Informed Consent Procedure in Clinical Trials Promoted by the Hospital: Knowledge and Perceptions of Primary Care Physicians
Gómez-Arbonés J, Salazar-Alarcon E, Solanilla-Puertolas M, Ortega-Bravo M, , Vallez-Valero L, Schoenenberger-Arnaiz JA
Journal of Clinical Trials & Research, 24 April 2020; 3(3) pp 197-202
Open Access
Abstract
Objectives
To evaluate Primary Care Physician’s (PCP) awareness degree concerning their patient’s participation in Clinical Trials (CT) analyze the communication methods used and obtain physicians personal views.
Methods
Authors performed a cross-sectional observational study that included CTs approved by the Institutional Review Board at a Regional University Hospital (n=78). Among these 37 CTs were selected. PCPs involved in these trials received a questionnaire regarding aspects of the CTs in which their patients participated. The communication systems established in the study protocols were analyzed.
Results
Out of 89 PCPs contacted, 82.1% were aware of their patient’s participation in CTs. The information reached them through verbal communication from the participant (56.3%). PCPs also accessed it through electronic medical records (EMR) (34.0%). A majority (97.4%) considered being informed about the participation of their patients in CTs should be compulsory.
Conclusion
Communication of patients’ participation in CTs fundamentally takes place through a verbal interaction between patients and their doctor. PCPs consider that the preferred method of communication would be an alarm system in the patient’s EMR.
Ethical review and informed consent guidelines of high impact anthropology, business, and education research journals
Ethical review and informed consent guidelines of high impact anthropology, business, and education research journals
Original Article
Antti Mikael Rousi
Learned Publishing, 11 January 2021
Abstract
Whereas participant protection protocols are norms in medical research, they are only recently being adopted in social and behavioural sciences. This study examined human subject guidelines in the top 40 high‐impact anthropology, business, and education research journals according to their impact factor as released in 2019. For these 120 journals, a unified classification framework was developed to capture the central elements of their ethical review and informed consent requirements. The findings suggest that the investigated journals do not view ethical review as an established norm for interview and survey studies. Only 10 (8%) journals required ethical review from all studies involving human participants. Informed consent was more frequently addressed, but none of the fields exhibited widely established guidelines similar to medical research journals. A total of 31 (26%) journals required informed consent from all studies involving human participants. There was little difference between the three disciplines investigated. Although the investigated journals represented social and behavioural sciences, their guidelines often concerned medical or intervention research with few requirements for interaction (e.g. survey) research. There is an opportunity for high‐impact journals to establish norms for adoption by researchers and other journals.
Old Challenges or New Issues? Genetic Health Professionals’ Experiences Obtaining Informed Consent in Diagnostic Genomic Sequencing
Old Challenges or New Issues? Genetic Health Professionals’ Experiences Obtaining Informed Consent in Diagnostic Genomic Sequencing
Research Article
Danya F. Vears, Pascal Borry, Julian Savulescu, Julian J. Koplin
American Journal of Bioethics, 5 October 2020; pp 12-23
Abstract
Background
While integrating genomic sequencing into clinical care carries clear medical benefits, it also raises difficult ethical questions. Compared to traditional sequencing technologies, genomic sequencing and analysis is more likely to identify unsolicited findings (UF) and variants that cannot be classified as benign or disease-causing (variants of uncertain significance; VUS). UF and VUS pose new challenges for genetic health professionals (GHPs) who are obtaining informed consent for genomic sequencing from patients.
Methods
We conducted semi-structured interviews with 31 GHPs across Europe, Australia and Canada to identify some of these challenges.
Results
Our results show that GHPs find it difficult to prepare patients to receive results because a vast amount of information is required to fully inform patients about VUS and UF. GHPs also struggle to engage patients – many of whom may be focused on ending their ‘diagnostic odyssey’ – in the informed consent process in a meaningful way. Thus, some questioned how ‘informed’ patients actually are when they agree to undergo clinical genomic sequencing.
Conclusions
These findings suggest a tension remains between sufficient information provision at the risk of overwhelming the patient and imparting less information at the risk of uninformed decision-making. We suggest that a shift away from ‘fully informed consent’ toward an approach aimed at realizing, as far as possible, the underlying goals that informed consent is meant to promote.
Rethinking Patient Consent in the Era of Artificial Intelligence and Big Data
Rethinking Patient Consent in the Era of Artificial Intelligence and Big Data
Feature Opinion
Amy L. Kotsenas, Patricia Balthazar, David Andrews, J. Raymond Geis, Tessa S. Cook
Journal of the American College of Radiology, 1 January 2021; 18(1) pp 180-184
Open Access
Excerpt
Electronic data allow health care workers and industry to analyze large data sets for population health and to develop artificial intelligence (AI) tools. Researchers may find patterns in the data to prevent disease, understand disease risk and cause, improve diagnosis, develop new treatments, improve patient safety, and evaluate health care policy. These new uses of massive amounts of patient data often result in retrospective data mining for purposes not anticipated when patients consented to allow their data to be used. Some propose that freely available data will ultimately benefit patients and the greater good. However, once data are freely available, users no longer control them, and the data may be used for any reason. It is fair to say that these data will be used by industry, and in health care organizations, in unanticipated ways that lead to financial gain, which may conflict with ethical standards for patient privacy and confidentiality. Perceiving data as a commodity to be used in any way that maximizes profit or income will lead to ethical lapses if clear policies and guidelines are not quickly established…
Ethical Issues in Consent for the Re-use of Data in Health Data Platforms
Ethical Issues in Consent for the Re-use of Data in Health Data Platforms
Alex McKeown, Miranda Mourby, Paul Harrison, Sophie Walker, Mark Sheehan, Ilina Singh
Science and Engineering Ethics, December 2020
Abstract
Data platforms represent a new paradigm for carrying out health research. In the platform model, datasets are pooled for remote access and analysis, so novel insights for developing better stratified and / or personalised medicine approaches can be derived from their integration. If the integration of diverse datasets enables development of more accurate risk indicators, prognostic factors, or better treatments and interventions, this obviates the need for the sharing and reuse of data; and a platform-based approach is an appropriate model for facilitating this. Platform-based approaches thus require new thinking about consent. Here we defend an approach to meeting this challenge within the data platform model, grounded in: the notion of ‘reasonable expectations’ for the reuse of data; Waldron’s account of ‘integrity’ as a heuristic for managing disagreement about the ethical permissibility of the approach; and the element of the social contract that emphasises the importance of public engagement in embedding new norms of research consistent with changing technological realities. While a social contract approach may sound appealing, however, it is incoherent in the context at hand. We defend a way forward guided by that part of the social contract which requires public approval for the proposal and argue that we have moral reasons to endorse a wider presumption of data reuse. However, we show that the relationship in question is not recognisably contractual and that the social contract approach is therefore misleading in this context. We conclude stating four requirements on which the legitimacy of our proposal rests.
An Electronic Tool to Support Patient-Centered Broad Consent: A Multi-Arm Randomized Clinical Trial in Family Medicine
An Electronic Tool to Support Patient-Centered Broad Consent: A Multi-Arm Randomized Clinical Trial in Family Medicine
Elizabeth H. Golembiewski, Arch G. Mainous, III, Kiarash P. Rahmanian, Babette Brumback, Benjamin J. Rooks, Janice L. Krieger, Kenneth W. Goodman, Ray E. Moseley, Christopher A. Harle
Annals of Family Medicine, January-February 2021; 19(1) pp 16–23
Abstract
Purpose
Patients are frequently asked to share their personal health information. The objective of this study was to compare the effects on patient experiences of 3 electronic consent (e-consent) versions asking patients to share their health records for research.
Methods
A multi-arm randomized controlled trial was conducted from November 2017 through November 2018. Adult patients (n = 734) were recruited from 4 family medicine clinics in Florida. Using a tablet computer, participants were randomized to (1) a standard e-consent (standard), (2) an e-consent containing standard information plus hyperlinks to additional interactive details (interactive), or (3) an e-consent containing standard information, interactive hyperlinks, and factual messages about data protections and researcher training (trust-enhanced). Satisfaction (1 to 5), subjective understanding (0 to 100), and other outcomes were measured immediately, at 1 week, and at 6 months.
Results
A majority of participants (94%) consented to future uses of their health record information for research. No differences in study outcomes between versions were observed at immediate or 1-week follow-up. At 6-month follow-up, compared with the standard e-consent, participants who used the interactive e-consent reported greater satisfaction (B = 0.43; SE = 0.09; P <.001) and subjective understanding (B = 18.04; SE = 2.58; P <.001). At 6-month follow-up, compared with the interactive e-consent, participants who used the trust-enhanced e-consent reported greater satisfaction (B = 0.9; SE = 1.0; P <.001) and subjective understanding (B = 32.2; SE = 2.6, P <.001).
Conclusions
Patients who used e-consents with interactive research details and trust-enhancing messages reported higher satisfaction and understanding at 6-month follow-up. Research institutions should consider developing and further validating e-consents that interactively deliver information beyond that required by federal regulations, including facts that may enhance patient trust in research.
Digital approach to informed consent in bariatric surgery: a randomized controlled trial
Digital approach to informed consent in bariatric surgery: a randomized controlled trial
Boris Zevin, Mohammad Almakky, Ugo Mancini, David I. Robertson
Surgical Endoscopy, 27 January 2021
Abstract
Background
Informed consent is of paramount importance in surgery. Digital media can be used to enhance patient’s comprehension of the proposed operation. The objective of this study was to examine the effects of adding a digital educational platform (DEP) to a standard verbal consent (SVC) for a laparoscopic Roux-en-Y gastric bypass (LRYGB) on patient’s knowledge of the procedure, satisfaction with the clinical encounter and duration of the consent appointment.
Methods
This prospective non-blinded randomized controlled trial allocated 51 patients, who were candidates for a LRYGB, into DEP+SVC (intervention, n = 26) or SVC (control, n = 25) groups. Data were collected at one Bariatric Centre of Excellence (Ontario, Canada) between December 2018 and December 2019. DEP consisted of a 29-slide video-supplemented module detailing the risks, benefits, expectations and outcomes for the LRYGB. Primary outcome was knowledge about the LRYGB operation following the consent discussion. Secondary outcomes were knowledge retention, patient satisfaction, and duration of time required to obtain an informed consent.
Results
Baseline demographic data were equivalent between groups except for a greater proportion of male patients in the DEP+SVC group (7/19 vs 0/25; p < 0.01). Baseline procedure-specific knowledge was equivalent between the groups (72.3 ± 11.3% vs 74.7 ± 9.6%; p = 0.41). Post-consent knowledge was significantly higher in the DEP + SVC vs SVC group (85.0 ± 8.8% vs 78.7 ± 8.7%; p = 0.01; ES = 0.72). The duration of time to obtain informed consent was significantly shorter for the DEP + SVC vs SVC group (358 ± 198 sec vs 751 ± 212 sec; p < 0.01; ES = 1.92). There was no difference in knowledge retention at 4–6 weeks (84.4 ± 10.2% vs 82.9 ± 6.8%; p = 0.55) and in patient satisfaction (31.5 ± 1.1 vs 31 ± 2.7; p = 0.10).
Conclusion
The addition of a DEP online module to a standard verbal consent for LRYGB resulted in improved patient’s understanding of the procedure-specific risks and benefits, high patient satisfaction, and over 50% time savings for the bariatric surgeon conducting the consent discussion.
Does the use of video improve patient satisfaction in the consent process for local-anaesthetic urological procedures?
Does the use of video improve patient satisfaction in the consent process for local-anaesthetic urological procedures?
Original Paper
Allison L. Moore, Justin B. Howlett, Manraj K. Phull, Lukhona L. Mpungose & Sebastian R. Samson
International Urology and Nephrology, 3 January 2021
Abstract
Purpose
To assess patient satisfaction with the use of portable video media (PVM) for the purpose of taking informed consent for common urological outpatient procedures performed under local anaesthesia.
Methods
Patients undergoing the following procedures were approached for recruitment: flexible cystoscopy with or without biopsy, transrectal ultrasound-guided prostate biopsy or flexible cystoscopy with insertion or removal of a ureteric stent. Audio-visual media were developed for each procedure, with each script translated from English into isiXhosa and Afrikaans. The study involved a cross-over for each patient between standard verbal consent (SVC) and PVM consent, with each patient randomised to start with SVC or PVM consent. Each of these consent arms was assessed via a questionnaire.
Results
Sixty patients completed participation, with PVM as the first exposure for 28 patients and 32 patients receiving SVC as their first arm of the study. When comparing the overall satisfaction between SVC and PVM consent (the total scores out of 18 for the questionnaire), patients scored significantly higher for PVM consent (M = 16.3 ± 2.4) compared to SVC (M = 15.4 ± 2.9) (p = 0.002). 92% of the total patient sample preferred PVM consent.
Conclusion
Portable video media proved superior to SVC in improving satisfaction in the consent process for common outpatient urological procedures performed under local anaesthesia.
Minors’ consent: a case study on organ donation from living minors
Minors’ consent: a case study on organ donation from living minors
Gunpirom Wisadsing
Public Health Policy & Laws Journal, January – April 2021; 7(1)
Open Access
Abstract
The primary objective of this article is to study the criteria for organ donation consent from living minors, which includes the conditions and methods of minors’ consent, the roles of parents’ consent with minors, and the responsibility of relevant organizations to consider minors’ consent for organ transplant donation. This article covers the comparative study of foreign laws in order to reflect an appropriate application of the laws to the Thai context.
Parental decision making regarding consent to randomization on Children’s Oncology Group AALL0932
Parental decision making regarding consent to randomization on Children’s Oncology Group AALL0932
Kellee Parker, Erika Cottrell, Linda Stork, Susan Lindemulder
Pediatric Blood & Cancer, 26 January 2021
Abstract
Background
Within pediatric oncology, parental decision making regarding participation in clinical trials that aim to reduce therapy to mitigate side effects is not well studied. The recently completed Children’s Oncology Group trial for standard‐risk acute lymphoblastic leukemia (AALL0932) included a reduction in maintenance therapy, and required consent for randomization immediately prior to starting maintenance. At our institution, 40% of children enrolled on AALL0932 were withdrawn from protocol therapy prior to randomization due to parental choice. This study sought to identify factors that impacted parental decision making regarding randomization on AALL0932.
Procedure
Parents of children enrolled on AALL0932 at our institution were eligible if their child met criteria for the average‐risk randomization. Parents were invited to participate in a 30‐50‐minute phone interview. Questions focused on factors that shaped parental decision making about randomization, as well as their perspectives about the clinical trial experience more generally.
Results
Fear of receiving less therapy and subsequent relapse was the predominant reason to decline randomization. Reasons given for consenting to randomization included trust in the physician, altruism, hope for less therapy, and potential for fewer side effects. Parents also reflected on ways to support future families making decisions about clinical trial participation.
Conclusion
While many parents recognize the importance of clinical trials aiming to mitigate side effects, the fear of their own child relapsing with less than standard therapy may dissuade them from study participation. Recognizing and addressing these concerns will be important for enrollment and retention in future clinical trials.
Center for Informed Consent Integrity 