Publications by authors named "Sara F Goldkind"
Importance: Exception From Informed Consent (EFIC) research requires community consultation (CC) and public disclosure (PD). Traditional methods of conducting CC and PD are slow, expensive, and labor intensive.
Objective: To describe the feasibility and reach of a novel interactive, media-based approach to CC and PD and to identify the similarities and differences between trial sites in website views, survey responses, online community forum attendance, and opt-out requests.
Background: The current global pandemic has created unprecedented challenges in the blood supply network. Given the recent shortages, there must be a civilian plan for massively bleeding patients when there are no blood products on the shelf. Recognizing that the time to death in bleeding patients is less than 2 h, timely resupply from unaffected locations is not possible.
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- Informed consent for research on heart attacks and strokes is complicated due to time constraints and emotional stress for patients and families, yet many prefer being involved in research decisions.
- A study with 27 participants revealed that respectful and professional behavior from researchers positively impacted the consent experience, along with clear discussions about risks, benefits, and trial details.
- Participants also appreciated post-consent follow-ups as valuable opportunities to ask questions and engage with the research process.
Article Synopsis
- Genome sequencing plays a critical role in diagnosing rare diseases, even when effective treatments are not available.
- The development of milasen, a customized drug for a specific patient, stemmed from the molecular diagnosis of a fatal neurodegenerative disease, leading to quick testing within a year.
- The study demonstrated that milasen was safe and effective, showing a reduction in seizures, and sets an example for creating personalized treatments rapidly for other patients.
Background Emergent informed consent for clinical trials in acute myocardial infarction (AMI) and stroke is challenging. The role and value of consent are controversial, and insufficient data exist regarding patients' and surrogates' experiences. Methods and Results We conducted structured interviews with patients (or surrogates) enrolled in AMI or acute stroke trials at 6 sites between 2011 and 2016.
View Article and Find Full Text PDFBackground: There has been debate about the role of consent in pragmatic trials comparing qualitatively similar interventions. Consent preferences may differ in acute care contexts, given severe illness, time constraints, and other barriers to consent. In addition, studies have not assessed the impact of disclosing financial considerations as a justification for trials.
View Article and Find Full Text PDFInclusion of children in medical decision making, to the extent of their ability and interest in doing so, should be the default position, ensuring that children are routinely given a voice. However, optimizing the involvement of children in their health care decisions remains challenging for clinicians. Missing from the literature is a stepwise approach to assessing when and how a child should be included in medical decision making.
View Article and Find Full Text PDFAlthough informed consent is important in clinical research, questions persist regarding when it is necessary, what it requires, and how it should be obtained. The standard view in research ethics is that the function of informed consent is to respect individual autonomy. However, consent processes are multidimensional and serve other ethical functions as well.
View Article and Find Full Text PDFBarriers to informed consent are ubiquitous in the conduct of emergency care research across a wide range of conditions and clinical contexts. They are largely unavoidable; can be related to time constraints, physical symptoms, emotional stress, and cognitive impairment; and affect patients and surrogates. US regulations permit an exception from informed consent for certain clinical trials in emergency settings, but these regulations have generally been used to facilitate trials in which patients are unconscious and no surrogate is available.
View Article and Find Full Text PDFPragmatic clinical trials can help answer questions of comparative effectiveness for interventions routinely used in medical practice. Pragmatic clinical trials may examine outcomes of one or more marketed medical products, and they are heterogeneous in design and risk. The Food and Drug Administration is charged with protecting the rights, safety, and welfare of individuals enrolled in clinical investigations, as well as assuring the integrity of the data upon which approval of medical products is made.
View Article and Find Full Text PDFBackground: Despite the fact that many pregnant women are affected by a range of serious health conditions and take medications for these conditions, there is widespread reticence to include them in clinical intervention research. Hence, their clinical care is typically not informed by evidence derived from pregnant populations.
Method: In October 2010, the National Institutes of Health Office of Research on Women's Health convened a workshop to address ethical, regulatory, and scientific issues raised by the enrollment of pregnant women in clinical research.