Effect of language and country of birth on the consent process and medical suitability of potential organ donors; a linked-data cohort study 2010–2015

Effect of language and country of birth on the consent process and medical suitability of potential organ donors; a linked-data cohort study 2010–2015
Karen M.J. Waller, James A. Hedley, Brenda M. Rosales, Nicole L. De La Mata, Imogen K. Thomson, John Walker, Patrick J. Kelly, Michael J. O’Leary, Elena Cavazzoni, Kate R. Wyburn, Angela C. Webster
Journal of Critical Care, 22 January 2020
Australia has unmet need for transplantation. We sought to assess the impact of cultural and linguistic diversity (CALD) on family consent and medical suitability for organ donation.
Cohort study of New South Wales donor referrals, 2010–2015. Logistic regression estimated effects of primary language other than English and birthplace outside Australia (odds ratios OR, with 95% confidence intervals, 95%CI). Outcomes were whether families were asked for consent to donation, provided consent for donation, and whether the referral was medically suitable for donation.
Of 2977 organ donor referrals, a similar proportion of families had consent for donation was sought between non-English speakers and English speakers (p = .07), and between overseas-born compared to Australian-born referrals (p = .3). However, consent was less likely to be given for both non-English speakers than English speakers (OR 0.44, 95%CI:0.29–0.67), and those overseas-born than Australian-born (OR 0.54, 95%CI:0.41–0.72). For referrals both overseas-born and non-English speaking, families were both less likely to be asked for consent (OR 0.67; 95%CI:0.49–0.91) or give consent (OR 0.24; 95%CI0.16–0.37). There was no difference in medical suitability between English speakers and non-English speakers (p = .6), or between Australian-born and overseas-born referrals (p = .6).
Intervention to improve consent rates from CALD families may increase donation.

There’s ‘consent’ and then there’s consent: Mobilising Māori and Indigenous research ethics to problematise the western biomedical model

There’s ‘consent’ and then there’s consent: Mobilising Māori and Indigenous research ethics to problematise the western biomedical model
Research Article
Kiri West-McGruer
Journal of Sociology, 13 January 2020  
Challenging western research conventions has a strong documented history in Indigenous critical theory and Kaupapa Māori research discourse. This article will draw from the existing research in these fields and expand on some of the core critiques of the biomedical model in Māori research environments. Of interest are the tensions produced by an over-reliance on individual informed consent as the panacea of ethical research, particularly when the research concerns communities who prioritise collective autonomy. These tensions are further exacerbated in research environments where knowledge is commodified and issues of knowledge ownership are present. Continuing a critique of the informed consenting procedure, this article considers its role in emulating a capitalist exchange of goods and perpetuating a knowledge economy premised on the exploitation of Indigenous people, resources and knowledge. Finally, this article will consider emerging ethical concerns regarding secondary data use in an era of big data.

Researcher and study participants’ perspectives of consent in clinical studies in four referral hospitals in Vietnam

Researcher and study participants’ perspectives of consent in clinical studies in four referral hospitals in Vietnam
Research Article
Jennifer Ilo Van Nuil, Thi Thanh Thuy Nguyen, Thanh Nhan Le Nguyen, Van Vinh Chau Nguyen, Mary Chambers, Thi Dieu Ngan Ta, Laura Merson, Thi Phuong Dung Nguyen, Minh Tu Van Hoang, Michael Parker, Susan Bull & Evelyne Kestelyn
BMC Medical Ethics, 10 January 2020; 21(4) 
Open Access
Within the research community, it is generally accepted that consent processes for research should be culturally appropriate and tailored to the context, yet researchers continue to grapple with what valid consent means within specific stakeholder groups. In this study, we explored the consent practices and attitudes regarding essential information required for the consent process within hospital-based trial communities from four referral hospitals in Vietnam.
We collected surveys from and conducted semi-structured interviews with study physicians, study nurses, ethics committee members, and study participants and family members regarding their experiences of participating in research, their perspectives toward research, and their views about various elements of the consent process.
In our findings, we describe three interrelated themes related to the consent process: (1) words and regulation; (2) reimbursement, suspicions, and joining; and (3) responsibilities. In general, stakeholders had highly varied perspectives of nghiên cứu (Eng.: research) and researchers used varying levels of detail regarding all aspects of the study in the consent process to build trust with and/or promote potential research participants’ choices about taking part in research. Findings additionally highlight how researchers felt that offering financial reimbursements in a hospital setting, where payment for services was routine, would be unfamiliar to participants and could raise suspicions about the research. Participants, however, focused their discussions on reimbursement or alternative reasons for joining the study, such as health related benefits or altruism. Finally, participants often relied on their physician to help them decide about joining a study or not.
Further research is needed to understand how researchers and participants make sense of and practice consent, and how that impacts participants’ decision-making about research participation. To promote valid consent within this context, it is important to engage with hospital-based trial communities as a whole. The data from this study will inform future research on consent, guide the revisions of consent related policies within our research sites and point to several larger issues surrounding researcher-participant expectations, communication, and trust.

Informed consent procedure in a double blind randomized anthelminthic trial on Pemba Island, Tanzania: do pamphlet and information session increase caregivers knowledge?

Informed consent procedure in a double blind randomized anthelminthic trial on Pemba Island, Tanzania: do pamphlet and information session increase caregivers knowledge?
Research Article
Marta S. Palmeirim, Amanda Ross, Brigit Obrist, Ulfat A. Mohammed, Shaali M. Ame, Said M. Ali, Jennifer Keiser
BMC Medical Ethics, 6 January 2020; 21(1)
Open Access
In clinical research, obtaining informed consent from participants is an ethical and legal requirement. Conveying the information concerning the study can be done using multiple methods yet this step commonly relies exclusively on the informed consent form alone. While this is legal, it does not ensure the participant’s true comprehension. New effective methods of conveying consent information should be tested. In this study we compared the effect of different methods on the knowledge of caregivers of participants of a clinical trial on Pemba Island, Tanzania.
A total of 254 caregivers were assigned to receive (i) a pamphlet (n = 63), (ii) an oral information session (n = 62) or (iii) a pamphlet and an oral information session (n = 64) about the clinical trial procedures, their rights, benefits and potential risks. Their post-intervention knowledge was assessed using a questionnaire. One group of caregivers had not received any information when they were interviewed (n = 65).
In contrast to the pamphlet, attending an information session significantly increased caregivers’ knowledge for some of the questions. Most of these questions were either related to the parasite (hookworm) or to the trial design (study procedures).
In conclusion, within our trial on Pemba Island, a pamphlet was found to not be a good form of conveying clinical trial information while an oral information session improved knowledge. Not all caregivers attending an information session responded correctly to all questions; therefore, better forms of communicating information need to be found to achieve a truly informed consent.

Pre-post implementation survey of a multicomponent intervention to improve informed consent for caesarean section in Southern Malawi

Pre-post implementation survey of a multicomponent intervention to improve informed consent for caesarean section in Southern Malawi
Original Research
Siem Zethof, Wouter Bakker, Felix Nansongole, Kelvin Kilowe, Jos van Roosmalen, Thomas van den Akker
BMJ Open, 6 January 2020
Open Access
Objective Surgical informed consent is essential prior to caesarean section, but potentially compromised by insufficient communication. We assessed the association between a multicomponent intervention and women’s recollection of information pertaining to informed consent for caesarean section in a low-resource setting, thereby contributing to respectful maternity care.
Pre-post implementation survey, conducted from January to June 2018, surveying women prior to discharge.
Rural 150-bed mission hospital in Southern Malawi.
A total of 160 postoperative women were included: 80 preimplementation and 80 postimplementation.
Based on observed deficiencies and input from local stakeholders, a multicomponent intervention was developed, consisting of a standardised checklist, wall poster with a six-step guide and on-the-job communication training for health workers.
Primary and secondary outcome measures
Individual components of informed consent were: indication, explanation of procedure, common complications, implications for future pregnancies and verbal enquiry of consent, which were compared preintervention and postintervention using χ2 test. Generalised linear models were used to analyse incompleteness scores and recollection of the informed consent process.
The proportion of women who recollected being informed about procedure-related risks increased from 25/80 to 47/80 (OR 3.13 (95% CI 1.64 to 6.00)). Recollection of an explanation of the procedure changed from 44/80 to 55/80 (OR 1.80 (0.94 to 3.44)), implications for future pregnancy from 25/80 to 47/80 (1.69 (0.89 to 3.20)) and of consent enquiry from 67/80 to 73/80 (OR 2.02 (0.73 to 5.37)). After controlling for other variables, incompleteness scores postintervention were 26% lower (Exp(β)=0.74; 95% CI 0.57 to 0.96). Recollection of common complications increased with 0.25 complications (β=0.25; 95% CI 0.01 to 0.49). Recollection of the correct indication did not differ significantly.
Recollection of informed consent for caesarean section changed significantly in the postintervention group. Obtaining informed consent for caesarean section is one of the essential components of respectful maternity care.

Assent and consent in adolescent research: teachers’ perspectives from a developing country

Assent and consent in adolescent research: teachers’ perspectives from a developing country
Research Article
Mahmoud A. Alomari, Nihaya A. Al-sheyab, Omar F. Khabour, Karem H. Alzoubi
Heliyon, January 2020; 6(1)
Open Access
Teachers play a vital role in facilitating research in schools. However, teachers’ views of informed consent/assent for children participation in research in the Middle East have not been investigated. In this study, focus group interviews were conducted to understand high-school teachers’ perspectives toward adolescent assents and consents. The teachers indicated that parent consent is important and should be coupled with sufficient information about the research study. The teachers added that assent is most important for children above 13 years old. Conversely, the teachers believed that parent approval is only important for invasive (such as research involves blood withdrawal) but not simple procedures. Most importantly, for procedures that are considered simple, part of the teachers do not acknowledge the significance of parental approval, such as body weight, or beneficial, such as new treatment. The results indicate that some of the teachers’ views were consistent with proper conduction of pediatric research. However, other views were worrisome and might warrant further studies and actions. Risks related need to be assessed and policies needs to be developed in order to ensure the proper conduction of pediatric research.

Medical Informed Consent in India: Blind Leading the Blind

Medical Informed Consent in India: Blind Leading the Blind
Review article
Sareen R
Journal of Community Medicine and Health Research, 4 December 2019; 1(3)
Open Access
This work is an endeavor to enable health care workers to understand the significance of ‘consent in medical treatment in India’. There have been increased litigations in recent years in health care therefore it is prudent to respect patient autonomy and refrain from too harsh medical paternalistic attitude. The Bolam test has been the yard stick for determining Medical negligence and it is also relevant in terms of consent for medical treatment. The landmark judgment by apex court in India emphasized on role of consent, absence of which shall be considered as deficiency of medical services actionable under tort. As the developed nations move towards ‘Informed consent’ we in India have a long way to go with rampant illiteracy, poor socioeconomic strata and limited resources it is like a dream. The review focuses on hurdles in the informed consenting process as well as the mandatory bare minimum requirements in Indian Law.

The Landscape of the Legal Aspects of Informed Consent for Medical Treatment in Papua New Guinea

The Landscape of the Legal Aspects of Informed Consent for Medical Treatment in Papua New Guinea
Alfred P. Minei, Rachelyn Ann S. Araña, Ronald R. Roldan Jr., Sam O. Kaipu
Journal of Health Science, 2019; 7
Open Access
The major challenges militating against the proper practice of informed consent identified in our desk top review are related to cultural issues of the people. Many patients continue to value strongly their kinship ties with the past and believe in the traditional methods of healing sickness. The patients must be given some information about what the doctor proposes to do. The underlying spirit of informed consent is new in PNG, and it strives against the traditional attitudes of doctors that they know it best for the patients and the strong culture in customs and patients’ misconceptions that affect their perceptions in making important health care decisions. Majority of the patients have some notion of informed consent, however not many people understand what it is. They still hang onto their traditional customs, beliefs and opinions that affect their health care decisions; they often look to their village elders, family and parents for advice in times of sickness or death in the family but where the law implies consent it is not often obtained. Summarization of current laws, reports of legal cases, and personal experiences were examined. Special requirements must be prescribed when patients are subjected to medical treatment. Documentation of a well-defined process, not only on paper, may not only protect the medical doctor from exposure to liability but increases the patient’s autonomy in decisions concerning health and encourages compliance with treatment; and advances the interests of both patient and doctor. Lack of informed consent can reinforce a claim of medical malpractice, and could well undermine relevant health care policy to protect patient autonomy.

The Paradox of Consent for Capacity Assessments

The Paradox of Consent for Capacity Assessments
Research Article
Peter Koch
The Journal of Law, Medicine and Ethics, 19 January 2020
The use of decision-making capacity assessments (DMCA) in clinical medicine is an underdeveloped yet quickly growing practice. Despite the ethical and clinical importance of these assessments as a means of protecting patient autonomy, clinicians, philosophers, and ethicists have identified a number of practical and theoretical hurdles which remain unresolved.2 One ethically important yet largely unaddressed issue is whether, and to what extent physicians ought to inform and obtain consent from patients prior to initiating a capacity assessment. In what follows, I address the following question: Must, or should, physicians obtain consent for capacity assessments? I argue that physicians have an ethical obligation to obtain express patient consent for capacity assessments, and in doing so, I challenge the predominant view which requires physicians to merely inform patients without obtaining consent. I then identify an underlying philosophical paradox that complicates the clinician’s duty to obtain consent: in short, consent is needed for an assessment of one’s ability to consent. Finally, I recommend a practical solution to this paradox of consent for capacity assessments by proposing a model of double consent from both the patient and health care representative.

Interventions to Improve Patient Comprehension in Informed Consent for Medical and Surgical Procedures: An Updated Systematic Review

Interventions to Improve Patient Comprehension in Informed Consent for Medical and Surgical Procedures: An Updated Systematic Review
Review Article
Johanna Glaser, Sarah Nouri, Alicia Fernandez, Rebecca L. Sudore, Dean Schillinger, Michele Klein-Fedyshin, Yael Schenker
Medical Decision Making, 16 January 2020
Patient comprehension is fundamental to valid informed consent. Current practices often result in inadequate patient comprehension.
An updated review to evaluate the characteristics and outcomes of interventions to improve patient comprehension in clinical informed consent.
Data Sources
Systematic searches of MEDLINE and EMBASE (2008–2018).
Study Selection
We included randomized and nonrandomized controlled trials evaluating interventions to improve patient comprehension in clinical informed consent.
Data Extraction
Reviewers independently abstracted data using a standardized form, comparing all results and resolving disagreements by consensus.
Data Synthesis
Fifty-two studies of 60 interventions met inclusion criteria. Compared with standard informed consent, a statistically significant improvement in patient comprehension was seen with 43% (6/14) of written interventions, 56% (15/27) of audiovisual interventions, 67% (2/3) of multicomponent interventions, 85% (11/13) of interactive digital interventions, and 100% (3/3) of verbal discussion with test/feedback or teach-back interventions. Eighty-five percent of studies (44/52) evaluated patients’ understanding of risks, 69% (41/52) general knowledge about the procedure, 35% (18/52) understanding of benefits, and 31% (16/52) understanding of alternatives. Participants’ education level was reported heterogeneously, and only 8% (4/52) of studies examined effects according to health literacy. Most studies (79%, 41/52) did not specify participants’ race/ethnicity.
Variation in interventions and outcome measures precluded conduct of a meta-analysis or calculation of mean effect size. Control group processes were variable and inconsistently characterized. Nearly half of studies (44%, 23/52) had a high risk of bias for the patient comprehension outcome.
Interventions to improve patient comprehension in informed consent are heterogeneous. Interactive interventions, particularly with test/feedback or teach-back components, appear superior. Future research should emphasize all key elements of informed consent and explore effects among vulnerable populations.