Valid Consent Research Articles

Informed Consent: What Must Be Disclosed and What Must Be Understood?

Over the last few decades, multiple studies have examined the understanding of participants in clinical research. They show variable and often poor understanding of key elements of disclosure, such as expected risks and the experimental nature of treatments. Did the participants in these studies give valid consent? According to the standard view of informed consent they did not. The standard view holds that the recipient of consent has a duty to disclose certain information to the profferer of consent because valid consent requires that information to be understood. The contents of the understanding and disclosure requirements are therefore conceptually linked. In this paper, we argue that the standard view is mistaken. The disclosure and understanding requirements have distinct grounds tied to two different ways in which a token of consent can be rendered invalid. Analysis of these grounds allows us to derive the contents of the two requirements. It also implies that it is sometimes permissible to enroll willing participants who have not understood everything that they ought to be told about their clinical trials.

Improving Informed Consent for Novel Vaccine Research in a Pediatric Hospital Setting Using a Blended Research-Design Approach.

It is necessary to conduct Clinical Trials in children, including for novel vaccines. Children cannot legally provide valid consent, but can assent to research participation. Informed consent and assent communications are frequently criticized for their lack of comprehensibility and often, researchers do not involve patients in informed consent design. We tested a blended research-design approach to co-design multimedia informed consent prototypes for experimental vaccine studies targeted at the pediatric population. We report details on the methodology utilized, and the insights, ideas, and prototype solutions we generated using social media data analysis, a survey, and workshops. A survey of clinical trial researchers indicated that while the most did not use technology for informed consent, they considered its utilization favorable. Social media analysis enabled researchers to quickly understand where community perspectives were concordant and discordant and build their understanding of the types of topics that they may want to focus on during the design workshops. Participatory design workshops for children and their families reaped insights, ideas, and prototypes for a range of tools including apps and websites. Participants felt that the prototypes were better able to communicate necessary content than the original text document format. We propose using a participatory, mixed-methods approach to design informed consent so that it is better adapted to patients' needs. Such an approach would be helpful in better addressing the needs of different segments of the populations involved in clinical trials. Further evidence should be gained about the impact of this strategy in improving recruitment, decreasing withdrawals and litigations, and improving patient satisfaction during clinical trials.

Mutuality in Sexual Relationships: a Standard of Ethical Sex?

In this paper we challenge the idea that valid consent is the golden standard by which a sexual encounter is deemed ethical. We begin by reviewing the recent public focus on consent as an ethical standard, and then argue for a standard that goes beyond legalistic and contractual foci. This is the standard of mutuality which extends beyond the assurance that all parties engaging in a sexual encounter are informed, autonomous, and otherwise capable of making a valid choice: one must also encounter the other with care and loving attention. We develop this claim using Iris Murdoch’s (1970) concept of an attitude of “loving attention,” which differentiates our view from the duty of due diligence to ensure that each person is a willing participant in sex, that the rights of others have not been violated, as emphasized by Dougherty (2018). We also address three objections to using mutuality as a measure of ethical sex, namely that it is patronizing, that it is a maximalist position that puts too great a burden on individuals and inhibits their freedom, and that it is an ideal rather than a requirement. We then look at three examples that test the construct of mutuality: the typical college hook-up, sex work, and anonymous sex through glory holes and similar set-ups.

A Qualitative Analysis of Ethical Perspectives on Recruitment and Consent for Human Intracranial Electrophysiology Studies

Intracranial electrophysiological research methods, including those applying electrodes on the cortical surface or in deep structures, have become increasingly important in human neuroscience. They also pose novel ethical concerns, as human studies require the participation of neurological patients undergoing surgery for conditions such as epilepsy and Parkinson’s disease. Research participants in this setting may be vulnerable to conflicts of interest, therapeutic misconception, and other threats to valid recruitment and consent. We conducted semi-structured interviews with investigators from NIH-funded studies involving recording or stimulation inside the human skull. We elicited perspectives on study recruitment and consent procedures, and analyzed transcripts using a modified grounded theory approach. We interviewed 26 investigators from 19 separate intracranial electrophysiology studies, who described two study types: opportunity studies (n = 15) and experimental trials (n = 4). Respondents described significant heterogeneity in recruitment and consent procedures, even among studies employing similar techniques. In some studies, clinician-investigators were specifically barred from obtaining consent, while in other studies clinician-investigators were specifically required to obtain consent; regulatory guidance was inconsistent. Respondents also described various models for subject selection, the timing of consent, and continuing consent for temporally extended studies. Respondents expressed ethical concerns about participants’ vulnerability and the communication of research-related risks. We found a lack of consensus among investigators regarding recruitment and consent methods in human intracranial electrophysiology. This likely reflects the novelty and complexity of such studies and indicates a need for further discussion and development of best practices in this research domain.

The Enemy is the Knife: Native Americans, Medical Genocide, and the Prohibition of Nonconsensual Sterilizations

In the early 1970s, Tribal Nations learned that doctors at Indian Health Service (IHS) hospitals were sterilizing at least 25 percent of Native American women of childbearing age. Most of the women were sterilized without their knowledge or without giving valid consent. This Article describes the legal history of how, twenty years after the sterilizations began, the U.S. Department of Health, Education, and Welfare, in 1978, finally created regulations that prohibited the sterilizations. It tells the heroic story of Connie Redbird Uri, a Native American physician and lawyer, who discovered the secret program of government sterilizations, and created a movement that pressured the government to codify provisions that ended the program. It explains the obstacles that Native activists faced when confronting the sterilizations, including the widespread acceptance of eugenic sterilizations, federal legislation that gave doctors economic incentives to perform the procedures, and paternalistic views about the reproductive choices of women, and especially women of color. Finally, this Article describes the long-lasting impacts of the federally-sponsored sterilization of Native women. The sterilizations devastated many women, reduced tribal populations, and terminated the bloodlines of some Tribal Nations. In the last decade, living victims of nonconsensual sterilization programs in other parts of the country have received compensation for their losses. Native American women deserve them too.

Comparative Study Of Clinical Outcome Of Laparoscopic Total Extraperitoneal Repair Vs Lichtenstein Repair In 50 Cases Of Inguinal Hernia

INTRODUCTIONAbdominal hernia includes groin hernia (70%), umbilical hernia (15%), epigastric hernia (7%) and incisional hernia (9%). After Bassini’s published paper on the techniques of tissue repair, numerous modifications like use of prosthetic material by Usher and open preperitoneal mesh repair introduced by Stoppa but these were associated with significant postoperative pain and morbidity. The concept of Tension free open mesh repair was first introduced by Lichtenstein. Totally extra peritoneal hernia repair (TEP) is a relatively new technique of repairing inguinal hernias laparoscopically where the dissection and repair are carried out without violating the peritoneal cavity laparoscopically. This study compares the results of laparoscopic hernioplasty by Total Extra-Peritoneal (TEP) technique and Lichtenstein tension free repair hernioplasty technique by open method and determine if the relative advantages achieved could be put in practice in large scale and also identify criteria which may help to choose the patient to a particular type of repair to obtain encouraging results for that particular patient.METHODS AND MATERIALS:The present study was carried out with 50 patients admitted in the department of general surgery at our hospital from period May 2018 to December 2019.Inclusion criteria: Patient aged 18 years and above giving written valid consent. Patients diagnosed as having unilateral incomplete inguinal hernia. Patients medically fit to undergo the procedure. Exclusion criteria:Single or multiple previous lower abdominal surgeries;Complicated inguinal hernia, i.e., irreducible, obstructed, or strangulated;Uncorrected coagulopathies;Patients unfit for general anaesthesiaRESULTIn our prospective Comparative study of laparoscopic and open inguinal hernioplasty, we studied 50 patients with unilateral direct inguinal hernia. Average operative time in open repair was 48 minutes and 70 minutes in laparoscopic repair. In TEP, complications such as difficulty in dissection was seen in 3 patients (12%), accidental opening of peritoneum in 2 patients (8%), and inadequate/inability to insufflate was seen in 1 patient (4%). On postoperative day 7, 8 patients (32%) have mild pain and 3 patients (12%) have moderate pain after open hernia repair. And rest 14(56%) patients experienced no pain. After laparoscopic hernia repair 16 patients (64%) have no pain and 7 patients (28%) have mild pain and 2 patients (8%) had moderate pain. Duration of hospital stay in open (3.5 days) is more compared to laparoscopic repair (2.5 days). Return to normal routine activities in open repair (15.3 days) is delayed than laparoscopic repair (12.92 days). CONCLUSION Here, we have done prospective comparative study of clinical outcome of laparoscopic TEP Vs Lichtenstein open inguinal repair in 50 cases of inguinal hernia. We have reached to following conclusion in our study. Incidence of wound infection and scrotal edema are more in open repair then TEP. TEP is less painful in the early postoperative period leading to earlier ambulation than open repair. TEP results in significantly earlier return to work and better cosmetic results. TEP results in decreased hospital stay and faster recovery than open repair. Average operative repair in TEP is more (70 mins) compared to open repair (48mins) Issue of steep learning curve for laparoscopic surgery should be addressed with better supervision and standardization of training in laparoscopy

The Enemy is the Knife: Native Americans, Medical Genocide, and the Prohibition of Nonconsensual Sterilizations

This Article describes the legal history of how, twenty years after the sterilizations began, the U.S. Department of Health, Education, and Welfare, in 1978, finally created regulations that prohibited the sterilizations. It tells the heroic story of Connie Redbird Uri, a Native American physician and lawyer, who discovered the secret program of government sterilizations, and created a movement that pressured the government to codify provisions that ended the program. It discusses the shocking revelation by several Tribal Nations that doctors at the IHS hospitals had sterilized at least 25 percent of Native American women of childbearing age around the country. Most of the women were sterilized without their knowledge or without giving valid consent. It explains the obstacles that Connie Redbird Uri and other Native activists faced when confronting the sterilizations, including the widespread acceptance of eugenic sterilizations, federal legislation that gave doctors economic incentives to perform the procedures, and paternalistic views about the reproductive choices of women, and especially women of color. Finally, this Article describes the long-lasting impacts of the federally-sponsored sterilization of Native women. The sterilizations devastated many women, reduced tribal populations, and terminated the bloodlines of some Tribal Nations.

Autonomy and the Folk Concept of Valid Consent

Autonomy and the Folk Concept of Valid Consent

Regional anaesthesia: risk, consent and complications

SummaryThe risks of regional anaesthesia relate primarily to the technical nature of the procedure, chief among them being neurological. While rare, the direct relationship between nerve damage and the procedure itself means that patients need to be aware of this complication when consent is sought. In order to give valid consent, a patient must be informed. The extent of the information required has been defined by a 2015 legal ruling which established that the standard is the expectation of a reasonable patient, rather than the information deemed consequential by a reasonable doctor. The implications of this for clinicians are profound, and mean that the process of consent must, for example, include alternatives to the proposed treatment. Additionally, patients must have capacity and give their consent without coercion. Effective communication of risk can be challenging. As well as the barriers to comprehension that can result from language, literacy and numeracy, clinicians need to be aware of their own biases, often in favour of a regional anaesthetic approach. Patients also have biases, and doctors must be aware of these in order to best target their provision of information. Careful use of language and employing adjuncts such as information leaflets and visual aids can help to maximise the individual's autonomy. Particular care must be taken in special situations such as where patients have capacity issues or time is limited by the emergency nature of the intervention.

Enigma of valid consent continues in 2021……

Enigma of valid consent continues in 2021……

Does Written Informed Consent Comprehensively Inform Surgical Patients and is This Effective in Patient’s Decision-Making?

Background: Informed consent (IC) is first fundamental principal step in health care helps patients to be conscious of consequences of their treatment decisions. The importance of obtaining a valid inform consent before any procedure well established with surgery and it is an important aspect of doctor patient relationship. Objective: To assess outcome of different management strategies in women presenting with primary postpartum hemorrhage (PPH). Study Design: Observational, prospective. Settings: General surgery department of Pakistan Institute of medical Sciences Hospital Islamabad Pakistan. Duration: Five months from March 2019 to July 2019. Methodology: All the patients were asked a set of standard questions, which related to the information they had provided before the operation as a part of standard informed consent practice. The surgeons had taken all the interviews with privacy and confidentiality after postoperatively at the earliest time the patient is comfortable to do so. The questions were asked in the simple languages, which were understandable to patients, so that patients could easily understand and respond to the same. The questionnaire sought information risks/benefits associated with a surgical procedure, alternate treatment options, whether providing additional detailed verbal and/or written information improved their understanding. All the information was recorded via study proforma. Results: Total 183 patients were interviewed post-operatively regarding inform consent and most of them 42.1% were between age 18-40 years. Males were 58.5% and females were 41.5%. Almost all cases had received informed consent, while some said they received just before the surgeries. There were some controversial answers regarding question of oral information influence the decision to proceed to the surgical procedure. Almost all patient had answered that they were informed regarding their conditions, surgical and anesthetic complications prior the surgery. Only 7.7% patient said that the time was not given for the questions and 10.4% patient were unsatisfied regarding informed consent, while the most of the cases were satisfied. Conclusion: In the study observation mostly, patients were satisfied and because mostly surgical consent element is generally understood, but some remained controversial and should consider its importance, beyond risks of the procedures, as well as acceptability and feasibility of intervention to surgical team and patients. Written information has not provided patients with adequate decision-making tools for imminent health matters, so pre-operative oral information also needed to adequate decision-making.

Forensic photo-documentation in adult sexual assault– what do patients think?

Historically, some forensic practitioners and policy makers have viewed the use of photography in forensic documentation for adult victims of sexual assault as controversial. Some argue that diagrams and verbal descriptions of injury are sufficient, suggesting that sexual assault victims are so traumatised at time of examination that they are not able to provide valid consent, that the imaging process itself is humiliating, and that any decision to have photographs taken might be later regretted. Objectively, a patient capable of consenting to a forensic examination has an equal capacity to consent for forensic imaging, even when this involves sensitive areas of the body, and the process of forensic photography is not inherently problematic. Literature on forensic photography is sparse, particularly from the patient perspective. Our Forensic Medical Unit is in an excellent position to investigate this issue, as it is one of the few services in Australia that routinely offers sexual assault forensic photography, including genital, as part of its standard procedures for injury documentation. Photographs, in adult sexual assault cases, are not routinely taken of normal anatomy nor are they ever taken without patient consent.This study explores the immediate and short-term experiential impacts of forensic photography from the victims’ perspective. Capacity to consent was assessed using a trauma informed, evidence-based interviewing tool at the start of their forensic assessment. Participants also completed questionnaires at the conclusion of their examination and on follow-up. Results show that victims not only have the capacity to provide informed consent but also found forensic photography, and the reasons for it, quite acceptable. A majority [80%; n = 87/108] indicated the photographic process had either been not at all or only a little embarrassing. When asked how they felt about having photographs taken, the majority 93.4% [n = 99/106) indicated that as well as having no regrets they were also happy with the way the images had been taken. 4.7% [n = 5] expressed some doubt about whether they had made the right decision. A similar pattern of responses was observed at follow-up which occurred, on average, seven weeks post examination. 72% [n = 26/36] said they did not think about the photographs at all or did so rarely. While 14% [n = 5/36] said they thought about them a fair bit or a lot of the time, most stated they had no concerns regarding the images that had been taken.Given its evidentiary salience and other benefits, such as its potential to promote greater transparency in the provision of forensic opinions and its usefulness in teaching, this study supports the case for the routine use of forensic photography in adult Sexual Assault Units more broadly.

Trends of poisoning in Central India, Indore Region (Madhya Pradesh)

Introduction: In this modern civilization, acute poisoning is one of the leading causes of morbidity and mortality and really becoming a burden for our community. Trends of poisoning are increasing as well as changing day by day due to the introduction of more and more chemicals. This study has been taken to understand the trends of poisoning and will be used to plan how to provide healthcare facility and educate the people. Only those cases that came to the Emergency Department and Mortuary with a history of acute poisoning were included in this study. Materials and Methods: A total of 120 poisoning cases were included from October 2015 to May 2017. The cases were analyzed on various epidemiological, clinical and investigational and postmortem findings through a pre-designed proforma after taking valid consent from the patients or their relatives. Samples were collected and analyzed in Analytical Toxicology lab. Result: Out of 120 acute poisoning cases, 75 were males and 45 were females. Maximum numbers of patients fall in 21-30 years age group. Most common poison was Organophosphorus (OPP) followed by Aluminium phosphide (Celphos). The mortality rate as per this present study was 21.67%. Conclusion: Due to the easy availability of insecticides, pesticides and household poisons; there is more exposure accidently or intentional, which creates a huge burden on hospitals. The government, WHO and other organizations have to make strict rules or to ban highly toxic chemicals. Education camps must be organized to train farmers how to use insecticides and pesticides in a proper way. Keywords: Aluminium Phosphide, Analytical toxicology lab, Insecticides, Mortuary, Organophosphorus, Pesticides, Poisoning.

Resolving Perceived Norm Conflict through Principles of Treaty Interpretation: The January 2019 EU Member States’ Declarations

In January 2019, EU Member States issued three declarations concerning the “consequences of Achmea” which stated that all claims under intra- EU BIT S were contrary to the EU legal order, and that tribunals presiding over such claims have no jurisdiction as there is no valid consent to arbitrate. The declaration signed by a majority of EU Member States (“Majority Declaration”) extended this proposition to intra- EU claims under the Energy Charter Treaty. Following this, a number of EU Member States have sought to argue that the Majority Declaration is a subsequent agreement between the States Parties to intra- EU investment treaties—or evidence of a subsequent practice establishing their agreement—that the dispute resolution provisions in those treaties must be interpreted to exclude intra- EU disputes from their scope and thus from the jurisdiction of tribunals constituted thereunder, relying on Article 31(3)(a) and (b) of the Vienna Convention on the Law of Treaties (“VCLT”). This paper considers: (i) the key cases in which the Majority Declaration has been invoked to contest jurisdiction in, or seek the termination of, intra- EU arbitration proceedings; (ii) the application of Article 31(3)(a) and (b) of the VCLT; and (iii) other fundamental tenets and rules of international law discussed in relation to those cases.

Professional consensus on orthodontic risks: What orthodontists should tell their patients

Effective communication of risk is a requisite for valid consent, shared decision-making, and the provision of person-centered care. No agreed standard for the content of discussions with patients about the risks of orthodontic treatment exists. This study aimed to produce a professional consensus recommendation about the risks that should be discussed with patients as part of consent for orthodontic treatment. A serial cross-sectional survey design using a modified electronic Delphi technique was used. Two survey rounds were conducted nationally in the United Kingdom using a custom-made online system. The risks used as the prespecified items scored in the Delphi exercise were identified through a structured literature review. Orthodontists scored treatment risks on a 1-9 scale (1=not important, 9=critical to discuss with patients). The consensus that a risk should be discussed as part of consent was predefined as ≥70% orthodontists scoring risk as 7-9 and<15% scoring 1-3. The electronic Delphi was completed by 237 orthodontists who reached a professional consensus that 10 risks should be discussed as part of consent for orthodontic treatment; demineralization, relapse, resorption, pain, gingivitis, ulceration, appliances breaking, failed tooth movements, treatment duration, and consequences of no treatment. A professional orthodontic consensus has been reached that 10 key risks should be discussed with patients as part of consent for orthodontic treatment. The information in this evidence base should be tailored to patients' individual needs and delivered as part of a continuing risk communication process.

Would Nonconsensual Criminal Neurorehabilitation Express a more Degrading Attitude Towards Offenders than Consensual Criminal Neurorehabilitation?

It has been proposed that reoffending could be reduced by manipulating the neural underpinnings of offenders’ criminogenic mental features with what have been called neurocorrectives. The legitimacy of such use of neurotechnology – criminal neurorehabilitation, as the use is called – is usually seen to presuppose valid consent by the offenders subjected to it. According to a central criticism of nonconsensual criminal neurorehabilitation, nonconsensual use of neurocorrectives would express a degrading attitude towards offenders. In this article, I consider this criticism of nonconsensual criminal neurorehabilitation. By using cases of autonomous persons who lead a subservient existence as an example, I propose that nonconsensual criminal neurorehabilitation need not express a more degrading attitude towards offenders than consensual criminal neurorehabilitation. The argument of this article does not show that nonconsensual criminal neurorehabilitation is morally or legally acceptable. Yet, in view of the argument, criticizing nonconsensual criminal neurorehabilitation for expressing a degrading attitude towards offenders is not compatible with simultaneously endorsing consensual criminal neurorehabilitation.

Double Prosecution of Illicit Organ Removal as Organ Trafficking and Human Trafficking, with the Example of Belgium

In 2015 the Council of Europe introduced a new criminal law convention to address organ trafficking. The main focus of the Council of Europe Convention against Trafficking in Human Organs is the crime of illicit organ removal. The act of illicit organ removal is also criminalised under international human trafficking instruments that consider it as a form of exploitation of a living organ donor. As both legal frameworks rely on two key concepts to determine if the respective crimes occurred, namely, valid consent to organ removal and the presence of monetary benefits, a clear overlap exists when an organ is removed from a living donor. The question arises as to whether the illicit organ removal, based on the same factual circumstances and material evidence, is sufficiently distinct for an offender to be prosecuted under both regimes simultaneously or in separate criminal proceedings, without violating the principle of ne bis in idem. This paper aims to answer that question by (1) examining the crime of illicit organ removal under both criminal regimes and (2) analysing Belgian criminal law frameworks on human trafficking and organ trafficking in the context of the applicability of the principle of ne bis in idem as developed by the European Court of Human Rights and the Court of Justice of the European Union. This analysis reveals the complexity of the issue. It also confirms the proximity of the legal definitions of both types of crimes, resulting in a considerable overlap and a clear risk of double prosecution and punishment. On the basis of these findings, recommendations are formulated on how to harmonise the application of both trafficking frameworks so as to minimise that risk.

Awareness and Understanding of Decision-Making Capacity and Its Relationship to Legally Valid Consent for Older Patients in Dentistry.

With a growing ageing population and increased life expectancy in the UK, oral healthcare professionals will be exposed to a greater number of patients with health conditions which may affect cognitive function, communication and capacity to consent to treatment. This often gives rise to a conundrum which clinicians may face when considering capacity, consent and the legal implications and frameworks surrounding this. Assessing patient capacity is encountered routinely in dental practice and so oral healthcare professionals should be well informed of their responsibilities in this context. This article summarises and introduces readers to key concepts regarding consent and capacity with reference to relevant cross-jurisdictional legislation.

Same-Day Consent for Regional Anesthesia Clinical Research Trials: It's About Time.

Same-Day Consent for Regional Anesthesia Clinical Research Trials: It's About Time.

A Difficulty Chart for Estimation of Treatment Duration of Palatally Impacted Canines

Treatment of maxillary impacted canine is a challenging process to dental specialists and orthodontists. The aim of the present study was to assess the duration of orthodontic treatment of palatally impacted canines, using a difficulty chart as an estimate of the prognosis, and relating it to the treatment time and to other factors that might affect the treatment duration. A cross-sectional study was undertaken using a self administered questionnaire to be completed by orthodontists (82 participants). An index was used as a tool to assess the prognosis and treatment duration. The study found that 48.7% of active orthodontic treatment time for palatally impacted canines was completed in 1.5 to 2 years. The number of active treatment visits per patient was between 16 and 22 (62% of treatment visits). In terms of the treatment performed, 81.7% of cases had space created prior to surgical exposure, and 59.8% had open surgical exposure. Failed to attend visits by the patient accounted for 48.4% and 62.2% did not require repeated surgical exposure. Interestingly, 85% of the cases had ‘good’ or ‘average’ prognosis (49% and 36%, respectively). A prognostic chart can provide an estimate for the treatment time to bring a palatally impacted canine into the arch. This information might be valuable for both orthodontists and their patients, to estimate the time of the planned treatment and provide a valid consent form.