Birthing Consent: Supporting Shared Decision Making and Informed Consent in Labour and Childbirth
Book Chapter
Laura Pascoe
Consent: Gender, Power and Subjectivity, 2023 [Routledge]
Abstract
Labour and childbirth are vulnerable yet powerful experiences for birth givers. In an ideal world, women and other birth givers are active and informed participants in their care and their consent is sought throughout labour, birth, and postpartum by their health providers. Due to competing interests and the medicalization of childbirth, however, many birth givers are unprepared for the choices they may face or are unaware that the decisions presented to them are theirs to make. Highlighting the perspectives of midwives and doulas who take a normal and physiologic approach to birth, this chapter explores why informed consent in labour and childbirth is so important, what gets in the way of informed consent, and concrete strategies to best facilitate informed consent. In particular, this chapter examines how health providers and doulas can facilitate informed consent to ensure that no matter what the birth experience, birth givers feel respected, cared for, and heard.
Informed consent in surgical practice with patients’ experiences: A cross-sectional study
Informed consent in surgical practice with patients’ experiences: A cross-sectional study
Seda Kumru, Pakize Yiğit, Meryem Demirtaş, Hüseyin Fındık
Patient Experience Journal, 2023; 10(3) pp 42-48
Abstract
This study aims to evaluate patients’ experiences and perspectives regarding informed consent in surgical practice. Data for this cross-sectional study were collected from 276 patients using a questionnaire developed by Falagas et al. Descriptive statistics were employed for all questions. Statistical tests such as the Mann-Whitney U test, Kruskal-Wallis test, and Spearman’s rank correlation analysis were performed, and Cohen’s effect sizes were reported. IBM SPSS 23.0 was used for all analyses, and p<0.05 was considered statistically significant. A high score on both The Delivered Information Index and The Patient-Physician Index represents a positive informed consent process. Among the participants, 65.2% indicated that they understood all parts of the consent form. Of all patients, 92.8% reported that information about the specific surgical procedure was provided by physicians. However, 47.5% of the patients reported that they did not feel comfortable with their surgeons. The mean score of the Delivered Information Index was 5.63 (2.38). The mean patient-physician relationship score was 14.38 (3.31). There was a moderate positive correlation between the delivered information index and the patient-physician relationship (r=0.50; p<0.001). In addition, there was a moderate positive correlation between the delivered information index and the time spent on the informed consent process, as well as between the patient-physician relationship and the time spent on the informed consent process (r=0.52; r=0.40, respectively). The study emphasized the lack of communication between patients and physicians, the limitation of information on treatment risks, adverse effects, and alternative treatment options.
Public health measures and the rise of incidental surveillance: Considerations about private informational power and accountability
Public health measures and the rise of incidental surveillance: Considerations about private informational power and accountability
Original Paper
A. Kamphorst, A. Henschke
Ethics and Information Technology, 16 November 2023
Open Access
Abstract
The public health measures implemented in response to the COVID-19 pandemic have resulted in a substantially increased shared reliance on private infrastructure and digital services in areas such as healthcare, education, retail, and the workplace. This development has (i) granted a number of private actors significant (informational) power, and (ii) given rise to a range of digital surveillance practices incidental to the pandemic itself. In this paper, we reflect on these secondary consequences of the pandemic and observe that, even though collateral data disclosure and additional activity monitoring appears to have been generally socially accepted as inevitable consequences of the pandemic, part and parcel of a larger conglomeration of emergency compromises, these increased surveillance practices were not directly justified by appeals to solidarity and public health in the same way that the instigating public health measures were. Based on this observation, and given the increased reliance on private actors for maintaining the digital space, we argue that governments have a duty to (i) seek and ensure that there are justifications for collateral data disclosure and activity monitoring by private actors in the context of (future) public health emergencies like the COVID-19 pandemic, and (ii) regulate and provide accountability mechanisms for and oversight over these private surveillance practices on par with governmental essential services that engage in surveillance activities.
Consent as Mechanism to Preserve Information Privacy: Its Origin, Evolution, and Current Relevance
Consent as Mechanism to Preserve Information Privacy: Its Origin, Evolution, and Current Relevance
Conference paper
Marietjie Botes
International Workshop on Security and Trust Management, STM 2023, 30 October 2023
Abstract
Informed consent and the requirements to obtain ethical-legal sound consent has a long and rich history that originated with the medical treatment of patients and then evolved into its application in the field of biomedical research. The same concepts and principles of consent has been adopted to be applied in the digital sphere. However, upon closer scrutiny it is clear why this principle, that originated for the protection of a person’s bodily integrity cannot be adequately applied in the digital sphere to protect people’s personal data. To the contrary it transpired that the ethical-legal requirements of consent has been made futile in the context of digital consent receipts by erroneously comparing and applying this concept to transactions receipts and commercial contracts. This paper investigates this evolution of biomedical consent to digital consent and analyze the difference between the concept of consent as it developed for biomedical application and compare that with the current application of consent in the digital sphere.
Consent: Legacies, Representations, and Frameworks for the Future
Consent: Legacies, Representations, and Frameworks for the Future
Book
Sophie Franklin, Hannah Piercy, Arya Thampuran, Rebecca White
Routledge, 2023
Abstract
Consent: Legacies, Representations, and Frameworks for the Future examines the conceptualisation of ‘consent’ across various historical periods, cultures, and disciplines to offer an expansive, pluralistic vision for future articulations of consent as it circulates throughout contemporary life in sexual encounters, medical contexts, and media representations.
This volume is distinctive in its diverse conceptual scope and commitment to cross-disciplinary dialogue, accommodating perspectives on consent that are contextually sensitive and culturally diverse. The chapters examine a range of topics, from socio-cultural engagements with consent in Latin American music, feminist movements in Pakistan, and BDSM in Poland, to theoretical and pedagogical ones exploring alternative possibilities for framing and understanding consent through intersectional approaches and institutional curricula.
Consent: Legacies, Representations, and Frameworks for the Future is of value to researchers, practitioners, undergraduate and postgraduate students, and general readers interested in histories, representations, and future possibilities of consent in its many manifestations.
Informed Consent: A Monthly Review
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November 2023 :: Issue 59
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: Center for Informed Consent Integrity – A Monthly Review_November 2023 Continue reading
Upcoming Calls For Public Consultation
We will selectively include calls for public consultation from multilateral agencies, governments, INGOs and other sources where there is a clear intersection with consent/assent. This might be obvious from the title of the draft guidance, regulations, etc., but more often, it will be a thematic area or topic – if properly addressed at all. If you would like to explore participation with our working group developing submissions for these calls, please contact us [david.r.curry@ge2p2global.org].
Call for input on the right to access and take part in scientific progress
Issued by Special Rapporteur in the field of cultural rights, UNHCHR
Deadline: 13 November 2023
Purpose: To inform the upcoming report of the Special Rapporteur to the Human Rights Council to be presented in March 2024
Key questions and types of input/comments sought via the questionnaire (Word):
English | Français | Español
[Excerpt]
…Participation in science
- How is the right of every person to participate in scientific progress and in decisions concerning its direction understood and implemented? What are the challenges? How are lack of representativeness of marginalized groups and inequalities in participation addressed?
- How is ‘citizen science’ (ordinary people doing science) understood in your country? Is it considered important, and what measures have been put in place to support it, particularly in terms of access to information and data, and participation in decision-making? What are the challenges? Please provide an example.
- To what extent are indigenous sciences and alternative sciences acknowledged, supported and included in policy decision-making? How is the conversation ensured between science and other kinds of knowledge?What are the limits to the right of every person to take part in scientific progress and in decisions concerning its direction and for which purposes? Please provide examples if any.
Request for Information (RFI): Inviting Comments and Suggestions on Opportunities and Challenges for the Collection, Use, and Sharing of Real-World Data (RWD) Including Electronic Health Records, for National Institutes of Health (NIH) Supported Biomedical and Behavioral Research
U.S. National Institutes of Health on 09/28/2023.
Responses must be received by December 14, 2023
Background
Researchers are increasingly using data collected in real-world settings to augment traditional research studies, as well as develop more effective treatments and interventions for patients. These “real-world data (RWD)”, defined by the U.S. Food and Drug Administration, are data relating to patient health status and/or the delivery of health care routinely collected from a variety of sources. Examples of RWD include data derived from electronic health records, medical claims data, data from product or disease registries, and data gathered from other sources (such as digital health technologies) that can inform on health status. While these data hold tremendous promise for biomedical and behavioral research, they can be collected from a variety of sources through multiple mechanisms, creating challenges for researchers and questions for those whose data are being shared.
Importantly, NIH is committed to ensuring participant privacy and autonomy are protected in all NIH-supported research. As NIH establishes health-related research data platforms that include access to RWD, NIH continues to prioritize maximizing data access while upholding participant preferences regarding the collection and use of their data…
Information Requested
NIH is requesting public comment on the use of RWD for NIH-supported biomedical and behavioral research, including opportunities for leveraging the benefits of RWD and strategies for its responsible use. NIH also seeks to better understand community perspectives on the potential value and constraints—including scientific, administrative, legal, business, and bioethical—for the increased use of RWD in biomedical and behavioral research.
Spotlight Articles
Generative AI – and LLMs [Large Language Models] which drive it – are receiving extensive (and appropriate) attention in the media, in regulatory contexts and in the academic literature. We feature here two articles which explore some of the intersections between generative AI and consent. The first, by Decker et al., explores how LLMs might be employed to potentially enhance ICF readability, improve articulation of risks, and “ease documentation burden for physicians.” The second, by Litt et al., also explores improvements in readability through aggregating ICFs posted with oncology clinical trials registered on clinicaltrials.gov and then applying a generative AI tool generate more useful consent content. We anticipate a good deal more activity exploring how generative AI can contribute to consent content, effectiveness and integrity.
Large Language Model−Based Chatbot vs Surgeon-Generated Informed Consent Documentation for Common Procedures
Original Investigation Surgery
Hannah Decker, Karen Trang, Joel Ramirez, Alexis Colley, Logan Pierce, Melissa Coleman, Tasce Bongiovanni, Genevieve B. Melton, Elizabeth Wick
JAMA Network Open, 9 October 2023; 6(10)
Abstract
Importance
Informed consent is a critical component of patient care before invasive procedures, yet it is frequently inadequate. Electronic consent forms have the potential to facilitate patient comprehension if they provide information that is readable, accurate, and complete; it is not known if large language model (LLM)-based chatbots may improve informed consent documentation by generating accurate and complete information that is easily understood by patients.
Objective
To compare the readability, accuracy, and completeness of LLM-based chatbot- vs surgeon-generated information on the risks, benefits, and alternatives (RBAs) of common surgical procedures.
Design, Setting, and Participants
This cross-sectional study compared randomly selected surgeon-generated RBAs used in signed electronic consent forms at an academic referral center in San Francisco with LLM-based chatbot-generated (ChatGPT-3.5, OpenAI) RBAs for 6 surgical procedures (colectomy, coronary artery bypass graft, laparoscopic cholecystectomy, inguinal hernia repair, knee arthroplasty, and spinal fusion).
Main Outcomes and Measures
Readability was measured using previously validated scales (Flesh-Kincaid grade level, Gunning Fog index, the Simple Measure of Gobbledygook, and the Coleman-Liau index). Scores range from 0 to greater than 20 to indicate the years of education required to understand a text. Accuracy and completeness were assessed using a rubric developed with recommendations from LeapFrog, the Joint Commission, and the American College of Surgeons. Both composite and RBA subgroup scores were compared.
Results
The total sample consisted of 36 RBAs, with 1 RBA generated by the LLM-based chatbot and 5 RBAs generated by a surgeon for each of the 6 surgical procedures. The mean (SD) readability score for the LLM-based chatbot RBAs was 12.9 (2.0) vs 15.7 (4.0) for surgeon-generated RBAs (P = .10). The mean (SD) composite completeness and accuracy score was lower for surgeons’ RBAs at 1.6 (0.5) than for LLM-based chatbot RBAs at 2.2 (0.4) (P < .001). The LLM-based chatbot scores were higher than the surgeon-generated scores for descriptions of the benefits of surgery (2.3 [0.7] vs 1.4 [0.7]; P < .001) and alternatives to surgery (2.7 [0.5] vs 1.4 [0.7]; P < .001). There was no significant difference in chatbot vs surgeon RBA scores for risks of surgery (1.7 [0.5] vs 1.7 [0.4]; P = .38).
Conclusions and Relevance
The findings of this cross-sectional study suggest that despite not being perfect, LLM-based chatbots have the potential to enhance informed consent documentation. If an LLM were embedded in electronic health records in a manner compliant with the Health Insurance Portability and Accountability Act, it could be used to provide personalized risk information while easing documentation burden for physicians.
Improving clinical trial consent form readability through artificial intelligence
Conference Presentation – ASCO Quality Care Symposium 2023
Henry Kazunaru Litt, Emma Greenstreet Akman, Dame Idossa, Narjust Florez, Ana I. Velazquez Manana
JCO Oncology Practice – Health Care Access, Equity, and Disparities, 26 October 2023; 18(11)suppl
Abstract
Background
High literacy levels are needed to understand oncology clinical trial (CT) informed consent forms (ICF), which represents a barrier to enrollment of older adults and diverse populations. ChatGPT-4 is an artificial intelligence chatbot that responds to user prompts and can summarize large amounts of text. We tested whether ChatGPT-4 could simplify CT information from ICFs.
Methods
On May 22, 2023, we searched clinicaltrials.gov for interventional, therapeutic, NIH-funded, CTs involving adults with the 14 most prevalent cancer types. Only CTs with available study protocols that were currently recruiting, “enrolling by invitation”, and “active not recruiting” were included. Trials that were diagnostic, preventative, or supportive were excluded. Publicly available ICFs from the resulting CTs were downloaded and analyzed. Using the ChatGPT-4 plugin askyourpdf.com, we asked ChatGPT-4 to review each ICF and answer 8 questions recommended by the NCCN for patients considering a CT in a 6th grade literacy level. Our prompt included the following 8 questions: “1) What are the treatments used in the clinical trial? 2) Has the treatment been used for other types of cancer? 3) What are the risks and benefits of this treatment? 4) What side effects should I expect and how will they be managed? 5) How long will I be in the clinical trial? 6) Will I be able to get other treatment if this doesn’t work? 7) How will you know if the treatment is working? 8) Will the clinical trial cost me anything?” Reading level (readability) was assessed for both the ICFs and ChatGPT-4’s question responses using the validated Flesch-Kincaid (FK), Gunning Fog (GF), and SMOG indices using the online Readable App. Data was summarized with descriptive statistics and t-test was used to compare text reading levels between ICFs and ChatGPT-4’s answers.
Results
Our search yielded 83 therapeutic oncology CTs, of which 70 had publicly available ICFs. ChatGPT-4 successfully analyzed 66 of the 70 ICFs (94.3%). The mean text reading levels of its answers were 6.2 (95% CI: 5.9-6.5), 8.6 (95% CI: 8.2-8.9), and 9.2 (95% CI: 8.9-9.4) based on FK, GF, and SMOG indices, respectively. Of 70 ICFs, 54 (77.1%) contained text that could be evaluated for readability analysis and were included in the analysis. The mean text reading levels was 7.9 (95% CI: 7.7-8.1), 9.3 (95% CI: 9.1-9.6), and 10.5 (95% CI: 10.2-10.8) based on FK, GF, and SMOG indices, respectively. ChatGPT-4’s text responses had a significantly lower reading level compared to ICFs text for all three readability indices (FK: p<0.01, GF: p=0.02, SMOG: p<0.01).
Conclusions
ChatGPT-4 presented key information from oncology CT ICFs at a 6th to 9th grade reading level, which was significantly lower than the original ICFs. While further studies are needed to assess ChatGPT-4’s accuracy, this study shows its potential as tool for improving patients’ understanding of oncology CTs.
uConsent: Addressing the gap in measuring understanding of informed consent in clinical research
uConsent: Addressing the gap in measuring understanding of informed consent in clinical research
Richard F. Ittenbach, J. William Gaynor, Jenny M. Dorich, Nancy B. Burnham, Guixia Huang, Madisen T. Harvey, Jeremy J. Corsmo
Clinical and Translational Science, 12 October 2023
Abstract
The purpose of this study was to establish the technical merit, feasibility, and generalizability of a new measure of understanding of informed consent for use with clinical research participants. A total of 109 teens/young adults at a large, pediatric medical center completed the consenting process of a hypothetical biobanking study. Data were analyzed using a combination of classical and modern theory analytic methods to produce a final set of 19 items referred to as the uConsent scale. A requirement of the scale was that each item mapped directly onto one or more of the Basic Elements of Informed Consent from the 2018 Final Rule. Descriptive statistics were computed for each item as well as the scale as a whole. Partial credit (Rasch) logistic modeling was then used to generate difficulty/endorsability estimates for each item. The final, 19- item uConsent scale was derived using inferential methods to yield a set of items that ranged across difficulty levels (−3.02 to 3.10 logits) with a range of point- measure correlations (0.12 to 0.50), within- range item- and model- fit statistics, varying item types mapped to both Bloom’s Taxonomy of Learning and required regulatory components of the 2018 Final Rule. Median coverage rate for the uConsent scale was 95% for the 25 randomly selected studies from ClinicalTrials.gov. The uConsent scale may be used as an effective measure of informed consent when measuring and documenting participant understanding in clinical research studies today.
Risk to Research Non-Participants: Ethical Dimensions of Protecting Bystanders in Xenotransplantation Clinical Trials
Risk to Research Non-Participants: Ethical Dimensions of Protecting Bystanders in Xenotransplantation Clinical Trials
Conference Presentation – IPITA-IXA-CTRMA 2023 Joint Congress Abstracts
Daniel Hurst, Luz Padilla, Daniel Rodger, Tamar Schiff, David KC Cooper
Transplantation, October 2023
Abstract
Introduction
Ethical issues regarding clinical xenotransplantation have been described for decades with most of the issues centering on animal welfare, the risks posed to the recipient, and the potential public health risks. Much less attention has been given to thinking through ethical issues for those who may care for xenograft recipients (e.g., caregivers, family members), especially when the recipient returns home. These caregivers or bystanders, due to their close interaction with the xenotransplantation recipient, face potential exposure to a xenozoonotic disease, with implications regarding informed consent for that risk, and whether or not such bystanders should be regularly monitored for infection, as is proposed for recipients.
Methods
This presentation raises concerns for the risks to bystanders in xenotransplantation which we believe have not been adequately addressed in the literature to date. We will propose several options for how bystanders should be informed of, and consented for, the risks of close contact with a xenotransplant recipient. The benefits and pitfalls of each potential option are explored.
Results
We conclude that only the xenograft recipient needs to provide their informed consent to the xenotransplantation and agree to lifelong (or long-term) monitoring. As no legal enforcement mechanism currently exists for requiring recipients to be monitored without evidence of infectious disease, such monitoring could only be strongly encouraged and agreed to at the point of xenotransplantation, but not required. In addition, we argue that the xenograft recipient, prior to xenotransplantation, should provide a list of members of the same household/close contacts for record keeping and future possible contact tracing. We propose at a minimum that all members listed should be provided with an information sheet or assent form that contains the basic elements of the informed consent form but does not require a signature or other declaration of agreement. This approach seeks to balance ethical concerns, namely the potential risks posed to bystanders and how strong a duty this creates to protect them and support their right to choose how or if they contiue to interact with the potential xenograft recipient, with the recipient’s reasonable right to patient privacy.
Conclusion
This presentation discusses a significant concern related to xenotransplantation, made increasingly pressing by the possibility of forthcoming clinical trials. By the end of the presentation, the audience will better understand the bystander risk, differing modes of mitigating that risk, and why it is important to foster dialogue and develop policy on this issue.
Center for Informed Consent Integrity 