Challenges in informed consent decision-making in Korean clinical research: A participant perspective
Research Article
Im-Soon Choi, Eun Young Choi, Iyn-Hyang Lee
PLOS ONE, 23 May 2019
Abstract
Objectives
This study investigated how the essential elements of informed consent are realised during the consent process and examined the challenges in obtaining genuine informed consent in Korea.
Methods
Through purposive sampling, we recruited 21 subjects from those participating in anticancer drug research since 2013. We undertook 1:1 in-depth interviews and analysed the data by framework analysis.
Results
Themes raised throughout the interviews were categorised into ‘disclosure’ and ‘understanding’ of clinical information and ‘decision’. Provider-centred information, both verbal and written, was delivered to each participant. There were few tools that the research staff might evaluate study participants’ level of understanding of the provided information during the clinical trial. Although participants did not understand basic clinical trial concepts as much as desired, they may not seek to solve difficulties through communication with trial researchers. Doubts were raised about whether participants had sufficient capacity and free will to provide informed consent.
Conclusion
There is a concern that informed consent can fall short of genuine in Korea. To ensure informed consent meets the international standard, greater efforts should be made to establish an explicit standard operational protocol for obtaining informed consent.
Month: June 2019
How should assent to research be sought in low income settings? Perspectives from parents and children in Southern Malawi
How should assent to research be sought in low income settings? Perspectives from parents and children in Southern Malawi
Research Article
Helen Mangochi, Kate Gooding, Aisleen Bennett, Michael Parker, Nicola Desmond Susan Bull
BMC Medical Ethics, 14 May 2019; 20(32)
Abstract
Background
Paediatric research in low-income countries is essential to tackle high childhood mortality. As with all research, consent is an essential part of ethical practice for paediatric studies. Ethics guidelines recommend that parents or another proxy provide legal consent for children to participate, but that children should be involved in the decision through providing assent. However, there remain uncertainties about how to judge when children are ready to give assent and about appropriate assent processes. Malawi does not yet have detailed guidelines on assent. Understanding perspectives among children and their parents can assist in developing contextually-appropriate assent guidance.
Methods
Qualitative research was conducted with children and parents in three settings in Southern Malawi (low- and high-income urban and rural), to take account of any variations between socioeconomic and cultural contexts. In each setting, interviews were conducted with parents and their children who had participated in paediatric research to understand their experiences of assent and views on appropriate assent practice. Focus groups were also conducted with children and parents, to understand broader social perspectives.
Results
We found widespread support for involving children in decisions on research participation. Participants identified a range of factors that affect children’s capacity to give assent, including intellectual capacity, emotional development, life experience and cultural norms. Age was often mentioned as a consideration, but deemed an unreliable sole indicator of capacity to assent. In relation to appropriate assent processes, participants emphasised considerations such as supporting effective understanding and minimizing harms. Views on how to achieve these aims varied; for example, there were different ideas about the appropriate order in which to approach children and parents, and about whose decision to respect in the event of disagreement.
Conclusions
Parents and children agreed about the value of involving children in decisions on research, and about the need to promote children’s decision-making capacity while respecting parents’ interests in children’s welfare. Developing practical guidance that meets these principles is challenging, particularly given the need for flexible approaches that suit different study types, children’s capacities and family environments. Further discussion within the Malawi research and ethics community will help develop contextually-appropriate guidelines.
A Critical Review of Thyroidectomy Consent in the UK
A Critical Review of Thyroidectomy Consent in the UK
Original Research
C.McIntyre, N.Tolley
International Journal of Surgery, 2 May 2019
Abstract
Background
In 2015-16, the National Health Service (NHS) Litigation Authority received 10,965 claims for clinical negligence with Surgery having the highest number of claims. Currently a sum amounting to 25% of the annual NHS budget has been ring-fenced to meet extant claims. Claims made on a basis of inadequate informed consent are increasingly seen with many achieving a successful plaintiff outcome. There are presently no UK guidelines for thyroidectomy consent.
Method
A prospective study was performed to investigate current consent practice among the British Association of Endocrine and Thyroid Surgeons (BAETS) membership and patients having previously undergone thyroidectomy. For surgeons, the Bolam legal test applied where surgeons declared what risks and complications they routinely consented for during their practice. A study was also undertaken in patients who had previously undergone thyroidectomy for cancer applying the rule of Montgomery.
Results
Consent practice from 193 surgeons and data from 415 patients was analysed. In total thyroidectomy for cancer, 95% of surgeons consent for Recurrent Laryngeal Nerve (RLN) injury and temporary or permanent voice change. 70% specifically consent for External Laryngeal Nerve (ELN) injury, 50% for tracheostomy and 55% for general anaesthetic associated complications. Analysis of patient data showed they would like to be consented for far more risks than they are presently informed about in general medical practice. There was significant variation in the consenting practice in BAETS surgeons.
Conclusion
A BAETS approved consensus guideline to standardise UK consent practice would be appropriate. This may reduce complaints, litigation claims and guide expert witnesses.
Unique characteristics of informed consent in clinical genetics and genetic counselling
Unique characteristics of informed consent in clinical genetics and genetic counselling
Havlovicová M, Curtisová V, Šubrt I
Journal of Czech Physicians, 2019 Spring; 158(1) pp 38-43
Abstract
Rapid development of clinical genetics was enabled by the advances of molecular genetic laboratory diagnostics. Genetic laboratory testing has unique characteristics, and results of germinal genome testing has consequences not only for the patient but also for his relatives. Genetic laboratory testing in the Czech Republic is governed by the act no. 373/2011, which explicitly states that the testing requires the completion of a written informed consent. This article explains in detail the process of obtaining an informed consent within a broader framework of genetic counselling. An informed consent with genetic laboratory testing not only informs the patient (this being its primary purpose), but can also serve as a lead for physicians of other clinical specialties intending to order genetic laboratory tests.
Implementation of Immunization Program: Does it Need Informed Consent?
Implementation of Immunization Program: Does it Need Informed Consent?
Rani Tiyas Budiyanti, Ayun Sriatmi, Nikie Astorina Yunita Dewanti
Indian Journal of Health & Medical Law, 2018; 1(2) pp 51-54
Abstract
Immunization program is important to prevent children from getting diseases that can be prevented by immunization. However, in the implementation of this program there were some controversies and rejections related to adverse events following immunization (AEFI), belief, and halal factor. This study aims to determine whether informed consent regarding immunization programs needs to be done considering the importance of immunization for children’s health. This research is a normative research with statue and comparative approach. The data comes from law, journal, proceedings, and articles about health law. In many countries, informed consent was needed in immunization program. But there is, any exception according to belief, philosophy, culture, and religion. In Indonesia, implementation of government program not needs informed consent. But it is not consistent with other regulation about implementation of immunization program. Indonesia needs to review the regulations regarding immunization and synchronize between regulations, so that in the implementation there are no conflicting regulations and overlapping with each other.
GDPR: Patient consent and the law
GDPR: Patient consent and the law
Suzanne Lurie
Practice Management, 8 May 2019; 29 (5) Legal
Abstract
This article examines the lawful bases for processing data under GDPR (general data protection regulation), why consent is not an appropriate lawful basis and which lawful basis a clinician should rely on for the processing of personal data.
Declaration of the Rights of People Affected by Tuberculosis
Declaration of the Rights of People Affected by Tuberculosis
STOP TB Partnership, TB People
Article 12. Right to informed consent, May 2019; pp 15-16
Excerpt
Every person affected by tuberculosis has the right to informed consent.
This means respecting a person’s autonomy, self determination and dignity through voluntary health services delivery. It includes the right to informed consent—verbal or written, depending on the situation—to all forms of testing, treatment and medical research associated with tuberculosis, with information provided in an age and gender appropriate, culturally sensitive manner, imparted in a non-technical, comprehensible manner in a language understood by the person receiving the information. For children affected by tuberculosis who lack capacity to give informed consent, all decisions made by their parents or legal guardians with respect to testing, treatment or medical research associated with tuberculosis must be made in the best interests of the child, based on accurate medical evidence.
The right to informed consent includes the right to refuse health care for tuberculosis, in accordance with Chapter 15 of the World Health Organization’s Ethics Guidance for the Implementation of the End TB Strategy. The Ethics Guidance establishes that it is never appropriate to force treatment of people with tuberculosis because, among other things, it amounts to an invasion of bodily integrity and may put health care workers at risk…
Editor’s note: Full text of the declaration is available at the title link above.
Medicolegal Importance of Consent in Medical Practice: A Study in Tertiary Medical Centre of Barabanki U.P.
Medicolegal Importance of Consent in Medical Practice: A Study in Tertiary Medical Centre of Barabanki U.P.
Singh Amit Kumar, Singh Anju, Singh DK
Indian Journal of Forensic Medicine & Toxicology, 7 May 2019; 13(2) pp 26-29
Abstract
Introduction
The Term consent means voluntary agreement, compliance or permission. section 13 of the Indian Contract Act lays down that two or more persons are said to consent when they agree upon the same thing in the same sense(meeting of the minds). From the times immemorial, medical practitioners played paternalistic role and were trusted with the responsibility of deciding the best treatment for their patients. With time, doctor patient relationship has changed from paternalistic to service provider and consumer type relationship. Patient being the consumer of services provided by the medical practitioner, have the right to full information concerning their diagnosis, treatment options, prognosis and possible complication. Informed Consent is the back of Patient’s Autonomy. The advancement in medical technology has further increased its importance. In the developing countries including India, general physicians play a vital role in providing health care to the patients but unfortunately majority of them are unaware about the ethical aspects of Medical Practice.
Method
Objective: To determine the level of awareness about consent among faculty members in Tertiary Medical centre of Barabanki U.P.
Period of study
2Month.
Material and method
A questionaire exploring the awareness about consent was offered to the faculty member of MIMS, Barabanki U.P.
Results
The survey revealed that 12 questionaire were given to RMP of MIMS, out of 12 questions in 7 questions more than 50% of RMP were aware of correct response and in 5 questions more than 50% of RMP were unaware of requirement/procedure obtaining consent in various clinical situations.
Conclusions
They were aware of only those situations which are discussed and debated at various forums.
US State Regulation of Decisions for Pregnant Women Without Decisional Capacity
US State Regulation of Decisions for Pregnant Women Without Decisional Capacity
Research Letter
Erin S. DeMartino, Beau P. Sperry, Cavan K. Doyle, Julie Chor, Daniel B. Kramer, David M. Dudzinski, Paul S. Mueller
JAMA, 23 April 2019; 321(16) pp. 1629-1631
All US states have laws addressing decision making for individuals who cannot make their own medical decisions, including provisions for advance directives and processes authorizing relatives or interested persons to direct care as surrogate decision makers,1 although variation among state laws is increasingly recognized.2,3 However, the prevalence and content of state statutes and official advance directive documents addressing “treatment decisions for divisionally incapacitated pregnant women” is unknown.
Can dynamic consent facilitate the protection of biomedical big data in biobanking in Malaysia?
Can dynamic consent facilitate the protection of biomedical big data in biobanking in Malaysia?
Original Paper
Mohammad Firdaus Abdul Aziz, Aimi Nadia Mohd Yusof
Asian Bioethics Review, 25 May 2019; pp 1–14
Abstract
As with many other countries, Malaysia is also developing and promoting biomedical research to increase the understanding of human diseases and possible interventions. To facilitate this development, there is a significant growth of biobanks in the country to ensure continuous collection of biological samples for future research, which contain extremely important personal information and health data of the participants involved. Given the vast amount of samples and data accumulated by biobanks, they can be considered as reservoirs of precious biomedical big data. It is therefore imperative for biobanks to have in place regulatory measures to ensure ethical use of the biomedical big data. Malaysia has yet to introduce specific legislation for the field of biobanking. However, it can be argued that its existing Personal Data Protection Act 2010 (PDPA) has laid down legal principles that can be enforced to protect biomedical big data generated by the biobanks. Consent is a mechanism to enable data subjects to exercise their autonomy by determining how their data can be used and ensure compliance with legal principles. However, there are two main concerns surrounding the current practice of consent in biomedical big data in Malaysia. First, it is uncertain that the current practice would be able to respect the underlying notion of autonomy, and second, it is not in accordance with the legal principles of the PDPA. Scholars have deliberated on different strategies of informed consent, and a more interactive approach has recently been introduced: dynamic consent. It is argued that a dynamic consent approach would be able to address these concerns.
Center for Informed Consent Integrity 