Informed consent in the genomics era.
Ontology highlight
ABSTRACT:
SUBMITTER: Mascalzoni D
PROVIDER: S-EPMC2535658 | biostudies-literature |
REPOSITORIES: biostudies-literature
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Project description:Purpose of Review:Genomic tests offer increased opportunity for diagnosis, but their outputs are often uncertain and complex; results may need to be revised and/or may not be relevant until some future time. We discuss the challenges that this presents for consent and autonomy. Recent Findings:Popular discourse around genomic testing tends to be strongly deterministic and optimistic, yet many findings from genomic tests are uncertain or unclear. Clinical conversations need to anticipate and potentially challenge unrealistic expectations of what a genomic test can deliver in order to enhance autonomy and ensure that consent to genomic testing is valid. Summary:We conclude that 'fully informed' consent is often not possible in the context of genomic testing, but that an open-ended approach is appropriate. We consider that such broad consent can only work if located within systems or organisations that are trustworthy and that have measures in place to ensure that such open-ended agreements are not abused. We suggest that a relational concept of autonomy has benefits in encouraging focus on the networks and relationships that allow decision making to flourish.
| S-EPMC6584705 | biostudies-other
Project description: Not available
| S-EPMC7473170 | biostudies-literature
Project description:Background: Currently, many initiatives are devoted to optimizing informed consent for participation in clinical research. Due to the digital transformation in health care, a shift toward electronic informed consent (eIC) has been fostered. However, empirical evidence on how to implement eIC in clinical research involving neonates is lacking. Methods: Semi-structured interviews were conducted with 31 health care professionals active in Belgium or the Netherlands. All health care professionals had experience in conducting clinical research involving neonates. Interviews were audio-recorded, transcribed and analyzed using the framework method. Results: Interviewees generally supported the use of eIC in clinical research involving neonates. For example, eIC could enable parents to receive study feedback via the eIC system. Requirements were expressed for parental involvement to decide on which feedback would be appropriate to return. Moreover, experts specialized in presenting information and designing electronic systems should be involved. Broad consensus among health care professionals indicates that the face-to-face-interaction between parents and the research team is vital to establish a relationship of trust. Therefore, it is necessary that the use of eIC runs alongside personal interactions with the parents. Concerns were raised about the accessibility of eIC to parents. For this reason, it was suggested that parents should always be given the possibility to read and sign a paper-based informed consent form or to use eIC. Conclusions: Health care professionals' views indicate that the use of eIC in clinical research with neonates may offer various opportunities. Further development and implementation will require a multi-stakeholder approach.
| S-EPMC8441012 | biostudies-literature
Project description:IntroductionPatients with acute ischemic stroke (AIS) and neurologic deficits are often unable to provide consent and excluded from emergency research participation. Experiences with exception from informed consent (EFIC) to facilitate research on potentially life-saving emergency interventions are limited. Here, we describe our multifaceted approach to EFIC approval for an ongoing randomized clinical trial that compares sedation versus general anesthesia (SEGA) approaches for endovascular thrombectomy during AIS.MethodsWe published a university clinical trial website with EFIC information. We initiated a social media campaign on Facebook within a 50 mile radius of Texas Medical Center. Advertisements were linked to our website, and a press release was issued with information about the trial. In-person community consultations were performed, and voluntary survey information was collected.ResultsA total of 193 individuals (65% female, age 46.7 ± 16.6 years) participated in seven focus group community consultations. Of the 144 (75%) that completed surveys, 88.7% agreed that they would be willing to have themselves or family enrolled in this trial under EFIC. Facebook advertisements had 134,481 (52% females; 60% ≥45 years old) views followed by 1,630 clicks to learn more. The website had 1130 views (56% regional and 44% national) with an average of 3.85 min spent. Our Institutional Review Board received zero e-mails requesting additional information or to optout.ConclusionOur social media campaign and community consultation methods provide a significant outreach to potential stroke patients. We hope that our experience will inform and help future efforts for trials seeking EFIC.
| S-EPMC8757510 | biostudies-literature
Project description: Not available
| S-EPMC1126664 | biostudies-literature
Project description: Not available
| S-EPMC1121943 | biostudies-literature
Project description:This article assesses the adequacy of informed consent to clinical genetic testing laws based on an examination of 15 states with institutions that had been involved in a National Institutes of Health-supported Clinical Sequencing Exploratory Research Consortium project. We identified relevant statutory provisions through a legal search engine and included statutes that describe the informed consent requirements for clinical genetic testing and/or the protections for genetic material, information, or data. We found that statutory definitions were often limited in problematic ways, such as focusing only on variants known to be associated with disease or negative health effects or associated with asymptomatic disease. Some statutes required complex levels of detail if applied to genomic technologies and set confusing disclosure standards for current use and future access. Others had exceptions from informed consent requirements for future research use, limited requirements for the destruction of specimens as opposed to derived data, or linked key definitional components to the evolving concept of "identifiability." Further reform and research are needed to ensure that state law protections advance as rapidly as the science they aspire to enable.
| S-EPMC5994926 | biostudies-literature
Project description:The doctrine of informed consent, as opposed to medical paternalism, is intended to facilitate patient autonomy by allowing patient participation in the medical decision-making process. However, regrettably, the surgical informed consent (SIC) process is invariably underestimated and reduced to a documentary procedure to protect physicians from legal liability. Moreover, residents are rarely trained in the clinical and communicative skills required for the SIC process. Accordingly, to increase professional awareness of the SIC process, a brief history and introduction to the current elements of SIC, the obstacles to patient autonomy and SIC, benefits and drawbacks of SIC, planning of an optimal SIC process, and its application to cases of an unruptured intracranial aneurysm are all presented. Optimal informed consent process can provide patients with a good comprehension of their disease and treatment, augmented autonomy, a strong therapeutic alliance with their doctors, and psychological defenses for coping with stressful surgical circumstances.
| S-EPMC5544373 | biostudies-other
Project description:IntroductionFrom the first day of residency, residents may be required to consent patients for interventions, procedures, or tests. The ability to perform an informed consent is considered one of the Association of American Medical College's Core Entrustable Professional Activities for entering residency. This case provides learners with the opportunity to obtain informed consent for a lumbar puncture procedure and to receive immediate structured feedback on their performance. This is a formative assessment, which has been used with both senior medical students and first-year residents at our institution.MethodsThe case involves a standardized patient with a history of leukemia who presents to the emergency department with a headache, fever, and lethargy. The learner is charged with the task of compassionately, honestly, and confidently explaining the process of a lumbar puncture in order to appropriately obtain informed consent.ResultsThis case was well received, with the vast majority of learners rating the instructions as clear and the tasks of the station as appropriate for the level of learner. Comments provided by the learners regarding the standardized patients' feedback indicate that this is a useful exercise to assist with the development of the crucial skill of obtaining informed consent.DiscussionOverall, learners are able to perform this task and find it a meaningful exercise. We are able to measure both content and communication skills. In our cohort, learners are able to perform above the targeted passing score. This provides some evidence of competency in terms of both content and communication skills.
| S-EPMC6464558 | biostudies-literature
Project description: Not available
| S-EPMC4338326 | biostudies-literature