Related Experiment Video
Updated: May 21, 2025
07:48
Working with Human Tissues for Translational Cancer Research
Published on: November 26, 2015
9.8K
Accelerating implementation of visual key information to improve informed consent in research: a single-institution
Angela Hill1, Ashley J Housten1, Krista Cooksey1
1Washington University in St Louis School of Medicine, St Louis, Missouri, USA.
BMJ Open
|March 19, 2025
Summary
A new visual key information (KI) template significantly improved patient understanding of clinical trial details, with 87.4% accuracy. This accessible format may reduce barriers to research participation and enhance informed consent.
Area of Science:
- Clinical Research
- Health Literacy
- Informed Consent
Background:
- Current informed consent processes often hinder effective communication of study details, potentially creating disparities in research participation.
- The mandatory key information (KI) section, introduced by the 2018 Common Rule, can be lengthy and complex, limiting its utility.
- Accessible visual aids are needed to improve comprehension of complex study information for participants.
Purpose of the Study:
- To assess the feasibility of an accessible visual key information (KI) template for improving informed consent in clinical trials.
- To evaluate the impact of a visual KI template on participant knowledge, decisional conflict, and confidence in communicating about research.
Main Methods:
- A parallel feasibility study and implementation testing were conducted at a Midwestern US academic center.
- Rapid implementation science methods were used to develop and adapt the visual KI template with expert and patient input.
- Patient participants in four clinical trials using the visual KI template were surveyed to assess knowledge, decisional conflict, and confidence.
Main Results:
- Participants achieved a high mean knowledge score of 87.4% regarding clinical trial details when using the visual KI template.
- Decisional conflict regarding trial participation was low (10.6%), and nearly all participants (96.5%) approved of the visual KI template.
- A significant majority (92.9%) felt confident discussing trial details with researchers after using the visual KI template.
Conclusions:
- Visual KI templates demonstrate potential to enhance participant comprehension and reduce barriers to clinical trial enrollment.
- Implementation science methodologies facilitate the rapid development and evaluation of effective interventions for improving informed consent.
- Accessible visual tools are crucial for promoting equitable and informed participation in research studies.
Related Concept Videos
01:56Ethics in Research
22.9K
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.
22.9K
01:27Nurses' Legal Responsibilities I
691
In healthcare, informed consent is a crucial process that involves thoroughly communicating medical treatment options to patients, including benefits, risks, potential side effects, and alternatives. This process enables patients to make well-informed decisions about their care, ensuring they understand the implications of their choices before consenting to or refusing treatment.
The legal responsibilities of a nurse regarding informed consent include the following:
The legal responsibilities of a nurse regarding informed consent include the following:
691
01:11Blinding
2.3K
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.
2.3K
02:07Blind Procedures
10.6K
Ideally, the people who observe and record the children’s behavior are unaware of who was assigned to the experimental or control group, in order to control for experimenter bias. Experimenter bias refers to the possibility that a researcher’s expectations might skew the results of the study. Remember, conducting an experiment requires a lot of planning, and the people involved in the research project have a vested interest in supporting their hypotheses. If the observers knew which...
10.6K