Prospectively informed consent. Medical search. Frequent questions

Written informed consent is obtained from patients with confirmed mitochondrial disease. (bmj.com)
Biomarkers to risk-stratify patients with RD could help individualize adjuvant therapy and inform future adjuvant therapy trials. (nature.com)
All of the patients were informed about the study design and gave written consent to join the study. (hindawi.com)
Cellular phone conversations between on-scene patients or their legally authorized representatives (LARs) and off-scene enrolling physician-investigators require immediate and reliable connection systems to obtain explicit informed research consent in prehospital treatment trials. (karger.com)
The NIH Field Administration of Stroke Therapy - Magnesium (FAST-MAG) Trial implemented a voice-over-internet protocol (VOIP) simultaneous ring system (multiple investigator cell phones called simultaneously and first responder connected to call) to enable physician-investigators to elicit consent immediately from competent patients or LARs encountered by 228 ambulances enrolling patients in a multicenter prehospital stroke trial. (karger.com)
Written informed consent was obtained from all patients upon inclusion. (wjgnet.com)
Approximately 1300 patients with metastatic breast cancer who have received no more than one line of systemic treatment for advanced disease will, after giving informed consent, donate archived primary tumour tissue, as well as will donate tissue collected prospectively from the biopsy of metastatic lesions and blood. (nih.gov)
Patients scheduled for lung resection for cancer (University Hospital of Reims, Reims, France) were prospectively recruited following standards approved by the institutional review board (IRB Reims-CHU-20110612). (ersjournals.com)
All patients with aneurysms treated with the WEB were prospectively included in a data base. (ajnr.org)
We prospectively examined the medical records of all patients, younger than 2 years, who underwent frontalis suspension surgery with PTFE to address a severe unilateral congenital ptosis. (researchsquare.com)
Retrospective review of a prospectively maintained database was conducted on all patients who underwent primary LRYGB at an American College of Surgeons Bariatric Surgery Center of Excellence from 1998-2012. (sages.org)
Patients were prospectively recruited between January 2021 and January 2022. (biomedcentral.com)
All patients signed a written informed consent to participate in the present study. (biomedcentral.com)
All patients filled out informed consent to enter in this study. (surgicalneurologyint.com)
However, this proved to be costly and resulted in a non-representative sample of patients This finding was of great importance in informing the debate around the need for patient consent for participation in clinical registries and anonymous databases. (wikipedia.org)
Serum samples were prospectively collected from 57 patients receiving salvage chemotherapy and 70 non-EGFR mutated patients receiving erlotinib. (biomedcentral.com)
We prospectively analyzed the IgG4-RD patients recruited in Peking Union Medical College Hospital from January 2011 to August 2018 and identified patients diagnosed with IgG4-RD complicating malignancies. (nature.com)
We consecutively collected data on patients with IgG4-RD and malignancies who were prospectively enrolled in the IgG4-RD cohort in PUMCH from January 2011 and June 2018. (nature.com)
Data were collected prospectively for 307 newly diagnosed patients, including detailed demographic data, disease history, health care consultations and referral process. (who.int)
Informed consent for treat- geal origin, with an annual age-standardized ment was signed by all patients. (who.int)
Clinical data were collected when patients were admitted and prospectively until hospital discharge. (cdc.gov)
Purpose: In the BRCAsearch study, unselected breast cancer patients were prospectively offered germline BRCA1/2 mutation testing through a simplified testing procedure. (lu.se)

The authors prospectively compared clinical outcomes in terms of healing & audiological outcomes of two groups. (thieme-connect.com)

Patient data (n = 768) from six prospectively collected cohorts, clinically assessed using DSM-IV and the Delirium Rating Scale-Revised-98 (DRS-R98), were pooled. (biomedcentral.com)

The study was approved by the local ethics committee, and written informed consent was obtained from all participants. (cdc.gov)
The present study was approved by the ethical committee of the Faculty of Medicine of El Minia university (approval number 623-3/2020), and informed written consent was obtained from the participants after detailed explanation of the study and its purpose. (thieme-connect.com)
One year after the test results were delivered, a study-specific questionnaire was mailed to the study participants who had consented to testing. (lu.se)
Among 12 persons tested prospectively before and during SARS-CoV-2 infection, ten of 12 participants (83%) had completed a primary COVID-19 vaccination series prior to the outbreak. (cdc.gov)
Parents of the participants in the study gave their informed consent before the study began. (bvsalud.org)

Demographic and clinical data were prospectively recorded. (cdc.gov)

Clinical data is recorded retrospectively and prospectively. (bmj.com)
This study represented a cross-sectional evaluation of prospectively collected data conducted between September 2002 and April 2014 using Bindal's scale. (surgicalneurologyint.com)
The registry initially required informed patient consent for complete data collection and follow up interviews. (wikipedia.org)
In 2005, it became a "prescribed entity" under Ontario's Personal Health Information Protection Act, permitting the collection of patient data without consent for the purposes of improving the provision of stroke care. (wikipedia.org)

To investigate prospectively the association between DMH and MIH and the etiologic factors involved in both defects. (bvsalud.org)

The purpose of this study was to ascertain the 30 and 90-day procedure-related morbidity and mortality of laparoscopic Roux-en-Y gastric bypass (LRYGB) at a single university hospital to facilitate consistent patient counseling and informed consent. (sages.org)
The findings of the IQS demonstrated that there needed to be alternative approaches and modifications made to the consenting process to facilitate a woman-centred strategy to recruitment, guided by the principles of the framework for good practice (Table 6 ). (biomedcentral.com)

This was a retrospective review that approved by the Ethics Committee of the Hunan Children's Hospital (KS2015-48) and all subjects provided written informed consent. (researchsquare.com)

Le retard au diagnostic a été classé en trois catégories : lié au patient, lié au professionnel et global. (who.int)
The patient, the consenting family member, or the legal guardian should be told about the procedure and any potential complications or disabilities. (medscape.com)
A patient need not have the same level of awareness at all times to provide legally adequate informed consent. (medscape.com)
On the other hand, deficits in understanding or reasoning may be so severe that a patient should not bear the responsibility for making informed choices. (medscape.com)
If a patient is considered unable to provide informed consent, the first alternative is any specific written document or empowerment executed when the patient was capable of choosing and intended to direct future care. (medscape.com)

This study describes the surgical technique utilizing breast MRI blood flow information to preserve important NAC blood supply, thereby, reducing ischemic complications.After IRB approval, a prospectively maintained database of all NSM by a single breast surgeon from 2018 to 2020 formed the study group. (stanford.edu)
These complexities add an additional layer of challenge to the usual requirements of consent including understanding the study purpose, the nature of the intervention(s), the right of withdrawal, risks and benefits of participation, how findings will be shared, confidentiality maintained and, in randomised studies, concepts such as equipoise and randomisation. (biomedcentral.com)
In particular, soluble fiber may be important in and 48 mo from 3358 children from the United States and Germany this respect, because it is converted to the short-chain fatty acids prospectively followed in the TEDDY (The Environmental Deter- acetate, propionate, and butyrate by bacterial fermentation in the minants of Diabetes in the Young) study. (lu.se)

Objectives We undertook a rapid systematic review with the aim of identifying evidence that could be used to answer the following research questions: (1) What is the clinical effectiveness of tests that detect the presence of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) to inform COVID-19 diagnosis? (bmj.com)
2) What is the clinical effectiveness of tests that detect the presence of antibodies to the SARS-CoV-2 virus to inform COVID-19 diagnosis? (bmj.com)

It is unclear whether the research literature on adolescent gender dysphoria (GD) provides sufficient evidence to adequately inform clinical decision making. (plos.org)
Decisional capacity is a prerequisite for providing legally and morally sufficient informed consent or refusal. (medscape.com)

With IRB approval and informed consent and assent, 24 consecutive subjects undergoing torso or extremity MRI were prospectively recruited. (arxiv.org)

All efforts should be made to inform women of trial information before the birth admission. (biomedcentral.com)

Some of these concerns, such as ensuring the welfare of research animals and obtaining appropriate consent for the use of human tissues, also apply to many other areas of research, but may require special consideration for research with human neural organoids, cell transplants, and chimeras. (nationalacademies.org)
Informed consent is a not an event, but a complex process [ 1 ] central to the ethical conduct of research [ 2 ]. (biomedcentral.com)
Gaining consent for research interventions initiated during the intrapartum period involves added complexities to the norm: not only are women required to assess the potential harm versus benefit to their baby in addition to themselves, but there may also be time pressure for the intervention to be initiated. (biomedcentral.com)

The inclusion of vignettes elicited less guarded views on the informed consent process. (biomedcentral.com)

topathological type were obtained from Diagnosing nasopharyngeal carcinoma a prospectively collected NPC database. (who.int)
[27 - 29] Algorithmic-enabled productivity and performance systems often represent a type of management control without worker consent when surveillance is not prospectively disclosed to workers. (cdc.gov)

Demographic and clinical data were prospectively recorded. (cdc.gov)
21 CFR Ch. I (4-1-01 Edition) a member of or consultant to the IRB tacted for consent within that window and who is not otherwise participating rather than proceeding without con- in the clinical investigation) finds and sent. (nih.gov)
The purpose of this chapter is to provide an ethical framework for obtaining informed consent and permission for registry participation and to distinguish registries from clinical research protocols with respect to these issues. (nih.gov)
It is important to note that registries are increasingly being used for research purposes even when initially developed for clinical or other purposes, and thus it is suggested that in all cases, consideration should be given to the informed consent issues, as well as HIPAA privacy requirements, discussed in this chapter. (nih.gov)
Informed consent explains risks and potential benefits about a clinical trial before someone decides whether to participate. (nih.gov)
The IRB at one site (Emory University, IRB00096348) provided waiver of informed consent for clinical investigations involving no more than minimal risk to human subjects ( https://www.fda.gov/media/106597/download ). (biomedcentral.com)
Clinical information was prospectively recorded ( 8 ). (cdc.gov)
However, this proved to be costly and resulted in a non-representative sample of patients This finding was of great importance in informing the debate around the need for patient consent for participation in clinical registries and anonymous databases. (wikipedia.org)
A broader understanding of the barriers and facilitators to POCT uptake in real world situations could help inform effective implementation of these technologies into clinical teams in the future. (biomedcentral.com)
The written consent form typically includes statements covering the intention to perform genetic analyses, establish cell lines, and to share data with the scientific community (including academic and industry) for research (non-clinical) use. (nih.gov)
At the Clinical Center, the original signed informed consent document must be forwarded to the Health Information Management Department for review and inclusion in CRIS. (nih.gov)
In this study we focused our attention on possible predictors, either in terms of clinical remission as well as in terms of x-ray remission (or lack of progression), in a cohort of ERA prospectively treated according to a very strict protocol. (bmj.com)

As a result of this finding, many jurisdictions now waive the requirement for informed consent for these purposes. (wikipedia.org)
This single-center prospective study was approved by the institutional review board, and the requirement for informed consent was waived. (biomedcentral.com)

and (5) specimen could be aliquoted and tested or frozen within 1 day while stored at 4 °C. All specimens were coded such that they were not individually identifiable and so that the results of the experimental PCR testing could not be used to inform patient care. (biomedcentral.com)
We prospectively collected radical nephrectomy (RN) specimens, to analyze the histological changes within peritumoral and distant parenchyma. (biomedcentral.com)
If, after the subject has signed the consent form, specimens and/or data are collected locally for research purposes, no analyses of these specimens and/or data may occur until the investigator has verified that the subject has returned a signed and dated informed consent document, unless the IRB has granted a waiver of documentation of consent. (nih.gov)

Treatment will continue until either objective disease progression, unacceptable toxicity occurs, consent is withdrawn, other discontinuation criterion is met, or study completion. (astrazenecaclinicaltrials.com)
Follow-up assessments should be performed every 8 weeks (±7 days) after the start of treatment until 4 month, and then every 12 weeks until objective disease progression as defined by RECIST 1.1 even if a patient discontinues treatment prior to progression (unless they withdraw consent). (astrazenecaclinicaltrials.com)

Between March 2008 and August 2015, we prospectively analysed 81 consecutive patients eligible for ASCT for haematological diseases. (ersjournals.com)
We prospectively studied the agreement between TcP co 2 and Pa co 2 measurements in 22 consecutive patients with AECOPD admitted to the respiratory support unit (RSU) from the emergency department with persistent ventilatory failure (Pa co 2 ⩾6 kPa) requiring NIV treatment. (bmj.com)
72 pure and 22 part-solid GGNs) were prospectively enrolled and underwent two consecutive computed tomographic (CT) examinations. (rsna.org)

To prospectively assess and compare the measurement variability of volume and mass for pure and part-solid ground-glass nodules (GGNs) with solid portions less than or equal to 5 mm by using a commercially available volumetric software program. (rsna.org)

After providing written, informed consent, patients were asked to submit 1 stool specimen for viral RNA detection during hospitalization, regardless of gastrointestinal symptoms. (cdc.gov)

This chapter identifies the best practices for obtaining informed consent and permission for registry participation. (nih.gov)
The institutional review board waived requirements for informed consent for this institutional PCI registry. (biomasswars.com)

President on the informed consent (ii) The adequacy of the plan to dis- waiver request. (nih.gov)
The informed consent document must be signed and dated by the subject, parent or the LAR, and a copy of the signed informed consent document must be provided to the subject who signed it (except when the IRB has approved a waiver of documentation of informed consent). (nih.gov)

When obtaining consent or assent from a participant who is considered part of a vulnerable population or who does not understand English, the applicable subparts (B-D) of the federal regulations for the protection of human subjects and NIH HRPP policies must be followed. (nih.gov)

The underlying contributing factors require a better understanding to inform the potential of interventions that could improve survival. (plos.org)
A research study in which one or more human subjects are prospectively assigned to one or more interventions (which may include placebo or other control) to evaluate the effects of those interventions on health-related biomedical or behavioral outcomes. (nih.gov)

4) DOD is to submit to FDA sum- affect the determination to use an in- maries of institutional review board vestigational new drug without in- meetings at which the proposed pro- formed consent. (nih.gov)
WHEREAS, the policies and procedures for obtaining consent for brain tissue donation, access to the medical records of the decedents and interviews with informants have been reviewed and approved by the appropriate authorities, including Institutional Review Board (IRB), at each participating NBB site, and have been reviewed by the NIH. (nih.gov)
this is considered human subjects research and as such requires approval from an institutional IRB and informed consent. (nih.gov)
All patients gave their informed consent to enter into the study, which was approved by our Ethics Institutional Committee. (bmj.com)

Case Examples 16 , 17 , and 18 provide descriptions of how different registries have approached informed consent. (nih.gov)
The focus of this chapter is on informed consent and authorization issues that arise in registries used for research. (nih.gov)

6) The IRB has reviewed and ap- evidence, which may include evidence proved informed consent procedures obtained through randomized placebo- and an informed consent document controlled investigations, is necessary consistent with § 50.25. (nih.gov)

To prospectively compare magnetic resonance (MR) imaging-defined abnormalities of osteoarthritis (OA) of the knee with radiographic severity measurements of OA of the knee and self-reported pain. (nih.gov)

Nonetheless, all patients signed an informed consent form. (ersjournals.com)
Be sure to use the most recent IRB-approved version of the consent form. (nih.gov)
Whenever possible, you should provide the potential subject with the consent form before the consent discussion so that they have time to read it and discuss with others if they desire (e.g., family member, their primary care provider). (nih.gov)
The subject should be provided with the consent form in advance of the consent conversation. (nih.gov)
After the consent process has been conducted and the investigator has responded to the subject's questions, the subject signs the consent form noting the current date. (nih.gov)
When the signed/dated consent form is returned to the investigator who conducted the consent discussion, the investigator signs and dates the consent form with the date they received the signed the consent from the subject. (nih.gov)
The investigator should then record another note in CRIS/medical/research record indicating the updated status, send a copy to medical records (or research record if there is no medical record), and provide a copy of the completed consent form to the subject. (nih.gov)

The consent should have a stamp with the IRB approval date. (nih.gov)

citation needed] The CSN also created a website to inform Canadians about sodium content in food. (wikipedia.org)

Written informed consent was obtained. (rsna.org)

In addition, we prospectively obtained peripheral blood mononuclear cells (PBMC) and plasma from patients after obtaining their informed consent before treatment. (esmo.org)
In addition, the process for obtaining electronic signature must be prospectively reviewed and approved by the IRB. (nih.gov)

Exception from informed con- without informed consent otherwise sent requirements for emergency conforms with applicable law. (nih.gov)
Patients were happy with the information they had been given but did not remember enough from the informed consent process to satisfy legal requirements. (pesudovs.com)

With informed owner consent, ultrasound, noncontrast CT, contrast radiography, and contrast CT (with contrast medium administered into the cloaca) were performed in conscious animals. (avmi.net)

Le retard au diagnostic a été classé en trois catégories : lié au patient, lié au professionnel et global. (who.int)

Safety information should be visit in siteand will be prospectively collected from informed consent to the end of the follow-up period, defined as 3028 days (± 7 days) after last dose of Savolitinib, or 90 days (± 7 days) after last dose of Durvalumab which comes later. (astrazenecaclinicaltrials.com)

Remote consent processes can be used but must be described in the protocol and approved by the IRB prior to use. (nih.gov)

Successfully enrolled, eligible patients will receive treatment of durvalumab (1500 mg, ivgtt, q4w) in combination with savolitinib (600mg for BW≥50kg, 400mg for BW＜50kg, p.o., q.d.) after informed consent signed. (astrazenecaclinicaltrials.com)

Fifty English-speaking patients who underwent non-urgent cataract extraction at Flinders Medical Centre, South Australia, were prospectively enrolled. (pesudovs.com)

Diseases2

Analytical, Diagnostic and Therapeutic Techniques and Equipment33

Psychiatry and Psychology28

Phenomena and Processes2

Disciplines and Occupations13

Anthropology, Education, Sociology and Social Phenomena41

Technology, Industry, Agriculture2

Humanities22

Information Science17

Named Groups11

Health Care89

Geographicals4

Patients22

Clinical outcomes1

Clinically1

Participants5

Demographic1

Data4

Investigate1

Facilitate2

Ethics committee1

Patient5

Study3

Diagnosis2

Sufficient2

Subjects1

Made1

Research3

Process1

Type2

Clinical12

Requirement for informed consent2

Specimens3

Progression2

Consecutive3

Assess1

Gastrointestinal1

Registry2

Waiver2

Assent1

Interventions2

Institutional4

Registries2

Investigations1

Compare1

Form7

Approval1

Citation1

Written informed consent1

Addition2

Requirements2

Contrast1

Patient1

Visit1

Protocol1

Treatment1

Medical1