Informed consent to clinical research in India: A private law remedy
Research Article
Himani Bhakuni
Medical Law International, 23 September 2020
Abstract
There is a well-established common law doctrine for ascertaining information disclosure in informed consent claims within the treatment context that governs the doctor–patient relationship. But there is no such doctrine in clinical research governing the researcher–participant relationship in India. India, however, is not exceptional in this regard. Common law countries like the United States and Canada at most have sparse, non-systematised, criteria for such cases; arguably, a doctrine for research is at its nascent stage. But the adequacy of the existing criteria for settling informed consent claims in research has hardly ever been discussed. Furthermore, a specific discussion on the applicability of this ‘nascent doctrine’ to India is non-existent. This article discusses both. The article examines case law from India and other common law jurisdictions that hint at developments in this area. It suggests that Indian courts need to move abreast with other jurisdictions to better protect India’s patients and research participants.
Month: October 2020
Informed consent, Montgomery and the duty to discuss alternative treatments in England and Australia
Informed consent, Montgomery and the duty to discuss alternative treatments in England and Australia
Research Article
Tracey Carver
Journal of Patient Safety and Risk Management, 9 September 2020
Abstract
The UK Supreme Court in Montgomery v Lanarkshire Health Board imposes a duty on healthcare professionals in relation to information disclosure. The obligation is to take reasonable care to ensure that patients are aware, not just of material risks inherent in any recommended treatment, but of any reasonable alternative treatments. While liability for information non-provision was previously decided according to whether the profession would deem disclosure appropriate, the law now judges the sufficiency of information from a patient’s perspective. In doing so, it adopts the approach advocated for Australia in Rogers v Whitaker. However, commentators, in this journal and elsewhere, have expressed concern that the disclosure obligation is unclear. Although Montgomery defines what is ‘material’ for the purpose of identifying notifiable treatment risks, it offers less guidance as to when alternative treatments will be sufficiently ‘reasonable’ to warrant disclosure. Through an analysis of Australian and UK case law and examples, this article considers the ambit of a practitioner’s duty to discuss alternatives. It concludes that although likely subject to further litigation, the identification of reasonable treatment options requiring disclosure will be influenced by the patient’s clinical condition, their prognosis and viable options from a medical perspective, and various non-clinical matters influenced by the test of materiality.
Informed Consent for Mobile Phone Health Surveys in Colombia: A Qualitative Study
Informed Consent for Mobile Phone Health Surveys in Colombia: A Qualitative Study
Research Article
Mariana Rodriguez-Patarroyo, Angelica Torres-Quintero, Andres I. Vecino-Ortiz, Kristina Hallez, Aixa Natalia Franco-Rodriguez, Eduardo A. Rueda Barrera, Stephanie Puerto, Dustin G. Gibson, Alain Labrique, George W. Pariyo, Joseph Ali
Journal of Empirical Research on Human Research Ethics, 25 September 2020
Abstract
Public health surveys deployed through automated mobile phone calls raise a set of ethical challenges, including succinctly communicating information necessary to obtain respondent informed consent. This study aimed to capture the perspectives of key stakeholders, both experts and community members, on consent processes and preferences for participation in automated mobile phone surveys (MPS) of non-communicable disease risk factors in Colombia. We conducted semi-structured interviews with ethics and digital health experts and focus group discussions with community representatives. There was meaningful disagreement within both groups regarding the necessity of consent, when the purpose of a survey is to contribute to the formulation of public policies. Respondents who favored consent emphasized that consent communications ought to promote understanding and voluntariness, and implicitly suggested that information disclosure conform to a reasonable person standard. Given the automated and unsolicited nature of the phone calls and concerns regarding fraud, trust building was emphasized as important, especially for national MPS deployment. Community sensitization campaigns that provide relevant contextual information (such as the name of the administering institution) were thought to support trust-building. Additional ways to achieve the goals of consent while building trust in automated MPS for disease surveillance should be evaluated in order to inform ethical and effective practice.
Enrolment of children in clinical research: Understanding Ghanaian caregivers’ perspectives on consent/assent procedures, and their attitudes towards storage of biological samples for future use
Enrolment of children in clinical research: Understanding Ghanaian caregivers’ perspectives on consent/assent procedures, and their attitudes towards storage of biological samples for future use
Research Article
George O Adjei, Amos Laar, Jorgen AL Kurtzhals, Bamenla Q Goka
Clinical Ethics, 13 September 2020
Abstract
Child assent is recommended in addition to parental consent when enrolling children in clinical research; however, appreciation and relevance ascribed to these concepts vary in different contexts, and information on attitudes towards storage of biological samples for future research is limited, especially in developing countries. We assessed caregivers’ understanding and appreciation of consent and assent procedures, and their attitudes towards use of stored blood samples for future research prior to enrolling a child in clinical research. A total of 17 in-depth interviews were conducted with primary caregivers of children (fathers [n = 3], mothers [n = 12], and grandmothers [n = 2]) at enrolment or on the immediate follow-up date. All caregivers recalled significant amount information from the study information sheet and were able to appropriately link such information to the consent process. While all participants confirmed information received prior to blood sampling as adequate, a few noted that the purpose was not sufficiently well communicated. Caregivers felt children were cognitively vulnerable, and prone to decisions that were not necessarily in their best interest. Nearly all caregivers felt it was their right and responsibility to overrule objections from their ward’s regarding enrolment into specific study or receipt of a therapeutic procedure. There were no objections or concerns regarding use of stored biological samples for future research purposes. There is thus, a need to improve understanding of caregivers on the information provided during the informed consent process. Context-specific studies on the age of assent in specific populations are needed.
Graduate students reported practices regarding the issue of informed consent and maintaining of data confidentiality in a developing country
Graduate students reported practices regarding the issue of informed consent and maintaining of data confidentiality in a developing country
Research Article
Samer Swedan, Omar F. Khabour, Karem H. Alzoubi, Alaa A.A. Aljabali
Heliyon, 9 September 2020; 6(9)
Abstract
Research involving human subjects requires strict adherence to ethical principles, including informed consent and assuring data confidentiality. Herein, a questionnaire was utilized to assess compliance of graduate students who conduct research involving human subjects in Jordan with proper practices related to informed consent and maintaining of data confidentiality. Among the 251 respondents, 55.4% were from health-related fields, 61.4% undertook research involving humans, and 48.6% did research requiring institutional review board approval. Only 37.1% of respondents reported exposure to research ethics education during their graduate study. Satisfactory adherence to informed consent practices was reported at rates of 56.0%–67.5%. Satisfactory adherence to practices related to data confidentiality and study participants’ anonymity was reported at rates of 67.3%–74.7%. Sharing of data or samples with others was reported at a rate of 24.3%. The rates of adherence to proper informed consent practices and practices that maintain data confidentiality were less than ideal. Significant policy changes need to be implemented to address these issues.
Prioritising African perspectives in psychiatric genomics research: Issues of translation and informed consent
Prioritising African perspectives in psychiatric genomics research: Issues of translation and informed consent
Eunice Kamaara, Camillia Kong, Megan Campbell
Bioethics, 14 November 2019
Abstract
Psychiatric genomics research with African populations comes with a range of practical challenges around translation of psychiatric genomics research concepts, procedures, and nosology. These challenges raise deep ethical issues particularly around legitimacy of informed consent, a core foundation of research ethics. Through a consideration of the constitutive function of language, the paper problematises like‐for‐like, designative translations which often involve the ‘indigenization’ of English terms or use of metaphors which misrepresent the risks and benefits of research. This paper argues that effective translation of psychiatric genomics research terminology in African contexts demands substantive engagement with African conceptual schemas and values. In developing attenuated forms of translational thinking, researchers may recognise the deeper motivational reasons behind participation in research, highlighting the possibility that such reasons may depart from the original meaning implied within informed consent forms. These translational issues might be ameliorated with a critical re‐examination of how researchers develop and present protocols to institutional ethics review boards.
Impact of new consent procedures on uptake of the schools-based human papillomavirus (HPV) vaccination programme
Impact of new consent procedures on uptake of the schools-based human papillomavirus (HPV) vaccination programme
Harriet Fisher, Matthew Hickman, Joanne Ferrie, Karen Evans, Michael Bell, Julie Yates, Marion Roderick, Rosy Reynolds, John MacLeod, Suzanne Audrey
Journal of Public Health, 26 September 2020
Open Access
Abstract
Background
Local policy change initiating new consent procedures was introduced during 2017–2018 for the human papillomavirus (HPV) vaccination programme year in two local authorities in the south–west of England. This study aims to assess impact on uptake and inequalities.
Methods
Publicly available aggregate and individual-level routine data were retrieved for the programme years 2015–2016 to 2018–2019. Statistical analyses were undertaken to show: (i) change in uptake in intervention local authorities in comparison to matched local authorities and (ii) change in uptake overall, and by local authority, school type, ethnicity and deprivation.
Results
Aggregate data showed uptake in Local Authority One increased from 76.3% to 82.5% in the post-intervention period (risk difference: 6.2% P = 0.17), with a difference-in-differences effect of 11.5% (P = 0.03). There was no evidence for a difference-in-differences effect in Local Authority Two (P = 0.76). Individual-level data showed overall uptake increased post-intervention (risk difference: +1.1%, P = 0.05), and for young women attending school in Local Authority One (risk difference: 2.3%, P < 0.01). No strong evidence for change by school category, ethnic group and deprivation was found.
Conclusion
Implementation of new consent procedures can improve and overcome trends for decreasing uptake among matched local authorities. However, no evidence for reduction in inequalities was found.
Implications and discussion
The new consent procedures increased uptake in one of the intervention sites and appeared to overcome trends for decreasing uptake in matched sites. There are issues in relation to the quality of data which require addressing.
Consent In Forefoot Surgery; What Does It Mean To The Patient?
Consent In Forefoot Surgery; What Does It Mean To The Patient?
Leo D. Baxendale-Smith, Scott D. Middleton, John C. McKinley, Colin E. Thomson
The Foot, 25 September 2020
Abstract
Aims
This study aimed to assess patient risk recall and find risk thresholds for patients undergoing elective forefoot procedures.
Methods
Patients were interviewed in the pre-assessment clinic (PAC) or on day of surgery (DOS); some in both settings. A standardised questionnaire was used for all interviews, regardless of setting. Patients were tested on which risks they recalled from their consent process, asked for thresholds for five pre-chosen risks and asked about a sham risk.
Results
Across all interviews, risk recall on DOS (2.34 risks/patient interview) was significantly lower (p = .05) than in PAC (2.95 risks/patient interview) – this was repeated when comparing results from patients interviewed in both settings only with PAC mean recall of 2.93 risks/patient interview and DOS mean recall of 2.57 risks/patient interview. The mean reported risk thresholds greatly exceeded X’s observed complication rates for forefoot procedures. The five risks tested for thresholds produced the same order in each interview setting, suggesting a patient-perceived severity ranking. Patients answering the sham risk question incorrectly tended to recall fewer risks across all interviews.
Conclusions
This study shows that patient risk recall is poor, as previous literature outlines, reinforcing that consent process improvements could be made. It also illustrates the value of PAC visits in patient education, as shown by higher levels of recall when compared to DOS.
Unplanned Cesarean Birth: Can the Quality of Consent Affect Birth Experiences?
Unplanned Cesarean Birth: Can the Quality of Consent Affect Birth Experiences?
Paul Burcher,Shazneen Hushmendy, Meredith Chan-Mahon, Megha Dasani, Jazmine Gabriel, Erin Crosby
AJOB Empirical Bioethics, 18 September 2020
Abstract
Background: Unplanned cesarean birth is associated with high levels of patient dissatisfaction and negative birth experiences, which in turn can negatively impact birth outcomes. Previous research has demonstrated that issues of physician-patient communication, mistrust, fear of the operating room (OR), and loss of control contribute to patient dissatisfaction with unplanned cesarean birth. We hypothesized that altering the nature and structure of the informed consent prior to the surgery might improve patient satisfaction and birth experience. Specifically, we explored whether educating resident physicians in counseling skills could shift the focus of informed consent from a checklist merely informing the patient of the risks, benefits, and alternatives to a discussion that informs the physician of the patient’s concerns and fears. By approaching consent in this manner, the goal of informed consent expands beyond autonomy rights to include beneficence as well. Methods: Residents received education to discuss issues of communication, fear, mistrust, and loss of control when seeking consent for an unplanned cesarean birth. Patients were randomized to receive either additional counseling that encouraged a discussion or a standard informed consent for cesarean birth. Participants were interviewed two weeks later and scored their satisfaction using a Likert scale on the four themes: communication, mistrust, fear of OR, and loss of control. Results: Both groups had very high patient satisfaction scores; there was no statistical difference between them. Conclusions: Both groups exhibited significantly higher levels of birth satisfaction than present in prior research. Training residents to discuss these issues while seeking consent for an unplanned cesarean birth may have improved patient satisfaction for all participants in this study. This suggests that educating residents to engage patients in a dialogue during informed consent counseling is more important than a specific script.
Informed consent: a shared decision-making process that creates a new professional obligation for care
Informed consent: a shared decision-making process that creates a new professional obligation for care
Guidelines
Arthur Rawlings, Lelan Sillin, Phillip Shadduck, Marian McDonald, Peter Crookes, Bruce MacFadyen Jr, John Mellinger, SAGES Ethics Committee
Surgical Endoscopy, 15 September 2020
Abstract
This statement on informed consent, developed by the SAGES Ethics Committee, has been reviewed and approved by the Board of Governors of SAGES. This statement is provided to offer guidance about the purpose and process of obtaining informed consent, and it is intended for practicing surgeons as well as patients seeking surgical intervention. It is an expression of well-established principles and extensive literature. Excluded from this document are discussions of informed consent for research and informed consent for introduction of new technology, as that has been addressed in previous publications (Strong in Surg Endosc 28:2272, 2014; Stefanidis in Surg Endosc 28:2257, 2014; as reported by Sillin (in: Stain (ed) The SAGES Manual Ethics of Surgical Innovation, Springer, Switzerland, 2016)).
Center for Informed Consent Integrity 