Consent Mechanisms Research Articles

Moving Towards Routine Non-Invasive Prenatal Testing (NIPT): Challenges Related to Women’s Autonomy

Women’s reproductive autonomy, and its translation into informed free choice regarding prenatal testing, is a dominant concept in the bioethical discourse concerning prenatal testing. This discourse is based on the premise that access to information regarding the pregnancy promotes autonomous decision-making. However, studies show that the offer of prenatal screening as a routine part of pregnancy care is not supported, to a large degree, by appropriate informed consent mechanisms. This means that the implementation of the concept of autonomy ought to be reconsidered. On the backdrop of these challenges, the introduction of Non-Invasive Prenatal Testing (NIPT) may present new challenges. The main advantages of NIPT, compared with earlier technologies, (namely the early availability of results, the non-invasive and risk-free nature of the test, as well as its increased accuracy) may exacerbate threats to women’s autonomy. Four of the most likely future uses of NIPT – first-tier screening, diagnosis, expanded targeted use, and whole-genome sequencing – will continue to challenge patients’ autonomy. To shed light on these developments, this paper presents some longstanding ethical concerns regarding prenatal screening, examines what makes NIPT different from earlier screening technologies, and charts the possible future courses of NIPT, while anticipating the ethical and social implications of the various signposts potentially encountered, particularly as they relate to reproductive autonomy.

Improving Consent in Information Privacy through Autonomy-Preserving Protective Measures (APPMs)

In this article, I argue that due to numerous shortcomings, current online consent mechanisms do not allow data subjects to think, decide and choose according to their internal beliefs, therefore impairing essential individual freedoms – or capabilities, following Martha Nussbaum’s Capabilities Approach. I identify the main shortcomings of consent in privacy as issues of cognitive limitations, information overload, information insufficiency, lack of intervenability and lack of free choice, describing the type of imbalance present in each category. Then, based on current privacy theories and focusing on the concepts of autonomy and protection – and how they can be combined and manifested in policymaking - I propose the Methodology for Autonomy-Preserving Protection (MAPP), a methodology to evaluate (old) or design (new) measures to improve consent and reinstall the freedoms of thought, decision and choice in this context. According to the MAPP, if an entity A wants to generate positive welfare to an individual B, then: 1) the intentions or goals of A must be transparent, known to B and open to legal questioning and criticism; 2) the actions of A must be transparent, non-manipulative, known to B and open to legal questioning and criticism; and 3) the actions of A must not interfere in the decision-making capacities of B, preserving her autonomy. Lastly, applying the methodology, I present a non-exhaustive list of Autonomy-Preserving Protective Measures (APPMs), showing how they can enable the three freedoms highlighted in the present work and support more effective consent mechanisms. Keywords: Information Privacy, Consent, Data Protection, Autonomy, Paternalism

Demonstrably Doing Accountability for the Internet of Things

This paper explores the importance of accountability to data protection, and how it can be built into the Internet of Things (IoT). The need to build accountability into the IoT is motivated by the opaque nature of distributed data flows, inadequate consent mechanisms, and lack of interfaces enabling end-user control over the behaviours of internet-enabled devices. The lack of accountability precludes meaningful engagement by end-users with their personal data and poses a key challenge to creating user trust in the IoT and the reciprocal development of the digital economy. The EU General Data Protection Regulation 2016 (GDPR) seeks to remedy this particular problem by mandating that a rapidly developing technological ecosystem be made accountable. In doing so it foregrounds new responsibilities for data controllers, including data protection by design and default, and new data subject rights such as the right to data portability. While GDPR is ‘technologically neutral’, it is nevertheless anticipated that realising the vision will turn upon effective technological development. Accordingly, this paper examines the notion of accountability, how it has been translated into systems design recommendations for the IoT, and how the IoT Databox puts key data protection principles into practice.

Rethinking Informed Consent in Biobanking and Biomedical Research: a Taiwanese Aboriginal Perspective and the Implementation of Group Consultation

The current informed consent mechanism is based mainly on the rationale of individualism, particularly for its emphasis on autonomy and self-determination. However, in biobanking and genetic research, research findings may pose a risk of harm to the collective, quite aside from a particular individual. Under this circumstance, individual consent needs to be supplemented by other mechanisms, such as group consent obtained from the relevant group or community. In Taiwan, the inclusion of Taiwanese aborigines in biobanking and genetic research challenges the conventional wisdom of individual consent-taking, which overlooks the significance of collective involvement in decision-making. This paper discusses the rationale of the group consent requirement in Taiwan, which seeks to include Taiwanese aborigines’ perspectives, and the related measures that have been pronounced to implement group consultation. It is further argued that consent procedures should not be transactional in being primarily focused on types of information that is to be communicated. Rather, it should be a process that ensures comprehension, empowerment and trust.

Eliciting meta consent for future secondary research use of health data using a smartphone application - a proof of concept study in the Danish population

BackgroundThe increased use of information technology in every day health care creates vast amounts of stored health data that can be used for research. The secondary research use of routinely collected data raises questions about appropriate consent mechanisms for such use. One option is meta consent where individuals state their own consent preferences in relation to future use of their data, e.g. whether they want the data to be accessible to researchers under conditions of specific consent, broad consent, blanket consent or not at all.This study investigates whether meta consent preferences can be successfully elicited by a smartphone application in the adult Danish population.MethodsA smartphone app was developed for the elicitation of meta consent preferences. An invitation to use the app was distributed to a stratified, representative sample of the Danish adult population. The meta consent choices, the use of the app, user experience data, and demographic data were logged and analysed statistically using IBM SPSS version 20.ResultsOf 1000 potential respondents 221 used the app. One hundred eighty-eight of the respondents were female and 103 male. The age range was 19 to 79 years with an average of 51 years (SD 16). Most users indicate 1) that they find the choices they are asked to make easy to understand (>75% find it ‘Easy’ or ‘Very easy’), 2) that the application is easy to use (>75% find it ‘Easy’ or ‘Very easy’), and 3) that this kind of choice should be offered to people (89% find it ‘Absolutely’ or ‘Somewhat’ important).ConclusionsIt is possible to collect meta consent preferences in the general, adult population using a smartphone app.

Towards an indicator system to assess equitable management in protected areas

Aichi Target 11 (AT11), adopted by 193 Parties to the Convention on Biological Diversity (CBD) in 2010, states that protected areas (PAs) must be equitably managed by 2020. However, significant challenges remain in terms of actual implementation of equitable management in PAs. These challenges include, among others, the lack of a standardized approach to assess and monitor social equity and the difficulty of reducing social equity to a series of metrics. This perspective addresses these challenges and it proposes a minimum set of ten indicators for assessing and monitoring the three dimensions of social equity in protected areas: recognition, procedure and distribution. The indicators target information on social equity regarding cultural identity, statutory and customary rights, knowledge diversity; free, prior and informed consent mechanisms, full participation and transparency in decision-making, access to justice, accountability over decisions, distribution of conservation burdens, and sharing of conservation benefits. The proposed indicator system is a first step in advancing an approach to facilitate our understanding of how the different dimensions of social equity are denied or recognized in PAs globally. The proposed system would be used by practitioners to mainstream social equity indicators in PAs assessments at the site level and to report to the CBD on the ‘equitably managed’ element of AT11.

PRISTANAK OBITELJI ZA UZIMANJEM ORGANA ILI TKIVA OD PREMINULE OSOBE RADI PRESAĐIVANJA U REPUBLICI HRVATSKOJ

The Republic of Croatia is a country with the system of presumed consent donation of organs and tissues after death, where the consent of the family, according to law, is not one of the conditions for organ or tissue removal for transplantation purposes. However, the consent is a condition required by the Codex of Medical Ethics and Deontology. The author primary proposes harmonization of the Codex with current legislation. Accordingly, this paper primarily analyses the typology of the Codex, ethical issues and ethical and positivist reasons to harmonize the Codex with current legislation. Furthermore, although the author in the first place considers that the Codex should be in line with legislation, he also considers the provision of family consent for organ and tissue removal itself flawed and poorly developed. In this regard, the author considers the comparative legislation and judgments of the European Court of Human Rights, analyses current provisions of the Codex in the part of the removal and transplantation of organs and tissues from deceased persons, states the facts that the Codex should contain so as to make the mechanism of family consent for organ and tissue removal and donation after death more effective. In fact, if the author’s original proposal for harmonization of the Codex with the current legislation is not accepted, a more detailed and precise elaboration of the mentioned current provisions of the Codex will be suggested. This will include exact definition of the family and relatives, exact deadlines and ways of informing the family, but also refining the concept of “ethical“ according to the Codex in part of the organ and tissue donation and removal from the deceased person.

North Korea's hegemonic rule and its collapse

ABSTRACTIdeological leadership through the Party was at the core of the North Korean leaders’ hegemonic rule over the people, which resulted in the great popularity of Kim Il-sung. Marketisation in the wake of the economic crisis, however, significantly impaired the mechanism for rule by consent, especially by triggering the influx of outside information and undermining the Party's ideological education activities. The economic crisis led the state to adjust the mechanism of consent and coercion in such a way that the state's control over society could be restored by relying more on rule by force, which was demonstrated by the much stricter penal system, bloody purges and, most of all, military-first politics. This, nonetheless, was a temporary measure because, in Guha's terms, ‘dominance without hegemony’ would not be durable in the long term. The regime can sustain itself in the long-term only through the reinstatement of the consent mechanism, which disintegrated owing to the marketisation. However, as the marketisation, being beneficial to those who have power as well as ordinary people, is irreversible in North Korea today, the reestablishment of hegemonic rule would not be attainable.

Biospecimen Complexity-the Next Challenge for Cancer Research Biobanks?

Purpose: Biospecimens (e.g., tissues, bloods, fluids) are critical for translational cancer research to generate the necessary knowledge to guide implementation of precision medicine. Rising demand and the need for higher quality biospecimens are already evident.Experimental Design: The recent increase in requirement for biospecimen complexity in terms of linked biospecimen types, multiple preservation formats, and longitudinal data was explored by assessing trends in cancer research publications from 2000 to 2014.Results: A PubMed search shows that there has been an increase in both raw numbers and the relative proportion (adjusted for total numbers of articles in each period) of the subgroups of articles typically associated with the use of biospecimens and both dense treatment and/or outcomes data and multiple biospecimen formats.Conclusions: Increasing biospecimen complexity is a largely unrecognized and new pressure on cancer research biobanks. New approaches to cancer biospecimen resources are needed such as the implementation of more efficient and dynamic consent mechanisms, stronger participant involvement in biobank governance, development of requirements for registration of collections, and models to establish stock targets for biobanks. In particular, the latter two approaches would enable funders to establish a better balance between biospecimen supply and research demand, reduce expenditure on duplicate collections, and encourage increased efficiency of biobanks to respond to the research need for more complex cases. This in turn would also enable biobanks to focus more on quality and standardization that are surely factors in the even more important arena of research reproducibility. Clin Cancer Res; 23(4); 894-8. ©2016 AACR.

Abstract 70: Importance of Both Self-consent and Proxy- consent Enrollments to Avoid Bias in Acute Stroke Randomized Trials

Background: Informed consent options for acute stroke randomized trials include self-consent from patients with retained competency, proxy consent from a legally authorized representative (LAR), and exception from informed consent in emergency circumstances (EFIC). Mechanisms other than self-consent trespass upon the ethical principle of autonomy (respect for persons), and should be used only if self-consent alone would bias the patient population. Methods: We analyzed acute stroke patients enrolled within 2h of symptom onset in the NIH Phase 3 Field Administration of Stroke Therapy - Magnesium (FAST-MAG) trial, comparing entry characteristics and outcomes with different consent mechanisms. Results: Among 1700 patients, median time from onset to study entry was 45 min (IQR 35-62). Overall, 60% of patients were competent and provided self-consent, 39% noncompetent and enrolled by proxy consent from an on-scene LAR, and 1% noncompetent enrolled using EFIC/delayed consent. Compared to self-consented patients, proxy-consented patients were: older, 73.8 vs 66.5, p<0.001; more often female, 47% vs 40%, p<0.02; and a higher frequency of several vascular risk factors, including hypertension, 81% vs 76%, p<0.05, diabetes, 26% vs20%, p<0.01, atrial fibrillation, 29% vs 17%, p<0.001, and coronary artery disease, 24% vs 19%, p<0.01. Proxy consent patients had more severe initial stroke deficits, prehospital LAMS, 4.1 vs 3.5, p<0.001. Proxy consent patients with acute cerebral ischemia had more advanced initial ischemic stroke lesions, ASPECTS 8.3 vs 9.3, p<0.001, and received tPA more often, 35% vs 20%, p<0.001. Proxy consent patients with intracerebral hemorrhage patient had larger initial hemorrhage volume (cc), 42.2 vs 22.6, p<0.001. Proxy consent patients had worse final outcomes, with freedom from disability (mRS 0-1) at 90d, 23.6% vs 44.3%, p<0.001. Conclusions: Proxy-informed consent patients differ systematically from self-consent patients, with older age, more comorbidities, more severe deficits, and worse long term outcomes. To ensure that acute stroke trial cohorts are representative of the general stroke population, it is important that enrollment mechanisms include proxy and/or deferred consent.

The Adoption of Cloud Computing in the Field of Genomics Research: The Influence of Ethical and Legal Issues.

This study aims to understand the influence of the ethical and legal issues on cloud computing adoption in the field of genomics research. To do so, we adapted Diffusion of Innovation (DoI) theory to enable understanding of how key stakeholders manage the various ethical and legal issues they encounter when adopting cloud computing. Twenty semi-structured interviews were conducted with genomics researchers, patient advocates and cloud service providers. Thematic analysis generated five major themes: 1) Getting comfortable with cloud computing; 2) Weighing the advantages and the risks of cloud computing; 3) Reconciling cloud computing with data privacy; 4) Maintaining trust and 5) Anticipating the cloud by creating the conditions for cloud adoption. Our analysis highlights the tendency among genomics researchers to gradually adopt cloud technology. Efforts made by cloud service providers to promote cloud computing adoption are confronted by researchers’ perpetual cost and security concerns, along with a lack of familiarity with the technology. Further underlying those fears are researchers’ legal responsibility with respect to the data that is stored on the cloud. Alternative consent mechanisms aimed at increasing patients’ control over the use of their data also provide a means to circumvent various institutional and jurisdictional hurdles that restrict access by creating siloed databases. However, the risk of creating new, cloud-based silos may run counter to the goal in genomics research to increase data sharing on a global scale.

Informed consent utilizing satellite imagery in forestry carbon trading with North Korea

Informed consent can assist in mitigating investment risks associated with forestry carbon trading in North Korea by supporting corporate responsibility. Scientific developments for collecting information necessary to informed consent far outpace the development of inter-Korean regulatory frameworks. This paper seeks to identify how the intersection of legal and technological disciplines can foster informed consent, through the responsible application of satellite data. The permanent record of standard satellite remote-sensing systems demonstrates its capability of presenting area-wide visual evidence of forest conditions. Such data are essential to initiating informed consent, establishing a carbon stock baseline, detecting and quantifying rates of land-cover change, and quantifying above-ground biomass stocks as specified in the Kyoto Protocol. This research could be a valuable reference for utilizing the capabilities of satellites with informed consent obligations in North Korea by suggesting the provision of realistic informed consent mechanisms.

Social Annotation Valence: The Impact on Online Informed Consent Beliefs and Behavior.

BackgroundSocial media, mobile and wearable technology, and connected devices have significantly expanded the opportunities for conducting biomedical research online. Electronic consent to collecting such data, however, poses new challenges when contrasted to traditional consent processes. It reduces the participant-researcher dialogue but provides an opportunity for the consent deliberation process to move from solitary to social settings. In this research, we propose that social annotations, embedded in the consent form, can help prospective participants deliberate on the research and the organization behind it in ways that traditional consent forms cannot. Furthermore, we examine the role of the comments’ valence on prospective participants’ beliefs and behavior.ObjectiveThis study focuses specifically on the influence of annotations’ valence on participants’ perceptions and behaviors surrounding online consent for biomedical research. We hope to shed light on how social annotation can be incorporated into digitally mediated consent forms responsibly and effectively.MethodsIn this controlled between-subjects experiment, participants were presented with an online consent form for a personal genomics study that contained social annotations embedded in its margins. Individuals were randomly assigned to view the consent form with positive-, negative-, or mixed-valence comments beside the text of the consent form. We compared participants’ perceptions of being informed and having understood the material, their trust in the organization seeking the consent, and their actual consent across conditions.ResultsWe find that comment valence has a marginally significant main effect on participants’ perception of being informed (F2=2.40, P=.07); specifically, participants in the positive condition (mean 4.17, SD 0.94) felt less informed than those in the mixed condition (mean 4.50, SD 0.69, P=.09). Comment valence also had a marginal main effect on the extent to which participants reported trusting the organization (F2=2.566, P=.08). Participants in the negative condition (mean 3.59, SD 1.14) were marginally less trusting than participants exposed to the positive condition (mean 4.02, SD 0.90, P=.06). Finally, we found that consent rate did not differ across comment valence conditions; however, participants who spent less time studying the consent form were more likely to consent when they were exposed to positive-valence comments.ConclusionsThis work explores the effects of adding a computer-mediated social dimension, which inherently contains human emotions and opinions, to the consent deliberation process. We proposed that augmenting the consent deliberation process to incorporate multiple voices can enable individuals to capitalize on the knowledge of others, which brings to light questions, problems, and concerns they may not have considered on their own. We found that consent forms containing positive valence annotations are likely to lead participants to feel less informed and simultaneously more trusting of the organization seeking consent. In certain cases where participants spent little time considering the content of the consent form, participants exposed to positive valence annotations were even more likely to consent to the study. We suggest that these findings represent important considerations for the design of future electronic informed consent mechanisms.

The Right to Try and the Future of the FDA in the Age of Personalized Medicine

Do citizens have the right to determine their own courses of treatment and to use medicines and devices that they think could improve their health? And, to the extent regulators seek to restrict that freedom, what is the practicality and cost of doing so? These questions animate the debate over the so-called “right to try,” a growing movement to allow terminally ill individuals to experiment with alternative medical treatments, therapies, and devices that are tightly controlled by the Food and Drug Administration (FDA). This essay argues that such an expansion of the right-to-try notion may be happening already as technological innovation decentralizes and democratizes medical decisions. This expansion does not mean that all FDA regulation will fade away, but it will necessitate a move away from the agency’s command-and-control methods of the past and toward a new focus on patient empowerment through enhanced choice, improved risk education, and clearer consent mechanisms.

Control and Consent Mechanisms in Work Organizations: The Case of Call Centers in Turkey

Control and Consent Mechanisms in Work Organizations: The Case of Call Centers in Turkey

Privacy and Security within Biobanking: The Role of Information Technology.

Along with technical issues, biobanking frequently raises important privacy and security issues that must be resolved as biobanks continue to grow in scale and scope. Consent mechanisms currently in use range from fine-grained to very broad, and in some cases participants are offered very few privacy protections. However, developments in information technology are bringing improvements. New programs and systems are being developed to allow researchers to conduct analyses without distributing the data itself offsite, either by allowing the investigator to communicate with a central computer, or by having each site participate in meta-analysis that results in a shared statistic or final significance result. The implementation of security protocols into the research biobanking setting requires three key elements: authentication, authorization, and auditing. Authentication is the process of making sure individuals are who they claim to be, frequently through the use of a password, a key fob, or a physical (i.e., retinal or fingerprint) scan. Authorization involves ensuring that every individual who attempts an action has permission to do that action. Finally, auditing allows for actions to be logged so that inappropriate or unethical actions can later be traced back to their source.

Big Data in medical research and EU data protection law: challenges to the consent or anonymise approach.

Medical research is increasingly becoming data-intensive; sensitive data are being re-used, linked and analysed on an unprecedented scale. The current EU data protection law reform has led to an intense debate about its potential effect on this processing of data in medical research. To contribute to this evolving debate, this paper reviews how the dominant 'consent or anonymise approach' is challenged in a data-intensive medical research context, and discusses possible ways forwards within the EU legal framework on data protection. A large part of the debate in literature focuses on the acceptability of adapting consent or anonymisation mechanisms to overcome the challenges within these approaches. We however believe that the search for ways forward within the consent or anonymise paradigm will become increasingly difficult. Therefore, we underline the necessity of an appropriate research exemption from consent for the use of sensitive personal data in medical research to take account of all legitimate interests. The appropriate conditions of such a research exemption are however subject to debate, and we expect that there will be minimal harmonisation of these conditions in the forthcoming EU Data Protection Regulation. Further deliberation is required to determine when a shift away from consent as a legal basis is necessary and proportional in a data-intensive medical research context, and what safeguards should be put in place when such a research exemption from consent is provided.

Patient and physician views about protocolized dialysis treatment in randomized trials and clinical care

ABSTRACTBackground: Pragmatic trials comparing standard-of-care interventions may improve the quality of care for future patients, but raise ethical questions about limitations on decisional autonomy. We sought to understand how patients and physicians view and respond to these questions in the contexts of pragmatic trials and of usual clinical care. Methods: We conducted scenario-based, semistructured interviews with 32 patients with end-stage renal disease (ESRD) receiving maintenance hemodialysis in outpatient dialysis units and with 24 nephrologists. Each participant was presented with two hypothetical scenarios in which a protocolized approach to hemodialysis treatment time was adopted for the entire dialysis unit as part of a clinical trial or a new clinical practice. Results: A modified grounded theory analysis revealed three major themes: (1) the value of research, (2) the effect of protocolized care on patient and physician autonomy, and (3) information exchange between patients and physicians, including the mechanism of consent. Most patients and physicians were willing to relinquish decisional autonomy and were more willing to relinquish autonomy for research purposes than in clinical care. Patients' concerns toward clinical trials were tempered by their desires for certainty for a positive outcome and for physician validation. Patients tended to believe that being informed about research was more important than the actual mechanism of consent, and most were content with being able to opt out from participating. Conclusions: This qualitative study suggests the general acceptability of a pragmatic clinical trial comparing standard-of-care interventions that limits decisional autonomy for nephrologists and patients receiving hemodialysis. Future studies are needed to determine whether similar findings would emerge among other patients and providers considering other standard-of-care trials.

A systematic literature review on security and privacy of electronic health record systems: technical perspectives.

Even though many safeguards and policies for electronic health record (EHR) security have been implemented, barriers to the privacy and security protection of EHR systems persist. This article presents the results of a systematic literature review regarding frequently adopted security and privacy technical features of EHR systems. Our inclusion criteria were full articles that dealt with the security and privacy of technical implementations of EHR systems published in English in peer-reviewed journals and conference proceedings between 1998 and 2013; 55 selected studies were reviewed in detail. We analysed the review results using two International Organization for Standardization (ISO) standards (29100 and 27002) in order to consolidate the study findings. Using this process, we identified 13 features that are essential to security and privacy in EHRs. These included system and application access control, compliance with security requirements, interoperability, integration and sharing, consent and choice mechanism, policies and regulation, applicability and scalability and cryptography techniques. This review highlights the importance of technical features, including mandated access control policies and consent mechanisms, to provide patients' consent, scalability through proper architecture and frameworks, and interoperability of health information systems, to EHR security and privacy requirements.

Controlling Your Online Profile: Reality or an Illusion? A Research into Informed Consent as a Mechanism to Regulate Commercial Profiling

Informational privacy is the right of an individual to determine for himself what information to share with which person. For informational privacy to be adequate protected individuals should have sufficient possibilities to give or withhold free, specific and informed consent to the proposed use. Informed consent is the mechanism for consent on the Internet. Controllers are obliged to provide the data subject with information, which are usually presented in privacy policies or terms and conditions. Based on this information the data subject consents to the proposed use. Consent is usually an action, which signifies acceptance of the terms and conditions. The European Commission has proposed a massive reform of the current data protection law. The proposed Data Protection Regulation (hereafter: Regulation) aims at enhancing the mechanism of informed consent, by increasing and clarifying the obligations of controllers and strengthening the rights of data subjects. Internet companies, such as Google and Facebook, use informed consent to establish profiles about their users and subsequently earn money of these profiles. However, several risks are connected to profiling, relating to inter alia discrimination, stereotyping and stigmatisation. In addition, profiles may not correspond with reality if they are based on flawed information. This might result in incorrect decisions being taken. Moreover, profiling results in privacy risks as data subjects are becoming increasingly transparent to companies. This thesis aims to research whether informed consent, as proposed in the Regulation, is a suitable mechanism for data subjects to effectively regulate the use of their data by companies for profiling purposes. It is argued that informed consent is a mechanism that works in theory only. Control over personal data would be feasible in practice if Internet companies would uphold the rules and if these companies are sufficiently monitored. However, processing activities are often difficult to understand because of their complex and obscure nature. This makes supervision complicated and almost impossible. In addition, data subjects are uninterested and often unaware of what they are consenting to. In addition, these data subjects are seldom aware that they are a product and represent a certain economic value. Moreover, data subjects lack market options. Leaving cyberspace and stop using the Internet completely is hardly an option nowadays. Furthermore, personal data are permanently collected and continuously processed for never-ending purposes. However, by upholding the purpose limitation principle society is unable to truly benefiting from Big Data. Services, such as Google Street View, would not be possible. Therefore, informed consent does not allow data subjects to effectively regulate the use of their information, nor is the mechanism likely to resolve the risks related to profiling. Therefore, I urge the Union legislators to seriously look for alternatives for informed consent, as I fear this mechanism will become completely meaningless. Several recommendations and alternatives are put forward to solve the informed consent problem. Informational norms might be created or the accountability of Internet companies could be increased. These options should be further researched.