy and understanding its absorption patterns under various physiological conditions. Conducting such studies on target patient populations provides more relevant data by simulating real-world disease states. However, practical challenges often necessitate the use of young, healthy adult volunteers as study subjects.Patients may exhibit altered drug absorption patterns due to the effects of the disease itself,...
229
01:56Ethics in Research
26.3K
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.
26.3K