Health Research with Data in a Time of Privacy: Which Information do Patients Want?

When hospitals ask broad consent for the secondary use of patient data for scientific research, it is unknown for which studies the data will be used. We investigated what patients at a cancer hospital consider to be an adequate level and most suitable method of information provision using questionnaires (n = 71) and interviews (n = 24). A part of the respondents indicated that they would feel sufficiently informed by either being notified about potential further use, or by receiving a general brochure before being asked for consent. Others stated that additional information would be interesting and appreciated. Yet, when discussing required resources needed to provide additional information, interviewees lowered the bar of what they considered minimally required, voicing the importance of spending resources on research.

FAIR Genomes metadata schema promoting Next Generation Sequencing data reuse in Dutch healthcare and research.

The genomes of thousands of individuals are profiled within Dutch healthcare and research each year. However, this valuable genomic data, associated clinical data and consent are captured in different ways and stored across many systems and organizations. This makes it difficult to discover rare disease patients, reuse data for personalized medicine and establish research cohorts based on specific parameters. FAIR Genomes aims to enable NGS data reuse by developing metadata standards for the data descriptions needed to FAIRify genomic data while also addressing ELSI issues. We developed a semantic schema of essential data elements harmonized with international FAIR initiatives. The FAIR Genomes schema v1.1 contains 110 elements in 9 modules. It reuses common ontologies such as NCIT, DUO and EDAM, only introducing new terms when necessary. The schema is represented by a YAML file that can be transformed into templates for data entry software (EDC) and programmatic interfaces (JSON, RDF) to ease genomic data sharing in research and healthcare. The schema, documentation and MOLGENIS reference implementation are available at https://fairgenomes.org .

Barriers and Facilitators for Implementing a National Guideline to Foster the Responsible Use of Residual Biospecimens and Data in Health Research.

Residual biospecimens that are stored in hospitals' diagnostic specimen archives can be used for scientific research under strict legal and ethical regulations. In the Netherlands, a Code of Conduct governs responsible secondary use of residual biospecimens. However, implementation of this Code seems to be challenging. This study aims to explore the most important factors that facilitate or hinder the implementation of the Code. In addition, it investigates what is needed to further foster the responsible use of residual biospecimens. A mixed-methods design was used. Questionnaires were sent out to pathologists, patient information centers, physicians, researchers, data protection officers (DPOs), members of research ethics committees, and members of the boards of directors of all hospitals in the Netherlands (81 hospitals). To further investigate the barriers and facilitators, interviews were conducted with pathologists, patient information centers, physician-researchers, DPOs, review boards, research coordinators, and quality managers of pathology departments. In total, 246 respondents filled out the questionnaire and 36 interviews were conducted. Major barriers for implementing were a lack of resources (time, money), a lack of attention for responsible use, and a lack of practical knowledge (knowing what to do, where to go with questions). In contrast, the perception that implementing the Code was necessary, either by the respondent or by colleagues, was considered "a driver" for implementation. Practical instruments such as checklists and roadmaps were considered necessary to foster implementation; however, the creation of such instruments was hindered by a lack of clear-cut answers regarding legal aspects. Therefore, more clarity and harmonization on how to interpret both the Code and legislation regarding secondary use were considered necessary.

Recall and Retention of Consent Procedure Contents and Decisions: Results of a Randomized Controlled Trial.

BACKGROUND: Residual tissue samples, i.e., samples excised for diagnosis or during treatment, are commonly used for medical research. In the Netherlands, they can be used provided the patient did not opt out of this use. Previous research has shown that recall of the informed consent procedure for tissue use is poor. Here, we investigate recall of three consent procedures: informed consent, opt-out, and opt-out plus (an opt-out procedure with an information procedure similar to that of informed consent). METHODS: Patients (n = 1,319) with a variety of diseases were randomized into three trial arms: informed consent, opt-out plus, and opt-out. Questionnaires were administered 6 weeks and 6 months after randomization. RESULTS: Six hundred and seventy-three and 553 patients returned the 6-week and 6-month questionnaire, respectively. In the informed consent arm, recall of having received a brochure (55.3%) or oral information (69.4%) was similar to that in the opt-out plus arm (48.5 and 71.6%, respectively), at the 6-week assessment. Significantly more respondents in the informed consent and the opt-out plus arms versus the opt-out arm recalled that they had been informed about being able to control tissue use and which consent procedure they had experienced (6-week questionnaire range 53.2-75.8 vs. 13.9-16.1%; 6-month questionnaire range 43.5-84.2 vs. 3.2-35.4%). There were no significant differences between the informed consent and opt-out plus arms in this regard. CONCLUSIONS: Recall of the consent procedure was similar in opt-out plus and informed consent procedures. Overall, recall was moderate, indicating that there is room for improvement in the quality of information provision.

Patients' Attitudes Towards the Return of Incidental Findings After Research with Residual Tissue: A Mixed Methods Study.

AIMS: To investigate the attitudes of patients toward the return of individual research results from scientific research with residual tissue. METHODS AND FINDINGS: We recruited 1319 patients from 6 Dutch hospitals. In total, 673 patients (51% response rate) completed the questionnaire and 146 were interviewed. Based on the questionnaire data, the majority of respondents (92%) wanted to be informed of incidental findings about both a curable (92%) and an incurable (76%) disease. Respondents' wishes to be informed about incidental findings did not vary significantly as a function of patient demographics or type of disease. The interview data show that respondents wished to be informed about incidental findings because they considered it to be normal practice; they expected the information to be of benefit for their health. Information should be provided by their physician. Yet, most respondents (84%) would consent to research even if they would not be informed about incidental findings, primarily because they recognized that there might be practical problems in providing such information, and because they valued scientific research highly. CONCLUSIONS: We conclude that, while the majority of patients want to be informed about incidental findings, they also recognize that this may be difficult.

Exceptions to the rule of informed consent for research with an intervention.

BACKGROUND: In specific situations it may be necessary to make an exception to the general rule of informed consent for scientific research with an intervention. Earlier reviews only described subsets of arguments for exceptions to waive consent. METHODS: Here, we provide a more extensive literature review of possible exceptions to the rule of informed consent and the accompanying arguments based on literature from 1997 onwards, using both Pubmed and PsycINFO in our search strategy. RESULTS: We identified three main categories of arguments for the acceptability of a consent waiver: data validity and quality, major practical problems, and distress or confusion of participants. Approval by a medical ethical review board always needs to be obtained. Further, we provide examples of specific conditions under which consent waiving might be allowed, such as additional privacy protection measures. CONCLUSIONS: The reasons legitimized by the authors of the papers in this overview can be used by researchers to form their own opinion about requesting an exception to the rule of informed consent for their own study. Importantly, rules and guidelines applicable in their country, institute and research field should be followed. Moreover, researchers should also take the conditions under which they feel an exception is legitimized under consideration. After discussions with relevant stakeholders, a formal request should be sent to an IRB.

Altruistic punishment and between-group competition : evidence from n-person prisoner's dilemmas.

Collective action, or the large-scale cooperation in the pursuit of public goods, has been suggested to have evolved through cultural group selection. Previous research suggests that the costly punishment of group members who do not contribute to public goods plays an important role in the resolution of collective action dilemmas. If large-scale cooperation sustained by the punishment of defectors has evolved through the mechanism of cultural group selection, two implications regarding costly punishment follow: (1) that people are more willing to punish defecting group members in a situation of intergroup competition than in a single-group social dilemma game and (2) that levels of "perverse" punishment of cooperators are not affected by intergroup competition. We find confirmation for these hypotheses. However, we find that the effect of intergroup competition on the punishment of defectors is fully explained by the stronger conditionality of punishment on expected punishment levels in the competition condition.

[Consent for the secondary use of human residual tissue: the patient is best served by an 'opting-out' procedure]. / Zeggenschap over nader gebruik van lichaamsmateriaal. Patiënt is het best gediend met 'geen bezwaar'-procedure.

In medical scientific research much use is made of human bodily material (residual tissue) which remains after treatment or diagnosis. Using this, relevant research questions can be answered. The way in which patients can consent to the secondary use of residual tissue is now formalised in a code of conduct, which allows such use unless the patient has objected to this use ('opting-out' procedure). A law is being formulated which will probably require the explicit permission of the patient for secondary use of residual tissue. It is expected that this requirement will lead to a lesser and more selective availability of residual tissue for research. Requesting explicit permission also means additional health care work. Patients demonstrate a preference for the 'opting-out' procedure, on condition that they are well informed about the use of the residual tissue. It is concluded that the interests of the patient are best served by the 'opting-out' procedure, provided that patients are well informed.

Social learning of novel route preferences in adult humans.

Non-human animals can acquire novel route preferences by following knowledgeable individuals. Such socially learned route preferences can be stably maintained over multiple transmission episodes, sometimes forming long-lived traditions. In humans, preferences for familiar routes or heavily used worn trails over unfamiliar ones have been described in various contexts. However, social learning of route preferences has not been experimentally demonstrated in humans. Here, we demonstrate that social learning and tradition influence route choice. We led adult male and female participants into a room by one of two routes. Participants followed the demonstrated route choices, and later remembered and preferred this choice even when determinably suboptimal (i.e. longer and not preferred by control participants) or when the choice was indicated as arbitrary (the demonstrator took one route to retrieve a poster that had ostensibly fallen). Moreover, route preferences were stably maintained over multiple transmission episodes. We suggest that simple social learning processes, often neglected in human and primate research, can result in long-lived route preferences that may influence a range of additional behaviour patterns.