Physician-Investigator, Research Coordinator, and Patient Perspectives on Dual-Role Consent in Oncology A Qualitative Study
Stephanie R. Morain, Dorit Barlevy, Steven Joffe, Emily A. Largent
JAMA Network Open, 25 July 2023; 6(7)
Abstract
Importance
Classic statements of research ethics generally advise against dual-role consent in which physician-investigators seek consent for research participation from patients with whom they have preexisting treatment relationships. Yet dual-role consent is common in clinical oncology research, as studies are often conducted in close relationship with clinical care.
Objective
To explore key stakeholders’ perspectives on dual-role consent in clinical oncology trials.
Design, Setting, and Participants
This qualitative study with 43 participants was conducted at a National Cancer Institute–designated comprehensive cancer center from 2018 to 2022. Semistructured qualitative interviews of physician-investigators, research coordinators, and patients were performed. Respondents were recruited from 3 populations: (1) physician-investigators engaged in clinical oncology research; (2) research coordinators engaged in clinical oncology research; and (3) patients, with and without prior clinical trial experience, who had received a new cancer diagnosis at least 2 months prior to enrollment in this study.
Main Outcomes and Measures
Interviews were audio recorded and professionally transcribed. A thematic analysis approach was used to develop a codebook that included both theory-driven, a priori codes and emergent, inductive codes. Two authors double-coded all transcripts and met regularly to compare coding, discuss discrepancies, refine the codebook, and draft memos describing relevant themes and their frequency.
Results
Among the 43 respondents, 28 (65.1%) were female; 9 (20.9%) were African American, 8 (18.6%) were Asian, 6 (14.0%) were Hispanic, and 21 (48.8%) were White; 15 were physician-investigators (6 [40.0%] with 6-10 years of experience, 4 [26.7%] with at least 20 years of experience), 13 were research coordinators (5 [38.5%] with 0-5 years of experience, 5 [38.5%] with 6-10 years of experience), and 15 were patients (9 [60.0%] aged 46-64 years). Four main themes were found: interviewees (1) perceived greater potential for role synergy than for role conflict; (2) reported dual-role consent as having mixed effects on the consent process, increasing prospective participants’ understanding and likelihood of agreement while also challenging voluntariness; (3) preferred a team-based approach to the consent process in which physician-investigators and research coordinators share responsibility for communicating with prospective participants and safeguarding voluntariness; and (4) offered strategies for managing tensions in dual-role consent.
Conclusions and Relevance
This qualitative study found that concerns about dual-role consent in clinical oncology, while valid, may be outweighed by corresponding advantages, particularly if appropriate mitigation strategies are in place. These findings support a team-based approach to informed consent, in which physician-investigators and research coordinators promote both the understanding and voluntariness of prospective participants.
Dynamic consent, communication and return of results in large-scale health data reuse: Survey of public preferences
Dynamic consent, communication and return of results in large-scale health data reuse: Survey of public preferences
Sam Ha Muller, Ghislaine Jmw van Thiel, Menno Mostert, Johannes Jm van Delden
Digit Health, 16 August 2023
Open Access
Abstract
Dynamic consent forms a comprehensive, tailored approach for interacting with research participants. We conducted a survey study to inquire how research participants evaluate the elements of consent, information provision, communication and return of results within dynamic consent in a hypothetical health data reuse scenario. We distributed a digital questionnaire among a purposive sample of patient panel members. Data were analysed using descriptive and nonparametric inferential statistics. Respondents favoured the potential to manage changing consent preferences over time. There was much agreement between people favouring closer and more specific control over data reuse approval and those in favour of broader approval, facilitated by an opt-out system or an independent data reuse committee. People want to receive more information about reuse, outcomes and return of results. Respondents supported an interactive model of research participation, welcoming regular, diverse and interactive forms of communication, like a digital communication platform. Approval for reuse and providing meaningful information, including meaningful return of results, are intricately related to facilitating better communication. Respondents favoured return of actionable research results. These findings emphasize the potential of dynamic consent for enabling participants to maintain control over how their data are being used for which purposes by whom. Allowing different options to shape a dynamic consent interface in health data reuse in a personalized manner is pivotal to accommodate plurality in a flexible though robust manner. Interaction via dynamic consent enables participants to tailor the elements of participation they deem relevant to their own preferences, engaging diverse perspectives, interests and preferences.
Treatment without consent in adult psychiatry inpatient units: a retrospective study on predictive factors
Treatment without consent in adult psychiatry inpatient units: a retrospective study on predictive factors
Giulia Meroni, Othman Sentissi, Stefan Kaiser, Alexandre Wullschleger
Frontiers of Psychiatry, 10 August 2023
Abstract
Background
Coercion is one of the most important challenges in mental health. In Switzerland, forced medication can be applied during an emergency (Art. 435 of the Civil Code) or over a longer period in case of endangerment of others or oneself (Art. 434). We aimed to analyze the predictors of this specific treatment without consent.
Methods
Forced medication prescriptions in the Division of Adult Psychiatry of the Geneva University Hospitals between 2018 and 2021 were retrospectively analyzed. Medication under Article 434 was the main outcome variable. Age, gender, admission mode, main diagnosis, and the Health of the Nation Outcome Scales (HoNOS) score at admission were considered as potential predictors. T-test and Pearson’s chi-square test were used to compare continuous and categorical variables. A logistic regression was performed to find significant predictors of forced medication.
Results
Seventy-one out of 4,326 inpatients were subjected to forced medication under Art. 434. HoNOS global scores at admission were not significantly different in the forced medication group compared to the control group. Aggressive behavior was lower in the former at the univariate level. Forced medication was associated at the multivariate level with female gender, involuntary admission, and psychosis.
Conclusion
Women suffering from psychosis are more at risk of receiving involuntary and repeated medication. The risk of deterioration in psychosocial functioning or behavioral disorganization seems to be the main argument for this coercive measure. Future studies should focus on the patient’s perception of this coercion to prevent it and improve adherence to care. Follow-up after discharge might be useful to evaluate a long-term benefit.
Ensuring Ethical Dental Care: Obtaining Legal Consent for Nonverbal Adults
Ensuring Ethical Dental Care: Obtaining Legal Consent for Nonverbal Adults
TDIC Risk Management Staff
Journal of the California Dental Association, 28 July 2023
Excerpt
When it comes to dental treatment, the importance of obtaining proper, legal consent cannot be overstated. Dentists often face unique challenges in obtaining consent to treat adults who are nonverbal or unable to provide consent on their own due to cognitive impairments or advanced age.
The Dentists Insurance Company Risk Management Advice Line, which provides guidance to TDIC policyholders and dental association members, regularly receives inquiries about the appropriate procedures for obtaining consent to treat adults with special needs. The following case study illustrates the need for compassionate care and vigilance to ensure valid consent is obtained…
Improving the Consent Process with an Informed Consent Video Prior to Outpatient Colonoscopy
Improving the Consent Process with an Informed Consent Video Prior to Outpatient Colonoscopy
Original Research
Emily W. Lopes, Leo Boneschansker, Jacqueline N. Chu, James M. Richter, Amiko M. Uchida, Paul Lochhead
Gastro Hep Advances, 28 July 2023
Abstract
Background & Goals
Informed consent should allow patients appropriate time and conditions to make decisions about their care. However, consent is often obtained immediately prior to colonoscopy. We conducted a quality improvement study to assess how a pre-procedure consent video two days prior to outpatient colonoscopy impacts patient satisfaction.
Study
Patients undergoing outpatient colonoscopy at a large academic medical center opted-in to a text-messaging platform for procedural information. Our intervention was an informed consent video two days before colonoscopy. Our primary outcome was a composite patient satisfaction score. Pre- and post-intervention scores were compared using ordinal or multinomial logistic models to calculate odds ratios (OR) or relative risk ratios (RRR) and 95% confidence intervals (CI), adjusting for age and sex.
Results
1,109 and 1,452 patients completed ≥1 survey question in the pre- and post-intervention phases, respectively. Overall patient satisfaction did not differ between groups [OR for a 1-point increment in satisfaction score between post- vs. pre-intervention groups=1.05; 95% CI: 0.90-1.22; p=0.51]. Compared to pre-intervention, post-intervention respondents were more likely to report higher satisfaction with time available to talk with their physician (OR of a 1-point increase in individual question response=1.29; 95% CI: 1.09-1.54; p=0.004). Compared to pre-intervention, more physicians in the post-intervention phase rated satisfaction with consent process efficiency as “very satisfied” or “satisfied” (p<0.001).
Conclusion
An informed consent video prior to colonoscopy resulted in similar overall patient satisfaction. However, post-intervention, patients were more likely to report sufficient time to talk with their physician, and physicians reported higher satisfaction with consent efficiency.
Surgical Informed Consent in Clinical Practice: Patients’ Perspective Undergoing Cesarean Section at Three Teaching Hospitals in Addis Ababa, Ethiopia
Surgical Informed Consent in Clinical Practice: Patients’ Perspective Undergoing Cesarean Section at Three Teaching Hospitals in Addis Ababa, Ethiopia
Eskinder Kebede, Tadios Tasew, Dawit Worku
Ethiopian Journal of Health Sciences, 17 August 2023
Abstract
Background
Informed consent is a communication process of providing the patient/parents/guardians with relevant information regarding the diagnosis and the treatment so that they can make informed decisions. This study was to assess the practice of surgical informed consent in Addis Ababa.
Methods
An institution-based cross-sectional study was undertaken in Addis Ababa in 2021. A total of 312 women who underwent cesarean section were interviewed immediately after their hospital discharge. Thirteen components of SIC were used based on international recommendations, including the Royal College of Surgeons’ standards of informed consent practices for surgical procedures.
Results
Almost all (100 %) of the respondents were asked to provide written consent, and 96.2 % of them signed the consent form. Most women (89.4%) received information about the indication(s). Few (18.6%) respondents were informed about the type of anesthesia to be administered while only 9 %( n= 28) of them were given an opportunity to choose the option of anesthesia. Only 44.9% of the respondents have received at least six of the 13 components of SIC suggested by the investigators. In this, the most secured data was the signature of the patient which is 96 %. The least documented element of SIC was alternative treatment.
Conclusion
A majority of women who underwent both elective and emergency cesarean section did not receive comprehensive information during the Surgical Informed Consent process in the study hospitals. There is a need that patients need to be counseled during antenatal visits, specifically when patients visit near term for antenatal checkups.
Knowledge and perception of surgical informed consent among adult surgical patients in Arba Minch and Jinka General Hospitals, Southern Ethiopia
Knowledge and perception of surgical informed consent among adult surgical patients in Arba Minch and Jinka General Hospitals, Southern Ethiopia
Tigabu Daniel, Yonas Abera, Menaye Yihune
Ethiopian Medical Journal, 4 August 2023
Open Access
Abstract
Background
The surgical informed consent process and format are not uniform nationally and internationally. The objective of this study was to assess the knowledge and perception of adult patients towards the legal nature of surgical informed consent in Arbaminch and Jinka General Hospitals, South Ethiopia.
Methods
Responses from 423 post-operative adult surgical patients were taken using pretested structured interviewer-administered questionnaires for five months. A hospital-based cross-sectional study of all adult surgical patients who were operated were involved before discharged from December 1 2021-April 30, 2022 in Arbaminch and Jinka general hospitals, Southern Ethiopia. Stratified sampling technique was used. The collected data entered into EPI-data version 3.1 and exported to SPSS (version 25) software for statistical analyses. A significant level was determined at a P-value <0.05 with 95% confidence interval.
Results
A total of 423 adults with a response rate of 100% were included in the study. Of the respondent’s consent, only 210 (49.6%) was taken by an operating surgeon, and the majority was taken by a general practitioner, nurse, and midwife. Surprisingly consent taken by the porter was 5(1.2%). Of the respondents, only 188(44.4%) had good knowledge and only 58 (13.7%) had a good perception regarding surgical informed consent. Patients exposed for consent signing previously, had 4.06 times higher knowledge than those unexposed (AOR=4.06, 95% CI 😦 1.80, 4.492)). Those patients living in an urban area were well aware of surgical informed consent (AOR=0.246, 95% CI:- (0.212, 1.660)). Level of understanding of surgical informed consent, significantly increased for those informed by an operating surgeon (AOR=4.45, 95% CI:- ( 1.95, 5.09)).
Conclusion
Majority of our patients had poor knowledge and poor perception regarding the legal nature of surgical informed consent. Living in urban, signing informed consent previously and consent taken by operating surgeon affected level of knowledge positively. The consent had to be taken at least by the operating surgeon.
Experiences of patients and next of kin on informed consent process for emergency surgery in two Urban university teaching hospitals in Uganda: a comparative cross sectional study
Experiences of patients and next of kin on informed consent process for emergency surgery in two Urban university teaching hospitals in Uganda: a comparative cross sectional study
Research
Olivia Kituuka, Erisa Mwaka, Ian Munabi, Moses Galukande
BMC Emergency Medicine, 2 August 2023; 23(82)
Open Access
Abstract
Informed consent for emergency surgery is a process in which a patient or their next of kin must make quick decisions required for surgery in a life-threatening situation or surgery that may have life-altering outcomes. The objective of the study was to describe patients and their next of kin experiences and factors influencing the informed consent process in two urban university teaching hospitals in Uganda.
Methods
A cross-sectional survey involving patients who underwent emergency surgery and their next of kin was conducted in two tertiary care hospitals; one public and one private-not-for profit institution. A questionnaire was administered to collect sociodemographic information, type of Surgery that was done, how informed consent was obtained and experiences and expectations from the informed consent process. Univariate and multivariate analyses of the variables was done.
Results
We collected data from 210 patients from a public hospital and 170 from a private-not-for profit hospital. Overall, most patients did not have the risks of the surgery communicated to them (79.7%), were not given alternative options (87.6%) and had no opportunity to ask questions (57.4%). Patients at the private institution had 3.35 times the odds of expecting the consent form to be explained to them than those at the public institution. Patients at the public hospital had 0.12 times the odds of preferring to have consent administered by a nurse than patients at the private institution OR 0.12 (0.05–0.29, p < 0.001). Patients in the public institution had 0.18 times the odds of preferring to have consent administered by a doctor than patients in the private institution OR 0.18 (0.08–0.45, p < 0.001).
Conclusion
Patients in both public and private institutions are not informed about the risks of surgery, alternative options and are not given the opportunity to ask questions. Interpretation of the findings of this study on patient preferences on who administered consent though statistically significant were inconclusive due to the responses not being mutually exclusive.
Consent through art: a critique of a visual method developed with peer-researchers in southern Nepal
Consent through art: a critique of a visual method developed with peer-researchers in southern Nepal
Joanna Morrison, Awantika Priyadarshani, Abriti Arjyal
International Journal of Social Research Methodology, August 2023
Abstract
Obtaining informed consent can be challenging during peer research when the boundaries between researcher and participant are blurred. We developed a novel visual consent method with illiterate artists in Nepal who conducted peer interviews in their communities. Artists discussed and sketched images related to ethical principles to create a visual consent form. This improved comprehension about research ethics and developed the confidence of artists to conduct peer interviews, but we found that artists memorised the form; they did not engage participants in looking at the pictures with them; and they did not use the pictures that they disagreed with. In future research, the visuals should be developed in consultation with participants and be used to explain the study to participants. The tool development process can be used to establish a joint understanding about the research, its harms, and benefits, and to develop relational and iterative consent processes in participatory action research.
An examination of the moral conundrum of informed consent within the framework of African values and belief systems : a case study
An examination of the moral conundrum of informed consent within the framework of African values and belief systems : a case study
Jamila Kathoon Adam, Francis Fabian Akpa-Inyang
Interdisciplinary Journal of Economics and Business Law, 2023; 12(1)
Abstract
The notion of bio-medical ethics, which places a strong focus on individual autonomy when considering informed consent, is mostly inspired by western European medical and moral traditions, leaving African traditions and values out of the practice of medical ethics. This is due to the fact that African customs and values favour communitarianism above individualism. In African culture, your strong relationships with people in the community which include sharing everything, including decision-making are what define you as a human being. As a result, it is clear that when applied to the majority of Africans, the idea of individual liberty in informed consent is inapplicable. This is because African communitarian ethics focuses on the interests of the family, community and society and not the individual. Thus, there might be a conflict in the application of the western principle of medical ethics in the general population in Africa. This review paper intends to use published articles, reports, case studies, and ethical principles to explore this potential conflict.
Center for Informed Consent Integrity 