Ethics of Clinical Trials

The 78-kDa glucose-regulated protein (GRP78) is a stress induced heat shock protein which, under limiting conditions, functions as a cell surface signaling receptor. Tumor cells are considered to be subjected to a physiologically stressful microenvironment due to their excessive growth. The role of GRP78 in tumor survival has been of notable interest. The present study aimed to assess the potential prognostic and predictive value of cell surface GRP78 expression in breast cancer tumor cells. Cell surface and cytoplasmic expression of GRP78 was examined by immunohistochemical staining of GRP78 in breast cancer archival paraffin-embedded tumor specimens. The cohort studied included breast cancer patients with operable T1,2, estrogen receptor-positive, node-negative cancer who were assessed using the Oncotype DX gene profile, as well as patients with locally advanced disease prior to and following neoadjuvant systemic treatment. GRP78 values were compared between the 2 groups, and prior to and following systemic treatment. Association analyses between GRP78 expression and prognostic markers were also performed. Cox regression analysis was used to examine the impact of these variables on disease-free survival (DFS). No differences in cytoplasmic GRP78 expression were observed. By contrast, the rates of cell surface GRP78 expression were 74.1% in the early stage operable patients, 36% in neoadjuvant systemic treatment patients prior to treatment and 62.5% in patients following systemic treatment (P<0.039). Positive cell surface GRP78 expression was associated with increased expression of the progesterone receptor (P=0.024), p53 expression (P=0.022) and improved DFS (P=0.047). In the case of GRP78 positivity, a trend for a superior response to chemotherapy was observed (P=0.19). The results of the present study indicated that cell surface GRP78 may be used as a marker for good prognosis in breast cancer and a potential marker for response to chemotherapy.

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“…The study was approved by the Institutional Review Board of the RMC, in accordance with the Helsinki Declaration of 1975 ( 20 ).…”

Section: Methodsmentioning

confidence: 99%

Cell surface GRP78: A potential marker of good prognosis and response to chemotherapy in breast cancer

et al. 2015

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“…The theory of double effect is often applied in medical ethics, especially in cases where the treatment of a patient can have both positive and negative effects. A doctor may prescribe pain medications to alleviate a patient's suffering, even though the medication may cause addiction or other negative side effects [76].…”

Section: Critical Decisions Must Be Made By Humansmentioning

confidence: 99%

Montreal Declaration for Responsible AI: 10 Principles and 59 Recommendations

Morandín-Ahuerma

2023

Preprint

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The “Montreal Forum on the Socially Responsible Development of Artificial Intelligence” was a conference that began in November 2017, where more than 400 participants from various sectors and disciplines discussed the ethical and social implications of AI. The conference also led to the creation of the “Montreal Declaration for the Responsible Development of Artificial Intelligence” which was released in late 2018 with more than 500 signatories. The declaration outlines 10 principles and 59 recommendations to guide the development of AI in a way that respects human dignity, autonomy, justice, and democracy. Montreal's AI ethics principles have also been criticized. For example, it is argued that it does not cover the potential malicious use of AI for activities such as warfare, surveillance, or personalized propaganda, and does not offer specific guidance or mechanisms for its application and enforcement. Either way, it is considered an important step in the development of AI ethics and has been widely recognized for its global and integrative approach, and as a reference point for subsequent efforts.

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“…54 Regarding ethical issues, every trial or decision-making should be justified by the four main principles of medical ethics: autonomy, beneficence, nonmaleficence, and justice. 55 Therefore, we should regard pediatric mandatory vaccination on the basis of these principles.…”

Section: Ethical Implications Of Mandatory Sars-cov-2 Vaccination Pro...mentioning

confidence: 99%

“…In addition, considering the fact that COVID‐19 may lead to severe consequences or mortality even in children, vaccination benefits the children per se, since they also get protected against SARS‐CoV‐2 infection 54 . Regarding ethical issues, every trial or decision‐making should be justified by the four main principles of medical ethics: autonomy, beneficence, nonmaleficence, and justice 55 . Therefore, we should regard pediatric mandatory vaccination on the basis of these principles.…”

Section: Introductionmentioning

confidence: 99%

COVID‐19 vaccination in children as a global dilemma through an ethical lens: A retrospective review

Assadi

Kiani

Gooshki

et al. 2022

Health Science Reports

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Background and Aims COVID‐19 pandemic led to a need to rapidly vaccinate as many people as possible. Children are an important part of the population with different characteristics which vaccinating them is a matter of great importance as it should be decided considering all aspects and ethics. Here, we present different aspects of COVID vaccination in children including the potential challenges. Methods We searched on PubMed, Google Scholar and Scopus in this regard, and all of the relevant papers published until June 28, 2021 were included if we could access their full‐texts. Results We found various expert opinions in this regard and tried to summarized them. Saving lives has similar ethical value as preventing evitable adverse event. Accordingly, mandating the children to receive the SARS‐CoV‐2 vaccine, needs risk‐benefit weighing with special consideration of ethical challenges. Conclusion Considering the vast range of benefits resulted from pediatric vaccination both for the children and the community, implementing the program in a scientific manner and also with the least financial expenses for the families seems to be reasonable and makes it both ethical and moral.

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Ethics of Clinical Trials

Cited by 7 publications

References 0 publications

Cell surface GRP78: A potential marker of good prognosis and response to chemotherapy in breast cancer

Cell surface GRP78: A potential marker of good prognosis and response to chemotherapy in breast cancer

Montreal Declaration for Responsible AI: 10 Principles and 59 Recommendations

COVID‐19 vaccination in children as a global dilemma through an ethical lens: A retrospective review

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