How to Elucidate Consent-Free Research Use of Medical Data: A Case for "Health Data Literacy".

The extensive utilization of personal health data is one of the key success factors of modern medical research. Obtaining consent to the use of such data during clinical care, however, bears the risk of low and unequal approval rates and risk of consequent methodological problems in the scientific use of the data. In view of these shortcomings, and of the proven willingness of people to contribute to medical research by sharing personal health data, the paradigm of informed consent needs to be reconsidered.

Attitude towards consent-free research use of personal medical data in the general German population.

Background: The design of appropriate consent procedures for the secondary use of personal health data is a key concern of current medical research. In Germany, the concept of 'data donation' has recently come into focus, defined as a legal entitlement to the research use of personal medical data without prior consent, combined with an easy-to-exercise right of the data subjects to opt-out.

Methods: Standardized online interviews of 3,013 individuals, representative of the German online population, were conducted in August 2022 to determine their attitude towards data donation for medical research.

Population-Based Biobanking.

Population-based biobanking is an essential element of medical research that has grown substantially over the last two decades, and many countries are currently pursuing large national biobanking initiatives. The rise of individual biobanks is paralleled by various networking activities in the field at both the national and international level, such as BBMRI-ERIC in the EU. A significant contribution to population-based biobanking comes from large cohort studies and national repositories, including the United Kingdom Biobank (UKBB), the CONSTANCES project in France, the German National Cohort (NAKO), LifeLines in the Netherlands, FinnGen in Finland, and the All of Us project in the U.

Secondary use of health care data and left-over biosamples within the 'Medical Informatics Initiative' (MII): a quasi-randomized controlled evaluation of patient perceptions and preferences regarding the consent process.

Background: Data collected during routine health care and ensuing analytical results bear the potential to provide valuable information to improve the overall health care of patients. However, little is known about how patients prefer to be informed about the possible usage of their routine data and/or biosamples for research purposes before reaching a consent decision. Specifically, we investigated the setting, the timing and the responsible staff for the information and consent process.

Secondary research use of personal medical data: patient attitudes towards data donation.

Background: The SARS-CoV-2 pandemic has highlighted once more the great need for comprehensive access to, and uncomplicated use of, pre-existing patient data for medical research. Enabling secondary research-use of patient-data is a prerequisite for the efficient and sustainable promotion of translation and personalisation in medicine, and for the advancement of public-health. However, balancing the legitimate interests of scientists in broad and unrestricted data-access and the demand for individual autonomy, privacy and social justice is a great challenge for patient-based medical research.

Consent to research participation: understanding and motivation among German pupils.

Background: The EU's 2006 Paediatric Regulation aims to support authorisation of medicine for children, thus effectively increasing paediatric research. It is ethically imperative to simultaneously establish procedures that protect children's rights.

Method: This study endeavours (a) to evaluate whether a template consent form designed by the Standing Working Group of the German-Research-Ethics-Committees (AKEK) adequately informs adolescents about research participation, and (b) to investigate associated phenomena like therapeutic misconception and motives for research participation.

Secondary research use of personal medical data: attitudes from patient and population surveys in The Netherlands and Germany.

Making routine clinical-care-data available for medical research requires adequate consent to legitimize use and exchange. While, public interest in supporting medical research is increasing, individuals often find it difficult to actively enable researchers to access their data. In addition to broad consent, the idea of (consent-free) data donation has been brought into play as another way to legitimize secondary research use of medial data.

Linking pre-existing biorepositories for medical research: the PopGen 2.0 Network.

The significance of human biorepositories for modern medical research, particularly for comprehensive population-based genetic analyses, is constantly growing. While large and centralized institutions are usually considered best suited to meet the increasing demand for high-quality "biobanks," most medical research institutions still host rather heterogeneous and fragmented biobanking activities, undertaken by clinical departments with oftentimes rather different scientific scope. Undoubtedly, most clinicians and medical researchers would appreciate infrastructural support in terms of the storage and handling of their biosamples, but they are also likely to expect access to their samples avoiding extensive formal requirements.

Patient views on research use of clinical data without consent: Legal, but also acceptable?

The research exemption implemented in the new EU General Data Protection Regulation (EU-GDPR) gives member states leeway in determining whether patient consent is required for secondary data use in medical research. However, even though broad consent has become common in data-rich medical research in many EU countries, giving up consent altogether is likely to be controversial. The aim of this study was to examine whether abolishing consent for secondary data use would be acceptable to patients.

Broad consent for health care-embedded biobanking: understanding and reasons to donate in a large patient sample.

PurposeTo facilitate ethically acceptable and practically successful health care-embedded biobanking, the attitudes and understanding of patients and their motivation to participate need to be explored.MethodsA questionnaire study was conducted among 760 outpatients of a northern German university hospital to assess their awareness of, and motivation for giving broad consent to health care-embedded biobanking, also addressing the issue of feedback on individual-level research findings.ResultsThe overall willingness to give broad consent was high (86.