BackgroundIn 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.MethodsHere, 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.ResultsWe 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.ConclusionsThe 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.

BackgroundDespite much debate, there is little evidence on consequences of consent procedures for residual tissue use. Here, we investigated these consequences for the availability of residual tissue for medical research, clinical practice, and patient informedness.MethodsWe conducted a randomised clinical trial with three arms in six hospitals. Participants, patients from whom tissue had been removed for diagnosis or treatment, were randomised to one of three arms: informed consent, an opt-out procedure with active information provision (opt-out plus), and an opt-out procedure without active information provision. Participants received a questionnaire six weeks post-intervention; a subsample of respondents was interviewed. Health care providers completed a pre- and post-intervention questionnaire. We assessed percentage of residual tissue samples available for medical research, and patient and health care provider satisfaction and preference. Health care providers and outcome assessors could not be blinded.ResultsWe randomised 1,319 patients, 440 in the informed consent, 434 in the opt-out plus, and 445 in the opt-out arm; respectively 60.7%, 100%, and 99.8% of patients’ tissue samples could be used for medical research. Of the questionnaire respondents (N = 224, 207, and 214 in the informed consent, opt-out plus, and opt-out arms), 71%, 69%, and 31%, respectively, indicated being (very) well informed. By questionnaire, the majority (53%) indicated a preference for informed consent, whereas by interview, most indicated a preference for opt-out plus (37%). Health care providers (N = 35) were more likely to be (very) satisfied with opt-out plus than with informed consent (p = 0.002) or opt-out (p = 0.039); the majority (66%) preferred opt-out plus.ConclusionWe conclude that opt-out with information (opt-out plus) is the best choice to balance the consequences for medical research, patients, and clinical practice, and is therefore the most optimal consent procedure for residual tissue use in Dutch hospitals.Trial RegistrationDutch Trial Register NTR2982

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.

We conclude that, while the majority of patients want to be informed about incidental findings, they also recognize that this may be difficult.

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.

Health research with data and biosamples in a time of privacy: what information do patients want? 2 Background: Patients value transparency concerning the potential use of their clinical data and samples in research. However, it is usually impossible to indicate for which future studies they will be used. To ensure patients will receive the information that they need, and to safeguard the continuation of trust in research, it is essential to investigate what patients consider to be an adequate type and level of information and transparency.Methods: We used a mixed method design (questionnaires and interviews), investigating the preferred information level of cancer patients in a cancer hospital between January-March 2020.Results: Seventy-one radiotherapy patients filled out the questionnaire (response rate 62%), and 24 patients were interviewed. A part of the participants indicated that they would be sufficiently informed by either being notified that data could be used for research, or by receiving a general brochure before being asked for consent.However, a minority of patients also wanted to receive additional information later in time, outlining research that has been carried out. Others stated that more information (additional to general information) would be interesting, but not required in order to feel properly informed. When bringing up that increased specificity of information would also require increased resources, most patients lowered the bar of what they considered minimally required, voicing that it is more important that resources are spent on research. Patients considered data protection the most important topic to be informed about. Conclusion:Patients indicated they need general information about use of their data in research. Additional, detailed information about the research that is completed (provided afterwards) was not deemed necessary to feel properly informed, though appreciated.

No abstract

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.