Implementing new consent procedures for the schools-based HPV vaccination programme: a qualitative study
Suzanne Audrey, Karen Evans, Michelle C Farr, Joanne Ferrie, Julie Yates, Marion R Roderick, Harri Fisher
British Journal of Child Health, 22 February 2021
Abstract
Background
The English schools-based human papillomavirus (HPV) programme was offered to young women aged 12-13 years. High coverage was achieved, but variations in uptake across local authorities were apparent. The requirement for written parental consent acted as a barrier to some young women with the potential to exacerbate health inequities.
Objectives
To consider the practicalities and implications of implementing new consent procedures for the schools-based HPV vaccination programme.
Design
Qualitative study.
Settings
Two local authority areas in the south-west of England with relatively lower uptake of the HPV vaccination programme.
Participants
The 53 participants included: the immunisation programme manager, three immunisation nurses, three members of staff in mainstream schools, five members of staff in alternative education provider settings, 19 young women, and 22 parents.
Methods
Digitally recorded, semi-structured interviews were undertaken. All transcripts were fully transcribed and anonymised. Thematic analysis was undertaken, assisted by the Framework approach to data management.
Results
The new consent processes for the HPV vaccination generally worked well. Telephoning parents on the day of the vaccination session was viewed as an acceptable and effective way to reach parents. Adolescent self-consent was rarely undertaken. This can be explained partially by the relative success in gaining parental verbal consent but concerns about disrupting relationships – between healthcare professionals, parents and school staff, or within families – made professionals reluctant to administer the vaccine without some form of parental consent. For young women with special educational needs and disabilities the consent process relied upon close communication between school staff and parents. Other young women whose access to the vaccine, or consent options, were unclear or problematic included: those who were registered with a school but attended an alternative setting for part of their timetable; those educated at home; those in the care of the local authority or living with a foster family, and; young people with gender dysphoria.
Conclusions
Expanding the consent procedures for the schools-based HPV vaccination programme to include parental telephone consent was broadly welcomed by the immunisation nurses, parents, and young women in our study. The requirement for young women to confirm that they had discussed vaccination with their parents, and that vaccination would not cause difficulties at home, meant adolescent self-consent was rare in this age-group. Greater understanding of the barriers to uptake outside of the mainstream school-based sessions is needed to further address inequalities in uptake.
Month: June 2021
Will EU’s GDPR Act as an Effective Enforcer to Gain Consent?
Will EU’s GDPR Act as an Effective Enforcer to Gain Consent?
Junhyoung Oh, Jinhyoung Hong, Changsoo Lee, Jemin Justin Lee, Simon S.Woo, Kyungho Lee
IEEE, 26 May 2021
Open Access
Abstract
Since the GDPR was implemented in 2018, organizations that collect data from the EU residents are required to receive the user’s consent. Organizational measures to ensure that the organizations are compliant to the recently enacted GDPR are still abstract and ambiguous. Moreover, data subjects and controllers have demanded the practice of obtaining consent from organizations. By observing the case law and guidelines related to the GDPR provisions, we deduced four consent conditions. Then, we examined how online service provider’s websites are making efforts to implement the GDPR framework. For this, we identified key characteristics of these websites, such as the existence of consent buttons. In order to help the data subjects obtain consent, we proposed an automatic tool that can check the consent conditions by checking the websites. Our study examined 10,000 websites for 26 days using the Python libraries with the tool automatically crawling the website information and analyzes the HTML structure according to the specified conditions. In addition, this tool crawls the privacy policy of each website. Moreover, it automatically determines whether it meets the four consent conditions by calculating it according to the formula defined in the consent condition. To evaluate the tool’s accuracy, the researchers manually analyzed 500 websites and compared the manual analysis with the results of the tool’s automatic analysis. We found that this tool differentiates itself through qualitative comparisons with other GDPR meters.
How Has ‘Montgomery’ Changed the Way We Document Risks on Consent Forms for Deceased Donor Kidney Transplantation? A Single-Centre Audit and Re-Audit
How Has ‘Montgomery’ Changed the Way We Document Risks on Consent Forms for Deceased Donor Kidney Transplantation? A Single-Centre Audit and Re-Audit
A M Hussein, C J Callaghan
British Journal of Surgery, 4 May 2021; 108(Supplement 2)
Abstract
Introduction
The 2015 Montgomery case changed the remit of risk discussions required during the consent process. This audit reviewed single kidney transplant (SKT) consent forms to establish which risks are documented, and whether this legal case affected discussions. Following the audit, we introduced a pre-printed consent form and closed the audit loop by assessing its uptake.
Method
Trust paper consent forms for all patients aged 50+ who received a deceased donor SKT in our centre in 2014 (n = 58; pre-Montgomery) and 2017 (n = 70; post-Montgomery) were reviewed to see if 20 perceived ‘gold standard’ risks were documented. A pre-printed procedure-specific consent form including all gold standard risks was then introduced in July 2019. A re-audit reviewed the case-notes of every alternate recipient aged 50+ of a deceased donor SKT from 01/08/19 to 29/02/20 to check if the pre-printed form was used.
Results
Overall, 53% of the 20 ‘gold standard’ risks were documented in 2014 versus 59% in 2017 (p = 0.55). There was a 91% uptake of the pre-printed consent form.
Discussion
This audit established the importance of using a pre-printed consent form to standardise risk discussions We propose that pre-printed procedure-specific forms should be encouraged throughout the NHS to support ‘Montgomery-appropriate’ consent discussions.
Consent in privacy laws: Analysis of India’s PDPB, ECPA of USA and GDPR of EU
Consent in privacy laws: Analysis of India’s PDPB, ECPA of USA and GDPR of EU
Prashant Mali
International Journal of Law, 25 March 2021; 7(2) pp 142-152
Open Access
Abstract
Consent refers to an affirmative action on the part of the individuals indicating their agreement to the use of their personal data by the collectors or processors for the purpose of processing. Consent has been viewed as an expression of a person‘s autonomy or control, which has the consequence of allowing another person to legally disclaim liability for acts, which have been consented to. Consent has many connotations in various privacy laws, somewhere it tows the line of prevailing international laws and in some laws it gets localized, but largely consent remains individuals’ will to share his / her data. This paper analysis the established privacy laws i.e. EU’s GDPR and ECPA of USA with long awaited India’s proposed Personal Data Protection Bill. The author has been involved in various government consultations on PDPB since 2006.
Towards a coherent model of informed consent : is there, and should there be, a coherent model of informed consent to surgery across medical ethics, medical professional regulation, and medical law? [DISSERTATION]
Towards a coherent model of informed consent : is there, and should there be, a coherent model of informed consent to surgery across medical ethics, medical professional regulation, and medical law? [DISSERTATION]
Louise Austin
University of Bristol, 2021; PhD Thesis
Abstract
Utilising the empirical ethics methodology and method of ‘reflexive balancing’ (RBL), this thesis asks: is there, or should there be, a coherent model of informed consent to surgery across medical ethics, medical professional regulation, and medical law? It concludes that whilst presently there is not a coherent model across these three areas, there should be, and a proposed model is outlined. In reaching this conclusion, the thesis draws upon ethical literature, the medical regulatory and legal standards of informed consent, and my empirical analysis of fitness to practice decisions and court judgments concerning informed consent in the context of surgery. Such a detailed analysis of these decisions and judgments has not been done before and this thesis, therefore, makes an original and significant contribution to existing scholarship. This contribution is developed further by the use of RBL to bring the data together to address the question the thesis asks. RBL has not previously been used to bring together medical ethics, medical professional regulation, and medical law. Chapter One sets out the methodology and methods underpinning the thesis. Chapters Two to Four illustrate there is not a coherent model of informed consent to surgery across medical ethics, medical professional regulation, and medical law. Chapters Five and Six set out the empirical analysis and Chapter Seven draws upon that analysis to develop a model of informed consent to surgery. RBL is then utilised to challenge that model, leading to a coherent model of informed consent to surgery across medical ethics, medical professional regulation, and medical law. This model enables autonomous choices about surgery, utilising objective and subjective perspectives in determining what information should be given to patients, and requiring understanding and reflection. The thesis concludes with recommendations for the model’s implementation, and for further research suggested by the thesis’ findings.
Medical Violence, Obstetric Racism, and the Limits of Informed Consent for Black Women
Medical Violence, Obstetric Racism, and the Limits of Informed Consent for Black Women
Colleen Campbell
Michigan Journal of Race and Law, Winter 2021; 26 (Special Issue)
Open Access
Abstract
The United States’ alarmingly high C-section rate and its equally alarming maternal mortality rate make it clear that reproductive healthcare is failing women. But it is especially failing Black women, who are today disproportionately exposed to these and other reproductive health risks just as they have been throughout history. The Michigan Journal of Gender & Law selected this Essay because it traces a direct line from early gynecology’s reliance on the bodies of unconsenting Black women to how medicine and the law’s failure to reckon with this history continues to harm Black women now. While these institutions now purport to embrace ethical principles like bodily autonomy and individual agency, this Essay critically examines why Black women must still navigate reproductive healthcare against a backdrop of both racist medical violence that puts their health at risk and a legal doctrine of informed consent that cannot realistically protect them.
Editor’s note: The Michigan Journal of Race & Law is a legal journal associated with the University of Michigan Law School that serves as a forum for the exploration of issues relating to race and law.
The right to free, prior, and informed consent (FPIC): Reflections on experiences of two Indigenous communities in northern regions of Canada and Chile [BOOK CHAPTER]
The right to free, prior, and informed consent (FPIC): Reflections on experiences of two Indigenous communities in northern regions of Canada and Chile [BOOK CHAPTER]
Terry Mitchell, Courtney Arseneau, José Aylwin, Darren Thomas
Decolonizing Law [Routledge 2021]
Abstract
In this chapter, we focus on the ongoing pressures faced by Indigenous communities in responding to growing global investments in extractive activities such as mining. In highlighting the obligations of states and businesses to adhere to consultation processes and practices of the right to free, prior, and informed consent (FPIC), we provide a comparative analysis of the barriers faced by Indigenous Peoples in mining affected communities in northern Ontario (Canada) and in northern Chile. We also call attention to the extraterritorial responsibilities of Canada’s mining investments in Chile, presenting the situation of global extractive practices as a new wave of colonialism known as extractive imperialism. We share reflections from our work across the two case study sites, including a workshop that brought together leaders from both regions to share experiences, strategies of resistance, and Indigenous perspectives of consultation and FPIC from across the Americas. We discuss key Pan-American findings of (1) a lack of consultation and information; (2) inducement and division; and (3) environmental impacts as parallel experiences across both regions. We conclude with reflections on decolonial approaches to consultation and policy recommendations for the implementation of FPIC and the monitoring of Indigenous rights in Canadian mining activities across the Americas.
Who Are the Métis? The Role of Free, Prior and Informed Consent in Identifying a Métis Rights-Holder [BOOK CHAPTER]
Who Are the Métis? The Role of Free, Prior and Informed Consent in Identifying a Métis Rights-Holder [BOOK CHAPTER]
Karen Drake
Indigenous-Industry Agreements, Natural Resources and the Law [Routledge 2020]
Abstract
Using free, prior and informed consent as a framework for analysis, this chapter explores issues related to the communities involved in Indigenous-industry agreements by relying on the particularly poignant experience of the Métis. A major issue that Indigenous-industry agreements encounter is the identification of the Indigenous party to the agreement. This chapter analyzes bases for identifying the Métis rights-holder for the purposes of consultation and consent. It argues that the Métis Nation of Ontario has developed an approach to consultation and that approach ensures that the Métis Nation of Ontario’s consent to Indigenous-industry agreements is fully informed. This approach also responds to some of the questions that impact Indigenous-industry agreements including questions regarding persons who qualify as rights-holders and to whom the duty to consult and accommodate is owed, how to determine the geographic scope of the rights-holder, and persons who are entitled to represent the rights-holder during consultation about the right.
Community Consent [BOOK CHAPTER]
Community Consent [BOOK CHAPTER]
Henk ten Have, Maria do Céu Patrão Neves
Dictionary of Global Bioethics [Springer 27 May 2021]
Abstract
In medical practice and research the principle of individual prior informed consent has a crucial role to play. However, the emphasis on individuals is not the same across the world. Communities in many cultures and traditions play an important role in determining human well-being and in individuals living their lives to the full. From a global perspective the moral status of a community is recognized in the concept of community consent.
Parental and professional perceptions of informed consent and participation in a time-critical neonatal trial: a mixed-methods study in India, Sri Lanka and Bangladesh
Parental and professional perceptions of informed consent and participation in a time-critical neonatal trial: a mixed-methods study in India, Sri Lanka and Bangladesh
Original Research
Maya Annie Elias, Kerry Woolfall, Maria Moreno Morales, Bensitta Lincy, Ismat Jahan, Samanmali P Sumanasena, Siddarth Ramji, Seetha Shankaran, Sudhin Thayyil
BMJ Global Health, 21 May 2021
Open Access
Abstract
Introduction
Time-critical neonatal trials in low-and-middle-income countries (LMICs) raise several ethical issues. Using a qualitative-dominant mixed-methods design, we explored informed consent process in Hypothermia for encephalopathy in low and middle-income countries (HELIX) trial conducted in India, Sri Lanka and Bangladesh.
Methods
Term infants with neonatal encephalopathy, aged less than 6 hours, were randomly allocated to cooling therapy or usual care, following informed parental consent. The consenting process was audio-video (A-V) recorded in all cases. We analysed A-V records of the consent process using a 5-point Likert scale on three parameters—empathy, information and autonomy. In addition, we used exploratory observation method to capture relevant aspects of consent process and discussions between parents and professionals. Finally, we conducted in-depth interviews with a subgroup of 20 parents and 15 healthcare professionals. A thematic analysis was performed on the observations of A-V records and on the interview transcripts.
Results
A total of 294 A-V records of the HELIX trial were analysed. Median (IQR) score for empathy, information and autonomy was 5 (0), 5 (1) and 5 (1), respectively. However, thematic analysis suggested that the consenting was a ceremonial process; and parental decision to participate was based on unreserved trust in the treating doctors, therapeutic misconception and access to an expensive treatment free of cost. Most parents did not understand the concept of a clinical trial nor the nature of the intervention. Professionals showed a strong bias towards cooling therapy and reported time constraints and explaining to multiple family members as key challenges.
Conclusion
Despite rigorous research governance and consent process, parental decisions were heavily influenced by situational incapacity and a trust in doctors to make the right decision on their behalf. Further research is required to identify culturally and context-appropriate strategies for informed trial participation.
Center for Informed Consent Integrity 