Jove
Visualize
Contact Us
JoVE
x logofacebook logolinkedin logoyoutube logo
ABOUT JoVE
OverviewLeadershipBlogJoVE Help Center
AUTHORS
Publishing ProcessEditorial BoardScope & PoliciesPeer ReviewFAQSubmit
LIBRARIANS
TestimonialsSubscriptionsAccessResourcesLibrary Advisory BoardFAQ
RESEARCH
JoVE JournalMethods CollectionsJoVE Encyclopedia of ExperimentsArchive
EDUCATION
JoVE CoreJoVE BusinessJoVE Science EducationJoVE Lab ManualFaculty Resource CenterFaculty Site
Terms & Conditions of Use
Privacy Policy
Policies

Related Concept Videos

Ethics in Research01:56

Ethics 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.
Nurses' Legal Responsibilities I01:27

Nurses' Legal Responsibilities I

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:
Randomized Experiments01:13

Randomized Experiments

The randomization process involves assigning study participants randomly to experimental or control groups based on their probability of being equally assigned. Randomization is meant to eliminate selection bias and balance known and unknown confounding factors so that the control group is similar to the treatment group as much as possible. A computer program and a random number generator can be used to assign participants to groups in a way that minimizes bias.
Simple randomization
Simple...
Blinding01:11

Blinding

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.
Types of Biopharmaceutical Studies: Controlled and Non-Controlled Approaches01:23

Types of Biopharmaceutical Studies: Controlled and Non-Controlled Approaches

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, controlled...
Bioavailability Study Design: Healthy Subjects Versus Patients01:15

Bioavailability Study Design: Healthy Subjects Versus Patients

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,...

You might also read

Related Articles

Articles linked to this work by shared authors, journal, and citation graph.

Sort by
Same author

Pharmacokinetics and pharmacodynamics of a long-acting monoclonal antibody against malaria in African adults.

The Journal of clinical investigation·2026
Same author

Ethical Challenges in the Delivery of Family-Centered Nursing Care.

Journal of family nursing·2026
Same author

Risk-calibrated sharing of human brain data.

Brain : a journal of neurology·2026
Same author

The next phase in Long COVID research: addressing the ethical challenges in trials of disease-modifying treatments.

EClinicalMedicine·2026
Same author

Safety and efficacy of the monoclonal antibody L9LS for malaria prevention in children exposed to perennial malaria transmission in Kenya: a randomised, double-blind, placebo-controlled, phase 2 trial.

Lancet (London, England)·2026
Same author

Ethical Considerations for Clinical Research in Persons with a Terminal Illness.

Aging and disease·2026

Related Experiment Video

Updated: May 22, 2026

Working with Human Tissues for Translational Cancer Research
07:48

Working with Human Tissues for Translational Cancer Research

Published on: November 26, 2015

Randomization to standard and concise informed consent forms: development of evidence-based consent practices.

Mary E Enama1, Zonghui Hu, Ingelise Gordon

  • 1Vaccine Research Center, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD 20892-3017, USA. Mary.Enama@nih.gov

Contemporary Clinical Trials
|May 1, 2012
PubMed
Summary

Concise informed consent forms are as effective as standard ones for participant comprehension and satisfaction in clinical trials. This approach supports evidence-based consent practices, ensuring ethical research conduct.

More Related Videos

A Novel Method for Involving Women of Color at High Risk for Preterm Birth in Research Priority Setting
14:43

A Novel Method for Involving Women of Color at High Risk for Preterm Birth in Research Priority Setting

Published on: January 12, 2018

A Familiarization Protocol Facilitates the Participation of Children with ASD in Electrophysiological Research
08:42

A Familiarization Protocol Facilitates the Participation of Children with ASD in Electrophysiological Research

Published on: July 31, 2017

Related Experiment Videos

Last Updated: May 22, 2026

Working with Human Tissues for Translational Cancer Research
07:48

Working with Human Tissues for Translational Cancer Research

Published on: November 26, 2015

A Novel Method for Involving Women of Color at High Risk for Preterm Birth in Research Priority Setting
14:43

A Novel Method for Involving Women of Color at High Risk for Preterm Birth in Research Priority Setting

Published on: January 12, 2018

A Familiarization Protocol Facilitates the Participation of Children with ASD in Electrophysiological Research
08:42

A Familiarization Protocol Facilitates the Participation of Children with ASD in Electrophysiological Research

Published on: July 31, 2017

Area of Science:

  • Clinical Trials
  • Research Ethics
  • Informed Consent

Background:

  • Informed consent is crucial for ethical clinical trials, but current practices are often policy-driven.
  • Developing evidence-based consent practices is essential for improving trial conduct.
  • This study investigated the impact of consent form length on participant understanding and satisfaction.

Purpose of the Study:

  • To assess participant comprehension of study information.
  • To evaluate participant satisfaction with concise versus standard informed consent forms.
  • To contribute to evidence-based practices in clinical trial consent.

Main Methods:

  • 111 participants in two Phase I influenza vaccine trials were randomized to either a standard or a concise informed consent form.
  • Concise forms contained 63% fewer words than standard forms.
  • Comprehension and satisfaction were assessed via questionnaires at enrollment and study completion.

Main Results:

  • No significant difference in comprehension scores between the concise and standard consent groups.
  • A trend indicated that participants with concise forms felt better informed.
  • Both groups found the length and detail of their respective consent forms appropriate.

Conclusions:

  • Concise informed consent forms are ethically viable and do not compromise participant comprehension or satisfaction.
  • Evidence-based consent practices can be developed by comparing different consent form lengths.
  • Well-trained staff and ongoing opportunities for discussion are key to ethical consent processes, regardless of form length.