Exploring the Ethical Dimensions of Peanut Allergy Immunotherapy Research

探索花生过敏免疫治疗研究的伦理维度

• 批准号: 10308499
• 负责人: JILL A FISHER
• 金额: $ 19.44万
• 依托单位: UNIV OF NORTH CAROLINA CHAPEL HILL
• 依托单位国家: 美国
• 财政年份: 2020
• 资助国家: 美国
• 起止时间: 2020-12-01 至 2023-11-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10308499
• 关键词: 1 year old; Accounting; Adult; Adverse reactions; Advocate; Affect; Allergen Immunotherapy; Allergens; Allergy to peanuts; Anaphylaxis; Area; Attention; Benefits and Risks; Bioethics; Biomedical Research; Caregivers; Child; Childhood; Clinic; Clinical; Clinical Trials; Clinical Trials Design; Complex; Conduct Clinical Trials; Consent; Development; Dimensions; Emerging Technologies; Enrollment; Ensure; Environment; Epidemic; Ethical Issues; Ethics; Ethnography; Evaluation; Event; Exposure to; FDA approved; Family; Food Hypersensitivity; Future; Goals; Hearing; Hypersensitivity; Immune system; Immunotherapy; Individual; Ingestion; Interview; Legal; Life; Measures; Mind; Modality; Observational Study; Oral; Outcome; Patient advocacy; Patients; Pediatric Research; Pharmacologic Substance; Population; Powder dose form; Prevalence; Principle-Based Ethics; Product Approvals; Protocols documentation; Public Health; Reaction; Recommendation; Research; Research Design; Research Personnel; Research Priority; Risk; Sales; Serious Adverse Event; Shapes; Social Sciences; Structure; Therapeutic; Thinking; Treatment Efficacy; United States; United States National Institutes of Health; adolescent patient; analytical method; clinical practice; desensitization; design; financial conflict of interest; food challenge; immunotherapy clinical trials; improved; innovation; interest; new technology; novel; novel therapeutics; product development; research and development; response; subcutaneous; symposium; technology development; willingness; 1 year old; Accounting; Adult; Adverse reactions; Advocate; Affect; Allergen Immunotherapy; Allergens; Allergy to peanuts; Anaphylaxis; Area; Attention; Benefits and Risks; Bioethics; Biomedical Research; Caregivers; Child; Childhood; Clinic; Clinical; Clinical Trials; Clinical Trials Design; Complex; Conduct Clinical Trials; Consent; Development; Dimensions; Emerging Technologies; Enrollment; Ensure; Environment; Epidemic; Ethical Issues; Ethics; Ethnography; Evaluation; Event; Exposure to; FDA approved; Family; Food Hypersensitivity; Future; Goals; Hearing; Hypersensitivity; Immune system; Immunotherapy; Individual; Ingestion; Interview; Legal; Life; Measures; Mind; Modality; Observational Study; Oral; Outcome; Patient advocacy; Patients; Pediatric Research; Pharmacologic Substance; Population; Powder dose form; Prevalence; Principle-Based Ethics; Product Approvals; Protocols documentation; Public Health; Reaction; Recommendation; Research; Research Design; Research Personnel; Research Priority; Risk; Sales; Serious Adverse Event; Shapes; Social Sciences; Structure; Therapeutic; Thinking; Treatment Efficacy; United States; United States National Institutes of Health; adolescent patient; analytical method; clinical practice; desensitization; design; financial conflict of interest; food challenge; immunotherapy clinical trials; improved; innovation; interest; new technology; novel; novel therapeutics; product development; research and development; response; subcutaneous; symposium; technology development; willingness

PROJECT SUMMARY An important area of pediatric research and development is peanut allergy immunotherapy. Researchers are pursuing oral, sublingual, subcutaneous, and epicutaneous products that activate the immune system through allergen exposure to desensitize individuals to peanuts. One such treatment is now FDA approved, and another is poised to receive market approval. However, immunotherapy conveys significant risk to patients, such as high rates of treatment-induced anaphylaxis. This project's objective is to identify empirically the on-the-ground ethical challenges that emerge in pediatric peanut immunotherapy (PIT) clinical trials. To date, there has been little attention to ethics within the broad domain of food allergy research and practice. Yet, PIT research involves many features that warrant ethical consideration, including clinical trials that enroll children, some as young as 1 year old, and risk-benefit profiles that differ from many other therapeutic areas. To explore these ethical issues, the project has 2 specific aims: (1) Document how stakeholders—investigators, caregivers, adolescents, patient advocates, FDA officers, and pharmaceutical company representatives—define and understand acceptable risks and benefits from peanut immunotherapy, both in terms of research protocols and the eventual products to be used in clinical practice; and (2) Identify the ethical challenges that emerge from these stakeholders' stances on peanut immunotherapy risks and benefits. For Aim 1, the project uses an ethnographic approach—consisting of observational studies and 125 semi-structured interviews—that focuses on 6 leading U.S. PIT research centers, academic food allergy conferences, patient advocacy events, and FDA hearings for PIT products. To accomplish Aim 2, the project employs analytic methods to ground the empirical findings from Aim 1 in bioethical frameworks, including principlism and research on vulnerable or complex populations. The proposed research is significant because it will develop an initial framework for the ethical conduct of PIT clinical trials that attends to the myriad interests that drive biomedical research, including the search for therapies that meaningfully improve the lives of children and adults with peanut allergy, the need to design and conduct clinical trials to meet the regulatory standards required by the FDA for the approval of products, and the commercial context in which investigators and companies have financial conflicts of interest that motivate the successful development of new therapies. This project is innovative because it explores a novel area of social science and bioethics research and because it investigates the entire sphere of PIT research and a wide array of stakeholders. This application is directly responsive to NIH's Notice of Interest in High Priority Research in Bioethical, Legal, and Societal Implications of Biomedical Research (NOT-LM-17-001), focusing in particular on new and emerging technology development and use, pediatric research, and the current and emerging regulatory environments.

项目摘要 小儿研究和发育的重要领域是花生过敏免疫疗法。研究人员是 追求口服，舌下，皮下和表皮产品，通过 过敏原暴露于对花生的脱敏。现在，一种这样的治疗方法已获得FDA批准，另一种治疗方法 被中毒以获得市场认可。但是，免疫疗法传达了对患者的重大风险，例如 治疗诱导的过敏反应的速率。该项目的目标是从经验上确定地面道德 小儿花生免疫疗法（PIT）临床试验中出现的挑战。迄今为止，几乎没有 注意食品过敏研究和实践的广泛领域中的伦理。但是，坑研究涉及 值得道德考虑的许多功能，包括注册儿童的临床试验，有些像年轻一样 1岁，风险效益的特征与许多其他治疗领域不​​同。探索这些道德问题， 该项目具有2个特定目的：（1）记录利益相关者（评估者，照顾者，青少年，患者）如何 倡导者，FDA官员和制药公司代表并理解可接受的风险 在研究方案和事件产品方面，花生免疫疗法受益于花生免疫疗法 用于临床实践； （2）确定从这些利益相关者的立场中产生的道德挑战 花生免疫疗法风险和益处。对于目标1，该项目使用人种学方法 - 观察性研究和125次半结构化访谈 - 侧重于6个美国领先研究中心， 学术食品过敏会议，患者宣传活动和FDA听证会。完成 AIM 2，项目员工的分析方法，以生物伦理框架中的AIM 1的经验发现， 包括对脆弱或复杂人群的首席主义和研究。拟议的研究很重要 因为它将开发一个初始框架，用于众所周知的PIT临床试验的道德行为 推动生物医学研究的兴趣，包括寻找有意义地改善生活的疗法 患有花生过敏的儿童和成人，需要设计和进行临床试验以满足监管 FDA要求批准产品的标准以及调查人员的商业环境 公司有利益冲突，激发了新疗法的成功发展。 该项目具有创新性，因为它探讨了社会科学和生物伦理学研究的新领域，并且因为 它研究了PIT研究的整个领域和各种各样的利益相关者。此应用程序直接 对NIH对对生物伦理​​，法律和社会意义的高优先研究的关注通知的反应 生物医学研究（非LM-17-001），尤其是针对新的和新兴的技术开发 以及使用，小儿研究以及当前和新兴的监管环境。