MSK eConsent: Digitalizing the informed consent process to improve participant engagement and understanding
Care Delivery and Regulatory Policy
Michael T. Buckley, Joseph M. Lengfellner, Matthew J. Koch, Benjamin Search, Carol Hoidra, Mary Lin, Sangeeta Kundu, Roy Cambria, Molly O’Shea, Jesse Galle, Jennifer Wang, Ann Rodavitch, Karima Yataghene, Jaclyn Pember, Stephanie Lucia Terzulli, Collette Houston, Eric Cottington, Paul Sabbatini
Journal of Clinical Oncology, 25 May 2020; 38(15)suppl.2066
Abstract
Background: eConsent was developed to digitize the research participant consenting experience with an educational engagement model. The eConsent platform tiers consent document content in an easy-to-navigate format, using videos, images, and access to supplementary information. We hypothesize that enhancing the consenting experience improves participant engagement and comprehension. Methods: Here we present two projects: 1) qualitative assessment of patient engagement in the eConsent process using a standardized 5-question survey sent to all patients who used it during 9 months in 2019, and 2) a report of our preliminary findings from exempt protocol, Assessing Participant Engagement and Protocol Education in the Consent Process (X19-055) that quantitatively compares paper and electronic consenting and a) assesses patient agency and b) tests comprehension of key consent elements in 2 protocols: Storage and Research Use of Human Biospecimens (06-107) and Genomic Profiling in Cancer Patients (12-245). Results: 1) 940 patients completed the qualitative experience survey (27% response). Most respondents (777; 83%) indicated that electronic consenting was very easy (371) or easy (406) to use. Only 25 (3%) said electronic consenting was somewhat difficult to use, 3 indicated it was difficult (0.3%), and 64 were neutral. Most (896; 95%) recommended electronic consenting to other MSK patients. Those who reported a 1 unit increase in technology discomfort, only reported a .48 unit increase in eConsent discomfort (P< .001). 2)Quantitative 10-question electronic tests were sent to each patient’s portal account within 72h after consenting via paper or eConsent to protocols 06-107 and 12-245. To date, for 06-107: 18 paper consenters completed the test with a score of 76% vs 23 eConsent users who scored 80%. For 12-245: 43 paper consenters scored 69% vs 13 eConsent users scoring 80%. Scores are a surrogate marker for patient comprehension and show that 12-245 protocol participants’ average testing scores are higher when participants are consented with eConsent vs paper (P < .01). 06-107 protocol participants’ average test scores are trending toward eConsent improving patient understanding (P= .11). We will follow this trend as our sample size increases to a total of 500 participants. Patient agency questions received favorable responses from most patients (100%-84%). Conclusions: eConsent enhances participant engagement and understanding and does not impose a digital burden on participants.
Capacity, consent and compulsion [BOOK CHAPTER]
Capacity, consent and compulsion [BOOK CHAPTER]
Margaret Brazier, Emma Cave
Medicine, patients and the law (sixth edition)
Manchester University Press, 29 May 2020; Chapter 6
Abstract/Excerpt
Capacity, Consent and Compulsion examines the Mental Capacity Act 2005 ten years on. This visionary piece of legislation has led to a substantial body of case law. Its rejection of a pure substituted judgement test in favour of a modified best interests test and its adoption of a two part test for (in)capacity have excited much academic debate. In 2007 the Act was amended to introduce new Deprivation of Liberty Safeguards (DoLS). The DoLS have been widely criticised. We consider measures to support those lacking capacity such as advance directives, lasting powers of attorney and court-appointed deputies. Central to the Act is the Court of Protection which adjudicates on disputes in both health care and welfare matters.
Designing a Solution to Manage Electronic Consent for Children
Designing a Solution to Manage Electronic Consent for Children
Gary Leeming , Sarah Thew, John Ainsworth
Studies in health technology and informatics, 16 June 2020; 270 pp 1103-1107
Abstract
Electronic systems for managing consent do exist but are generally only able to record consent from the research subject directly. Consent for research is also challenging to integrate into many electronic patient record systems. The Born In Bradford study is a large, from birth cohort study in the North of England which requires consent to be recorded by the pregnant mother of a child who will be included in the study from birth. This creates a complex challenge for consent management that has previously been achieved through paper-based processes. As the study begins a new phase with the objective of inviting all new parents within the Bradford region to participate in the study the solution also needs to work with existing maternity systems. This paper considers the specific challenges of converting the often grey rules around consent of children into an electronic system that is transparent and supports the trust of both the family and the clinical and care teams recruiting research subjects into a large cohort study, and describes the user centred design and technical approach taken to resolve it.
Is consent causing confusion for clinicians? A survey of child and adolescent Mental health professional’s confidence in using Parental Consent, Gillick Competence and the Mental Capacity Act
Is consent causing confusion for clinicians? A survey of child and adolescent Mental health professional’s confidence in using Parental Consent, Gillick Competence and the Mental Capacity Act
Research Article
Clare Fenton
Clinical Child Psychology and Psychiatry, 6 June 2020
Abstract
All professionals engaged in clinical work should be competent to assess consent for the interventions they provide. This study assesses CAMHS clinicians confidence and knowledge in the various forms of consent and the number of minors admitted to mental health units in England under parental consent alone.
An online questionnaire using vignettes of possible scenarios was sent to child and adolescent mental health practitioners in Tees Esk and Wear Valleys Trust. A freedom of information request was used to determine the number of young people admitted through parental consent.
Thirteen of the 20 trusts contacted had no knowledge of the number of young people admitted under parental consent. A total of 93 participants completed the survey. Out of six vignettes, there were two where the majority of responses were discordant with current legal advice. Both of these vignettes considered the use of parental consent for admission to a mental health unit.
This study provides further evidence to indicate that the current consent processes in CAMHS causes confusion for clinicians. There continues to be very few safeguards for children admitted under parental consent, with most trusts in England and Wales having no centralised knowledge of whether this is occurring and the numbers involved if it is.
Racial/ethnic, language, and health literacy disparities on perception of voluntariness during informed consent for pediatric cancer clinical trials
Racial/ethnic, language, and health literacy disparities on perception of voluntariness during informed consent for pediatric cancer clinical trials
Paula Aristizabal, Arissa MA, Bianca Perdomo, Jesse Nodora, Maria E. Martinez
Eleventh AACR Conference on The Science of Cancer Health Disparities in Racial/Ethnic Minorities and the Medically Underserved, 2-5 November 2018; New Orleans, LA
Open Access
Abstract
Background
Valid consent for research requires that the decision for participation be both fully informed and voluntary. Previous studies on informed consent have shown that when presented with a clinical trial for their child, parents often do not understand the many components of informed consent, including voluntariness of participation. In addition, individuals with limited English proficiency have reported lower understanding and satisfaction during informed consent. There is limited research on factors associated with perception of voluntariness during participation in pediatric cancer clinical trials. Our aim was to examine contextual factors associated to perception of voluntariness in parents who had consented to participation of their child in a clinical trial for cancer treatment, focused on characterizing differences between non-Hispanics and Hispanics, as the latter is the fastest-growing ethnic group in the U.S.
Methods
Parents (n=97) of children aged 0-17 years with newly diagnosed cancer, who had consented to participation of their child in a clinical trial for treatment at Rady Children’s Hospital-San Diego, were prospectively recruited. Participants completed questionnaires assessing sociodemographics, health literacy, perception of voluntariness, decisional regret, satisfaction, and acculturation level, if Hispanic. Outcomes and their correlates were analyzed using logistic regression.
Results
Fifty participants (51.5%) were Hispanic and 47 (48.5%) non-Hispanic. We found that parents who were Hispanic compared to non-Hispanics (p<0.001), Spanish-speaking compared to English-speaking (p=0.048), and those with lower health literacy (p<0.001) had lower perception of voluntariness. Decisional regret was overall low and satisfaction was overall high across all subgroups and neither measure was significantly impacted by sociodemographics, health literacy or acculturation.
Conclusions
In this study, with equivalent numbers of Hispanics and non-Hispanics, we found that Hispanic parents of children with newly diagnosed cancer, and particularly Spanish-speakers and those with low health literacy, had inadequate perception of voluntariness. To our knowledge, this is the first study to associate lower health literacy with lower perception of voluntariness in parents of children with newly diagnosed cancer despite overall high rates of satisfaction with the informed consent process for pediatric cancer clinical trials. True voluntariness of participation is essential to the ethical practice of informed consent, and our study suggests that many participants with low health literacy, particularly Hispanics and Spanish-speaking individuals, are not making truly informed decisions. Tailored interventions can improve decision-making, reduce clinical trial participation inequities and, ultimately, eliminate survival disparities by effectively and equally translating discoveries and treatment benefits to diverse populations.
Egyptians’ social acceptance and consenting options for posthumous organ donation; a cross sectional study
Egyptians’ social acceptance and consenting options for posthumous organ donation; a cross sectional study
Research Article
Ammal M. Metwally, Ghada A. Abdel-Latif, Lobna Eletreby, Ahmed Aboulghate, Amira Mohsen, Hala A. Amer, Rehan M. Saleh, Dalia M. Elmosalami, Hend I. Salama, Safaa I. Abd El Hady, Raefa R. Alam, Hanan A. Mohamed, Hanan M. Badran, Hanan E. Eltokhy, Hazem Elhariri, Thanaa Rabah, Mohamed Abdelrahman, Nihad A. Ibrahim, Nada Chami
BMC Medical Ethics, 15 June 2020; 21(49)
Open Access
Abstract
Background
Organ donation has become one of the most effective ways to save lives and improve the quality of life for patients with end-stage organ failure. No previous studies have investigated the preferences for the different consenting options for organ donation in Egypt. This study aims to assess Egyptians’ preferences regarding consenting options for posthumous organ donation, and measure their awareness and acceptance of the Egyptian law articles regulating organ donation.
Methods
A cross sectional study was conducted among 2743 participants over two years. Each participant was required to rank eleven consenting options from 1 (most preferred) to 11 (least preferred), and to report his awareness and acceptance of the seven articles of the Egyptian law of organ donation.
Results
47% of the participants expressed willingness to donate their organs after death. This percentage increased to 78% when consenting options were explained to participants. “Informed consent by donor only” was the most preferred type of consent for one third of respondents. Awareness of the law articles regulating organ donation was relatively low ranging from 56% to 23%.
Conclusion
Currently, around half of the Egyptian population agree to posthumous organ donation. This percentage could be increased significantly by raising the awareness about how the process of donation could be regulated and how the patient’s right of decision could be protected.
Empirical Investigation on the Contents of the Patients Informed Consent Forms for Medical Imaging Services in the Government Hospitals in Nairobi City County, Kenya
Empirical Investigation on the Contents of the Patients Informed Consent Forms for Medical Imaging Services in the Government Hospitals in Nairobi City County, Kenya
Victoria Otysula Koi, Dr. Andrea Yitambe, Dr. Peterson Warutere
International Academic Journal of Health, Medicine and Nursing, 5 June 2020; 2(1) pp 66-79
Open Access
Abstract
Informed consent is a requirement by the law to allow patients to make decisions with respect to their health and well-being. It is an ethical and legal requirement that patients seeking medical imaging services should give an informed consent prior to seeking treatment with respect from healthcare providers. However, the extent of usage of the informed consent process vary across medical procedures. The study therefore seeks to assess the contents of the patients Informed Consent Forms for medical imaging services in the government hospitals in Nairobi City County, Kenya. The study adopted a descriptive cross-sectional study design. The study specifically focused on administration of informed consent, contents of the patients Informed Consent Forms and modes of informed consent used among patients for medical imaging services. Imaging departments in Kenyatta National hospital, Mbagathi, Mama Lucy, National spinal injury and National Mathare Hospitals in Nairobi City County were chosen as the area of study. Patients in the imaging departments of the selected hospitals were recruited for study. The sample size selected was 307 respondents. The respondents were selected using systematic random sampling at a predetermined interval of 3. Collected data was coded for analysis by use of SPSS. Analysis was conducted on descriptive and inferential statistics. Frequency tables, pie charts and graphs were used to present the quantitative data. Inferential statistics were done using Chi Square tests to determine the association between study variables at 95% confidence interval (p<0.05). The ethical considerations were strictly followed during data collection. It was further revealed that age (χ2=3.782; df= 4; p=0.016;), level of education (χ2=3.89; df= 4; p=0.030), revelation of reason for referral (χ2=26.081; df=1; p=0.001), provision of right to refuse or defer imaging (χ2=33.468; df= 1; p=0.001), giving consent for treatment (χ2=70.733; df=1; p=0.001), decision making for wellbeing (χ2=12.056; df=1; p=0.001), preoperative counseling (χ2=9.533; df=1; p=0.002), cases of negligence from clinicians (χ2=22.414; df=1; p=0.001), understanding information provided by clinicians (χ2=4.394; df=1; p=0.036), adaptation of informed consent doctrine meeting physicians and patients (χ2=7.648; df=1; p=0.006), performance of diagnosis from patients’ past medical history (χ2=9.788; df=1; p=0.002), advice on alternative treatment options available (χ2=8.065; df=1; p=0.005), disclosure of information by practitioners (χ2=19.406; df=1; p=0.001) and physical examination done before medication (χ2=9.006; df=1; p=0.003) were significantly associated with informed consent administration among respondents. The study concludes majority of the domains of the contents of informed consent had a significant statistical association with administration of informed consent among respondents. These research findings provide a great insights and information to leaders, managers, law makers, governing and oversight authorities in decision making, policy formulation, strategic planning and regulation in a context specific to provide a conducive environment for practicing medical imaging procedures in an ethical and legal manner.
Examination of Informed Consent Forms in Masters and Doctorate Theses of Educational Sciences
Examination of Informed Consent Forms in Masters and Doctorate Theses of Educational Sciences
Ozgur Onen, Funda Eryilmaz Balli
International Online Journal of Educational Sciences, May 2020; 12(2) pp 119-131
Abstract
The purpose of this study is to examine the informed consent forms of the master’s theses and doctorate dissertations in educational sciences departments in Turkey; and to reach a conclusion about whether the informed consent forms have the related informed consent criteria (competence, voluntariness, disclosure, recommendation, understanding, decision and authorization) as proposed by previous studies. This study is designed as documentary analysis, and the data was obtained from master and doctorate theses which have been approved by social sciences and educational sciences institutions, and submitted to the National Theses Center founded by the Council of Higher Education (CoHE). Results indicated some deficiencies on consent forms, and some studies even did not report consent forms in master thesis and doctorate dissertations. The results of the study are discussed in the light of the existing literature. Finally, for ensuring responsible research conduct, some recommendations were provided.
Knowledge about informed consent among doctors in postgraduate courses in Bangladesh
Knowledge about informed consent among doctors in postgraduate courses in Bangladesh
Original Article
Kazi Taib Mamun, Nabeela Mahboob, Mohammad Abdullah Al Mahmud, K. Zaman
Ibrahim Medical College Journal of Medical Science, 7 March 2020; 14(1)
Open Access
Abstract
Background and objectives
Informed consent is now accepted as the cornerstone of medical practice and research. Concept of consent is an endeavor by which the patient can take part in clinical judgment concerning their treatment and protects patient and doctors against any litigation. However, in research informed consent is not merely a form that is signed, but is a process in which the participant has an understanding of the research and its risks. In view of this, the objective of the study was to assess the knowledge regarding informed consent among the doctors pursuing postgraduate courses in a medical institute in Bangladesh.
Methodology
A descriptive cross sectional study was carried out among 160 postgraduate medical students in Dhaka city. A self-administered structured questionnaire consisting of 36 questions was used to assess their knowledge regarding informed consent. The response format was based on a 3-point Likert scale. Frequency distribution was used for statistical analysis.
Results
The age range of the participants was from 25-40 years. Of the total participants, 48% were males and 42% were females. Majority of the respondents acknowledged the importance of an informed consent and 86.3% of the doctors agreed that only verbal consent was not adequate. Only 66.2% agreed that consent for participation in research should always be voluntary and informed. Majority (76.9%) agreed not to recruit individuals with mental or behavioral disorders not capable of giving adequately informed consent. Only 27.5% were aware that assent should be taken from children participating in a research. Out of total participants, 71.2% and 81.2% agreed that the participants should be informed about the laboratory test results. Management/referral must be ensured in case of abnormal test results respectively. For genetic research, 88.1% and 81.3% agreed for pre- and post-counseling respectively.
Conclusion
There is need to initiate further educational programs to aware the doctors of the importance of informed consent in research, clinical practice and patient care.
Recall of consent information by day care prostate biopsy patients: An assessment of the role of a third-party check
Recall of consent information by day care prostate biopsy patients: An assessment of the role of a third-party check
Original Article
II Nnabugwu, FO Ugwumba, EI Udeh, SK Anyimba
Nigerian Journal of Clinical Practice, 11 June 2020
Open Access
Abstract
Background: To evaluate the extent of recall of consent information by daycare prostate biopsy patients in our low-literacy setting. And to evaluate the role of a 3rd party check on patient’s recall of consent information. Subjects and Methods: As part of our standard of care, a formal informed consent session for day care prostate biopsy takes place 3 days prior to the procedure. For this study, before leaving the outpatient clinic the same day, the patient acknowledged before a third-party that his concerns were or were not satisfactorily addressed. The extent of recall of consent information was assessed on the morning of the procedure using a researcher-administered questionnaire. Consecutive patients participated in this cross-sectional study for day care prostate biopsy at a tertiary hospital in southeast Nigeria from February to November 2015 after obtaining due consent. Results: The recall of the risks associated with the planned procedure was poorer than the recall of the nature of the disease condition or the nature of the planned procedure. However, it was observed that aggregate recall was significantly poorer among patients who negatively attested to a satisfying consent session (OR 0.125; P < 0.0005). Conclusion: The use of a third-party in determining patient satisfaction after a consent session may be a better indicator of patient comprehension and subsequent recall of consent information, especially in low-literacy settings. Using a third-party, in this manner, may assist in checking paternalism inherent in the patient-doctor relationship.
Center for Informed Consent Integrity 