Fundamental Ethical Agreement To Do No Harm
This study is part of a larger research project that examined the ethical and regulatory issues of big data research. We chose to focus on behavioural sciences, particularly phycology and sociology, for two main reasons. First, the largest research project to examine the challenges posed by big data methods for regulators such as research ethics committees (RECs) and institutional evaluation boards (IRBs) [25]. In both Switzerland and the United States, big data research methods in both areas challenge the concept of human research – because of the increasing distance and distance between researchers and researchers who are brought with digitized means for data collection (. For example, social media profiles, data networks, transaction protocols, etc.) analysis [18]. As a result, existing laws regulating academic research, such as the Human Research Act (HRA) [26], the Federal Data Protection Act [27] and the Common Rule [18], are increasingly being challenged. Second, behavioural studies using big data methodologies are currently among the most under-regulated types of research projects [26, 28, 29]. Indeed, the current definition of the human subject leaves many big data projects outside the regulatory framework, despite possible ethical challenges. Thus, HRA research, which includes anonymized data from research participants, is not subject to ethics authorization [26]. The authors of the Belmont report used medical tradition to examine the ethical principle of charity.
It is generally said that the first principle of medical ethics is “do no harm”.” This principle can go back 2500 years to hippocrates. However, the National Commission has acknowledged that “even avoiding damage requires learning, which is harmful; when this information is obtained, people may be exposed to the risk of harm. In addition, the Hippocratic Oath requires physicians to benefit their patients “in accord with their best judgment.” To learn what is really useful, people`s exposure to risk may be necessary. Identifying when the pursuit of certain benefits is warranted, despite the risks, is the difficult question that investigators and IRBs face on a daily basis. Availability of data: Raw data and project transcripts cannot be disclosed due to ethical constraints (such as the simple re-identification of participants and the sensitive nature of certain parts of the interviews). The main points of contact for the provision of data access requests for this manuscript are: the director of the Institute of Biomedical Ethics (Bernice Elger: b.elger@unibas.ch), the author (Maddalena Favaretto: maddalena.favaretto@unibas.ch) and Anne-Christine Loschnigg (a.loschnigg@unibas.ch). Data sharing depends on the data processing by the data requirementr in accordance with all applicable local requirements. On request, an agreement on the exchange of data between the Institute of Biomedical Ethics and the one requesting the following data is agreed: 1) The data disclosed must be deleted before the end of 2023, in accordance with the recruitment email sent to study participants in accordance with the NFP 75 project proposal to the North-West/Central Switzerland Ethics Committee (EKNZ); 2) Individuals who request the data agree to ensure their confidentiality, they should not seek to re-identify participants and the data should not be shared with another third party who is not involved in the data exchange agreement signed between the Institute of Biomedical Ethics and those requesting the data; 3) Data are only transmitted after the Institute of Biomedical Ethics has received explicit written consent from study participants for data transmission.