Patients’ Perceptions and Understanding of Pre-operative Informed Consent in a Tertiary Care Setting- Dar-es-salaam
Research Article
Steven Michael, Willbroad Kyejo, Allyzain Ismail, Eric Aghan, Columba Mbekenga, Athar Ali
BMC Medical Ethics, 11 October 2024
Abstract
Background
Informed consent, grounded in the ethical principle of autonomy, represents a patient’s agreement to undergo a procedure. Given its critical role in protecting human rights and autonomy, obtaining informed consent before any surgery or procedure is now a mandatory practice. However, many studies question whether informed consent is conducted genuinely, ensuring proper understanding of the information disclosed, or merely serves as a medico-legal formality. This has led to increased malpractice, misunderstanding, anxiety, and overall postoperative dissatisfaction.
Methods
This descriptive qualitative study was conducted at Aga Khan Hospital using individual in-depth interviews. Fourteen patients who had undergone elective surgery were recruited. Baseline data were presented in tables, and inductive thematic analysis was used to interpret the qualitative data.
Results
Seven themes emerged from the data: Consent as a legal formality, autonomy and decision-making, insufficient information, time constraints and lack of opportunities for questions, use of medical jargon, patients’ desired information, and overall satisfaction with care. Despite patients’ higher levels of education and the hospital’s patient-centered care approach, many felt the information provided was insufficient, superficial, and difficult to understand.
Conclusion
The study found a significant gap between the information patients desired and what was provided. Insufficient information, coupled with the use of medical jargon and time constraints, adversely affected the informed consent process. Enhancing clarity in communication and allowing adequate time for discussions could improve patient understanding and satisfaction.
Year: 2024
Towards Personal Data Sharing Autonomy: A Task-driven Data Capsule Sharing System
Towards Personal Data Sharing Autonomy: A Task-driven Data Capsule Sharing System
Qiuyun Lyu, Yilong Zhou, Yizhi Ren, Zheng Wang, Yunchuan Guo
arXiv, August 2024
Abstract
Personal data custodian services enable data owners to share their data with data consumers in a convenient manner, anytime and anywhere. However, with data hosted in these services being beyond the control of the data owners, it raises significant concerns about privacy in personal data sharing. Many schemes have been proposed to realize fine-grained access control and privacy protection in data sharing. However, they fail to protect the rights of data owners to their data under the law, since their designs focus on the management of system administrators rather than enhancing the data owners’ privacy. In this paper, we introduce a novel task-driven personal data sharing system based on the data capsule paradigm realizing personal data sharing autonomy. It enables data owners in our system to fully control their data, and share it autonomously. Specifically, we present a tamper-resistant data capsule encapsulation method, where the data capsule is the minimal unit for independent and secure personal data storage and sharing. Additionally, to realize selective sharing and informed-consent based authorization, we propose a task-driven data sharing mechanism that is resistant to collusion and EDoS attacks. Furthermore, by updating parts of the data capsules, the permissions granted to data consumers can be immediately revoked. Finally, we conduct a security and performance analysis, proving that our scheme is correct, sound, and secure, as well as revealing more advantageous features in practicality, compared with the state-of-the-art schemes.
Symposia/Conferences/Webinars
SYMPOSIA/CONFERENCES/WEBINARS
We will selectively include information on major symposia and conferences which address issues, evidence, analysis or debates involving consent/assent. This listing will include [1] meetings already concluded but which are posting presentations/recordings, etc.; [2] future meetings which have posted registration/logistics information, and [3] meetings which have announced calls for abstracts/panels, etc.
Patient-Centered Informed Consent in Clinical Study of FDA-Regulated Medical Products
FDA Patient Engagement Advisory Committee Meeting
Webinar: October 30, 2024
Video recording: [7:13] https://www.youtube.com/live/Th3fkIpi3vc
AGENDA:
On October 30, 2024, the Committee discussed and made recommendations on “Patient-Centered Informed Consent in Clinical Study of FDA-Regulated Medical Products.”
The individuals who volunteer to participate in clinical research play an integral role in advancing scientific knowledge and supporting the development of potentially life-saving therapies for patients in need. Informed consent is a key element in clinical studies and can be one of a patient’s first interactions with the clinical community. Too often, however, informed consent forms are lengthy and difficult for potential research participants to understand. FDA has worked to improve informed consent over the years, including several recent activities such as developing a draft guidance in identifying key information in informed consent.
The Committee will provide recommendations on the informed consent process and the areas of focus of the informed consent. The Committee will also provide recommendations on factors to consider when communicating informed consent to clinical study participants to increase the likelihood of participants understanding the key elements of research. FDA intends to make background material available to the public no later than 2 business days before the meeting. If FDA is unable to post the background material on its website prior to the meeting, the background material will be made publicly available on FDA’s website at the time of the advisory committee meeting, and the background material will be posted on FDA’s website after the meeting.
Background material and the link to the online teleconference and/or video conference meeting are available at https://www.fda.gov/AdvisoryCommittee….
Briefing Documents providing further information:
Informed Consent: A Monthly Review
_________________
October 2024 :: Issue 70
In preparing this digest, we monitor a broad range of academic journals and utilize Google Scholar to search articles referencing informed consent or assent. After careful consideration, a selection of these results appear in the digest. We also monitor other research, analysis, guidance and commentary beyond the academic literature globally, including calls for public consultation and symposia/conferences which address consent/assent in whole or in part. We recognize that some of the arguments presented in this edition may be controversial and may warrant closer scrutiny. We have elected to be generous in our inclusion with the goal of presentating of a wholistic landscape of informed consent literature as it is being published. 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_October 2024
SPOTLIGHT – Upcoming Meeting
SPOTLIGHT – Upcoming Meeting
The spotlight this month is shining on an important upcoming meeting at the US Food and Drug Administration. On October 30th the FDA Patient Advisory Committee will “provide recommendations on the informed consent process and the areas of focus of the informed consent” from a patient/trial participant view. The committee will also provide specific recommendations for how the informed consent process be undertaken given these considerations.
The meeting will be open to the public for both observation and participation. We see this as an opportunity to have a real impact in the informed consent policy making space and we invite you to consider participating. We have applied to give oral testimony and will submit written comments as below.
Ways to participate
Interested persons may present data, information, or views, orally or in writing, on issues pending before the Committee, or individuals may participate in virtual breakout scenario discussions
- Written submissions may be made on or before 3 October 2024 to letise.williams@fda.hhs.gov
- Sign up to participate in virtual breakout session on or before 16 October 2024
- Oral presentation requests should be submitted on or before 25 September 2024 [deadline passed]
Patient Engagement Advisory Committee Meeting: Patient-Centered Informed Consent in Clinical Study of FDA-Regulated Medical Products
Food and Drug Administration
30 October 2024 [Virtual], 10:00-17:00 EST
Summary
The Food and Drug Administration (FDA or Agency) announces a forthcoming public advisory committee meeting of the Patient Engagement Advisory Committee (the Committee). The general function of the Committee is to provide advice and recommendations to the Agency on FDA’s regulatory issues. The meeting will be open to the public.
Agenda
The meeting presentations will be heard, viewed, captioned, and recorded through an online teleconferencing and/or video conferencing platform. On October 30, 2024, the Committee will discuss and make recommendations on “Patient-Centered Informed Consent in Clinical Study of FDA-Regulated Medical Products.” The individuals who volunteer to participate in clinical research play an integral role in advancing scientific knowledge and supporting the development of potentially life-saving therapies for patients in need. Informed consent is a key element in clinical studies and can be one of a patient’s first interactions with the clinical community. Too often, however, informed consent forms are lengthy and difficult for potential research participants to understand. FDA has worked to improve informed consent over the years, including several recent activities such as developing a draft guidance in identifying key information in informed consent.
The Committee will provide recommendations on the informed consent process and the areas of focus of the informed consent. The Committee will also provide recommendations on factors to consider when communicating informed consent to clinical study participants to increase the likelihood of participants understanding the key elements of research…
For Further Information Contact: Letise Williams [Letise.Williams@fda.hhs.gov; 301-796-8398] or FDA Advisory Committee Information Line [1-800-741-8138 (301-443-0572 in the Washington, DC area)]
The Need for an Evolving Informed Consent Process in a Fetal Therapy Trial
The Need for an Evolving Informed Consent Process in a Fetal Therapy Trial
Case Commentaries
Meredith A. Atkinson, Erika Ezumba, Jena L. Miller
The American Journal of Bioethics, 16 September 2024
Excerpt
… In the face of uncertainty about the longer-term burden of morbidity and mortality in surviving neonates, the study team had to consider what level of detail regarding neonatal outcomes observed in infants born to trial participants to share with potential participants during the study screening process, while the study continued active recruitment. In addition, they had to determine if and how such information should be modified over the course of the trial as additional neonates were born to trial participants, and an increasing amount of data on the clinical course and outcomes of the neonates became available. Given the high potential burden in neonatal survivors and their families, including the need for intensive caregiver-provided, at-home care for infants who survive to hospital discharge and a need for life-long renal replacement therapy, the consent discussion takes place over days and in collaboration with multiple specialists… More
information is required to deeply characterize long-term outcomes among survivors and the psychosocial impact on the family, whether the amnioinfusion intervention is offered through a research protocol or as clinical care. This will require systematic collection of prospective data beyond the primary outcome defined in the RAFT trial, including observational data from institutions where the intervention is offered as clinical care.
Ethical analysis of informed consent methods in longitudinal cohort studies: A Chinese perspective
Ethical analysis of informed consent methods in longitudinal cohort studies: A Chinese perspective
Kun Li, Mingtao Huang, Xiaomei Zhai, Chen Wang
Developing World Bioethics, 13 September 2024
Abstract
In longitudinal cohort studies involving large populations over extended periods, informed consent entails numerous urgent challenges. This paper explores challenges regarding informed consent in long-term, large-scale longitudinal cohort studies based on the longitudinal and dynamic nature of such research. It analyzes and evaluates widely recognized broad consent and dynamic consent methods, highlighting limitations concerning their ability to adapt to evolving research objectives and participant perspectives. This paper discusses trust-based informed consent and emphasizes the needs to establish and maintain trust with research participants and to balance information disclosure with respect for participants’ autonomy. Informed consent in long-term studies is an evolving process that must adapt to changing research environments. Based on participant trust, researchers should observe and assess potential research risks. Finally, the paper recommends enhancing institutional credibility, implementing reconsent procedures, and ensuring robust ethical oversight to safeguard participants’ rights despite the complexity of modern biomedical research.
Readability of informed consent documents and its impact on consent refusal rate
Readability of informed consent documents and its impact on consent refusal rate
Original Article
Yash V. Kamath, Yashashri C. Shetty, Ishita C. Lanjewar, Ankita Kulkarni
Perspectives in Clinical Research, 30 August 2024
Abstract
Introduction
Informed consent documents (ICDs) are integral to a research project and must provide all required information to the participant. We undertook a 6-year retrospective cross-sectional analysis of ICDs to assess the same.
Methods
We accessed 300 ICDs from studies submitted to institutional ethics committee. Studies were selected using random proportional-to-size sampling across years and study types (thesis, pharma, government, investigator initiated [OA] studies). We used the Flesch–Kincaid Reading Ease Score (FRES), estimated reading time (ERT) and scored ICDs out of 13 points on the basis of the Indian Council of Medical Research (ICMR)-mandated headings (ICD Quality Score [IQS]). Information pertaining to the consent refusal rate (CRR) of each study was correlated with FRES, ERT, and other parameters. P <0.05 was considered statistically significant.
Results
Two hundred and ninety-three ICDs had complete information. Median FRES was 48.3 (interquartile range [IQR] = 7), median ERT was 4.5 min (IQR = 1.3), the median expected duration of participation was 35 min (IQR = 40); compensation was provided by 23 projects and median compensation was Rs. 2500 (IQR = Rs. 4750). Mean IQS improved from 11.95 to 12.60 in 6 years (Kruskal–Wallis test, P < 0.001). FRES was weakly negatively correlated to the CRR (r = −0.120, P = 0.039), while the expected duration of participation was weakly positively correlated (r = 0.144, P = 0.014).
Conclusion
Pharma studies performed better and ICDs have improved in their readability and ICMR guidelines compliance.
Informed consent and coercion in recruitment advertisements for oocyte donors
Informed consent and coercion in recruitment advertisements for oocyte donors
Research
Ruby Lake, Isa Berzansky, Andrea Lanes, Serene Srouji, Elizabeth Ginsburg, Iris Insogna
BMC Women’s Health, 20 September 2024
Open Access
Abstract
Background
As the use of donor eggs for in vitro treatment has increased, both medically affiliated and private donor egg agencies have turned to online advertisements to recruit donors. The American Society for Reproductive Medicine provides recommendations encouraging ethical recruitment of donors, however there is no formal regulation for the informed consent process for egg donor recruitment and compensation. Underrepresentation of risks and targeted financial incentives may pose a risk to the informed consent process.
Methods
Data from online advertisements for egg donors active between January 1 – August 31, 2020, were collected to analyze content related to risks, Covid-19 precautions, donor payment, and desired donor characteristics. Advertisements for egg donors on Google, Craigslist, and social media were analyzed. Primary outcomes included the mention of the risks of egg donation, including the risk of Covid-19 exposure, in donor egg advertisements. Secondary outcomes included language targeting specific donor characteristics and financial compensation.
Results
103 advertisements were included. 35.9% (37/103) of advertisements mentioned some risk of the egg donation process, and 18.5% (19/103) mentioned risks or precautions related to Covid-19 exposure. Of advertisements for private donor egg agencies, 40.7% (24/59) mentioned any risk, compared to 29.6% (13/44) of medically affiliated egg donation programs; the difference was not statistically significant (p-value = 0.24). Agencies targeting students and donors of a specific race were more likely to offer payments over $10,000 for an egg donation cycle. Among advertisements offering over $20,000 for donor compensation, 72.7% (8/11) recruited women under the age of 21.
Conclusion
Egg donor recruitment advertisements, for both medically affiliated programs and private agencies, were unlikely to mention risks including the risk of exposure to Covid-19. Non-medically affiliated private donor egg agencies were more likely to violate multiple American Society for Reproductive Medicine ethics guidelines, including offering higher than average compensation, and recruiting donors from young and vulnerable populations.
Co-designing body donor program consent processes
Co-designing body donor program consent processes
Georgina C. Stephens
Anatomical Sciences Education, July 2024
Abstract
Objective
It is widely accepted that body donation programs should obtain informed consent from prospective donors during life. However, consent forms vary in detail, are typically developed by anatomical and legal experts, and may not include features valued by prospective donors. Concomitantly, anatomy students report concerns that prospective donors are not adequately informed about dissection procedures. To address these issues, this study aimed to bring together prospective body donors, anatomy students, anatomy educators, and a governance expert to co- design a donor-centered consent process.
Methods
Utilizing participatory co- design, focus group discussions were used to explore participants’ perspectives on informed donor consent. The facilitator worked with participants to identify priorities for inclusion in donor consent processes. Framework analysis is being used to analyze data, and priorities identified in each group will inform the development of a draft donor consent process, on which further participant feedback will be sought.
Results
Forty-one people expressed interest in study participation. Two focus groups (n = 11 participants) have been held, wherein prospective body donors emphasized their desire for their bodies to contribute to anatomical education, including dissection and representation in educational resources. Group members agreed consent forms should explicitly detail how donor bodies are utilized for learning and include personalized elements such as naming preferences. Further focus groups are planned for September and October 2023.
Conclusion
This ongoing study is expected to yield recommendations for community involvement in developing body donor program consent processes, and how community participation can enhance educational activities, such as preparing students for dissection.
Center for Informed Consent Integrity 