Dynamic consent

Last updated

Dynamic consent is an approach to informed consent that enables on-going engagement and communication between individuals and the users and custodians of their data. It is designed to address the many issues that are raised by the use of digital technologies in research and clinical care that enable the wide-scale use, linkage, analysis and integration of diverse datasets and the use of AI and big data analyses. These issues include how to obtain informed consent in a rapidly-changing environment; growing expectations that people should know how their data is being used; increased legal and regulatory requirements for the management of secondary use of data in biobanks and other medical research infrastructure. The concept has been developed in 2007 by an Italian group [1] who introduced the concept of an ongoing process between researcher and participant where "technology now allows the establishment of dynamic participant–researcher partnerships." Dynamic Consent therefore describes a personalised, digital interface that enables two-way communication between participants and researchers [2] and is a practical example of how software can be developed to give research participants greater understanding and control over how their data is used. [3] It also enables clinical trial managers, researchers and clinicians to know what type of consent is attached to the use of data they hold and to have an easy way to seek a new consent if the use of the data changes. It is able to support greater accountability and transparency, streamlining consent processes to enable compliance with regulatory requirements.

Contents

Background

Researchers are required to obtain informed consent from potential participants before any research begins – this is a fundamental principle of medical research as laid out in the Declaration of Helsinki. Traditionally this has been done through a paper consent form which is accompanied by a subject information sheet that describes the risks and benefits of being involved in the research. Increasingly, this also outlines how an individual's data will be protected and their privacy maintained. This constitutes a formal agreement that specifies how a research participant’s data will be used in that particular study. Participants should be informed about the purpose(s) for which their data will (or may) be used; where it will be stored; the expected retention time; if any other parties are involved; the amount and the sensitivity of the information exchanged; whether the data will be shared onward to yet other parties; whether the consent to use these data can be revoked. Consent to data processing is also a requirement of data protection and privacy laws in most countries. Traditionally, participants have obtained details of how their data will be used from patient information sheets and face-to-face interactions with researchers or healthcare staff.

However, now both medical research and data processing are changing through developments in information communication technology, especially the internet with examples including genetic databases and registries, electronic health records, biobanks, and online digital services and databases. More and more data is being collected online and being stored in large data sets with the intention for them to be used by many researchers, research groups and institutions for a variety of purposes. These include different research projects, as well as public health assessments, marketing, and the design of algorithms and data mining.

The collection and use of data in this way raises some challenges. Firstly with regard to privacy: can participants' data and identity truly be anonymised and sensitive data be kept safe and confidential? Individuals, in general, are not aware of how their personal information is used, for what purpose and which parties have a copy. They are not usually given the opportunity to declare their specific consents and privacy-related personal data management preferences. Secondly, with regard to consent: informed consent requires a person to know in advance what they are agreeing to and what the likely risks and benefits of agreeing will be. But with these large, linked data sets, it is often not clear at the time someone is asked to consent how their data will be used in the future.

This is known as a broad consent or a blanket consent. Blanket consent means that a person effectively agrees to permit any and all uses of their data once it is provided. Broad consent is more common and involves agreeing to a broad set of potential future uses under a particular governance framework. Broad consent has become the standard practice in many genetic registries and biobanks. [4] Its legal and ethical adequacy has been questioned. [5] In addition, consent is still frequently done as a one-off procedure with a paper form for participants to sign. These forms are often lost or filed away, and over time people forget what they have consented to and why.

Operation

Dynamic consent is a personalised digital interface to facilitate participant engagement in clinical and research activities over time. It seeks to address some of the issues raised by the traditional, paper-based, static consent approach, where consent must be obtained for all future activities in a face to face interview. Dynamic consent operates through a secure IT interface for consent and communication that enables participants to view a digital record of their consent decisions, subsequent to their initial agreement. Some versions of dynamic consent also have the functionality for people to personalise according to their preferences, which can be changed at any time. [6]

Further, dynamic consent aims to put people in control of their data and how it is used, reflecting patient-centric initiatives happening elsewhere in medical research. [7] Through the tool, participants can consent to new projects or change their consent choices; they can complete surveys and receive information about research findings. Preferences are linked with a participant's samples and data and so if these are shared, so too are the individual's preferences. It enables people to give a range of different kinds of consent, for example, a broad consent to low-risk epidemiological research or an explicit consent to a new, high-risk proposal. This flexibility is enabled by the digital interface where preferences can be changed in line with new situations.

Dynamic consent may facilitate recruitment in research, as information is provided to potential participants in a user-friendly and standardised way across research sites and irrespective of the participants' geographical location. [8] [9] Dynamic consent enables two-way, ongoing communication between researchers and research participants. For instance, research participants are able to upload additional health data, or researchers may inform participants about new research opportunities or findings. Such ongoing interface may increase the participants' understanding of research and positively impact retention rates. [10] [11] Dynamic consent may be useful in supporting Indigenous data sovereignty and supporting culturally-acceptable data governance in health research involving Indigenous people and communities. [12]

This digital interface is dynamic because individuals can:

First Genetic Trust

In 2001 First Genetic Trust (FGT) put forward the idea that they act as a 'broker' of genetic information. They would be a third party between people taking part in research that involved their genetic data and those carrying out the research. FGT recommended a method that would protect 'the confidentiality of individual medical and genetic information, allowing access to select information and the use or application of an individual's DNA only when the patient has given specific consent.' [14] This system has characteristics of dynamic consent before the term was coined. [15]

EnCoRe

The EnCoRe project – Ensuring Consent and Revocation – began in 2008 and ran until 2012. [16] It was funded by the Engineering and Physical Sciences Research Council (EPSRC), the Economic and Social Research Council (ESRC) and the UK government's Technology Strategy Board. Institutional partners for the project were Hewlett-Packard (and specifically the Hewlett-Packard Systems Security Lab in Bristol), the Warwick Manufacturing Group at the University of Warwick, QinetiQ, HW Communications, HeLEX from the University of Oxford and the London School of Economics.

The project's aim was to give individuals more control over any personal data they disclose to organisations, with an overall vision to make giving and revoking consent as reliable and easy as turning a tap on and off. This was an attempt to tackle the lack of any legal requirement for organisations to obtain consent before using personal data about individuals. EnCoRe aimed to enable people to determine what their information is used for, who it is shared with and for how long and where it is stored.

Three case studies were carried out as part of the EnCore project, each with different requirements for consent and revocation. A technical architecture was produced for each scenario, setting out all the functions needed for the management (including capture and revocation) and enforcement of individuals' consents. The three reports are publicly available online. [17]

It was in the EnCoRe project that the term 'dynamic consent' was coined by Professor Jane Kaye's team at the University of Oxford and become one of the outputs of the EnCoRe project. It is now used to describe this new way of obtaining consent.

InBank

Over time, the focus of dynamic consent has shifted from simply enabling participants to change their consent preferences to incorporating it as part of a larger apparatus that facilitates communication between participants and researchers or health professionals. The InBank team at the University of Manchester looked at dynamic consent as a way of collecting and sharing electronic health records. The work was UK-focused, considering dynamic consent in the context of the NHS and positioning it as a device to increase or restore public trust. The public scandal over the care.data initiative was positioned as evidence of a deficit in trust, and equally that it showed a lack of transparent and accountable governance of people's personal medical records in the UK. [18] [19]

RUDY

RUDY is a study of rare diseases led by researchers at the University of Oxford. [20] RUDY is an internet-based platform that enables registration and capture of patient reported outcome measures (PROMs) and events to be done online within a dynamic consent framework. [21]

CHRIS

The CHRIS (Cooperative Health Research in South Tyrol) Study is a prospective epidemiological study investigating chronic conditions, particularly cardiovascular, metabolic, neurological and psychiatric diseases and was the first study to implement dynamic consent in biobanking. [22] It describes itself as 'a true partnership between the people participating, the staff working in the healthcare system and the research personnel'. [23] The study is designed to be longitudinal so a dynamic consent process was set up which enables participants to receive ongoing information about the project as well as an interactive consent webpage with dynamic options. [24]

PEER

In the US, the Platform for Engaging Everyone Responsibly (PEER) has been set up by non-profit health advocacy organisation Genetic Alliance and software company Private Access. Not only can participants choose to consent to only some aspects of research and not to others, but they can also specify preferences for types of data access by third parties and consent to other activities that are offered, such as the use of their biological samples after death. [25]

CTRL

In Australia, the Australian Genomic Health Alliance (Australian Genomics) has developed and is trialling a dynamic consent platform called 'CTRL' for people participating in genomic research.

Some empirical studies that were carried out before dynamic consent was developed concluded that it is unnecessary, that people are happy to give broad or 'one-off' consent for some kinds of research. For example, a face-to face interview study of 1001 Scottish adults as part of the prospective Scottish Family Health Study genetic database carried out in 2009 found that respondents preferred 'scenarios where consent is only asked for at the start of the study' over options to renew consent every 5 or 10 years. [26]

Similarly, a survey of US adults published in 2010, reported a preference for a broad, 'one off' consent at the time of donation to a biobank over giving specific consent for each new study. [27] A meta-analysis of the qualitative sociological literature on public and patient attitudes to biobanking published 2002-9 reached a similar conclusion: 'few people demanded recurrent, project-specific consent and few wished to place limits on the uses to which their tissue could be put'. [28] However, these studies did not present dynamic consent to their respondents as an alternative to a broad consent.

There have been some criticism of dynamic consent by a Norwegian team of researchers, who argued that dynamic consent would be an unwanted burden on participants and a waste of time for researchers. 'In a dynamic consent model, participants will be asked for consent continuously, simply because each new project is a new project. Thus, they will be asked to re-consent both for trivial and essential reasons, and often the former'. [29] However, this opinion was based on an erroneous understanding of dynamic consent as requiring consent for each new study, rather being able to be tailored to the needs and ethical requirements of a particular study.

Steinsbekk et al. in their publication criticising dynamic consent also argued that rather than increasing the number of people taking part in research, dynamic consent may have the opposite effect. 'Being confronted with the detailed complexity of biomedical research, and being asked again and again for an 'opinion' (a consent), it is likely that at least some people will struggle with feelings of falling short – that their own competence or knowledge do not suffice. This could easily be interpreted as a 'lack of respect' for the passive participant, and result in lower participation as people would rather choose to stay away from such studies than face shortcomings.' [29]

Researchers raise concerns about the impact of consent withdrawal (more easily facilitated by dynamic consent) on the integrity of their research data sets. There are also questions about the equity impacts of a dynamic consent approach, including fears that the 'digital divide' may impede its utility for some participants. [30] One paper has looked at the potential use of a dynamic consent approach in relation to legacy collections of human tissue and data from Australian Aboriginal and Torres Strait Islander peoples, [12] noting that access to the internet and suitable technology may be a challenge in remote communities. The increasing need for a consent mechanism that can accommodate family [31] or other group-based decision making instead of or in addition to individual consent presents another avenue for development of dynamic consent. [12] [32]

Rebuttals

There are a number of important limitations to consider when evaluating the results of studies of consent practices. In many cases, while a statistically significant preference for one form of consent over another can be found, this is not necessarily indicative of a clear majority preference. For example, Haddow et al., 2011, characterised their reported consent preferences as 'not strong'. Another study reported that while 58% of respondents described re-consent as 'a waste of time', 51% also felt that being asked for it was an indication that they were 'respected and involved' participants in research. [33]

In the case of prospective public attitude surveys on biobanking, of which there are many in the existing literature, Johnsson et al., 2010, found that reported willingness to share data and tissue for research was prone to both overestimating and underestimating recorded participation levels in different cases, leading to questions about the usefulness of this type of research in making predictions of future behaviours. [34]

Researchers have proposed an evaluation and reporting framework for dynamic consent in order to support and structure future assessment of the effects of the approach. [35] Australian Genomics is evaluating the effects of its 'CTRL' platform compared with standard consent processes. [36] A 10 year evaluation of the concept by Mascalzoni et al. [37] found that even though a low change rate was reported in the baseline, participants valued the possibility of changing their informed consent choices.

Related Research Articles

<span class="mw-page-title-main">Informed consent</span> Process for obtaining subject approval prior to treatment or research

Informed consent is a principle in medical ethics and medical law and media studies, that a patient must have sufficient information and understanding before making decisions about their medical care. Pertinent information may include risks and benefits of treatments, alternative treatments, the patient's role in treatment, and their right to refuse treatment. In most systems, healthcare providers have a legal and ethical responsibility to ensure that a patient's consent is informed. This principle applies more broadly than healthcare intervention, for example to conduct research and to disclose a person's medical information.

<span class="mw-page-title-main">Clinical trial</span> Phase of clinical research in medicine

Clinical trials are prospective biomedical or behavioral research studies on human participants designed to answer specific questions about biomedical or behavioral interventions, including new treatments and known interventions that warrant further study and comparison. Clinical trials generate data on dosage, safety and efficacy. They are conducted only after they have received health authority/ethics committee approval in the country where approval of the therapy is sought. These authorities are responsible for vetting the risk/benefit ratio of the trial—their approval does not mean the therapy is 'safe' or effective, only that the trial may be conducted.

<span class="mw-page-title-main">UK Biobank</span> Long-term biobank study of 500,000 people

UK Biobank is a large long-term biobank study in the United Kingdom (UK) which is investigating the respective contributions of genetic predisposition and environmental exposure to the development of disease. It began in 2006.

Genetic discrimination occurs when people treat others differently because they have or are perceived to have a gene mutation(s) that causes or increases the risk of an inherited disorder. It may also refer to any and all discrimination based on the genotype of a person rather than their individual merits, including that related to race, although the latter would be more appropriately included under racial discrimination. Some legal scholars have argued for a more precise and broader definition of genetic discrimination: "Genetic discrimination should be defined as when an individual is subjected to negative treatment, not as a result of the individual's physical manifestation of disease or disability, but solely because of the individual's genetic composition." Genetic Discrimination is considered to have its foundations in genetic determinism and genetic essentialism, and is based on the concept of genism, i.e. distinctive human characteristics and capacities are determined by genes.

<span class="mw-page-title-main">Genetic Alliance</span>

Genetic Alliance is a nonprofit organization, founded in 1986 by Joan O. Weiss, working with Victor A. McKusick, to advocate for health benefits in the accelerating field of genomic research. This organization is a network of over 1,000 disease advocacy organizations, universities, government organizations, private companies, and public policy organizations. They aim to advance genetic research agendas toward health benefit by engaging a broad range of stakeholders, including healthcare providers, researchers, industry professionals, public policy leaders, as well as individuals, families and communities. They create programs using a collaborative approach, and aim to increase efficiency and reduce obstacles in genetic research, while ensuring that voices from the involved disease communities are heard. They also promote public policies to advance healthcare. Genetic Alliance provides technical support and informational resources to guide disease-specific advocacy organizations in being their own research advocates. They also maintain a biobank as a central storage facility for several organizations who otherwise would not have the infrastructure to maintain their own repository.

<span class="mw-page-title-main">Biobank</span> Repository of biological samples used for research

A biobank is a type of biorepository that stores biological samples for use in research. Biobanks have become an important resource in medical research, supporting many types of contemporary research like genomics and personalized medicine.

A Tumor Bank, A Tumor Bank is sometimes also referred to as a Tissue Bank, since normal tissues for research are also often collected. However, this function is distinct from a Tissue Bank which collects and harvests human cadaver tissue for medical research and education, and banks which store Biomedical tissue for organ transplantation.

Generation Scotland is a biobank, a resource of biological samples and information on health and lifestyle from thousands of volunteer donors in Scotland.

Shared decision-making in medicine (SDM) is a process in which both the patient and physician contribute to the medical decision-making process and agree on treatment decisions. Health care providers explain treatments and alternatives to patients and help them choose the treatment option that best aligns with their preferences as well as their unique cultural and personal beliefs.

DECIPHER is a web-based resource and database of genomic variation data from analysis of patient DNA. It documents submicroscopic chromosome abnormalities and pathogenic sequence variants, from over 25000 patients and maps them to the human genome using Ensembl or UCSC Genome Browser. In addition it catalogues the clinical characteristics from each patient and maintains a database of microdeletion/duplication syndromes, together with links to relevant scientific reports and support groups.

Biobank ethics refers to the ethics pertaining to all aspects of biobanks. The issues examined in the field of biobank ethics are special cases of clinical research ethics.

Return of results is a concept in research ethics which describes the extent of the duty of a researcher to reveal and explain the results of research to a research participant.

Privacy for research participants is a concept in research ethics which states that a person in human subject research has a right to privacy when participating in research. Some typical scenarios this would apply to include, or example, a surveyor doing social research conducts an interview with a participant, or a medical researcher in a clinical trial asks for a blood sample from a participant to see if there is a relationship between something which can be measured in blood and a person's health. In both cases, the ideal outcome is that any participant can join the study and neither the researcher nor the study design nor the publication of the study results would ever identify any participant in the study. Thus, the privacy rights of these individuals can be preserved.

Clinical research ethics are the set of relevant ethics considered in the conduct of a clinical trial in the field of clinical research. It borrows from the broader fields of research ethics and medical ethics.

CARTaGENE is a population based cohort based on an ongoing and long-term health study of 40, 000 men and women in Québec. It is a regional cohort member of the Canadian Partnership for Tomorrow's Health (CanPath). The project's core mandate is to identify the genetic and environmental causes of common chronic diseases affecting the Québec population. The overall objective from a public health perspective is to develop personalized medicine and public policy initiatives targeting high-risk groups. CARTaGENE is under the scientific direction of Sébastien Jacquemont, M.D., Ekaterini Kritikou, Ph.D. and Philippe Broët, M.D. Ph.D., of the Sainte-Justine Children's Hospital University Health Center. Based in Montréal Québec, Canada, CARTaGENE is operated under the infrastructure of the Sainte-Justine Children's Hospital University Health Center and has seen funding from Genome Canada, the Canadian Foundation for Innovation and Génome Québec and the Canadian Partnership Against Cancer (CPAC) since 2007 among other sources. The program was initially founded by Professors Claude Laberge and Bartha Knoppers, and developed through two phases of participant recruitment under the direction of Professor Philip Awadalla as Scientific Director of the cohort from 2009 to 2015, who is now the National Scientific Director of the Canadian Partnership for Tomorrow's Health (CanPath).

<span class="mw-page-title-main">Andrew Kasarskis</span> American biologist

Andrew Kasarskis is an American biologist. He is the Chief Data Officer (CDO) at Sema4. He was previously CDO and an Executive Vice President (EVP) at the Mount Sinai Health System in New York City and, before that, vice chair of the Department of Genetics and Genomic Sciences and Co-director of the Icahn Institute for Genomics and Multiscale Biology at the Icahn School of Medicine at Mount Sinai. Kasarskis is known for taking a network-based approach to biology and for directing the first medical school class offering students the opportunity to fully sequence and analyze their own genomes.

Genetic privacy involves the concept of personal privacy concerning the storing, repurposing, provision to third parties, and displaying of information pertaining to one's genetic information. This concept also encompasses privacy regarding the ability to identify specific individuals by their genetic sequence, and the potential to gain information on specific characteristics about that person via portions of their genetic information, such as their propensity for specific diseases or their immediate or distant ancestry.

DNA encryption is the process of hiding or perplexing genetic information by a computational method in order to improve genetic privacy in DNA sequencing processes. The human genome is complex and long, but it is very possible to interpret important, and identifying, information from smaller variabilities, rather than reading the entire genome. A whole human genome is a string of 3.2 billion base paired nucleotides, the building blocks of life, but between individuals the genetic variation differs only by 0.5%, an important 0.5% that accounts for all of human diversity, the pathology of different diseases, and ancestral story. Emerging strategies incorporate different methods, such as randomization algorithms and cryptographic approaches, to de-identify the genetic sequence from the individual, and fundamentally, isolate only the necessary information while protecting the rest of the genome from unnecessary inquiry. The priority now is to ascertain which methods are robust, and how policy should ensure the ongoing protection of genetic privacy.

References

  1. ↑ Mascalzoni, D; Hicks, Andrew; Pramstaller, P; Wjst, M (2007). "Informed consent in the genomics era". PLOS Med. 5 (9): 141–6. doi: 10.1371/journal.pmed.0050192 . PMC   2535658 . PMID   18798689.
  2. ↑ Kaye, J; Whitley, EA; Lund, D; Morrison, M; Teare, H; Melham, K (2015). "Dynamic consent: a patient interface for twenty-first century research networks". Eur. J. Hum. Genet. 23 (2): 141–6. doi:10.1038/ejhg.2014.71. PMC   4130658 . PMID   24801761.
  3. ↑ Wee, Richman; Henaghan, Mark; Winship, Ingrid (December 2013). "Dynamic consent in the digital age of biology: online initiatives and regulatory considerations". Journal of Primary Health Care. 5 (4): 341–347. doi: 10.1071/HC13341 . PMID   24294625.
  4. ↑ "WMA - The World Medical Association-WMA Declaration of Taipei on Ethical Considerations regarding Health Databases and Biobanks". www.wma.net. Retrieved 2017-12-13.
  5. ↑ Timothy Caulfield; Jane Kaye (2009-09-01). "Broad Consent in Biobanking: Reflections on Seemingly Insurmountable Dilemmas". Medical Law International. 10 (2): 85–100. doi:10.1177/096853320901000201. ISSN   0968-5332. S2CID   143779293.
  6. ↑ "Platform for Engaging Everyone Responsibly". Genetic Alliance. Retrieved 17 January 2017.
  7. ↑ Dwamena, Francesca; Holmes-Rovner, Margaret; Gaulden, Carolyn M; Jorgenson, Sarah; Sadigh, Gelareh; Sikorskii, Alla; Lewin, Simon; Smith, Robert C; Coffey, John (2012-12-12). "Interventions for providers to promote a patient-centred approach in clinical consultations". Cochrane Database of Systematic Reviews. 2013 (12): CD003267. doi:10.1002/14651858.cd003267.pub2. ISSN   1465-1858. PMC   9947219 . PMID   23235595.
  8. ↑ Budin-Ljøsne, I; et al. (25 Jan 2017). "Dynamic Consent: a potential solution to some of the challenges of modern biomedical research". BMC Medical Ethics. 18 (18(1):4): 4. doi: 10.1186/s12910-016-0162-9 . PMC   5264333 . PMID   28122615.
  9. ↑ Pang, Patrick Cheong-Iao; Chang, Shanton; Verspoor, Karin; Clavisi, Ornella (2018-10-30). "The Use of Web-Based Technologies in Health Research Participation: Qualitative Study of Consumer and Researcher Experiences". Journal of Medical Internet Research. 20 (10): e12094. doi: 10.2196/12094 . ISSN   1438-8871. PMC   6234342 . PMID   30377139.
  10. ↑ Budin-Ljøsne, Isabelle; Teare, Harriet J. A.; Kaye, Jane; Beck, Stephan; Bentzen, Heidi Beate; Caenazzo, Luciana; Collett, Clive; D’Abramo, Flavio; Felzmann, Heike (2017-01-25). "Dynamic Consent: a potential solution to some of the challenges of modern biomedical research". BMC Medical Ethics. 18 (1): 4. doi: 10.1186/s12910-016-0162-9 . ISSN   1472-6939. PMC   5264333 . PMID   28122615.
  11. ↑ Pang, Patrick Cheong-Iao; Chang, Shanton; Verspoor, Karin; Clavisi, Ornella (2018-10-30). "The Use of Web-Based Technologies in Health Research Participation: Qualitative Study of Consumer and Researcher Experiences". Journal of Medical Internet Research. 20 (10): e12094. doi: 10.2196/12094 . ISSN   1438-8871. PMC   6234342 . PMID   30377139.
  12. 1 2 3 Prictor, Megan; Huebner, Sharon; Teare, Harriet J.A.; Burchill, Luke; Kaye, Jane (2020-03-01). "Australian Aboriginal and Torres Strait Islander Collections of Genetic Heritage: The Legal, Ethical and Practical Considerations of a Dynamic Consent Approach to Decision Making". The Journal of Law, Medicine & Ethics. 48 (1): 205–217. doi:10.1177/1073110520917012. hdl: 11343/240286 . ISSN   1073-1105. PMID   32342777. S2CID   216594887.
  13. ↑ Teare, HJA; Morrison, M; Whitley, EA; Kaye, J (2015). Towards 'Engagement 2.0': Insights from a study of dynamic consent with biobank participants. Digital Health 0(0): 1-13. doi:10.1177/2055207615605644 Archived 2016-11-17 at the Wayback Machine
  14. ↑ "First Genetic Trust selects HP as technology partner". Hewlett Packard (HP) Co. Newsroom. 11 February 2002. Retrieved 14 September 2012.
  15. ↑ Wee, Richman (September 2013). "Dynamic consent in the digital age of biology". Journal of Primary Health Care. 5 (3): 259–261. doi: 10.1071/HC13259 . PMID   23998180.
  16. ↑ "Welcome to the EnCoRe project website!". EnCoRe. Retrieved 23 January 2017.
  17. ↑ "Public deliverables, papers and other publications". EnCoRe. Retrieved 23 January 2017.
  18. ↑ Williams, Hawys; Spencer, Karen; Sanders, Caroline; Lund, David; Whitley, Edgar; Kaye, Jane; Dixon, William (2015). "Viewpoint. Dynamic Consent: A Possible Solution to Improve Patient Confidence and Trust in How Electronic Patient Records Are Used in Medical Research". JMIR Medical Informatics. 3 (1): e3. doi: 10.2196/medinform.3525 . PMC   4319083 . PMID   25586934.
  19. ↑ Dixon, William; Spencer, Karen; Williams, Hawys; Sanders, Caroline; Lund, David; Whitley, Edgar; Kaye, Jane (2014). "A dynamic model of patient consent to sharing of medical record data". BMJ. 348: 348. doi:10.1136/bmj.g1294. PMID   24500352. S2CID   40824611.
  20. ↑ Teare, Harriet J. A.; Hogg, Joanna; Kaye, Jane; Luqmani, Raashid; Rush, Elaine; Turner, Alison; Watts, Laura; Williams, Melanie; Javaid, M. Kassim (2017-04-26). "The RUDY study: using digital technologies to enable a research partnership". European Journal of Human Genetics. 25 (7): 816–822. doi:10.1038/ejhg.2017.57. PMC   5520069 . PMID   28443622.
  21. ↑ Javaid, MK; Forestier-Zhang, L; Watts, L; Turner, A; Ponte, C; Teare, H; Gray, D; Gray, N; Popert, R; Hogg, J; Barrett, J; Pinedo-Villanueva, R; Cooper, C; Eastell, R; Bishop, N; Luqmani, R; Wordsworth, P; Kaye, J (2016). "The RUDY study platform – a novel approach to patient driven research in rare musculoskeletal diseases". Orphanet Journal of Rare Diseases. 11 (1): 150. doi: 10.1186/s13023-016-0528-6 . PMC   5101709 . PMID   27825362.
  22. ↑ Piciocchi, Cinzia; Ducato, Rossana; Martinelli, Lucia; Perra, Silvia; Tomasi, Marta; Zuddas, Carla; Mascalzoni, Deborah (2017-09-18). "Legal issues in governing genetic biobanks: the Italian framework as a case study for the implications for citizen's health through public-private initiatives". Journal of Community Genetics. 9 (2): 177–190. doi:10.1007/s12687-017-0328-2. ISSN   1868-310X. PMC   5849700 . PMID   28921376.
  23. ↑ "The CHRIS Study". The CHRIS Study. Retrieved 30 November 2016.
  24. ↑ Pattaro, Cristian; Gogele, Martin; Mascalzoni, Deborah; Melotti, Roberto; Schwienbacher, Christine; De Grandi, Alessandro; Foco, Luisa; D'Elia, Yuri; Linder, Barbara; Fuchsberger, Christian; Minelli, Cosetta; Egger, Clemens; Kofink, Lisa; Zanigni, Stefano; Schafer, Torsten; Facheris, Maurizio; Smárason, Sigurður; Rossini, Alessandra; Hicks, Andrew; Weiss, Helmuth; Pramstaller, Peter (2015). "The Cooperative Health Research in South Tyrol (CHRIS) study: rationale, objectives, and preliminary results". Journal of Translational Medicine. 13: 348. doi: 10.1186/s12967-015-0704-9 . PMC   4635524 . PMID   26541195.
  25. ↑ "Platform for Engaging Everyone Responsibly". Genetic Alliance. Retrieved 30 November 2016.
  26. ↑ Haddow, Gill; Cunningham-Burley, Sarah; Murray, Lorraine (April 2010). "Can the governance of a population genetic data bank effect recruitment? Evidence from the public consultation of Generation Scotland". Public Understanding of Science. 20 (117): 117–129. doi:10.1177/0963662510361655. S2CID   146354210.
  27. ↑ Simon, Christian; L'Heureux, Jamie; Murray, Jeffrey; Winokur, Patricia; Weiner, George; Newbury, Elizabeth; Shinkunas, Laura; Zimmerman, Bridget (2011). "Active choice but not too active: Public perspectives on biobank consent models". Genetics in Medicine. 13 (9): 821–831. doi:10.1097/GIM.0b013e31821d2f88. PMC   3658114 . PMID   21555942.
  28. ↑ Lipworth, Wendy; Forsyth, Rowena; Kerridge, Ian (2011). "Tissue donation to biobanks: a review of sociological studies". Sociology of Health and Illness. 33 (5): 792–811. doi:10.1111/j.1467-9566.2011.01342.x. hdl: 2123/11613 . PMID   21592141.
  29. 1 2 Kristin Solum, Steinsbekk; Myskja, Bjørn Ka°re; Solberg, Berge (2013). "Broad consent versus dynamic consent in biobank research: Is passive participation an ethical problem?". European Journal of Human Genetics. 21 (9): 897–902. doi:10.1038/ejhg.2012.282. PMC   3746258 . PMID   23299918.
  30. ↑ Prictor, Megan; Teare, Harriet J. A.; Kaye, Jane (2018). "Equitable Participation in Biobanks: The Risks and Benefits of a "Dynamic Consent" Approach". Frontiers in Public Health. 6: 253. doi: 10.3389/fpubh.2018.00253 . ISSN   2296-2565. PMC   6133951 . PMID   30234093.
  31. ↑ Minari, Jusaku; Teare, Harriet; Mitchell, Colin; Kaye, Jane; Kato, Kazuto (2014-12-17). "The emerging need for family-centric initiatives for obtaining consent in personal genome research". Genome Medicine. 6 (12): 118. doi: 10.1186/s13073-014-0118-y . ISSN   1756-994X. PMC   4295276 . PMID   25593596.
  32. ↑ Dankar, Fida K.; Gergely, Marton; Malin, Bradley; Badji, Radja; Dankar, Samar K.; Shuaib, Khaled (2020-01-01). "Dynamic-informed consent: A potential solution for ethical dilemmas in population sequencing initiatives". Computational and Structural Biotechnology Journal. 18: 913–921. doi: 10.1016/j.csbj.2020.03.027 . ISSN   2001-0370. PMC   7182686 . PMID   32346464.
  33. ↑ Master, Zubin; Claudio, Jaime; Rachul, Christen; Jean, Wang; Minden, Mark; Caulfield, Timothy (2013). "Cancer patient perceptions on the ethical and legal issues related to biobanking". BMC Medical Genomics. 6 (8): 8. doi: 10.1186/1755-8794-6-8 . PMC   3599691 . PMID   23497701.
  34. ↑ Johnsson, Linus; Helgesson, Gert; Rafnar, Thorunn; Halldorsdottir, Ingibjorg; Chia, Kee-Seng; Eriksson, Stefan; Hansson, Mats G (2010). "Hypothetical and factual willingness to participate in biobank research". European Journal of Human Genetics. 18 (11): 1261–4. doi:10.1038/ejhg.2010.106. PMC   2987483 . PMID   20648060.
  35. ↑ Prictor, Megan; Lewis, Megan A.; Newson, Ainsley J.; Haas, Matilda; Baba, Sachiko; Kim, Hannah; Kokado, Minori; Minari, Jusaku; Molnár-Gábor, Fruzsina; Yamamoto, Beverley; Kaye, Jane (2019-11-15). "Dynamic Consent: An Evaluation and Reporting Framework". Journal of Empirical Research on Human Research Ethics. 15 (3): 175–186. doi:10.1177/1556264619887073. hdl: 11343/240287 . ISSN   1556-2654. PMID   31729900. S2CID   208037438.
  36. ↑ "CTRL - Australian Genomics" . Retrieved 2020-05-18.
  37. ↑ Mascalzoni, D; Patarro, C; Pramstaller, PP; Gögele, M; De Grandi, A; Biasiotto, R (2022). "Ten years of dynamic consent in the CHRIS study: informed consent as a dynamic process". Eur. J. Hum. Genet. 30 (12): 1391–1397. doi:10.1038/s41431-022-01160-4. PMC   4130658 . PMID   36064788.
This page is based on this Wikipedia article
Text is available under the CC BY-SA 4.0 license; additional terms may apply.
Images, videos and audio are available under their respective licenses.