Data for Thinking Healthy Programme Pakistan trial (THPP-Pakistan)

An anonymised dataset of 570 women (one row per woman) who gave informed consent to participate in a cluster randomised, parallel, superiority, controlled trial in Rawalpindi, Pakistan in 2014-2017. The intervention was an adapted version of the Thinking Healthy Programme, delivered by peers; the control was enhanced usual care. Further details are available in the published protocol and paper. The dataset contains records of variables on stratified randomisation and clusters, socio-demographic information, depression and related outcomes, and therapy adherence. Visits occurred at baseline, and 3 and 6 months post-natal

Carlos Nino's Conception of Consent in Crime

In this paper I discuss the nature of consent in general, and as it applies to Carlos Nino’s consensual theory of punishment. For Nino the criminal’s consent to change her legal-normative status is a form of implied consent. I distinguish three types of implied consent: 1) implied consent which is based on an operative convention (i.e. tacit consent); 2) implied consent where there is no operative convention; 3) “direct consent” to the legal-normative consequences of a proscribed act – this is the consent which Nino employs. I argue that Nino’s conception of consent in crime exhibits many common features of “everyday” consent, which justify that it be classed as a form of (implied) consent. h us, Nino is right to claim that the consent in crime is similar to the consent in contracts and to the consent to assume a risk in tort law

Improving the quality of consent to randomised controlled trials by using continuous consent and clinician training in the consent process

Objectives: To assess whether continuous consent, a process whereby information is given to research participants at different stages in a trial, plus clinician training in that process was effective when used by clinicians gaining consent to the TOBY trial. The TOBY trial is a randomised controlled trial investigating the use of whole body cooling for neonates with evidence of perinatal asphyxia. Obtaining valid informed consent for TOBY is difficult; as such, it is a good test of the effectiveness of continuous consent. Methods: Semi-structured interviews were conducted with 30 sets of parents who gave consent to TOBY and with 10 clinicians who sought it using the continuous consent process. Analysis focused on the validity of parental consent based upon the consent components of competence, information, understanding and voluntariness. Results: 19/27 (70%) couples had no significant problems with consent validity at the point of signature. Problems lay mainly with the parents’ competence and understanding. Mothers particularly had competence problems in the early stages of consent. The understanding problems were primarily to do with side effects. Problems in both areas (competence and understanding) reduced markedly, particularly for mothers, in the post signature phase when further discussion took place. Randomisation was generally understood but unpopular. Clinicians did not always give information in stages during the short period of time available before parents gave consent. However, most clinicians were able to give follow up information. Discussion: The consent validity compares favourably with similar trials examined in a comparable study (the Euricon study). Conclusion: Researchers should consider adopting elements of the continuous consent process and clinician training in RCTs, particularly where they have concerns about the quality of consent they are likely to obtain using a conventional process.</p

Model consent clauses for rare disease research

Background: Rare Disease research has seen tremendous advancements over the last decades, with the development of new technologies, various global collaborative efforts and improved data sharing. To maximize the impact of and to further build on these developments, there is a need for model consent clauses for rare diseases research, in order to improve data interoperability, to meet the informational needs of participants, and to ensure proper ethical and legal use of data sources and participants' overall protection. Methods: A global Task Force was set up to develop model consent clauses specific to rare diseases research, that are comprehensive, harmonized, readily accessible, and internationally applicable, facilitating the recruitment and consent of rare disease research participants around the world. Existing consent forms and notices of consent were analyzed and classified under different consent themes, which were used as background to develop the model consent clauses. Results: The IRDiRC-GA4GH MCC Task Force met in September 2018, to discuss and design model consent clauses. Based on analyzed consent forms, they listed generic core elements and designed the following rare disease research specific core elements; Rare Disease Research Introductory Clause, Familial Participation, Audio/Visual Imaging, Collecting, storing, sharing of rare disease data, Recontact for matching, Data Linkage, Return of Results to Family Members, Incapacity/Death, and Benefits. Conclusion: The model consent clauses presented in this article have been drafted to highlight consent elements that bear in mind the trends in rare disease research, while providing a tool to help foster harmonization and collaborative efforts

Could There Ever be an App for that? Consent Apps and the Problem of Sexual Assault

Rape and sexual assault are major problems. In the majority of sexual assault cases consent is the central issue. Consent is, to borrow a phrase, the ‘moral magic’ that converts an impermissible act into a permissible one. In recent years, a handful of companies have tried to launch consent apps which aim to educate young people about the nature of sexual consent and allow them to record signals of consent for future verification. Although ostensibly aimed at addressing the problems of rape and sexual assault on university campuses, these apps have attracted a number of critics. In this paper, I subject the phenomenon of consent apps to philosophical scrutiny. I argue that the consent apps that have been launched to date are unhelpful because they fail to address the landscape of ethical and epistemic problems that arise in the typical rape or sexual assault case: they produce distorted and decontextualised records of consent which may in turn exacerbate the other problems associated with rape and sexual assault. Furthermore, because of the tradeoffs involved, it is unlikely that app-based technologies could ever be created that would significantly address the problems of rape and sexual assault

Third-Party Bankruptcy Releases: An Analysis of Consent Through the Lenses of Due Process and Contract Law

Bankruptcy courts disagree on the use of third-party releases in Chapter 11 bankruptcy plans, the different factors that circuit courts consider when deciding whether to approve a third-party release, and the impact of the various consent definitions on whether a release is or should be binding on the creditor. Affirmative consent, “deemed consent,” and silence are important elements in this discussion. Both contract law and due process provide lenses to evaluate consent definitions to determine whether nondebtor third-party releases should bind certain creditor groups. This Note proposes a solution that follows an affirmative consent approach to protect against due process violations and promote consistency across bankruptcy courts

Informed consent in refractive surgery: in-person vs telemedicine approach.

Purpose:The aim of this study was to compare the quality of consent process in refractive surgery between patients who had a preoperative consent discussion with the surgeon using a telemedicine approach and those who had a face-to-face discussion. Methods:Patients treated between January and December 2017 (8,184 laser vision correction [LVC] and 3,754 refractive lens exchange [RLE] patients) that attended day 1 and 1-month postoperative visit were retrospectively reviewed. Preoperative consent preparation included a consultation with an optometrist, observation of an educational video, and written information. Patients then selected either a face-to-face appointment with their surgeon (in-clinic group) or a telemedicine appointment (remote group) for their consent discussion, according to their preference. Patient experience questionnaire and clinical data were included in a multivariate model to explore factors associated with consent quality. Results:Prior to surgery, 80.1% of LVC and 47.9% of RLE patients selected remote consent. Of all LVC patients, 97.5% of in-clinic and 98.3% of remote patients responded that they were adequately consented for surgery (P=0.04). Similar percentages in the RLE group were 97.6% for in-clinic and 97.9% for remote patients (P=0.47). In a multivariate model, the major predictor of patient's satisfaction with the consent process was postoperative satisfaction with visual acuity, responsible for 80.4% of variance explained by the model. Other significant contributors were postoperative visual phenomena and dry eyes, difficulty with night driving, close-up and distance vision, postoperative uncorrected distance visual acuity, change in corrected distance visual acuity, and satisfaction with the surgeon's approach. The type of consent (remote or in-clinic) had no impact on patient's perception of consent quality in the regression model. Conclusion:The majority of patients opted for telemedicine-assisted consent. Those who chose it were equally satisfied as those who had a face-to-face meeting with their surgeon. Dissatisfaction with surgical outcome was the major factor affecting patient's perception of consent quality, regardless of the method of their consent

Ten years on: consent under the Sexual Offences Act 2003

As the clock ticked over from 30th April to 1st May 2004 the Sexual Offences Act 20031 came into force and the Sexual Offences Act 19562 was repealed, fundamentally changing the law on sexual offences in England and Wales. Perhaps the most major changes were in respect of consent. This article examines on the changes the Act made to three aspects of consent: the provision of a statutory definition, the effect of deception of C on the validity of C’s consent and the role of D’s belief in C’s consent. To this end the article considers the pre-SOA 2003 law on consent, the impetus and proposals for reform, the Act and how it has been implemented by the courts and finally how the Act could be improved to provide greater clarity substantively and procedurally to achieve the aims which lay behind the reform of consent in the first place

THE “NEW BODY SNATCHERS”: ANALYZING THE EFFECT OF PRESUMED CONSENT ORGAN DONATION LAWS ON PRIVACY, AUTONOMY, AND LIBERTY

This Note examines, in three parts, presumed consent laws as they pertain to organ donation. Part I discusses presumed consent and explains the salient features of presumed consent laws. It then discusses case law that addresses the aftermath of unauthorized organ or tissue harvesting. Part II evaluates the United States Supreme Court\u27s evolving conceptions of the rights of individual and family-based privacy, autonomy, and liberty, for subsequent application to the presumed consent organ donation controversy. Part III analyzes presumed consent laws in light of the donors and their families\u27 privacy, autonomy, and liberty interests. The Note concludes that current presumed consent organ donation laws in the United States are both unethical and unconstitutional