Informed Consent Guidelines for Optimizing the Use of Telomerase-Positive Stem Cells
Henry E Young, Mark O Speight
Journal of Regenerative Medicine & Biology Research, 22 July 2020
Open Access
Abstract
The objectives of the work, based on previous characterization studies, pre-clinical animal models of induced diseases, e.g., Parkinson disease, cardiovascular disease, pulmonary disease, and type-I diabetes mellitus, and early clinical human studies of Parkinson disease, cardiovascular disease, and pulmonary diseases, were to established a set of criteria that needed to be followed for using telomerase-positive stem cells in future human clinical trials. From this set of criteria, informed consent guidelines were established to optimize the safety and efficacy of using endogenous adult-derived telomerase-positive stem cells to restore organ function by either repair and/or regeneration of cells and tissues resulting from tissue damage and/or loss. Inclusion criteria were any male or female, 18 to 120 years of age, with preferably no serious comorbidities. Exclusion criteria were use of alcohol, tobacco products, vaping, recreational drugs, lidocaine, and/or chemotherapeutic drugs. We also cautioned use of caffeine and corticosteroids, as well as limiting moderate to strenuous physical activity within a two week window before and after stem cell treatment. Following these inclusion and exclusion criteria, endogenous adult-derived autologous and/or allogeneic telomerase-positive stem cells have proven to be both safe and effective at restoring (up to 50% above pre-treatment values in compliant individuals) organ function for diseases and/or disorders caused by trauma or chronic diseases. Conditions treated thus far, within IRB-approved human study protocols, include neurodegenerative, cardiovascular, pulmonary, autoimmune, renal, and orthopedic disorders.
Month: September 2020
Medicaid Sterilization Consent Forms: Variation in Rejection and Payment Consequences
Medicaid Sterilization Consent Forms: Variation in Rejection and Payment Consequences
Research Letter
Neena Qasba, Baystate HealthFollow
American Journal of Obstetrics and Gynecology, July 2020
Open Access
Abstract
Objective
In 1974, the federal Sterilization Consent Form (SCF) was created for those with publicly funded insurance to document appropriate informed consent by a clinician for sterilization procedures. This form must be signed by the clinician and patient at least 30 days before the procedure and expires 180 days after being signed. While there are numerous barriers to desired sterilization, the Medicaid consent process is a major cause of unfulfilled sterilization requests. As long as they comply with federal statutes, states may modify the Medicaid SCF, further complicating this process. However, data regarding this state-level variability is largely unavailable. Federal policy dictates that the global obstetrical fee should not be affected by SCF rejection. We sought to describe how individual state Medicaid policies differed in terms of what constitutes proper SCF completion and the payment ramifications of a rejected SCF.
Study design
A 25-question survey was administered with Qualtrics XM® to 50 United States state Medicaid Directors or the most appropriate state official based on a review of the state website. The survey assessed state officials’ knowledge of criteria used to assess completion and validity of SCFs, SCF rejection rate, and payment ramifications for rejected SCFs. Data were collected from January to May 2020. Deidentified data were analyzed and reported in aggregate. This study was given Exempt Status by the Tufts Health Sciences Institutional Review Board.
Results
There were 41 responses from 36 states for a 72% participation rate. Four states had submitted multiple nonidentical responses. Criteria for SCF rejection included an incomplete form (35, 85%), mismatching or incorrect dates/times on the SCF (28, 68%), and that greater than 180 days had passed since the patient’s signature rendering the form expired (27, 66%) (Figure 1A). Ten respondents (24%) estimated a SCF rejection rate of less than or equal to 10% while four respondents (10%) indicated a greater than 30% rejection rate (Figure 1B). The majority of respondents indicated that the ramification of a rejected SCF included the loss of payment for the postpartum sterilization procedure for the provider (32, 78%) as well as facility (29, 71%). Five respondents stated that a rejected SCF resulted in loss of the entire obstetrical global payment for provider and facility (5, 12% provider; 5, 12% facility).
Conclusion
From our survey, it is clear that wide variation exists between states or within individual states, in the criteria used by state Medicaid offices to assess SCF completion, rate of rejections, and subsequent payment ramifications for providers and facilities. While the majority of respondents identified objective measures (e.g. incorrect dates) as major reasons to reject SCFs, many also used subjective reasons (e.g. signature legibility). Though federal policy dictates that the global fee should not be affected by SCF rejection, our study found 12% of respondents indicated a loss of the global fee. The fear of payment loss can be a significant barrier to desired sterilization. Ensuring greater transparency and consistency in the Title XIX sterilization consent process within and between states is a key step to ensuring equitable access to postpartum sterilization.
Why ‘understanding’ of research may not be necessary for ethical emergency research
Why ‘understanding’ of research may not be necessary for ethical emergency research
Dan Kabonge Kaye
Philosophy, Ethics, and Humanities in Medicine, 26 August 2020; 15(6)
Open Access
Abstract
Background
Randomized controlled trials (RCTs) are central to generating knowledge about effectiveness of interventions as well as risk, protective and prognostic factors related to diseases in emergency newborn care. Whether prospective participants understand the purpose of research, and what they perceive as the influence of the context on their understanding of the informed consent process for RCTs in emergency obstetric and newborn care are not well documented.
Methods
Conceptual review.
Discussion
Research is necessary to identify how the illnesses may be prevented, to explore the causes, and to investigate what medications could be used to manage such illness. Voluntary informed consent requires that prospective participants understand the disclose information about the research, and use this to make autonomous informed decision about participation, in line with their preferences and values. Yet the emergency context affects how information may be disclosed to prospective research participants, how much participants may comprehend, and how participants may express their voluntary decision to participate, all of which pose a threat to the validity of the informed consent. I challenge the claim that the ‘understanding’ of research is always necessary for ethical informed consent for research during emergency care. I argue for reconceptualization of the value of understanding, through recognition of other values that may be equally important. I then present a reflective perspective that frames moral reflection about autonomy, beneficence and justice in research in emergency research.
Conclusion
While participant ‘understanding’ of research is important, it is neither necessary nor sufficient for a valid informed consent, and may compete with other values with which it needs to be considered.
In Defence of informed consent for health record research – why arguments from ‘easy rescue’, ‘no harm’ and ‘consent bias’ fail
In Defence of informed consent for health record research – why arguments from ‘easy rescue’, ‘no harm’ and ‘consent bias’ fail
Thomas Ploug
BMC Medical Ethics, 20 August 2020; 21(75)
Open Access
Abstract
Background
Health data holds great potential for improved treatments. Big data research and machine learning models have been shown to hold great promise for improved diagnostics and treatment planning. The potential is tied, however, to the availability of personal health data. In recent years, it has been argued that data from health records should be available for health research, and that individuals have a duty to make the data available for such research. A central point of debate is whether such secondary use of health data requires informed consent.
Main body
In response to recent writings this paper argues that a requirement of informed consent for health record research must be upheld. It does so by exploring different contrasting notions of the duty of easy rescue and arguing that none of them entail a perfect duty to participate in health record research. In part because the costs of participation cannot be limited to 1) the threat of privacy breaches, but includes 2) the risk of reduced trust and 3) suboptimal treatment, 4) stigmatization and 5) medicalisation, 6) further stratification of solidarity and 7) increased inequality in access to treatment and medicine. And finally, it defends the requirement of informed consent by arguing that the mere possibility of consent bias provides a rather weak reason for making research participation mandatory, and that there are strong, independent reasons for making.
Conclusion
Arguments from the duty of easy rescue in combination with claims about little risk of harm and potential consent bias fail to establish not only a perfect duty to participate in health record research, but also that participation in such research should be mandatory. On the contrary, an analysis of these arguments indicates that the duty to participate in research is most adequately construed as an imperfect duty, and reveals a number of strong reasons for insisting that participation in health records research is based on informed consent.
Consenting and ethical considerations in embryo cryopreservation
Consenting and ethical considerations in embryo cryopreservation
Arian Khorshid, Ruben Alvero
Current Opinion in Obstetrics and Gynecology, 27 July 2020
Abstract
Purpose of review
An emerging body of literature has elucidated the growing burden of surplus embryos left in storage without any clear disposition. An out dated consent process is a significant but easily remedied contributor to this problem. We propose a novel approach to consenting for disposition of surplus embryos.
Recent findings
Decisional conflicts that stem from the moral status of embryos and from evolving personal values contribute to surplus embryos being left in storage. Barriers to donation of embryos to research or to other patients also discourage embryo disposition decisions. A flawed informed consent process compromises the physician–provider relationship and complicates decision-making.
Summary
Centralizing the process of donating embryos to research and to patients would lower barriers to these disposition options. The informed consent protocol must be redesigned as a longitudinal, narrative process compatible with the evolving values and fertility outcomes of patients. Counselors should be integrated into all discussions regarding embryo disposition from the onset of fertility treatment through its conclusion to facilitate the decision-making process.
Desperate Times: Protecting the Public From Research Without Consent or Oversight During Public Health Emergencies
Desperate Times: Protecting the Public From Research Without Consent or Oversight During Public Health Emergencies
Ideas and Opinions
Mary Catherine Beach, Howard M. Lederman, Megan Singleton, Roy G. Brower, Joseph Carrese, Daniel E. Ford, Bhakti Hansoti, Craig W. Hendrix, Ellen Verena Jorgensen, Richard D. Moore, Philip Rocca, Jonathan M. Zenilman
Annals of Internal Medicine, 27 July 2020; (57) pp 163–165
Open Access
Excerpt
…Obtaining informed consent may be impracticable in some public health surveillance activities. The ethical basis for using surveillance data without consent, particularly in emergency situations, is that it serves a compelling common good. Many—including the authors—agree that public health activities should proceed without informed consent when it is not possible or would undermine effective public health response. However, in the absence of a legal requirement, consent should be considered if possible. Obtaining consent may not be difficult, especially when data are collected prospectively. Even if informed consent is impracticable, information about the scope and purpose of the surveillance should be available to participants and to the public…
20th Anniversary Update of the Ottawa Decision Support Framework Part 1: A Systematic Review of the Decisional Needs of People Making Health or Social Decisions
20th Anniversary Update of the Ottawa Decision Support Framework Part 1: A Systematic Review of the Decisional Needs of People Making Health or Social Decisions
Review Article
Lauren Hoefel, Annette M. O’Connor, Krystina B. Lewis, Laura Boland, Lindsey Sikora, Jiale Hu, Dawn Stacey
Medical Decision Making, 13 July 2020
Abstract
Background. The Ottawa Decision Support Framework (ODSF) has been used for 20 years to assess and address people’s decisional needs. The evidence regarding ODSF decisional needs has not been synthesized. Objectives. To synthesize evidence from ODSF-based decisional needs studies, identify new decisional needs, and validate current ODSF decisional needs. Methods. A mixed-studies systematic review. Nine electronic databases were searched. Inclusion criteria: studies of people’s decisional needs when making health or social decisions for themselves, a child, or a mentally incapable person, as reported by themselves, families, or practitioners. Two independent authors screened eligibility, extracted data, and quality appraised studies using the Mixed Methods Appraisal Tool. Data were analyzed using narrative synthesis. Results. Of 4532 citations, 45 studies from 7 countries were eligible. People’s needs for 101 unique decisions (85 health, 16 social) were reported by 2857 patient decision makers (n = 36 studies), 92 parent decision makers (n = 6), 81 family members (n = 5), and 523 practitioners (n = 21). Current ODSF decisional needs were reported in 2 to 40 studies. For 6 decisional needs, there were 11 new (manifestations): 1) information (overload, inadequacy regarding others’ experiences with options), 2) difficult decisional roles (practitioner, family involvement, or deliberations), 3) unrealistic expectations (difficulty believing outcome probabilities apply to them), 4) personal needs (religion/spirituality), 5) difficult decision timing (unpredictable), and 6) unreceptive decisional stage (difficulty accepting condition/need for treatment, powerful emotions limiting information processing, lacking motivation to consider delayed/unpredictable decisions). Limitations. Possible publication bias (only peer-reviewed journals included). Possible missed needs (non-ODSF studies, patient decision aid development studies, 3 ODSF needs added in 2006). Conclusion. We validated current decisional needs, identified 11 new manifestations of 6 decisional needs, and recommended ODSF revisions.
Center for Informed Consent Integrity 