Broad consent for biobanks is best – provided it is also deep

Abstract Background As biobank research has become increasingly widespread within biomedical research, study-specific consent to each study, a model derived from research involving traditional interventions on human subjects, has for the sake of feasibility gradually given way to alternative consent models which do not require consent for every new study. Besides broad consent these models include tiered, dynamic, and meta-consent. However, critics have pointed out that it is normally not known at the time of enrolment in what ways samples deposited in a biobank may be used in future research and that, for a consent to be informed, exactly this kind of knowledge is required. Therefore, there is an ongoing debate about the ethical acceptability of going for less than study-specific consent. Main text In light of this debate we address the question of how to best protect participants against relevant risks and violations of autonomy. We apply the central aims of the informed consent process to the unique circumstances of biobank research where samples and data in many cases are stored for long periods of time and reused in subsequent studies. Thereby we are able to formulate a set of criteria focusing both on the risk of informational harm and the potential violation of participants’ values. We compare existing models of consent based on their ability to satisfy the criteria, and we find that the broad consent model offers the best level of protection for participants, although, it suffers from a few important deficiencies with regards to protection against participant value violations and long-term protection of autonomy, if it is applied without qualifications. For this reason, we propose modifications to the current broad consent model, in order to ensure that it provides protection of autonomy and participant values through strong ethical review and continuous communication. Conclusion We conclude that a modified form of broad consent is ethically superior in biobank research, not only because it is most feasible but primarily because it offers the best available protection against the hazards facing research subjects in this form of research.

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Effects of alcohol on food and energy intake in human subjects: evidence for passive and active over-consumption of energy

British Journal Of Nutrition ◽

10.1079/bjn20041139 ◽

2004 ◽

Vol 92 (S1) ◽

pp. S31-S34 ◽

Cited By ~ 58

Author(s):

Martin R. Yeomans

Keyword(s):

Energy Intake ◽

Time Course ◽

Human Subjects ◽

Pharmacological Action ◽

Future Research ◽

Appetite Control ◽

Short Term ◽

Term Energy ◽

Appetite Stimulation

The effects of alcohol on food and energy intake in human subjects have been the subject of a number of controlled studies recently. Unlike the evidence for other macronutrients, there is minimal evidence for any compensatory reduction in food intake in response to energy ingested as alcohol. In contrast, all studies testing intake within 1 h of preload ingestion report a higher intake of food following alcohol relative to energy-matched controls, although this short-term stimulatory effect is not evident if the test meal is delayed beyond 1 h. This time-course suggests that short-term stimulation of appetite may be mediated by the pharmacological action of alcohol on the appetite control system, either through enhanced orosensory reward or impaired satiety. In the long term, energy ingested as alcohol is additive to energy from other sources, suggesting that moderate alcohol consumption results in long-term passive over-consumption alongside short-term active over-consumption of energy through appetite stimulation. Despite the consistency of enhanced energy intake after moderate alcohol, evidence of an association between alcohol in the diet and obesity remains contentious, although the most recent results suggest that alcohol intake correlates with BMI. Future research needs to address this issue and clarify the mechanisms underlying appetite stimulation by alcohol.

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Review of Legal Instruments and Codes on Medical Experimentation with Children

Cambridge Quarterly of Healthcare Ethics ◽

10.1017/s0963180100005442 ◽

1994 ◽

Vol 3 (4) ◽

pp. 560-573 ◽

Cited By ~ 2

Author(s):

Sujit Choudhry

Keyword(s):

Medical Research ◽

Scientific Knowledge ◽

Research Subjects ◽

Ongoing Debate ◽

Medical Experimentation ◽

Research With Children ◽

Child Research ◽

The Subject ◽

Long Term Consequences

Medical research with children has been the subject of ongoing debate. The reason for controversy is clear. As with research on adults, one must strike a balance between two goals – promoting the health of children through advances in scientific knowledge and protecting child research subjects from exploitation and harm. However, because of their age and relative immaturity, children cannot protect their own interests as well as adult subjects can. Yet as they progress toward adulthood, increasing care must be taken to involve children in decisions that affect them, even to the extent of allowing them to make choices that may have serious and long-term consequences.

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Broad donor consent for human biobanks in Germany and Europe: a strategy to facilitate cross-border sharing and exchange of human biological materials and related data

Journal of Laboratory Medicine ◽

10.1515/labmed-2017-0064 ◽

2019 ◽

Vol 43 (6) ◽

pp. 291-299 ◽

Cited By ~ 1

Author(s):

Roland Jahns ◽

Jörg Geiger ◽

Irene Schlünder ◽

Daniel Strech ◽

Matthias Brumhard ◽

...

Keyword(s):

Biological Samples ◽

Biological Material ◽

Task Force ◽

Working Party ◽

Future Research ◽

Broad Consent ◽

Research Issues ◽

Related Data ◽

Cross Border

Abstract Background Human biobanks are generally recognized as essential resources for effective biomedical research. All over the world biosamples and data from human subjects are collected in large biobanks. The biological material is stored long term for current and future (undetermined) research issues, which often require cross-border exchange of biosamples and related data. Content Commonly, the informed consent for research on human biospecimen is intended to cover only defined, specific research objectives. In June 2016, the biobank Task-Force of the Working Party of the German Medical Ethics Committees (WP-GMEC) updated its template for the broad use of human biological samples and related data. It complies with the current Organisation for Economic Co-operation and Development (OECD) and World Medical Association (WMA) recommendations and furnishes a framework that permits long-term storage and multi-purpose research use of human biological material and related data, including cross-border research. However, both (i) human biobanks storing and (ii) research projects requesting “broad consent” biological samples generally require an ethical approval; in addition, “broad consent” conditions should be reciprocated by making biobank processes transparent and by fostering both donor and public involvement. Outlook The broad consent template of the WP-GMEC clearly states that biological samples and data donated for medical research serve to address current and future research questions. It appears perfectly suited as a template for a Europe-wide harmonized broad consent facilitating biobank-based cross-border research.

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The biobank consent debate: why ‘meta-consent’ is still the solution!

Journal of Medical Ethics ◽

10.1136/medethics-2018-105258 ◽

2019 ◽

Vol 45 (5) ◽

pp. 295-297 ◽

Cited By ~ 6

Author(s):

Thomas Ploug ◽

Soren Holm

Keyword(s):

Informed Consent ◽

Medical Ethics ◽

The ‘Expiry Problem’ of broad consent for biobank research - And why a meta consent model solves it

Journal of Medical Ethics ◽

10.1136/medethics-2020-106117 ◽

2020 ◽

Vol 46 (9) ◽

pp. 629-631 ◽

Cited By ~ 3

Author(s):

Thomas Ploug ◽

Søren Holm

Keyword(s):

Significant Problem ◽

Governance Structures ◽

Broad Consent ◽

Biobank Research ◽

The Cost ◽

Changes Over Time ◽

Meta Consent ◽

Over Time

In this response to Neil Manson’s latest intervention in our debate about the best consent model for biobank research we show, contra Manson that the ‘expiry problem’ that affects broad consent models because of changes over time in methods, purposes, types of data used and governance structures is a real and significant problem. We further show that our preferred implementation of meta consent as a national consent platform solves this problem and is not subject to the cost and burden objections that Manson raises.

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Epistemic Strategies in Ethical Review: REB Members’ Experiences of Assessing Probable Impacts of Research for Human Subjects

Journal of Empirical Research on Human Research Ethics ◽

10.1177/1556264619872369 ◽

2019 ◽

Vol 15 (5) ◽

pp. 383-395

Author(s):

Susan M. Cox ◽

Michael McDonald ◽

Anne Townsend

Keyword(s):

Human Subjects ◽

Research Participation ◽

Ethical Review ◽

Evidence Based ◽

Ethical Standards ◽

Research Subjects ◽

Indirect Contact ◽

Research Ethics Boards ◽

Epistemic Strategies ◽

Depth Interviews

Research ethics boards (REBs) are charged with applying ethical standards to protect the rights and interests of research subjects. Little, however, is known about how REB members perceive probable impacts of research participation for subjects. Drawing on in-depth interviews with 40 Canadian REB members, we identify three frequently reported epistemic strategies, including reliance on a local REB culture or ethos, use of resident authorities, and protective imagination. Far less commonly described strategies included direct or indirect contact with research subjects. REB members also reflected upon significant gaps in their knowledge and thus the importance of knowing what we don’t know. Recommendations arising from this support an evidence-based practice for ethics review involving clear epistemic standards for REBs learning about subjects’ experiences.

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Ethical review of biobank research: Should RECs review each release of material from biobanks operating under an already-approved broad consent and data protection model?

European Journal of Medical Genetics ◽

10.1016/j.ejmg.2015.09.008 ◽

2015 ◽

Vol 58 (10) ◽

pp. 545-549 ◽

Cited By ~ 7

Author(s):

Daniel Strech

Keyword(s):

Data Protection ◽

Ethical Review ◽

Broad Consent ◽

Biobank Research

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STUDI STRATEGI PENANGANAN PINJAMAN/PEMBIAYAAN KSP/KSPPS DI ERA PANDEMI COVID-19 DI DAERAH ISTIMEWA YOGYAKARTA

Kajian Bisnis STIE Widya Wiwaha ◽

10.32477/jkb.v29i2.272 ◽

2021 ◽

Vol 29 (2) ◽

pp. 39-56

Author(s):

Suhartono Suhartono ◽

Achmad Tjahjono

Keyword(s):

Social Media ◽

Descriptive Study ◽

Research Area ◽

Future Research ◽

Research Subjects ◽

Short Term ◽

Online Systems ◽

Qualitative Descriptive ◽

Collection Methods

The objectives of this study are: Mapping short-term and long-term strategies for Koperasi Simpan Pinjam (KSP) and or Koperasi Simpan Pinjam Syari’ah (KSPPS) in handling loans in the Covid-19 pandemic era and mapping KSP/KSPPS strategies in handling non-performing loans. in the era of the covid-19 pandemic. This research is a qualitative descriptive study. The data collected is in the form of data on the handling of loans/financing carried out by KSP and KSPPS. Data collection methods used are documentation, questionnaires and interviews. Documents in the form of RAT reports for 2020 and 2021, questionnaires and interviews were conducted online using google forms and chat, with the research subjects being KSP and KSPPS managers throughout DIY. The results of the study indicate that there are 5 (five) short-term strategies and 4 (four) long-term strategies that need to be implemented, while there are 3 (three) strategies that need to be implemented in handling non-performing loans. The limitation of this study is that in digging up data, it only uses Google Forms which are distributed to several social media groups as well as individual KSP/KSPPS managers and also interviews with online systems so that the sample cannot be large. Meanwhile, recommendations that can be given for future research are that more research samples can be added, and the research area can be expanded.

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Physical and Psychological Benefits of Written Emotional Expression

European Psychologist ◽

10.1027/1016-9040/a000231 ◽

2015 ◽

Vol 20 (4) ◽

pp. 242-251 ◽

Cited By ~ 3

Author(s):

Éva Kállay

Keyword(s):

Mental Health ◽

Expressive Writing ◽

Mental Health Problems ◽

Cost Effective ◽

Health Problems ◽

Future Research ◽

Psychological Benefits ◽

Cost Effective Treatment ◽

Meta Analyses

Abstract. The last several decades have witnessed a substantial increase in the number of individuals suffering from both diagnosable and subsyndromal mental health problems. Consequently, the development of cost-effective treatment methods, accessible to large populations suffering from different forms of mental health problems, became imperative. A very promising intervention is the method of expressive writing (EW), which may be used in both clinically diagnosable cases and subthreshold symptomatology. This method, in which people express their feelings and thoughts related to stressful situations in writing, has been found to improve participants’ long-term psychological, physiological, behavioral, and social functioning. Based on a thorough analysis and synthesis of the published literature (also including most recent meta-analyses), the present paper presents the expressive writing method, its short- and long-term, intra-and interpersonal effects, different situations and conditions in which it has been proven to be effective, the most important mechanisms implied in the process of recovery, advantages, disadvantages, and possible pitfalls of the method, as well as variants of the original technique and future research directions.

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Using the Change4Life Disney Branded 10-minute Shake Ups During the COVID-19 ‘Lockdown’

10.31219/osf.io/q8jz4 ◽

2020 ◽

Author(s):

Emily Budzynski-Seymour ◽

James Steele ◽

Michelle Jones

Keyword(s):

Perceived Exertion ◽

Affective Responses ◽

Online Resources ◽

Future Research ◽

Affective States ◽

Perceived Effort ◽

Qualitative Feedback ◽

Bidirectional Relationship ◽

The Uk

Physical activity (PA) is considered essential to overall health yet it is consistently reported that children are failing to meet the recommended levels. Due to the bidirectional relationship between affective states and PA, affective responses are a potential predictor to long term engagement. Since late March 2020 the UK government enforced ‘lockdown’ measures to help control the spread of Coronavirus (COVID-19); however, this has impacted children’s PA. Using online resources at home to support PA is now common. The primary aim of this research was to investigate the use of the Change4Life 10-minute Shake Ups to support PA by examining the effects of Disney branding upon children’s (n=32) post activity affective responses and perceived exertion. The secondary was to investigate the effect of the lockdown on PA habits. Children had similar positive affective responses and perceived effort to activities; however, branding was considered to be a key contributing factor based upon qualitative feedback from parents. Children’s PA levels dropped slightly since ‘lockdown’ was imposed; though online resources have been utilised to support PA. The use of immersive elements such as characters and narrative in PA sessions, as well as utilising online resources during ‘lockdown’ appear potentially promising for future research.

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