Informed Consent

9

Review clinical trials related to Informed Consent. Use filters to narrow results by trial status, phase, treatment, biological sex and sponsor.

Condition / disease
Location
Status: Not yet recruiting

Consent Understanding and Propofol Requirement During Endobronchial Ultrasound

The goal of this observational study is to learn whether a participant's understanding of the informed consent information is related to the amount of propofol needed during endobronchial ultrasound (EBUS). EBUS is a procedure that uses a thin camera and ultrasound to look at lymph nodes and other areas inside the chest. Propofol is a sedative medicine used to help participants stay comfortable during the procedure. Before EBUS, all participants will receive the usual information about the procedure as part of routine care. After this routine consent process, participants will answer short questions about what they understood. They will also answer questions about their anxiety before the procedure. The study will not change the usual consent process, sedation plan, or medical care. During EBUS, participants will receive usual sedation and monitoring according to routine clinical practice. The research team will record how much sedative medicine is used, whether extra sedation is needed, whether any important clinical events occur, and how participants recover after sedation. The main question is whether participants who understand the consent information better need less propofol during EBUS.

Participants needed: 75
Trial details
Age: 18+Biological sex: AllType: ObservationalSponsor: Uludag UniversityUpdated: Jul 1, 2026Locations: 1
Eligibility criteria

Age 18 years or older [+4]

Active psychiatric disease that may affect the informed consent process, anxiety... [+7]

Status: Not yet recruiting

Supporting Just-In-Time Consent for Prenatal Screening: The INFORM Study

This clinical trial is about prenatal genetic screening. It will test an intervention to help people make decisions about screening. The intervention is a short set of information cards about screening. This intervention is for pregnant participants. They will use the intervention on their mobile phone before they see their doctor. The study has one main question: * Do participants who use the intervention feel more confident when they make a decision about screening? Researchers will compare participants who use the intervention to participants who do not. All participants will have their usual care when they visit their doctor. What will participants do? * Participants must be pregnant. They will sign up for the study before their first doctor's visit for their pregnancy. This is the visit where their doctor usually talks with them about screening. * Some participants will use the intervention before their first doctor's visit. Other participants will not use it. * All participants will talk with a researcher on the phone after their first doctor's visit. * Participants who use the intervention will answer a short survey on their phone. * A few participants who use the intervention will talk with a researcher a second time on the phone.

Participants needed: 1,400
Trial details
Age: 18+Biological sex: FemaleType: InterventionalSponsor: Case Western Reserve UniversityUpdated: Jul 1, 2026Locations: 3
Eligibility criteria

Currently pregnant and receiving care at a participating collaborative site - Un... [+4]

Not pregnant, not a patient at a partner clinical site [+4]

Status: Not yet recruiting

QR Code-Based Video-Supported Anesthesia Information and Preoperative Anxiety

This study aims to evaluate the effects of QR code-based video-supported anesthesia information on preoperative anxiety, comprehensibility of information, and patient satisfaction in adult patients undergoing elective surgery. Participants will be randomly assigned in a 1:1 ratio to either a control group receiving standard written informed consent and routine verbal anesthesia information or an intervention group receiving the same standard information plus a standardized video-based educational intervention accessed through a QR code. The primary outcome is the change in the Amsterdam Preoperative Anxiety and Information Scale (APAIS) anxiety score before and after the information process. Secondary outcomes include comprehensibility of information and patient satisfaction assessed using a structured Likert-type questionnaire. The findings may contribute to the standardization of patient information processes in anesthesia outpatient clinics through a low-cost and easily implementable digital educational approach.

Participants needed: 284
Trial details
Age: 18+Biological sex: AllType: InterventionalSponsor: Elazıg Fethi Sekin Sehir HastanesiUpdated: Jun 16, 2026Locations: 1
Eligibility criteria

Age 18 years or older [+4]

Emergency surgery [+7]

Status: Recruiting

AI-Driven Consent Simplification Study

The overarching goal of this pilot is to explore how generative artificial intelligence (genAI) can be used to improve the accessibility and understandability of informed consent materials in clinical research. The study will test the extent to which informed consent text can be improved by large language models (LLM; specifically, ChatGPT and NotebookLM) along with other AI tools (specifically, ElevenLabs) through qualitative and quantitative analyses. Simplifying such forms using genAI may facilitate better comprehension, ensuring truly informed consent. Improving informed consent form (ICF) comprehension can lead to more informed and willing participation in clinical studies. This improved understanding may result in higher enrollment rates, better subject retention, and more accurate data collection as individuals will have a clearer understanding of study procedures and risks.

Participants needed: 230
Trial details
Age: 18+Biological sex: AllType: ObservationalSponsor: University of California, Los AngelesUpdated: May 8, 2026Locations: 1
Eligibility criteria

Age 60 years and above [+9]

Group 1: None [+2]

Status: Recruiting

Optimizing Timing of Cesarean Delivery Consent on Labor and Delivery

Nationally, 32.1% of pregnant patients deliver via cesarean delivery, including both patients who undergo a planned cesarean delivery and patients who intend to undergo vaginal delivery and are recommended to deliver via cesarean delivery. The investigators aim to understand how to optimize the patient experience for patients who present to the hospital intending to deliver vaginally but are recommended to deliver via cesarean delivery (an unplanned cesarean delivery). Practices regarding timing of informed consent for possible cesarean delivery vary widely across hospitals in the United States; some institutions will consent every patient on admission to the hospital for possible cesarean delivery, whereas some institutions consent patients for possible cesarean delivery only if a patient's clinical course suggests cesarean delivery may be indicated. This study aims to determine optimal timing for consent for possible cesarean delivery by randomizing patients to either be consented for possible cesarean delivery on admission to the hospital or if it appears to be clinically indicated. This study will only assess altered timing of a surgical consent process and will not impact the clinical care participants receive. After delivery, participants will share their experiences with the consent process and with their overall childbirth experience.

Participants needed: 200
Trial details
Age: 18+Biological sex: FemaleType: InterventionalSponsor: Duke UniversityUpdated: Apr 23, 2026Locations: 1
Eligibility criteria

18 years of age or older [+3]

Trial of labor after cesarean delivery [+6]

Status: Recruiting

Patient Preferences on Same-day Bilateral Intravitreal Dexamethasone Injections

Intravitreal injections with dexamethasone implant (Ozurdex®) provide a reasonable and long-lasting treatment option in the cases of diabetic macular edema, as well as macular edema resulting from retinal vein occlusion and noninfectious posterior uveitis. During the course of these diseases, both eyes may be affected and may need therapy. The treatment burden associated with frequent medical visits associated with treatments in both eyes and follow-ups can be significant for patients and caregivers alike. Same-session bilateral ophthalmic procedures have proven safe and cost-effective, with patients consistently expressing a strong preference for this approach, particularly in the cases of cataract surgery and anti-VEGF injections when given the choice. The safety profile of same-day bilateral dexamethasone injections aligns with those of unilateral injections. This patient preference study will focus on addressing the practical aspects of same-day bilateral dexamethasone injections from the patients' perspective and aims to explore the impact of personal and socio-economic variables, and the overall perspective of patients on choosing same-day bilateral dexamethasone injections. Understanding and mitigating the challenges patients face can lead to a more patient-friendly and resource-saving approach. Based on the outcomes of this study, considerations may be made to introduce bilateral injections at our department, potentially optimizing patient experience and clinical resources. The aim of the study is to establish patient preferences regarding the administration of intravitreal dexamethasone implant injections in both eyes on the same day, in the same session and to identify key motivating and limiting factors from the patients' perspective.

Participants needed: 200
Trial details
Age: 18+Biological sex: AllType: ObservationalSponsor: Rigshospitalet, DenmarkUpdated: Jul 24, 2025Locations: 1
Eligibility criteria

Having received at least one intravitreal dexamethasone implant in either eye [+3]

Status: Recruiting

Implementing a Novel Consent Process for Biospecimen Research After Newborn Screening

The purpose of this study is to implement an electronic consent education process for the retention and research use of residual dried bloodspots at four hospitals in Michigan and assess the impact of the new education, both on patients and hospital staff. The research team will recruit women who have just given birth to answer surveys about the Michigan BioTrust consent process. Surveys will be collected from participants in the hospital and again four weeks later. The research team will collect survey data from patient participants at each hospital prior to hospital staff implementation of the new education process and again after staff implementation.

Participants needed: 5,980
Trial details
Age: 18+Biological sex: AllType: InterventionalSponsor: Erin RothwellUpdated: Jun 19, 2025Locations: 2
Eligibility criteria

Adult (> 18 years) [+2]

Parents of infants who are born pre-term (< 37 weeks gestation) [+2]

Status: Not yet recruiting

Effectiveness of Immersive Virtual Reality in Nursing Students' Learning

Teaching using VR for basic cardiopulmonary resuscitation and patient examination (experimental group) will not result in differences in knowledge and skill acquisition compared to traditional classroom-based simulation teaching (control group), but it will lead to greater satisfaction and self-confidence. Open, single-center randomized clinical trial involving fourth-year nursing degree students at a public university. Participants will be assigned based on their usual teaching groups (ratio of 6-8 students per instructor) and, according to randomization, will receive a 1:1 assignment to either the control group (classroom-based simulation teaching) or the experimental group (classroom-based simulation teaching combined with VR headset teaching). The CONSORT checklist will be followed to report the study.

Participants needed: 140
Trial details
Age: 18+Biological sex: AllType: InterventionalSponsor: Universitat Jaume IUpdated: Feb 21, 2025
Eligibility criteria

Not listed

Status: Not yet recruiting

Analysis of the Persistence, Reservoir and HIV Latency

The APRIL study aims at analyzing HIV reservoirs, latency and persistence on antiretroviral therapy. It enrolls HIV-infected adults providing blood samples of which peripheral blood mononuclear cells are stored. The frequency, phenotype and inducibility of HIV-infected cells are then analyzed. These parameters may vary across the different clinical and therapeutic settings.

Participants needed: 500
Trial details
Age: 18+Biological sex: AllType: ObservationalSponsor: University Hospital, Strasbourg, FranceUpdated: Mar 2, 2023
Eligibility criteria

HIV-infection [+3]

HIV-uninfected [+3]