Optimizing Informed Consent Discussions: Developing a Narrative for Transfusion Consent

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Optimizing Informed Consent Discussions: Developing a Narrative for Transfusion Consent
Michelle P. Zeller, Marissa Laureano, Aditi Khandelwal, Shannon J. Lane, Richard Haspel, Mark Fung
Transfusion Medicine Reviews, 9 September 2023
Abstract
    Ensuring patient informed consent is a key tenet of modern medicine. Although transfusion of blood products is among the most common medical procedures performed in hospitalized patients, there is evidence that informed consent for transfusion is at times incomplete, poorly understood, hurried and/or inaccurate. This study aimed to develop a narrative that can be used as a framework for practicing physicians and for educational purposes to optimize the process for obtaining informed consent for blood transfusion.

The narrative was developed using a modified-Delphi approach with 5 Rounds that included feedback from Transfusion Medicine (TM) experts, transfusion-provider physicians and lay people. The surveys collected qualitative and quantitative data analyzed using thematic content analysis and descriptive statistics, respectively. Results from Round 1 and 2 generated a draft narrative and rounds 3 to 5 informed further modifications.

Round 1 included draft narrative scripts from 28 TM experts; thematic coding generated 97 topics. In round 2, 22/28 of the initial experts rated items identified from Round 1. Those with a Content Validity Index (CVI) ≥ 0.8 were used by the authors to develop a narrative. In Round 3, 20/24 participants from Round 2 reviewed the narrative with 100% agreeing on the items included and 90% agreeing the flow was logical. In Round 4, 23 transfusion prescribers (non-TM physicians) reviewed the narrative for flow, manner, length and usability; there was 83% agreement with non-exclusion of important topics; 91% felt it would be effective for teaching trainees. Round 5 included 24 non-medical lay people of different demographics. Most participants (92%) thought that the script was appropriate in length and there were opportunities to ask questions. Participants could also identify the adverse transfusion reactions and understood that they could refuse the transfusion. A narrative for obtaining informed consent for blood transfusion was created through multiple rigorous iterations of review and feedback with both transfusion providers and the lay public. The narrative, developed for a specific clinical scenario, was well-received by medical and non-medical participants and can be used, and modified, to help ensure patients understand the risks and benefits of blood transfusion.

Minimum standard assessment of informed consent for internal medicine transition to residency program: A cohort study

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Minimum standard assessment of informed consent for internal medicine transition to residency program: A cohort study
Mannat Marwaha, Raman Bhalla, Shivani Rao, Catherine Chen
Health Science Reports, 10 August 2023
Abstract
Background and Aims
Interns must be proficient in obtaining informed consent (IC), which is the Association of American Medical College’s 11th of 13 Entrustable Professional Activities (EPAs). Medical students have limited opportunity to practice IC during clerkships, resulting in inconsistent proficiency. We aimed to create a tool to assess whether our transition to residency (TTR) workshop enables fourth‐year medical students to meet a minimum standard of obtaining IC.
Methods
Sixty fourth‐year medical students were enrolled in the internal medicine virtual TTR course during AY2021. The curriculum prioritizes deliberate practice activities. Pre‐ and postworkshop assignments involved students typing verbatim what they would say during IC encounters. We modified an IC abstraction tool created by Spatz et al. to assess a minimum standard for students’ IC assignments. Our final 7‐item tool consisted of the following domains: “What,” “Why,” “How,” “Benefits,” “Quantitative Risks,” “Qualitative Risks,” and “Alternatives,” weighing 1 point each. A minimum standard was obtained with a score of 6 or more points by appropriately discussing at least one domain involving risk and all other domains.
Results
Students scored highly on the prework domains pertaining to “What,” “Why,” and “How” of the procedure with no significant difference on postwork. Significant improvement was achieved on postwork domains covering “Benefits” (p = 0.039) and “Alternatives” (p = 0.031). For domains involving “Qualitative” and “Quantitative Risks,” there were no statistically significant improvements from pre‐ to postwork scores. Fifteen and 22 students met the minimum standard for IC on pre‐ and postwork, respectively.
Conclusion
Our students demonstrated a good a priori understanding of the “What,” “Why,” and “How” domains. After the workshop, they more reliably discussed “Benefits” and “Alternatives.” Our abstraction tool helped assess the strengths and weaknesses in our students’ IC skillset and helped recognize areas of our curriculum that will benefit from improvements to bring students to meet the minimum standard.

A troubling foundational inconsistency: autonomy and collective agency in critical care decision-making

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A troubling foundational inconsistency: autonomy and collective agency in critical care decision-making
Stowe Locke Teti
Theoretical Medicine and Bioethics, 28 March 2023; 44 pp 279–300
Abstract
‘Shared’ decision-making is heralded as the gold standard of how medical decisions should be reached, yet how does one ‘share’ a decision when any attempt to do so will undermine autonomous decision-making? And what exactly is being shared? While some authors have described parallels in literature, philosophical examination of shared agency remains largely uninvestigated as an explanation in bioethics. In the following, shared decision-making will be explained as occurring when a group, generally comprised of a patient and or their family, and the medical team become a genuine intentional subject which acts as a collective agent. Collective agency can better explain how some medical decisions are reached, contrary to the traditional understanding and operationalization of ‘autonomy’ in bioethics. Paradoxically, this often occurs in the setting of high-stakes moral decision-making, where conventional wisdom would suggest individuals would most want to exercise autonomous action according to their personally held values and beliefs. This explication of shared decision-making suggests a social ontology ought to inform or displace significant aspects of autonomy as construed in bioethics. It will be argued that joint commitments are a fundamental part of human life, informing and explaining much human behavior, and thus suggesting that autonomy – conceived of as discrete, individuated moral reasoning of a singular moral agent – is not an unalloyed ‘good.’

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Informed Consent: A Monthly Review
_________________

September 2023 :: Issue 57

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_September 2023

Upcoming Calls For Public Consultation

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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].

Public Consultation: ICH E6(R3) [GCP] Principles, Annex 1 and Annex 2
ICH – The E6(R3) EWG is working on the revision of the E6(R2) Guideline “Good Clinical Practice” (GCP) with a view to addressing the application of GCP principles to the increasingly diverse trial types and data sources being employed to support regulatory and healthcare related decision-making on drugs, and provide flexibility whenever appropriate to facilitate the use of technological innovations in clinical trials.
   Public consultation dates:
ANVISA, Brazil – Deadline for comments by 31 August 2023
EC, Europe – Deadline for comments by 26 September 2023
FDA, United States – Deadline for comments by 5 September 2023
HSA, Singapore – Deadline for comments by 30 September 2023
Health Canada, Canada – Deadline for comments by 20 October 2023
MHLW/PMDA, Japan – Deadline for comments by 9 September 2023
MHRA, UK – Deadline for comments by 31 August 2023
NMPA, China – Deadline for comments by 31 August 2023
Swissmedic, Switzerland – Deadline for comments by 26 September 2023
TFDA, Chinese Taipei – Deadline for comments by 31 August 2023 

Public consultation on WHO guidance for best practices for clinical trials
WHO -19 July 2023
Call for consultation: Deadline 15 Sep 2023

WHO launches a global stakeholder survey on solutions for strengthening clinical trial infrastructure and capacity
This global stakeholder survey will be open until 10th September 2023.
   The outcomes of the public consultation and the global survey will guide the WHO in a series of upcoming regional and global consultations with Member States and non-State-actors towards the implementation of the WHA resolution 75.8 on clinical trials.

Symposia/Conferences

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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 meeting which have  posted registration/logistics information, and [3] meetings which have announced calls for abstracts/panels, etc.

17th World Congress of Bioethics
3-6 June 2024
Doha, Qatar
  The WCB 2024 theme is “Religion, Culture, and Global Bioethics”. This theme aims to engage bioethics researchers from a broad range of fields and disciplines and to take full advantage of hosting the WCB in the Arab-Muslim world and the Middle East
Call for Abstracts now open, deadline September 30, 2023.
Editor’s Note: We are certainly aware of the continuing, active debate in the bioethics community and beyond about the site selection for this meeting. The Foundation is reviewing its options regarding participation, submitting abstracts, etc.  

8th World Conference on Research Integrity (Hybrid)
2-5 June 2024
Megaron Athens International Conference Centre (MAICC)
Athens, Greece
The biannual WCRIs cater to all disciplinary fields, all professional ranks, and all career stages, and involve all stakeholders in research integrity, including universities, research institutes, research funders, publishers, and governments. Each WCRI emphasises a specific theme, but all cater for the whole range of research integrity issues and responsible research practices. The 8th WCRI will put thematic emphasis on: Catalysing the translation of research into trustworthy policy and innovation.
Call for Abstracts now open, deadline October 17, 2023.

Spotlight Articles

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In this issue’s Spotlight section we include two recent articles analyzing the structure and components of ICFs [informed consent forms].

In Characterization of Key Information Sections in Informed Consent Forms Posted on ClinicalTrials.gov published in the Journal of Clinical Translational Science the authors assess the presence, length, readability and other parameters of KIs [key information sections] in ICFs posted on ClinicalTrials.gov in alignment with the revised Common Rule. The authors argue that “…widely adopted guidelines could also facilitate compliance analyses that are currently challenged by the broad subjectivity in interpreting the KI requirement [in the revised Common Rule].”

In the Perspectives in Clinical Research article Redefining informed consent form in cell and gene therapy trials, Dalal et at. address the need to adapt the informed consent process and ICFs to the unique context of gene therapy trials [see Fig 3 below] as well as the  cultural contexts in which the trials are implemented.

 

Characterization of Key Information Sections in Informed Consent Forms Posted on ClinicalTrials.gov
Luke Gelinas, Walker Morrell, Tony Tse, Ava Glazier, Deborah A. Zarin, Barbara E. Bierer
Journal of Clinical and Translational Science, 14 August 2023
Abstract
Introduction
Recent revisions to the United States Federal Common Rule governing human studies funded or conducted by the federal government require the provision of a “concise and focused” key information (KI) section in informed consent forms (ICFs). We performed a systematic study to characterize KI sections of ICFs for federally-funded trials available on ClinicalTrials.gov.
Methods
We downloaded ICFs posted on ClinicalTrials.gov for treatment trials initiated on or after the revised Common Rule effective date. Trial records (n=102) were assessed by intervention type, study phase, recruitment status, and enrollment size. The ICFs and their KI sections, if present, were characterized by page length, word count, readability, topic, and formatting elements.
Results
Of the 102 trial records, 76 had identifiable KI sections that were, on average, 10% of the total length of full ICF documents. KI readability grade level was not notably different than other sections of ICFs. Most KI sections were distinguished by section headers and included lists but contained few other formatting elements. Most KI sections included a subset of topics consistent with the basic elements of informed consent specified in the Common Rule.
Conclusion
Many of the KI sections in the study sample aligned with practices suggested in the preamble to the revised Common Rule. Further, our results suggest that some KI sections were tailored in study-specific ways. Nevertheless, guidelines on how to write concise and comprehensible KI sections would improve the utility and readability of KI sections.

Redefining informed consent form in cell and gene therapy trials
Review Article
Varsha Dalal, Geeta Jotwani, Munna Lal Yadav
Perspectives in Clinical Research, 28 July 2023
Abstract
Informed consent is a foundation of the ethical conduct of research involving human participants. Based on the ethical principle of respect for persons, the goal of informed consent is to ensure that participants are aware of the risks and potential benefits and make a voluntary decision about participating in clinical trial research. The extraordinary scientific advances happening globally have demonstrated the potential of regenerative therapies in transforming the health of the nation by providing a therapeutic option for diseases that were previously considered incurable. These therapies, which include cells and gene therapy (GT) labeled as Advanced Therapeutic Medicinal Products globally, have complex mechanisms of action. Owing to their highly personalized and intricate nature of these therapies, developing the latter often presents unique challenges above and beyond those encountered for small molecule drugs. We recently looked through some cell and GT clinical trials and realized the lacunae in the informed consent form (ICF) provided by the investigators. Especially in a country like India, where the general understanding and perception of patients is limited regarding clinical trials, it is felt that any lapses in the consent process may jeopardize the informed decision‑making and safety of the participants and tarnish the reputation of India globally. The present article highlights the need for appropriate patient and public education on the various aspects of cell and gene therapies and aims to address all the elements of ICF in light of the challenges associated with these innovative therapies.

 

Consent document translation expense hinders inclusive clinical trial enrolment

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Consent document translation expense hinders inclusive clinical trial enrolment
Maria A. Velez, Beth A. Glenn, Maria Garcia-Jimenez, Amy L. Cummings, Aaron Lisberg, Andrea Nañez, Yazeed Radwan, Jackson P. Lind-Lebuffe, Paige M. Brodrick, Debory Y. Li, Maria J. Fernandez-Turizo, Arjan Gower, Maggie Lindenbaum, Manavi Hegde, Jenny Brook, Tristan Grogan, David Elashoff, Michael A. Teitell, Edward B. Garon
Nature, 2 August 2023
Abstract
Patients from historically under-represented racial and ethnic groups are enrolled in cancer clinical trials at disproportionately low rates in the USA. As these patients often have limited English proficiency, we hypothesized that one barrier to their inclusion is the cost to investigators of translating consent documents. To test this hypothesis, we evaluated more than 12,000 consent events at a large cancer centre and assessed whether patients requiring translated consent documents would sign consent documents less frequently in studies lacking industry sponsorship (for which the principal investigator pays the translation costs) than for industry-sponsored studies (for which the translation costs are covered by the sponsor). Here we show that the proportion of consent events for patients with limited English proficiency in studies not sponsored by industry was approximately half of that seen in industry-sponsored studies. We also show that among those signing consent documents, the proportion of consent documents translated into the patient’s primary language in studies without industry sponsorship was approximately half of that seen in industry-sponsored studies. The results suggest that the cost of consent document translation in trials not sponsored by industry could be a potentially modifiable barrier to the inclusion of patients with limited English proficiency.

Advance Consent In Acute Stroke Trials: Survey Of Canadian Research Ethics Board Chairs

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Advance Consent In Acute Stroke Trials: Survey Of Canadian Research Ethics Board Chairs
Manuscript
Rena Seeger, Ubong Udoh, Brian Dewar, Stuart Nicholls, Mark Fedyk, Robert Fahed, Jeff Perry, Michael D Hill, Bijoy Menon, Richard H Swartz, Alexandre Y Poppe, Sophia Gocan, Jamie Brehaut, Katie Dainty, Victoria Shepherd, Dar Dowlatshahi, Michel Shamy
24 July 2023 [Cambridge University Press]
Abstract
Advance consent could allow individuals at high risk of stroke to provide consent before they might become eligible for enrollment in acute stroke trials. This survey explores the acceptability of this novel technique to Canadian Research Ethics Board (REB) chairs that review acute stroke trials. Responses from 15 REB chairs showed that majority of respondents expressed comfort approving studies that adopt advance consent. There was no clear preference for advance consent over deferral of consent, although respondents expressed significant concern with broad rather than trial-specific advance consent. These findings shed light on the acceptability of advance consent to Canadian ethics regulators.

Continuous quality improvement: reducing informed consent form signing errors

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Continuous quality improvement: reducing informed consent form signing errors
Research
Tsui-Wen Hsu, Chi-Hung Huang, Li-Ju Chuang, Hui-Chen Lee, Chih-Shung Wong
BMC Medical Ethics, 4 August 2023; 24(59)
Open Access
Abstract
Background
Adherence to ethical guidelines and regulations and protecting and respecting the dignity and autonomy of participants by obtaining a valid informed consent form (ICF) prior to participation in research are crucial; The subjects did not add signatures next to the corrections made to signatures or dates on the ICF, Multiple signatures in other fields, ICF missing/missing signature, Incorrect ICF version Signed after modification, Correction tape used to correct signature, Impersonated signature, Non-research-member signature, however, ICFs are often not properly completed, which must be addressed. This study analyzed ICF signing errors and implemented measures to reduce or prevent these errors.
Methods
We used the plan–do–check–act (PDCA) cycle to help improve the correctness and validity of ICF signing.
Results
Interim and final reports from January 2016 to February 2020 including 363 ICFs were studied. The total proportion of correct ICF signatures (200, 83.3%) following the PDCA intervention was significantly higher than that before the intervention (P < 0.05). Analysis of the types of signing error demonstrated that signature errors were significantly reduced after the intervention, particularly for subjects did not add signatures next to the corrections made to signatures or dates on the ICF (16, 6.7%) and impersonated signature (0; P < 0.05).
Conclusions
The proportions of other error types—multiple signatures in other fields, missing or unsigned ICF, incorrect signature order, incorrect ICF version, use of correction tape to correct signature, and non-medical profession members signing the ICF—did not differ significantly.