Ethical evaluation of informed consent forms used in cardiology clinics and the importance of institutional standardized approach
Original Article
Aksüyek Savaş Çelebi, Perihan Elif Ekmekçi, Müberra Devrim Güner
Turkish Society of Cardiology, 9 February 2021; 49(6) pp 477-487
Open Access
Abstract
Objective
This study aimed to evaluate the content of informed consent forms (ICFs) used during cardiology interventions by the university, research and training (R&T), and private hospitals with regard to ethical standards and compare them with the Turkish Society of Cardiology (TSC) templates and among various institutions.
Methods
A total of 185 forms from the university, R&T, and private hospitals and 19 TSC templates were selected and analyzed for 26 criteria. Compliance with TSC templates was also evaluated. Data were presented as the percentage of ICFs satisfying the criteria and compared using the Fisher exact test, and 95% confidence intervals were calculated.
Results
TSC templates were more compatible and included more information to comply with ethical standards than ICFs of all 3 types of healthcare institutions. The areas of improvement for these templates were prospects of treatment and alternative treatments, quality of life, explanation for third-party consent, duration of hospitalization, and time to return to normal life. Among the 3 types of hospitals, R&T-ICFs were more compatible with templates. Private hospital ICFs had the poorest compliance with TSC templates. Separate anesthesia ICFs and detailed information about exposure to radioactivity were lacking.
Conclusion
The current ICFs for cardiology interventions have major ethical deficiencies and need urgent improvement. Professional societies such as TSC are essential institutions to develop and provide guidance and templates for ICFs to meet the ethical standards during the informed consent process and standardization of the process among various institutions.
Informed Consent in Dentistry – When, Why and How
Informed Consent in Dentistry – When, Why and How
Jelena Roganović
Studia Universitatis Babes-Bolyai Bioethica, 2021; 65 pp 147
Abstract
For dentists, as well as for other health care practitioners, it is mandatory to obtain informed consent from their patients, implying that a dialog has taken place and that patients understand the risks, benefits and alternatives to rendered treatments. Having in mind that majority of dental procedures are surgical in nature, leading to irreversible change to orofacial tissues and with the risk of unwanted side effects, well-documented informed consent process needs to be a basic norm in the dental practice. Clinical experience suggests that verbal discussion along with providing informed consent forms may not be enough and that patients response and understanding may improve by adding adjunctive materials like brochures or videos related to planned procedures. Many companies for implants and dental materials supply dental offices with the brochures and pamphlets, mostly for marketing purposes. Therefore, the use of these materials must be used with caution while objectively discussing other reasonable options. With the increasingly growing phenomenon of dental tourism, an important dentist-patient relationship ethical issues arise. Namely, issues regarding patient autonomy over practitioner choice, patient safety, and optimal care are under constant reconsideration while informed consent has to specify circumstances underlying treatment plan and posttreatment care. Currently, there is a paucity of information regarding informed consent in dentistry, and vital ethical issues associated with recent developments in dental practice need to be addressed in the near future.
Raising Awareness of Data Sharing Consent Through Knowledge Graph Visualisation
Raising Awareness of Data Sharing Consent Through Knowledge Graph Visualisation
Research Article
Christof Bless, Lukas Dötlinger, Michael Kaltschmid, Markus Reiter, Anelia Kurteva, Antonio J. Roa-Valverde, Anna Fensel
IOS Press, 2021; 53 pp 44 – 57
Open Access
Abstract
Knowledge graphs facilitate systematic large-scale data analysis by providing both human and machine-readable structures, which can be shared across different domains and platforms. Nowadays, knowledge graphs can be used to standardise the collection and sharing of user information in many different sectors such as transport, insurance, smart cities and internet of things. Regulations such as the GDPR make sure that users are not taken advantage of when they share data. From a legal standpoint it is necessary to have the user’s consent to collect information. This consent is only valid if the user is aware about the information collected at all times. To increase this awareness, we present a knowledge graph visualisation approach, which informs users about the activities linked to their data sharing agreements, especially after they have already given their consent. To visualise the graph, we introduce a user-centred application which showcases sensor data collection and distribution to different data processors. Finally, we present the results of a user study conducted to find out whether this visualisation leads to more legal awareness and trust. We show that with our visualisation tool data sharing consent rates increase from 48% to 81.5%.
Informed Consent: A Monthly Review
___________________________
September 2021
This digest aggregates and distills key content addressing informed consent from a broad spectrum of peer-reviewed journals and grey literature, and from various practice domains and organization types including international agencies, INGOs, governments, academic and research institutions, consortiums and collaborations, foundations, and commercial organizations. We acknowledge that this scope yields an indicative and not an exhaustive digest product.
Informed Consent: A Monthly Review is a service of the Center for Informed Consent Integrity, a program of the GE2P2 Global Foundation. The Foundation is solely responsible for its content. Comments and suggestions should be directed to:
Editor
Paige Fitzsimmons, MA
Associate Director, Center for Informed Consent Integrity
GE2P2 Global Foundation
paige.fitzsimmons@ge2p2global.org
PDF Version: GE2P2 Global_Informed Consent – A Monthly Review_September 2021
A literature review of consent declines and consent withdrawals in randomized controlled trials conducted during the COVID-19 pandemic
A literature review of consent declines and consent withdrawals in randomized controlled trials conducted during the COVID-19 pandemic
Original Article
NJ Gogtay, HJ Sheth, MR Maurya, MN Belhekar, UM Thatte
Journal of Postgraduate Medicine, 16 August 2021; 67(3) pp 134-138
Abstract
Objectives
We evaluated the extent of consent declines and consent withdrawals during the COVID-19 pandemic as seen in published randomized controlled trials (RCTs) and compared it with non-COVID-19 RCTs published at the same time and two historical controls.
Methods
PubMed/Medline only was searched using key-word “COVID-19” and “RCTs” separately, and filtered for COVID-19 RCTs and non-COVID-19 RCTs respectively, published during a nine-month period (1 Feb – 1 Nov 2020). Exclusions were study protocols, observational studies, interim analysis of RCT data and RCTs with missing data. Primary outcome measures were the proportion of consent declines and consent withdrawals as percentage of total participants screened and randomized respectively in COVID-19 RCTs. We compared consent declines and consent withdrawals of COVID-19 RCTs with non-COVID-19 RCTs and two earlier studies on the same topic that served as historical controls (non-pandemic setting).
Results
The search yielded a total of 111 COVID-19 RCTs and 49 non-COVID-19 RCTs. Of these, 39 (35.13%) COVID-19 RCTs and 11 (22.45%) non-COVID-19 RCTs were finally analysed. A total of 770/17759 (4.3%) consent declines and 100/7607 (1.31%) consent withdrawals were seen in 39 COVID-19 RCTs. A significant difference was observed in consent declines between COVID-19 vs non-COVID-19 RCTs [4.3% vs 11.9%, p < 0.0001] and between COVID-19 RCTs vs two historical controls [(4.3% vs 8.6%, p < 0.0001) and (4.3% vs 21.1%, p < 0.0001), respectively].
Conclusion
RCTs conducted during the COVID-19 pandemic appear to have significantly lower consent declines relative to non-COVID-19 RCTs during pandemic and RCTs conducted in non-pandemic settings.
Informed consent and informed intervention: SARS-CoV-2 vaccinations not just call for disclosure of newly emerging safety data but also for hypothesis generation and testing
Informed consent and informed intervention: SARS-CoV-2 vaccinations not just call for disclosure of newly emerging safety data but also for hypothesis generation and testing
Letter to the Editor
Johannes C. Fischer, Albrecht G. Schmidt, Edwin Bölke, Verena Keitel, Torsten Feldt, Björn Jensen, Noemi F. Freise, Dieter Häussinger, E. Marion Schneider, Derik Hermsen, Detlef Kindgen-Milles, Wolfram Trudo Knoefel, Jan Haussmann, Balint Tamaskovics, Christian Plettenberg, Kathrin Scheckenbach, Stefanie Corradini, Jutta Rox, Vera Balz, Kitti Maas, Livia Schmidt, Olaf Grebe, Anja Erhardt, Peter Arne Gerber, Matthias Peiper, Bettina Alexandra Buhren, Artur Lichtenberg, Amir Rezazadeh, Wilfried Budach, Christiane Matuschek
European Journal of Medical Research, 6 August 2021; 26(87)
Open Access
Abstract
Background
COVID-19 infection is a major threat to patients and health care providers around the world. One solution is the vaccination against SARS-CoV-2.
Methods
We performed a comprehensive query of the latest publications on the prevention of viral infections including the recent vaccination program and its side effects.
Results
The situation is evolving rapidly and there is no reasonable alternative to population-scale vaccination programs as currently enrolled.
Conclusion
Therefore, regulatory authorities should consider supplementing their conventional mandate of post-approval pharmacovigilance, which is based on the collection, assessment, and regulatory response to emerging safety findings.
Anti-Coronavirus Disease 2019 Vaccines: Need for Informed Consent.
Anti-Coronavirus Disease 2019 Vaccines: Need for Informed Consent.
Mazraani M, Barbari A
Experimental and Clinical Transplantation, 1 August 2021; 19(8) pp 753-762
Abstract
Vaccines are among some of the most efficacious medical and public health methods ever employed to contain a pandemic, in addition to providing protective and preventive measures. Evaluation of vaccine associated adverse events through experimentation and empirical evidence is an integral part of thoroughly assessing the safety of vaccines before authorization of their widespread use. History has highlighted the importance of continuous search for possible vaccine-related adverse effects and vaccine-induced immunogenicity long after licensure, suggesting that a primary concern with new vaccines is not only efficacy but also safety, particularly over the long term. Many of the various anti-COVID-19 vaccines have used different types of technology, with some being introduced for the first time or rushed shortly into testing, bypassing animal experimentations. They have been adopted for use through emergency use authorizations, leading to a less than optimal collection of broad data on safety, immunogenicity, effectiveness, and time span of protection, as well as short follow-up of few months, despite many infectious disease experts arguing that it takes 10 years to develop a vaccine. Given the valid concerns on well-recognized short-term and long-term safety issues, such as antibody-dependent enhancement and other processes like molecular mimicry and potential genomic transformation, the experimental nature of the vaccination process, the limited short term follow-up in the main trials, and the dismissal by law of pharma companies and health care providers from any medico-legal responsibilities, the application of an informed consent should become not only a necessity but also mandatory by law in accordance with all declarations on human rights. Such information should be provided to every potential recipient in the form of an official written digital consent prior to the registration for or the receipt of the vaccine.
Editor’s note: Experimental and Clinical Transplantation is the official journal of the Middle East Society for Organ Transplantation.
How Spanish Biobanks have Adapted the Informed Consent Process During the COVID-19 Pandemic
How Spanish Biobanks have Adapted the Informed Consent Process During the COVID-19 Pandemic
Pablo Enguer-Gosálbez, Jaime Fons-Martínez, Jacobo Martínez-Santamaría, Ana María Torres-Redondo, Cristina Villena-Portella, Aurora García-Robles, Javier Díez-Domingo
BioLaw Journal, 2021
Open Access
Abstract
Due to the situation caused by the Covid-19 pandemic, biobanks have adapted, among other processes, the obtaining of informed consents (IC). This paper details the most relevant elements of the applicable regulations, describes the adaptations done by some of the biobanks of the Spanish Biobank Network to manage the IC process, which have been approved by their Ethics Committees, and draws some conclusions from the results obtained from the survey carried out on these biobanks.
Are investigators’ access to trial data and rights to publish restricted and are potential trial participants informed about this? A comparison of trial protocols and informed consent materials
Are investigators’ access to trial data and rights to publish restricted and are potential trial participants informed about this? A comparison of trial protocols and informed consent materials
Research Article
Asger S. Paludan-Müller, Michelle C. Ogden, Mikkel Marquardsen, Karsten J. Jørgensen, Peter C. Gøtzsche
BMC Medical Ethics, 28 August 2021; 22(115)
Open Access
Abstract
Objectives
To determine to which degree industry partners in randomised clinical trials own the data and can constrain publication rights of academic investigators.
Methods
Cohort study of trial protocols, publication agreements and other documents obtained through Freedom of Information requests, for a sample of 42 trials with industry involvement approved by ethics committees in Denmark. The main outcome measures used were: proportion of trials where data was owned by the industry partner, where the investigators right to publish were constrained and if this was mentioned in informed consent documents, and where the industry partner could review data while the trial was ongoing and stop the trial early.
Results
The industry partner owned all data in 20 trials (48%) and in 16 trials (38%) it was unclear. Publication constraints were described for 30 trials (71%) and this was not communicated to trial participants in informed consent documents in any of the trials. In eight trials (19%) the industry partner could review data during the trial, for 20 trials (48%) it was unclear. The industry partner could stop the trial early without any specific reason in 23 trials (55%).
Conclusions
Publication constraints are common, and data is often owned by industry partners. This is rarely communicated to trial participants. Such constraints might contribute to problems with selective outcome reporting. Patients should be fully informed about these aspects of trial conduct.
An evaluation of the process of informed consent: views from research participants and staff
An evaluation of the process of informed consent: views from research participants and staff
Research
Lydia O’ Sullivan, Laura Feeney, Rachel K. Crowley, Prasanth Sukumar, Eilish McAuliffe, Peter Doran
Trials, 18 August 2021; 22(544)
Open Access
Abstract
Background
The process of informed consent for enrolment to a clinical research study can be complex for both participants and research staff. Challenges include respecting the potential participant’s autonomy and information needs while simultaneously providing adequate information to enable an informed decision. Qualitative research with small sample sizes has added to our understanding of these challenges. However, there is value in garnering the perspectives of research participants and staff across larger samples to explore the impact of contextual factors (time spent, the timing of the discussion and the setting), on the informed consent process.
Methods
Research staff and research participants from Ireland and the UK were invited to complete an anonymous survey by post or online (research participants) and online (research staff). The surveys aimed to quantify the perceptions of research participants and staff regarding some contextual factors about the process of informed consent. The survey, which contained 14 and 16 multiple choice questions for research participants and staff respectively, was analysed using descriptive statistics. Both surveys included one optional, open-ended question, which were analysed thematically.
Results
Research participants (169) and research staff (115) completed the survey. Research participants were predominantly positive about the informed consent process but highlighted the importance of having sufficient time and the value of providing follow-up once the study concludes, e.g. providing results to participants. Most staff (74.4%) staff reported that they felt very confident or confident facilitating informed consent discussions, but 63% felt information leaflets were too long and/or complicated, 56% were concerned about whether participants had understood complex information and 40% felt that time constraints were a barrier. A dominant theme from the open-ended responses to the staff survey was the importance of adequate time and resources.
Conclusions
Research participants in this study were overwhelmingly positive about their experience of the informed consent process. However, research staff expressed concern about how much participants have understood and studies of patient comprehension of research study information would seem to confirm these fears. This study highlights the importance of allocating adequate time to informed consent discussions, and research staff could consider using Teach Back techniques.
Center for Informed Consent Integrity 