Use Of Consent Forms Research Articles

Shortened consent forms for genome-wide sequencing: Parent and provider perspectives.

BackgroundConsent forms for exome and/or genome sequencing, collectively called genome‐wide sequencing (GWS), frequently contain detailed information on complex topics such as sequencing analysis and incidental findings. Considering recent endeavors by the health care community to simplify GWS consent forms, it is important to gain stakeholders' perspectives on the content, length, and use of consent forms.MethodsThematic analysis was conducted on data obtained from focus groups with two participant cohorts: parents who previously provided consent for trio‐based GWS as part of the translational pediatric GWS CAUSES Study, and genetic health care providers (HCP) who provide pre‐test counseling for GWS.ResultsGenetic HCP indicated that consent forms cannot replace pre‐test counseling, and as such, a simplified consent form focusing on the implications of GWS would be beneficial to both patients and HCP. Although parents' primary concerns varied when considering GWS, they all highly valued information. Parents also indicated the need for community and support after the return of GWS results. Both participant cohorts recommended that consent forms be available online and include an appendix for supplementary information.ConclusionIt is important to include both parents and HCP in the design of GWS consent forms, and also, to help connect families who have a shared diagnosis after the post‐test counseling session.

Current use of chromosomal microarray by Australian paediatricians and implications for the implementation of next generation sequencing.

Chromosomal microarray (CMA) is an important diagnostic test for children with multiple congenital anomalies or certain developmental behavioural problems suggestive of an underlying genetic diagnosis. However, there are medical and ethical complexities to its use and few Australian policies to guide practice. We aimed to describe the current practice of Australian paediatricians in relation to CMA testing. We hypothesised that there are knowledge gaps in their use of CMA. Online survey completed between September 2015 and January 2016 by paediatricians in secondary care settings. Participants were members of the Australian Paediatric Research Network. One hundred and sixty five (43%) of 383 active members responded. Our main outcome measures comprised: (i) the indications for which paediatricians request CMA; (ii) their approach to consent; (iii) their interpretation of results; and (iv) their understanding of the impact on patient management. A significant proportion of paediatricians (21-52%) did not regularly use CMA for conditions with established evidence of diagnostic yield. Paediatricians under-estimated the potential for CMA findings to alter patient management. There was wide variability in paediatricians' approach to consent, and low use of consent forms and fact sheets. Paediatricians reported difficulties interpreting CMA results, with high rates of referral to clinical genetics services. The reported practice of Australian paediatricians is not consistent with international standards on CMA. Australian practice could be improved by a standardised approach to ordering CMA, consenting patients and interpreting results. We provide resources for CMA ordering and make recommendations about preparation for next generation sequencing.

The Ongoing Dilemma on the Use of Antipsychotics to Manage the Behavioral Symptoms of Dementia

For over a decade now, the ongoing dilemma on whether to use antipsychotics to manage the behavioral symptoms of dementia is still being discussed because we have yet to come to a consensus of what is best for these patients. The article by Greenblatt and Greenblatt1 exemplifies this dilemma. After nonpharmacological treatments are tried and either failed or provided suboptimal results, what is a nursing home practitioner to do for those numerous patients with behavioral symptoms associated with dementia? The FDA boxed warnings about the increased risk of sudden death associated with the use of antipsychotics in this population is used as “evidence” by attorneys to show how patients are being chemically restrained in nursing homes or are being treated inappropriately.2 As a result, there is substantial information available for clinicians to use on how to mitigate risk when prescribing antipsychotics to dementia patients through the use of consent forms and thorough appropriate documentation. Greenblatt and Greenblatt make a worthy notation in their review. The American Society of Consultant Pharmacists has made an effort to bring a perspective in regard to the FDA boxed warnings because the reality is that most of the nursing home residents will need management beyond nonpharmacological interventions. Many medications, not just antipsychotics, are used off-label every day.3 The review also comments on a sad reality: most nursing homes are not well staffed, and an adequate trial of nonpharmacological treatments requires the intervention of well-trained staff members. Some institutions, specifically adult day care centers, have tried—in many cases successfully—to decrease the burden on the caregiver by structuring their services when they are needed the most: they are open from 7 pm to 7 am, when dementia patients may experience worsening of their behavioral symptoms. Perhaps, that is a schedule that nursing homes should consider because traditionally staffing is decreased during the evening and overnight shifts when dementia symptoms are worse for patients. The efficacy of antipsychotics in managing the agitation, anxiety, aggression, and paranoia of dementia patients is inconclusive, with many remaining questions, as noted by Greenblatt and Greenblatt. Which antipsychotic works best? Neurologists and psychiatrists rely on their own experience in choosing the antipsychotics, based on the patient's comorbidities, the drug's side effect profile, or simply which is the preferred agent based on the institution's drug formulary. The review of the possible mechanisms of increased risk of cardiovascular events by antipsychotics is described in the review. We simply do not know the exact mechanism(s) of toxicity, nor do we know which antipsychotic(s) are most likely to contribute to these toxic events. Almost 11 years have passed since the first FDA warning was issued about the use of antipsychotics in dementia patients and the increased risk of sudden death. We still have inconclusive answers for most of the original questions. However, progress has been made to provide some guidance to practitioners in which a step approach can be used to manage dementia patients, as described in the “Clinical Considerations” section of the review, which is based on the recommendations set forth by the Centers for Medicare and Medicaid Services (1). The “Dementia Care Principles” described in Table 2 in Greenblatt and Greenblatt,1 are a good starting point for nursing homes on what they should be striving to achieve for their dementia patients. The successful management of behavioral symptoms in dementia patients is a great challenge that nursing homes as well as home caregivers continue to face. Even though current literature is inconclusive in regard to the risk of prescribing antipsychotics in this patient population, once nonpharmacological treatments fail, pharmacotherapy is the next best option.

Consent Forms and Consent Formalism

Law enforcement officers frequently use written consent forms to obtain permission for searches. Consent forms are pervasive — indeed, more than ninety percent of state police departments use them in at least some circumstances. Moreover, consent forms are popular — traditional advocates for civil liberties, such as the ACLU, have championed their use. Yet even though consent forms are an integral part of our law enforcement culture, virtually no scholarly literature has examined their use.This Article is the first to provide an in-depth examination of the use of consent forms. Our analysis is founded on two original empirical data sets. The first is a survey of state police department practices in nearly every state, which demonstrates that officers routinely use consent forms. The second is a data set consisting of every published appellate case involving a consent form decided between 2005 and 2009, which reveals that fewer than 5% of defendants prevailed — less than half the rate at which defendants prevail in Fourth Amendment consent cases overall.With these novel empirical data as our foundation, we draw three conclusions. First, we argue that a signed consent form does not signify that a suspect rendered consent voluntarily. The form does little to improve a suspect’s understanding of her rights, particularly when the suspect is poorly-educated, frightened, or not fluent in English. Second, we argue that consent forms do not prevent coercion. If an officer can use coercion or other psychological tactics to obtain verbal consent, surely she can also do so to obtain a signature on a consent form. And finally, we conclude that consent forms implicitly discourage courts from closely examining whether consent was voluntary because the forms provide the illusion of voluntariness. That is, obtaining a signed consent form effectively insulates law enforcement from later invalidation of the search on voluntariness grounds. In light of these problems, we urge that police departments reexamine their use of consent forms and that courts rethink the way in which they evaluate consent forms.The Article concludes with four proposals to remedy the problems with consent forms. First, courts should state explicitly that a signed consent form does not automatically indicate that an alleged consent was in fact voluntary. Second, courts should analyze consent forms using a more searching inquiry into voluntariness imported from contract law. Third, rather than advocating the use of consent forms, civil rights organizations should use their resources to educate people about their rights. That way, people need not rely on a consent form to educate them after a situation has already arisen. And finally, these organizations should press law enforcement entities to use audio and video recording equipment to create a more accurate and complete account of an instance of alleged consent. Appendices to article are available from authors on request.

Completion of consent forms in colorectal surgery: are we getting it right?

The General Medical Council and Department of Health both recognise that although the acquisition of written informed consent for surgery is not a legal requirement, it remains a good practice.1...

Increased plasma levels of phthalate esters in women with advanced-stage endometriosis: a prospective case-control study

We performed the present prospective case-control study to evaluate whether the plasma concentrations of phthalate esters are elevated in women with advanced-stage endometriosis in a Korean population. Measuring plasma levels of monoethylhexyl phthalate and di-(2-ethylhexyl) phthalate in 97 women with advanced-stage endometriosis and 169 control women by liquid chromatography-tandem mass spectrometry, we found that the concentrations of monoethylhexyl phthalate, as well as di-(2-ethylhexyl) phthalate, are significantly higher in those with advanced-stage endometriosis, which supports the hypothesis that exposure to phthalate might play a role in the establishment of endometriosis.

Value and limitation of consent forms

The increase in medical negligence cases, particularly those based on informed consent, has led to a greater use of consent forms. This however, has led to a certain misunderstanding as to their nature and effect, for consent forms do not provide the protection that many doctors believe they do. Consent forms are not contracts, which bind the patient. At most they are evidence that proper discussion between the doctor and the patient has taken place; but they are never conclusive evidence. Their value lies only in that they act as reminders to doctors that consent, to be valid, has to be based on proper information and advice that the patient is entitled to.