Clinical trials: Consent
Data Sharing
Ethical Challenges of Consent in Data Sharing
In recent years, Mahidol Oxford Tropical Medicine Research Unit (MORU) has coordinated some of the largest international studies involving many sites in low-income and hard-to-reach settings.
- Trial name
- Data Sharing (NCT03346720)
- Testing
- Semi-structured interviews, Focus group discussions (FGDs)
- Where
- 3 sites in Thailand
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- University of Oxford
Prostate Biopsy
Impact of Procedure Materials on Patient Anxiety, Depression, and Pain in Prostate Biopsy Consent
The gold standard for diagnosing prostate cancer is an ultrasound-guided prostate biopsy. Despite its low complication rates, the procedure can cause significant stress, discomfort and anxiety in patients.
- Trial name
- NCT06802783
- Testing
- Photo consent
- Where
- Turkey (Türkiye)
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- Marmara University
Consent Forms, Anesthesia
Effectiveness of Large Language Model for Anaesthesia and Procedural Consent
Patient understanding of anaesthesia risks remains inconsistent due to time constraints, language barriers, and variable clinician communication styles.
- Conditions
- Consent Forms, Anesthesia, Artificial Intelligence (AI)
- Trial name
- PEAR (NCT06949462)
- Testing
- PEAR
- Where
- 2 sites in Singapore
- Volunteers
- 120 people, healthy volunteers welcome
- Sponsor
- Singapore General Hospital
COVID-19 Pneumonia
Study to Evaluate the Dynamic Consent Model Based on the Blockchain-based Clinical Trial Platform METORY
Blockchain technology has gained attention for its decentralized feature and data integrity. The study aims to apply blockchain technology to implement dynamic consent model and evaluate the real-world experience as a form of…
- Trial name
- NCT05047016
- Testing
- Virtual investigational product
- Where
- 2 sites in South Korea
- Volunteers
- 60 people, healthy volunteers welcome
- Sponsor
- Seoul National University Hospital
Ethics, Narrative
Current Status of Porcine Derived Products in Surgery
Porcine derived products are being used as biological grafts in mainly in orthopedic surgery, neurosurgery, cardiovascular surgery and general surgery.
- Trial name
- NCT04664452
- Testing
- Questionnaire
- Volunteers
- 500 people, healthy volunteers welcome
- Sponsor
- Ankara University
Dental Anxiety
Effects of Consent Methods Performed According to Intelligence Types on Anxiety Associated with Third Molar Surgery
The aim of this study is to investigate the effect of information provided in accordance with intelligence type on anxiety associated with wisdom tooth surgery.
- Trial name
- NCT04613947
- Testing
- Informed consent, Third molar surgery
- Where
- Turkey (Türkiye)
- Volunteers
- 80 people, healthy volunteers welcome
- Sponsor
- Ordu University
Cancer, Alzheimer Disease
Implement and Test Visual Consent Template and Process
The investigators plan to conduct a stepped wedge randomized control trial to implement and test the consent template and process in three studies. Randomization will occur at the research coordinator/research team level.
- Trial name
- NCT06804837
- Testing
- Visual consent, Standard consent
- Where
- 3 sites in United States
- Volunteers
- 266 people, healthy volunteers welcome
- Sponsor
- Washington University School of Medicine
Informed Consent
Informed Consent and Clinical Trials
To understand the patients' meaning of the informed consent process in clinical trials. Objective of the study is: to assess, in a cohort of subjects included in clinical trials, whether the information and the informed Consent…
- Trial name
- NCT01635842
- Where
- Italy
- Volunteers
- 50 people, healthy volunteers welcome
- Sponsor
- Azienda Usl di Bologna
Parental Consent, Newborn
Recruiting to Clinical Trials on the Telephone
This study examined the use of the telephone for the purpose of informing expectant mothers about a randomized clinical trial assessing neonatal Bacille Calmette-Guérin vaccination.
- Conditions
- Parental Consent, Newborn, Vaccination
- Trial name
- NCT02570061
- Testing
- telephone, consultation face-to-face
- Volunteers
- 125 people, healthy volunteers welcome
- Sponsor
- Gorm Greisen
Cognitive Decline, Cognitive Dysfunction
Open-label, Post-marketing, Prospective Study to Assess Impact of COVID-19 on Cognitive Function in Patients
The objective of this study is to compare the impact of the coronavirus disease (SARS-CoV-2, or COVID-19) on cognitive function in the population of patients who have been diagnosed, treated and recovered from the COVID-19…
- Conditions
- Cognitive Decline, Cognitive Dysfunction, Brain Health, Post CoV-2 Syndrome
- Trial name
- COVID19 (NCT04950673)
- Testing
- Cognivue
- Where
- 4 sites in United States
- Volunteers
- 1,000 people, healthy volunteers welcome
- Sponsor
- Cognivue, Inc.
Healthy
Modified Consent Form Utility
Subjects enrolling into a nutrition study of the effects of tea on fat absorption will be randomized to receive either a standard informed consent document or a modified document that is shorter and more easily understood than…
- Trial name
- NCT00715923
- Testing
- Modified consent form, Standard consent form
- Where
- United States
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- University of California, Davis
Cancer
Improving Consent Experiences in Clinical Trials
This is a study to evaluate the impact of evidence-based visual key information (VKI) pages on participant's experiences with informed consent for research, enrollment in high-accruing studies that choose to use VKIs as part of…
- Trial name
- NCT07293520
- Testing
- Standard Consent Form, Visual Key Information (VKI) page
- Volunteers
- healthy volunteers welcome
- Sponsor
- Washington University School of Medicine
Pediatric, Critical Illness
Examining Health Literacy in Biorepository Consents
Previous research has shown that most parents would allow their child's leftover blood to be included in a de-identified biorepository using opt-out consent in an outpatient setting.
- Conditions
- Pediatric, Critical Illness, Consent
- Trial name
- NCT04953169
- Testing
- Biobank Video, Non-Video
- Where
- United States
- Volunteers
- healthy volunteers welcome
- Sponsor
- Ann & Robert H Lurie Children's Hospital of Chicago
Pregnancy, Down Syndrome
An Interactive Informed Consent and Education Program for Pregnant Women
The purpose of this study is to determine whether an interactive education program for prenatal testing is effective in improving pregnant women's understanding of and expectations towards prenatal screening and diagnosis.
- Trial name
- NCT01176019
- Testing
- Information about Prenatal Screening and Diagnosis
- Where
- 2 sites in United States
- Volunteers
- 150 people, healthy volunteers welcome
- Sponsor
- Northwestern University
Patient Satisfaction
The Use of an Online Learning and Consent Platform in Infertility Treatment
The primary purpose of this study is to objectively assess if interactive multimedia tutorials (online videos) enhances patients' comprehensive understanding of assisted reproductive technology (ART) adding EngagedMD, an online…
- Trial name
- NCT03962257
- Testing
- EngagedMD online learning platform
- Where
- 3 sites in United States
- Volunteers
- 100 people, healthy volunteers welcome
- Sponsor
- University of North Carolina, Chapel Hill
Attitude to Computers, Attitude of Health Personnel
An Interactive Patient-Centered Consent for Research Using Medical Records
The goal of this project is to develop and evaluate a novel, electronic informed consent application for research involving electronic health record (EHR) data.
- Conditions
- Attitude to Computers, Attitude of Health Personnel, Researcher-Subject Relations, Trust
- Trial name
- NCT03063268
- Testing
- Trust-Enhanced Messaging on E-Consent, Interactive features on E-Consent, Standard E-Consent
- Where
- United States
- Volunteers
- 734 people, healthy volunteers welcome
- Sponsor
- University of Florida
Health Risk Behaviors
Sexually Active Adolescent Focused Education
SAAFE will be pilot tested in 2 geographically distinct areas (Washington, DC and Deep South) with 100 participants from each site to 1) primarily assess the efficacy of improved self-efficacy, knowledge about HIV/STIs and…
- Trial name
- SAAFE (NCT03646032)
- Testing
- SAAFE, Control
- Where
- 2 sites in United States
- Volunteers
- 178 people, healthy volunteers welcome
- Sponsor
- Benten Technologies, Inc.
MSM, HIV Infections
Risk Taking Behaviour in MSM and the Denial of Sexually Transmitted Diseases and HIV
Four focus groups , each of 10-15 males, ages 20-50 years old, MSM will be conducted by a medical sociologist. Two groups will be HIV negative participants and two groups of HIV positive MSM. Every group will meet for two hours.
- Conditions
- MSM, HIV Infections, Risky Behaviors
- Trial name
- MSM HIV (NCT01279005)
- Volunteers
- 50 people, healthy volunteers welcome
- Sponsor
- Rambam Health Care Campus
Lumbar Radiculopathy
Comparison Between the Imaging Consent Form and the Existing Narrative Consent Form
This is a single-center, randomized, double-blind clinical study to compare patient comprehension and anxiety by comparing a traditional paper consent form to a multimedia consent form for patients undergoing transforaminal…
- Trial name
- NCT05874427
- Testing
- Multimedia informed consent, Standard informed consent
- Where
- South Korea
- Volunteers
- 34 people, healthy volunteers welcome
- Sponsor
- Seoul National University Hospital
Risk
Remembering Risk Using Visual Risk Display of MINS to Obtain Informed Consent to Undergo Elective Surgery
Disclosure of anticipated risks to individuals considering undergoing an elective operative procedure is an important aspect of informed consent process.
- Trial name
- NCT05098535
- Testing
- Visual Aid, Scripted Risk Discussion
- Where
- Canada
- Volunteers
- 108 people, healthy volunteers welcome
- Sponsor
- Queen's University