Informed Consent in Societies with Different Ethos of ‘Selfhood’
Muna Al-Saadoon, Samir Al-Adawi
Sultan Qaboos University Medical Journal, 12 May 2019;19(1) pp. e1–3
Excerpt
It has been well established that many illnesses, disabilities and distress are influenced by psychosocial factors.1 These psychosocial factors are central to the predisposition, onset, course, and outcome of illnesses.2 Thus, biopsychosocial factors are of major importance in designing intervention and management plans. According to Sirri et al., “When patient behaviors differ from those expected or recommended by physicians, the greater this discrepancy, the less likely the course of the disease will be predicted solely by bio medical factors” (P. 74).3 However, social and cultural factors appear to be marginalised when applying informed consent in traditional societies around the world where factors underpinning cultural beliefs or practices and social behaviour might be different to what is often taught in medical schools…

Editor’s note: Full text of this excerpt can be found at the title link

Informed Consent in Africa – Integrating Individual and Collective Autonomy
Research Ethics Forum Series
Retha Visagie, Soné Beyers, J. S. Wessels
Social Science Research Ethics in Africa, 24 May 2019; 7 pp 165-179
Abstract
Free, prior informed consent is a universally acknowledged ethical requirement for research with human participants. In social sciences, informed consent guidelines are mostly critiqued for its inherent universalism and support of the individualised principlist notion of autonomy. Therefore, social science researchers working with rural communities in Africa cannot ignore the values, concepts and theories relevant to collective autonomy. This chapter advocates for an integrated informed consent approach founded on Afro-communitarianism. We argue that the process of obtaining free, prior informed consent is deeply entrenched in cultural values. A one-size-fits-all approach to informed consent is in itself a form of disrespect for those concerned. The significant contribution of the chapter is a comparative analysis of individual and collective autonomy as it pertains to informed consent from two theoretical perspectives, namely principlism and Afro-communitarianism. We hope to encourage social researchers working in these settings to consider an African perspective on how to preserve participant autonomy.

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.

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
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?
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.

Preference and Values of Stroke Interventions, Kingdom of Saudi Arabia
Reem Alamri , Adel Alhazzani , Saeed A. Alqahtani, Hayfa Al-Alfard, ShahadMukhtar, Khadejah Alshahrany, Faisal Asiri
Neurology Research International, 1 April 2019
Background
Acute ischemic stroke (AIS) occurs when there is a sudden occlusion of the arterial blood supply to part of the brain resulting in sudden focal neurological deficits. Recent major clinical trials of reperfusion therapy had proved the efficacy of timely stroke intervention to restore blood flow. Development of acute stroke protocols waiving the informed consent to obtain necessarily brain images or provide thrombolytic therapy is important to streamline and organize efforts to achieve the goal of early intervention and better functional outcome.
Objective 
This study aims to identify the preference and values of acute stroke interventions standard of care therapy without informed consent in the absence of surrogate decision-makers.
Methods
A cross-sectional survey was conducted in the Kingdom of Saudi Arabia using an electronic questionnaire. The questionnaire addressed the patients’ preference of acute stroke protocol waiving the informed consent for hyperacute brain images and delivering thrombolytic therapy or mechanical thrombectomy in absence of surrogate. All Saudi population aging from 18 to 65 years were invited to participate.
Results
The study included 2004 participants with ages ranging from 18 to 65 years with mean age of 30.1 years. About 66% of the participants were females and 95% were Saudi. Overall, 90.5% of the participants agreed on performing computed tomography angiography (CTA) by the medical staff for the acute strokes without consenting followed by 79% for thrombolytic therapy, 70.8% for mechanical thrombectomy, and only 49.3% for acute lifesaving surgical intervention.
Conclusion
Researchers found that the high percentage of participants had favorable response and positive perception toward providing acute stroke intervention and mechanical thrombectomy without informed consent. However, the study showed skeptical acceptance among participants regarding invasive surgical measures.

Informed Consent in Medical Decision Making In India
Rateesh Sareen, Akanksha Dutt
Journal of Counselling and Family Therapy, April 2019; 1(1)
Abstract
Consent is one of the key elements for protection of welfare of patients or research participants. The physician has a legal and ethical responsibility to provide adequate information to the patient so that he or she is able to process the information and make appropriate decisions. The patient’s consent must be voluntary and competent. In order to meet the requirements for effective, informed decision making, a physician must disclose material facts, which are relevant to decision making, including the patient’s diagnosis, proposed treatment, risks and benefits of the treatment, alternative treatments along with their risks and benefits, and the risks of refusal. A physician must answer truthfully about the number of similar procedures or cases performed, and disclose success rates, and any financial conflict(s) of interest. The physician must advise patients of all personnel involved in their care and their respective roles, including residents, students, and equipment representatives.

Editor’s note: The vision of the Journal of Counselling and Family Therapy is to provide opportunities to bring fore new knowledge and concepts from various inter-linked subjects concerned with the study of mental health, disorders and related issues.