Informed Consent

12

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

Shared Decision-Making During Anesthesia Consent for Elective Cesarean Delivery

Shared decision-making (SDM) is the accepted ethical and legal standard for informed consent, but it is not known how it operates in anesthesia consent for cesarean delivery. Neuraxial anesthesia is recommended for most cesarean deliveries, and many anesthesiologists therefore present it as the only primary option, with general anesthesia (GA) available only as a rescue. Others present GA as a genuine alternative the patient can choose. This study will observe the existing variation in practice and will not change care. A trained observer will attend the pre-operative anesthesia consent encounter for women having an elective cesarean delivery at BC Women's Hospital and record which options were presented, using the observer-rated OPTION-5 instrument. Written research consent and a questionnaire follow 24-48 hours after delivery, and include the 9-item Shared Decision Making Questionnaire (SDM-Q-9). The primary aim is to compare patient-perceived SDM (SDM-Q-9) between consultations in which GA was offered as a genuine primary option and those in which it was not. This study hypothesizes that the SDM-Q-9 score will be higher when GA was offered as a primary option. Secondary aims are to describe observed SDM, decisional conflict, provider-level variation, and women's preference to be offered a choice in a future cesarean. The findings will inform a planned interventional trial of a standardized consent model.

Participants needed: 105
Trial details
Age: 19+Biological sex: FemaleType: ObservationalSponsor: University of British ColumbiaUpdated: Oct 8, 2026Locations: 1
Eligibility criteria

Age 19 years or older [+4]

Conversion to urgent/emergency cesarean delivery before consent is completed [+3]

Status: Recruiting

Human Voice vs AI-Cloned Voice Audio Added to Written Consent Before Ureteroscopy or Retrograde Intrarenal Surgery (AUDIO-CONSENT)

Before kidney stone surgery with a flexible or semirigid ureteroscope, patients must read and sign a written consent form, but many patients find these forms long and hard to understand. This study tests whether listening to an audio recording of the same consent form, in addition to the usual written form and the surgeon's explanation, helps patients understand the operation better. It also asks whether it matters if the recording is read by a real urologist or produced by artificial intelligence (AI) from a clone of that same urologist's voice. Adults scheduled for their first ureteroscopy or retrograde intrarenal surgery at three hospitals in Turkey will be randomly assigned to one of three groups: (A) standard written consent only, (B) standard consent plus an audio recording read by a urologist, or (C) standard consent plus the same text produced by an AI-cloned version of the same urologist's voice. All three groups receive exactly the same information, word for word; only the way it is delivered differs. Patients in group C are told that the voice was produced by AI. The main outcome is a 10-question knowledge test on the content of the consent form, taken immediately after the consent process. Anxiety (State-Trait Anxiety Inventory) and satisfaction are also measured on the same day. No forms are completed on the day of surgery.

Participants needed: 240
Trial details
Age: 18+Biological sex: AllType: InterventionalSponsor: Aydin Adnan Menderes UniversityUpdated: Oct 7, 2026Locations: 3
Eligibility criteria

Age 18 years or older [+3]

Hearing or visual impairment preventing use of the study materials [+5]

Status: 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: Sep 22, 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: 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: Aug 25, 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

Physician vs Artificial Intelligence Counseling Before Elective Cesarean Delivery: A Randomized Controlled Trial

This randomized controlled trial will compare two methods of providing preoperative counseling before elective cesarean delivery: counseling by an obstetrician-gynecologist and counseling delivered through an artificial intelligence (AI)-based system. The study aims to evaluate the effects of these counseling methods on patients' anxiety levels, understanding of medical information, and satisfaction with the counseling process. Women scheduled for elective cesarean delivery will be randomly assigned to receive either standard physician counseling or AI-based counseling containing the same medical information. Anxiety, knowledge, and satisfaction will be assessed using questionnaires before and after counseling.

Participants needed: 50
Trial details
Age: 18+Biological sex: FemaleType: InterventionalSponsor: Wolfson Medical CenterUpdated: Aug 13, 2026Locations: 1
Eligibility criteria

Women aged 18 years or older [+4]

Non-elective cesarean delivery (urgent or emergency cesarean delivery) that does... [+5]

Status: Not yet recruiting

Chatbot Implementation In The Clinical Informed Consent Process

The purpose of this study is to determine the feasibility of implementing the chatbot "CoCo" in the IC process for research studies. We hypothesize that implementing a chatbot into the IC process will facilitate accurate information delivery and enhance participant comprehension and process satisfaction compared to traditional remote consent methods.

Participants needed: 100
Trial details
Age: 18+Biological sex: AllType: InterventionalSponsor: M.D. Anderson Cancer CenterUpdated: Aug 10, 2026Locations: 1
Eligibility criteria

Ability to understand and willingness to provide informed consent. [+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: Jul 31, 2026Locations: 2
Eligibility criteria

Adult (> 18 years) [+2]

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

Status: Not yet recruiting

Digital-Supported Versus Standard Consent for Advanced Therapeutic Endoscopy

This study will evaluate whether a digital-supported informed consent process improves patient understanding before advanced therapeutic endoscopy procedures. Patients undergoing advanced therapeutic endoscopy are often asked to make decisions about procedures that may be complex and involve important risks, benefits, and alternatives. Standard informed consent is usually provided through discussion with the treating physician. However, this process can vary between clinicians and may be affected by time pressures in busy endoscopy units. In this study, eligible adult patients scheduled for elective advanced therapeutic endoscopy will be randomly assigned to one of two consent pathways. One group will receive standard physician-led informed consent. The other group will receive a digital-supported consent pathway that includes a standardized procedure-specific educational video, an offline artificial intelligence-based question-answering tool, and final confirmation with the treating physician before the procedure. The digital tool is designed to provide plain-language information about the procedure, including why it is being done, expected benefits, common and serious risks, alternatives, what to expect before and after the procedure, and the patient's right to ask questions or decline the procedure. The AI question-answering tool will use only investigator-approved educational content and will not provide individualized medical advice. Questions requiring patient-specific medical judgment will be directed back to the treating clinical team. The main outcome of the study is patient comprehension of the consent information, measured after the assigned consent process and before the procedure. The study will also evaluate patient anxiety, satisfaction, confidence in decision-making, usability of the consent process, workflow outcomes, and consent-related safety or ethical concerns.

Participants needed: 180
Trial details
Age: 18+Biological sex: AllType: InterventionalSponsor: Unity Health TorontoUpdated: Jul 23, 2026Locations: 1
Eligibility criteria

Adults aged 18 years or older [+4]

Emergent or urgent procedures where the consent process cannot reasonably incorp... [+6]

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: 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]