Big data carryes a moral burden: the heart will stop, who will decide the data to stay?

Title: Ethical aspects of sudden cardiac arrest research using observational data: a narrative review
Journal:
Marieke A. R. Bak, Marieke T. Blom, Hanno L. Tan and Dick L. Willems
Published: 2018/09/13
Digital ID: 10.1186/s1 3054-018-2153-3
Original Link:
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In recent years, the collection and use of personal data has come under increasing scrutiny and attracted wide public attention, as is the case with the promulgation of the EU General Data Protection Regulation (GDPR).
in a future article, Marieke Bak, one of the authors of
's latest article, will address this challenge and describe the particular difficulties faced in collecting data and obtaining patient consent in emergency medical situations.a major health problem caused by cardiac arrest (SCA), with 20% of natural deaths in Europe caused by cardiac arrest. Cardiac arrest patients die within minutes if they are not treated immediately, with a global average survival rate of only 7%. To improve survival in cardiac arrest patients, we need to understand the complex factors that lead to cardiac arrest and determine survival, and this study needs to be based on a wealth of relevant data.
large numbers of patient queues have been established around the world for research, for example in Europe, ESCAPE-NET will aggregate existing SCA datasets from different countries. The data collected by ESCAPE-NET includes information related to treatment, medical history and prescriptions, as well as socioeconomic indicators such as income. In addition, patients' genetic information is increasingly stored in biological databases.
although randomized clinical trials (RCTs) are often considered the holy grail of medical research, observational studies that collect data regularly have important advantages in terms of external erration, cost and burden of study participants. The full characteristics of cardiac arrest patients can be obtained by linking the collected patient information to a large data set for research. This will help guide personalized medicine and improve treatment prognosios.with the implementation of regulations and provisions such as the EU General Data Protection Regulation (GDPR), many ethical issues and legal uncertainties have begun to attract attention. Emergency medical conditions such as cardiac arrest are particularly complex, in which patients are unable to sign consent in advance and most do not survive the event.
In this study, we reviewed the literature on cardiac arrest and other acute conditions to determine the harm that the use of relevant data in the study may cause to patients and measures to mitigate them.
the risk of participating in non-interventional studies was not obvious compared to randomized controlled clinical trials, but it remained. In the absence of a reasonable methodology, it is unethical to use resources and involve participants in the study, so it is important to start thinking about these ethical issues as early as possible, especially in emergency medical situations where data quality is usually low.
create a risk profile based on incorrect research findings, the resulting bias may result in health differences between different groups, such as race. Therefore, equity should be taken into account when selecting people for cardiac arrest studies. More broadly, we should be careful about using big data to ensure that social injustice is not exacerbated.
at the individual level, collecting patient details increases the risk of re-identification, even more so when the patient's DNA information is also collected. Individuals have the right to privacy, which is based on fundamental values such as autonomy, individuality, dignity and respect, although it is not clear whether and when this right of privacy can be applied to deceased patients. At present, there are fewer documents about the direct harm of privacy disclosure in medical research, but it is certain that data breaches are harmful because they at least undermine public trust in research institutions and thus hinder research.
in research that collects genetic information, another ethical issue relates to the disclosure of clinically actionable results, such as genetic or genetic variants that increase the risk of certain treatable diseases. Participants have a right not to be aware of these results, but this may put researchers who are sadded with information about these results in a moral dilemma., given the potentially harmful effects, studies often require the informed consent of participants. In the early draft of the GDPR, all studies required informed consent, raising concerns about "excessive data protection". Subsequently, after examination, the relevant parties to the draft was amended. The need for patients' informed consent in emergencies such as cardiac arrest will lead to research bias, as the vast majority of such patients who are unable to give informed consent will be excluded and this practice may go against the patient's desire to donate data to science.
case, sometimes the study was conducted without consent, or at a later time the patient's permission was requested. But the best time to ask for deferred consent is not clear. From an ethical and legal point of view, there is also uncertainty as to whether informed consent from the deceased's family should be required, and the GDPR does not apply to data from deceased individuals.
other ways to ensure reliable processing of patient data include security measures such as encrypting or using data areas, as well as oversight by ethics committees and data protection agencies. The new GDPR requires agencies dealing with large-scale health and genetic data to set up data protection officers (DPoAs) to conduct data protection impact assessments (DPIAs), establish safeguards and contract with parties that process data.
addition to unifying and strengthening the rights of data subjects, GDPRS can also have a negative impact. The hype surrounding the law, coupled with high fines for violators, seems to have caused a kind of anxiety caused by the GDPR. In a new study, we interviewed researchers involved in cardiac arrest and found that many of them spent their time studying the details of the GDPR and negotiating with parties who were afraid to share data, rather than doing scientific research itself.
we should pay continuous attention to the ethical aspects of health big data research and provide guidance on a case-by-case basis. At the same time, we need to ensure that bureaucratic obstacles do not prevent these important studies, which should have been the focus.。 Sudden cardiac arrest (SCA) accounts for half of all cardiac deaths in Europe. In recent years, large-scale SCA registries have been set up to enable observational studies into risk factors and the effect of treatment approaches. The increasing scale and variety of data sources, coupled with the implementation of a new European data protection legal framework, causes researchers to struggle with how to handle these 'big data'. Data protection in the SCA setting is especially complex since patients become at least temporarily incapacitated, and are thus unable to provide prospective informed consent, and because the majority of patients do not survive. A narrative review employing a systematic literature search was conducted to thematically analyse ethical aspects of non-interventional emergency medicine and critical care research. Although the identified issues may apply to a wider patient population, we describe them within the context of SCA research. Potential harms were found to include: privacy breaches, genetic discrimination and issues associated with the disclosure of individual findings, study design and application of research results. Measures proposed to mitigate harms were: alternative informed consent models including deferred or waived consent and data governance approaches promoting data security, responsible sharing and public engagement. The themes identified in this study may serve as a basis for a much-needed ethical framework regarding research with data from patients with acute and critical illness such as SCA.。 (
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(Source: Science.com)