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The Register of Innovative where can i buy ventolin over the counter usa Drugs is maintained pursuant to C.08.004.1 of the Food and Drug Regulations. The register indicates the drugs that are eligible for data protection. Under C.08.004.1 (3) a subsequent manufacturer that seeks a notice of compliance on the basis of a direct or indirect comparison between the new drug and an innovative drug may not file a submission before the end of a period of six years after the day on which the first notice of compliance was issued for the innovative new drug where can i buy ventolin over the counter usa. In addition, the notice of compliance cannot be issued before the end of a period of eight years after the day on which the first notice of compliance was issued to the innovator. The format of the Register of Innovative where can i buy ventolin over the counter usa Drugs is an electronic table, which is updated weekly.
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For comments or questions, please contact by hc.opml-bmbl.sc@canada.ca or by telephone at 613-941-7281.What is where can i buy ventolin over the counter usa the Notice of Compliance (NOC) Data Extract?. The data extract is a series of compressed ASCII text files of the database. The uncompressed size of the files is approximately 19.0 MB. In order to utilize the data, the file must be loaded into an existing database or information where can i buy ventolin over the counter usa system. The typical user is most likely a third party claims adjudicator, provincial formulary, insurance company, etc.
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D.C. Diagnosis is STATâs weekly newsletter about the politics and policy of health and medicine. Sign up here to receive it in your inbox.The FDAâs panel of outside treatment experts will meet Thursday to discuss approval standards for an eventual asthma treatment. These meetings are typically attended only by the nerdiest biotech investors and FDA lawyers, but this one is expected to attract so much attention that the FDA is setting up a Youtube stream for the event instead of its typical (often rage-inducing) internal streaming service.The meeting wonât discuss individual treatments.
Instead itâll be about the FDAâs approval standards, additional studies the FDA might require of treatment makers and what type of follow-up should be required to monitor the safety of any treatment thatâs either fully FDA approved or authorized for emergency use.advertisement A number of treatment makers, doctors groups, and advocates are already flooding the FDA with other suggested topics to discuss. They include:How drug makers should manage their ongoing studies in the event their treatment is granted emergency authorization. Pfizer, Johnson &. Johnson, the Biotechnology Innovation Organization and the Infectious Diseases Society of America all raised a version of this concern in their comments.
Their concerns seem to stem from a line in the FDAâs recent guidance that suggests the agency will require drug makers to continue to collect placebo-controlled data, even if their treatment is authorized for emergency use. The groups argue that in that scenario, drug makers would have an ethical obligation to tell their study participants whether they were receiving a placebo.How the FDA would decide to issue an emergency authorization for a select high-risk group, like health care workers. Johnson &. Johnson raised this question in their comments.Why isnât the FDA conducting inspections of treatment plants before authorizing a treatment?.
IDSA wants the answer to that question.Why hasnât Emily Miller been fired?. This one isnât your typical question for an expert panel, but thatâs the question posed by the activist coalition Treatment Action Group. ÂThe agency can restore public trust by improving transparency and communications, and by removing staff whoâve been involved in perpetrating political interference. Emily Miller, who was briefly and disastrously appointed FDA spokesperson and continues to post misinformation on asthma treatment therapeutics, should not be an agency employee,â the group wrote.STATâs Helen Branswell has more on the stakes of Thursdayâs meeting here.advertisement The fight between drug middlemen and pharmacists heats upSTAT loves drug pricing billboards.
So our eyebrows shot up when we caught wind of this splashy new ad accusing independent pharmacies of making drugs more expensive. The billboard says itâs paid for by Texans for Affordable Rx. That campaign, it turns out, is paid for by the Pharmaceutical Care Management Association, the lobby for drug middlemen. Itâs unclear if PCMA is running the campaign nationwide, but with some sleuthing, STAT was able to uncover similar campaigns in Illinois, Michigan, Pennsylvania, Georgia, Florida, North Carolina, Maryland, Oklahoma and Wisconsin.The campaign is perhaps the most aggressive to date from PCMA, which has been battered with criticisms from both drug makers and independent pharmacies for years.Most of the campaignâs websites slam independent pharmacies, which have accused middlemen of cutting their reimbursement and pushing them out of business.
Many websites suggest pharmacists are making six-figure salaries, and imply that therefore, independents are âdoing just fine.âThese websites also include some interesting state-specific âflavor,â like this gem from PCMAâs Wisconsin website. ÂThereâs a term folks use to describe Wisconsinites. Midwest Nice. What does that mean?.
Well, it means that if you run out of brats during a Packers tailgate at Lambeau, thereâs always somebody close by with one or two to share. It means youâll always get a wave from passing boats when youâre fishing out on Lake Winnebago. And more than anything else, it means you can always rely on your neighbors to watch out for you. We embrace that Wisconsinite sentiment â and when it comes to prescription drug costs weâre watching out for you, too.âIn a statement, PCMA said the campaign was meant to educate policymakers and consumers about drug prices and âthe real motivations behind special interest groups in the prescription drug supply chain â specifically the costly independent pharmacy lobby agenda.â The group did not answer STATâs questions about where PCMA was running campaigns and how much money the campaign cost.
State health officials. To fight asthma treatment, we need moneyPublic health departments have submitted their asthma treatment vaccination plans to the Centers for Disease Control and Prevention, but they insist the ideas canât truly be implemented unless they get more federal funding.âItâs one thing to write a strong plan. Itâs quite another to implement the plan,â Claire Hannan, the executive director of the Association of Immunization Managers, said Monday on a call with reporters. Without funding, she said, the vaccination plans states have submitted to the CDC for review amount to just âwish lists.âThe Association of State and Territorial Health Officials has been calling on Congress to greenlight more than $8 billion in funding for treatment distribution and administration.
Thatâd go toward hiring people who can give the shots, building IT systems to track who has received a dose and when people need to get their second dose, and supporting all the logistics, storage, and transportation of the treatments.The state health leaders also stressed the need to fund an effective communications campaign to spread the word about the treatments when they are available and to convince people that the immunizations are safe and effective, whatâs increasingly looking like an uphill challenge.Pharmaâs support for GOP attorneys general could backfireObamacare, generally, has benefited the drug industry. So why is pharma giving so much money to the Republican attorneys general who want to repeal it?. STATâs Ed Silverman explores that question in a new story this morning.Drug makers gave $1.6 million last election cycle to the Republican Attorneys General Association. The lionâs share of those donations went to Texas AG Ken Paxton, the lead plaintiff in Texas v.
California, the lawsuit challenging the Affordable Care Act, which will be heard by the Supreme Court Nov. 10.Drug makers insist that they donate to both Democrats and Republicans and typically do not specify how their donations be used, but one government accountability expert told STAT the donations show âcompanies donât pay attention to the consequences of their spending.âRead more here. The drug industryâs influence in state politicsA new exclusive analysis conducted by STAT and the National Institutes on Money in Politics finds that more than one-quarter of all state lawmakers nationwide have already accepted money from the pharmaceutical industry since the start of 2019, and that drug makers have poured more than $5 million into state political races over the same time frame.While the spending pales in comparison to how much drug makers typically spend on a federal level, their spending is often much more impactful on a state level. And if youâve been following drug pricing long, you know that much of the action happens in the states â from first-of-their-kind insulin affordability programs to prescription drug affordability boards..
D.C buy ventolin online no prescription where can i buy ventolin over the counter usa. Diagnosis is STATâs weekly newsletter about the politics and policy of health and medicine. Sign up here to receive it in your inbox.The FDAâs panel of outside treatment experts will meet Thursday where can i buy ventolin over the counter usa to discuss approval standards for an eventual asthma treatment.
These meetings are typically attended only by the nerdiest biotech investors and FDA lawyers, but this one is expected to attract so much attention that the FDA is setting up a Youtube stream for the event instead of its typical (often rage-inducing) internal streaming service.The meeting wonât discuss individual treatments. Instead itâll be about the FDAâs approval standards, additional studies where can i buy ventolin over the counter usa the FDA might require of treatment makers and what type of follow-up should be required to monitor the safety of any treatment thatâs either fully FDA approved or authorized for emergency use.advertisement A number of treatment makers, doctors groups, and advocates are already flooding the FDA with other suggested topics to discuss. They include:How drug makers should manage their ongoing studies in the event their treatment is granted emergency authorization.
Pfizer, Johnson &. Johnson, the Biotechnology Innovation Organization and the Infectious Diseases Society of America all raised a version of this concern where can i buy ventolin over the counter usa in their comments. Their concerns seem to stem from a line in the FDAâs recent guidance that suggests the agency will require drug makers to continue to collect placebo-controlled data, even if their treatment is authorized for emergency use.
The groups where can i buy ventolin over the counter usa argue that in that scenario, drug makers would have an ethical obligation to tell their study participants whether they were receiving a placebo.How the FDA would decide to issue an emergency authorization for a select high-risk group, like health care workers. Johnson &. Johnson raised this question in their comments.Why isnât the FDA where can i buy ventolin over the counter usa conducting inspections of treatment plants before authorizing a treatment?.
IDSA wants the answer to that question.Why hasnât Emily Miller been fired?. This one isnât your typical question for an expert panel, but thatâs the question posed by the activist coalition Treatment Action Group. ÂThe agency can restore public trust by improving transparency and communications, and by removing staff whoâve where can i buy ventolin over the counter usa been involved in perpetrating political interference.
Emily Miller, who was briefly and disastrously appointed FDA spokesperson and continues to post misinformation on asthma treatment therapeutics, should not be an agency employee,â the group wrote.STATâs Helen Branswell has more on the stakes of Thursdayâs meeting here.advertisement The fight between drug middlemen and pharmacists heats upSTAT loves drug pricing billboards. So our eyebrows shot up when we caught wind where can i buy ventolin over the counter usa of this splashy new ad accusing independent pharmacies of making drugs more expensive. The billboard says itâs paid for by Texans for Affordable Rx.
That campaign, it turns out, is paid for by the Pharmaceutical Care Management Association, the lobby for drug middlemen where can i buy ventolin over the counter usa. Itâs unclear if PCMA is running the campaign nationwide, but with some sleuthing, STAT was able to uncover similar campaigns in Illinois, Michigan, Pennsylvania, Georgia, Florida, North Carolina, Maryland, Oklahoma and Wisconsin.The campaign is perhaps the most aggressive to date from PCMA, which has been battered with criticisms from both drug makers and independent pharmacies for years.Most of the campaignâs websites slam independent pharmacies, which have accused middlemen of cutting their reimbursement and pushing them out of business. Many websites suggest pharmacists are making six-figure salaries, and imply that therefore, independents are âdoing just fine.âThese websites also include some interesting state-specific âflavor,â like this gem from PCMAâs Wisconsin website.
ÂThereâs a term folks use to describe Wisconsinites where can i buy ventolin over the counter usa. Midwest Nice. What does where can i buy ventolin over the counter usa that mean?.
Well, it means that if you run out of brats during a Packers tailgate at Lambeau, thereâs always somebody close by with one or two to share. It means where can i buy ventolin over the counter usa youâll always get a wave from passing boats when youâre fishing out on Lake Winnebago. And more than anything else, it means you can always rely on your neighbors to watch out for you.
We embrace that Wisconsinite sentiment â and when it comes to prescription drug costs weâre watching out for you, too.âIn a statement, PCMA said the campaign was meant to educate policymakers and consumers about drug prices and âthe real motivations behind special interest groups in the prescription drug supply chain â specifically the costly independent pharmacy lobby agenda.â The group did not answer STATâs questions about where PCMA was running campaigns and how much money the campaign cost. State where can i buy ventolin over the counter usa health officials. To fight asthma treatment, we need moneyPublic health departments have submitted their asthma treatment vaccination plans to the Centers for Disease Control and Prevention, but they insist the ideas canât truly be implemented unless they get more federal funding.âItâs one thing to write a strong plan.
Itâs quite another to implement the plan,â Claire Hannan, the executive director of where can i buy ventolin over the counter usa the Association of Immunization Managers, said Monday on a call with reporters. Without funding, she said, the vaccination plans states have submitted to the CDC for review amount to just âwish lists.âThe Association of State and Territorial Health Officials has been calling on Congress to greenlight more than $8 billion in funding for treatment distribution and administration. Thatâd go toward hiring people who can give the shots, building IT systems to track who has received a dose and when people need to get their second dose, and supporting all the logistics, storage, and transportation of the treatments.The state health leaders also stressed the need to fund an effective communications campaign to spread the word about the treatments when they are available and to convince people that the immunizations are safe and effective, whatâs increasingly looking like an uphill challenge.Pharmaâs support for GOP attorneys general could where can i buy ventolin over the counter usa backfireObamacare, generally, has benefited the drug industry.
So why is pharma giving so much money to the Republican attorneys general who want to repeal it?. STATâs Ed Silverman explores that question in a new story this morning.Drug makers gave $1.6 million last election cycle to the Republican Attorneys General Association. The lionâs share of those donations went to Texas AG Ken Paxton, the lead plaintiff in Texas v.
California, the lawsuit challenging the Affordable Care Act, which will be heard by the Supreme Court Nov. 10.Drug makers insist that they donate to both Democrats and Republicans and typically do not specify how their donations be used, but one government accountability expert told STAT the donations show âcompanies donât pay attention to the consequences of their spending.âRead more here. The drug industryâs influence in state politicsA new exclusive analysis conducted by STAT and the National Institutes on Money in Politics finds that more than one-quarter of all state lawmakers nationwide have already accepted money from the pharmaceutical industry since the start of 2019, and that drug makers have poured more than $5 million into state political races over the same time frame.While the spending pales in comparison to how much drug makers typically spend on a federal level, their spending is often much more impactful on a state level.
And if youâve been following drug pricing long, you know that much of the action happens in the states â from first-of-their-kind insulin affordability programs to prescription drug affordability boards..
What if I miss a dose?
If you miss a dose, take it as soon as you can. If it is almost time for your next dose, take only that dose. Do not take double or extra doses.
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Choice is probably one of https://cubcadet.projektweb.at/renova-tablet-online/ the most often discussed areas in bioethics, alongside the related concepts of informed consent can i use ventolin when pregnant and autonomy. It is generally, prima facie, portrayed as a can i use ventolin when pregnant good thing. In healthcare, the 2000s saw the UK Prime Minister Tony Blair pursue the âChoice Agendaâ where, âAs capacity expands, so choice will can i use ventolin when pregnant grow.
Choice will fundamentally change the balance of power in the NHS.â1 In a consumerist society giving consumers more choice is seen as desirable. However, choice is not a good in itself, giving people more choice can i use ventolin when pregnant in certain situations can be problematic. I.e.
Consumerism drives economic growth and this has a detrimental effect on the environment. And increasing the range of choices a patient is offered is often not the best way to improve the quality of healthcare provision.2 The assumptions behind the valuing of choice need careful unpacking and this Issue of the Journal of Medical Ethics includes papers that explore choice in a number of areas.This Issue's Editorâs choice is Tom Walkerâs âThe Value of Choiceâ,3 which puts forward a suggestion for the importance of the symbolic value of choice. There are a number of ways of categorising the value of choice in healthcare.
One account sees choice as valuable because it is by choosing that individuals make their life their own. Another account sees choice as valuable for instrumental reasons, people are generally, assuming they are sufficiently informed, the best judge of their own best interests. Walker argues for an additional third reason, the symbolic value of choice, originally proposed by Scanlon.
This sees choice as valuable because being given the option to choose, whether or not one takes it up, not the act of choosing is what makes choice valuable. Being offered the option to choose has a âcommunicative roleâ in that it communicates that the person has standing and, for certain types of choice, being denied the opportunity to choose, âcan be both demeaning and stigmatising.â Walker states that denying someone the opportunity to choose in certain circumstances does not communicate anything untoward, and he goes to explore how we might determine when not allowing someone a choice would be demeaning. Here he stresses the importance of context in making this determination, it is not fixed by the features of a patient, but what being âallowedâ or âdeniedâ the opportunity to make a choice reveals about the healthcare professionalâs view of the patient.
ÂIt communicates that they either see those patients as competent and equal members of society, or that they do not.â Denying a patient the opportunity to choose an ineffective treatment, for example, does not communicate a negative judgement. Walker says his account, âis intended to supplement existing accounts, not replace them. Because choice is valuable for more than one reason no single account can capture everything that matters.âThe importance of pointing to the context of the choice is highlighted in Walkerâs paper and it is only through careful examination of the context of that offering that we can determine if, in fact, this is an area where choice should be offered and to whom.
Such an examination is carried out in Cameron Beattieâs paper,4 which considers the High Court review of service provision at the youth-focussed gender identity Tavistock Clinic. Beattie disagrees with the High Courtâs view that it is âhighly unlikelyâ that under-13s, and âdoubtfulâ that 14â15 years old, can be competent to consent to puberty blocker therapy for gender dysphoria. Beattie argues that having puberty blocker therapy is a choice that minors should be given the opportunity to make.
In principle, children of that age could be competent to make the decision and that the decision is no more complex than other medical decisions that Gillick competence has conventionally been applied to. Children of this age fall into what Walker calls a âtransitionalâ group, âOf particular importance here is the extent to which societal features mean members of some groups find it particularly hard to be recognised as competent and equal members of society. That includes members of groups subject to discriminationâ¦.It also includes those who are in what we might call transitional groups such as teenagers struggling to be recognised as competent.â In the case of denying puberty blockers, the symbolic value of choice is clear.The paper by Zeljka Buturovic5 examines the debate over young childless women requesting sterilisation.
There has been a discussion in the literature that critiques doctorsâ hesitancy to accede to this type of request and Buturovic argues against these criticisms. The argument is that rather than a doctorâs refusal to sterilise a young childless woman or putting up obstacles to this being examples of, variously, inconsistency, paternalism, pronatalist bias and discrimination, it is understandable that doctors should be reluctant to follow this unusual request, and such hesitancy is of potential benefit to the young woman. This hesitancy can act as a filter for women who are not seriously committed to sterilisation.
This, in essence, is the opposite argument to Beattieâs paper, that the barriers put up to prevent people exercising their choice in this case are warranted. Young childless women should have their choice scrutinised and if necessary delayed so that it can be ascertained if the choice is a genuine one, and âto weed out (the) confused and uncommitted.â Ultimately, that choice should be available for young childless woman, but it is a choice, given its long-term consequences and likely lack of reversibility, that should be carefully considered.These papers show that choice is a contextually based, complex and multi-facetted concept and approaches such as Walkerâs, give us tools to think more carefully about the value of choice and what that means in particular situations. A consideration of choice is not complete without thinking about the effects of our choices on others, and this needs to be at the forefront of any ethical analysis.
The âchoice-agendaâ can often be a proxy for an individualistic conception of personal responsibility and a construction of the âgoodâ of the choice as being solely about that individualâs right to exercise a choice, rather than a more nuanced consideration of the wider, or even limited, effects of that choice on others. Although we have well-worn ways of thinking about harm â harm to others and liberty limiting principles6 â how the exercising of individual choice might harm others is often debatable and unclear, and political with a small and large P!. For instance, in July 2021 Boris Johnson, the UK prime minister, announced that mask wearing would now be one of personal choice.
The government would end the legal obligation to wear a face covering, âWe will move away from legal restrictions and allow people to make their own informed decisions about how to manage the ventolin.â Johnson went on to say. ÂGuidance will suggest where you might choose to do so - especially when cases are rising and where you come into contact with people you don't usually meet in enclosed spaces, such as obviously crowded public transport.â7 This mandate for âfreedom-dayâ was criticised in a number of letters in high ranking medical journals,8 9 arguing, âThe narrative of âcaution, vigilance, and personal responsibilityâ is an abdication of the governmentâs fundamental duty to protect public health. ÂPersonal responsibilityâ does not work in the face of an airborne, highly contagious infectious disease.
Infectious diseases are a matter of collective, rather than individual, responsibility.â8 In this case, someoneâs personal choice to not wear a mask on public transport, where social distancing is impossible, conflicts with someone elseâs choice to travel to work as safely as they can. As the critics of this policy and work in public health ethics notes, one personâs choice can have a significant detrimental effect on others, and in situations like this, such as this mask wearing example, where not allowing choice, that is maintaining the legally mandated requirement to wear a face mask (unless there are reasons for an exemption), is an ethically acceptable restriction on âpersonal choice.â In Walkerâs terminology disallowing this choice it is not demeaning or stigmatising, as it applies to everyone, and does not fail to recognise any particular person or group as equal members of society.Choice is often portrayed as a good thing like parenthood and apple pie and the use of choice by politicians to whip up support and bolster their political agendas, as shown by the examples of Blair and Johnson, shows the rhetorical power of the concept. But to really address in what circumstances choices should be offered, to whom and what type of choice, we need theoretical tools to help us understand and be attentive to the wider implications and the papers in this Issue help us to do that.Ethics statementsPatient consent for publicationNot applicable.Ethics approvalThis study does not involve human participants.IntroductionLarge-scale, international data sharing opens the door to the study of so-called âBig Dataâ, which holds great promise for improving patient-centred care.
Big Data health research is envisioned to take precision medicine to the next level through increased understanding of disease aetiology and phenotypes, treatment effects, disease management and healthcare expenditure.1 However, lack of public trust is proven to be detrimental to the goals of data sharing.2 The case of care.data in the UK offers a blatant example of a data sharing initiative gone awry. Criticism predominantly focused on limited public awareness and lack of clarity on the goals of the programme and ways to opt out.3 Citizens are becoming increasingly aware and critical of data privacy issues, and this warrants renewed investments to maintain public trust in data-intensive health research. Here, we use the term data-intensive health research to refer to a practice of grand-scale capture, (re)use and/or linkage of a wide variety of health-related data on individuals.Within the European Union (EU), the recently adopted General Data Protection Regulation (GDPR) (EU 2016/679) addresses some of the concerns the public may have with respect to privacy and data protection.
One of the primary goals of the GDPR is to give individuals control over their personal data, most notably through consent.4 Other lawful grounds for the processing of personal data are listed, but it is unclear how these would exactly apply to scientific research. Legal norms remain open to interpretation and thus offer limited guidance to researchers.5 6 In Recital 33, the GDPR actually mentions that additional ethical standards are necessary for the processing of personal data for scientific research. This indicates a recognised need for entities undertaking activities likely to incite public unease to go beyond compliance with legal requirements.7 Complementary ethical governance then becomes a prerequisite for securing public trust in data-intensive health research.A concept that could be of use in developing ethical governance is that of a âsocial license to operateâ.7 The social license captures the notion of a mandate granted by society to certain occupational groups to determine for themselves what constitutes proper conduct, under the condition that such conduct is in line with societyâs expectations.
The term âsocial licenseâ was first used in the 1950s by American sociologist Everett Hughes to address relations between professional occupations and society.8 The concept has been used since to frame, for example, corporate social responsibility in the mining industry,9 governance of medical research in general8 and of data-intensive health research more specifically.7 10 As such, adequate ethical governance then becomes a precondition for obtaining a social license for data sharing activities.Key to an informed understanding of the social license is identifying the expectations society may hold with regard to sharing of and access to health data. Here, relevant societal actors are the subjects of Big Data health research, constituting both patients and the general public. Identification of patientsâ and public views and attitudes allows for a better understanding of the elements of a socially sanctioned governance framework.
We know of the existence of research papers that have captured these views using quantitative or qualitative methods or a combination of both. So far, systematic reviews of the literature have limited their scope to citizens of specific countries,11 12 qualitative studies only13 or the sharing of genomic data.14 Therefore, we performed an up-to-date narrative review of both quantitative and qualitative studies to explore predominant patient and public views and attitudes towards data sharing for health research.MethodsWe searched the literature databases PubMed (MEDLINE), Embase, Scopus and Google Scholar in April 2019 for publications addressing patientsâ and public views and attitudes towards the use of health data for research purposes. Synonyms of the following terms (connected by âANDâ) were used to search titles and/or abstracts of indexed references.
Research (See box 1 and online supplementary appendix 1). To merit inclusion, an article had to report results from an original research study (qualitative, quantitative or mixed methods) on attitudes of individuals regarding use of data for health research. We restricted eligibility to records published in English and studies performed between 2009 and 2019.
We chose 2009 as a lower limit because we assume that patientsâ and public perspectives might have changed substantially with increasing awareness and use of digital (health) technologies. Systematic reviews and meta-analyses synthesising the empirical literature on this topic also qualified for review. Reports from stakeholder meet-ups and workshops were eligible as long as they included patients or the public as participants.
Since we were only interested in empirical evidence, expert opinion and publications merely advocating for the inclusion of patientsâ and public views in Big Data health research were excluded. Studies that predominantly reported on views of other stakeholdersâsuch as clinicians, researchers, policy makers or industryâwere excluded. Articles reporting on conference proceedings, or views regarding (demographic) data collection in low or middle income countries or for public health and care/quality improvement were not considered relevant to this review.
Despite our specific interest in data sharing within the European context, we broadened eligibility criteria to include studies performed in the USA, Canada, Australia and New Zealand. Additional articles were identified through consultation with experts and review of references in the manuscript identified through the literature database searches. Views and attitudes of patients and the public were identified from selected references and reviewed by means of thematic content analysis.Supplemental materialBox 1 Key search terms(patient* OR public OR citizen*)AND(attitude* OR view* OR perspective* OR opinion* OR interview* OR qualitative* OR questionnaire* OR survey*)AND(âdata sharingâ OR âdata accessâ OR âdata transferâ)ANDResearchResultsStudy characteristicsSearches in PubMed (MEDLINE), Embase, Scopus and Google Scholar resulted in a total of 1153 non-unique records (see online supplementary appendix 1).
We identified 27 papers for review, including 12 survey or questionnaire studies (quantitative), 8 interview or focus group studies (qualitative), 1 mixed methods study and 6 systematic reviews (see table 1). Most records were excluded because they were not relevant to our research question or because they did not report on findings from original (empirical) research studies. Ten studies reported on views of patients, 11 on views of the public/citizens and 6 studies combined views of patients, research participants and the public.View this table:Table 1 Study characteristicsWillingness to share data for health researchReviewed papers suggest widespread support for the sharing of data for health research.Four systematic reviews synthesising the views of patients and the public report that willingness for data to be linked and shared for research purposes is high11â14 and that people are generally open to and understand the benefits of data sharing.15Outpatients from a German university hospital who participated in a questionnaire study (n=503) expressed a strong willingness (93%) to give broad consent for secondary use of data,16 and 93% of a sample of UK citizens with Parkinsonâs disease (n=306) were willing to share their data.17 Wide support for sharing of data internationally18 19 and in multicentre studies20 was reported among patient participants.
Goodman et al found that most participants in a sample of US patients with cancer (n=228) were willing to have their data made available for âas many research studies as possibleâ.21 Regarding the use of anonymised healthcare data for research purposes, a qualitative study found UK rheumatology patients and patient representatives in support of data sharing (n=40).22Public respondents in survey studies recognised the benefits of storing electronic health information,23 and 78.8% (n=151) of surveyed Canadians felt positive about the use of routinely collected data for health research.24 The majority (55%) of a sample of older Swiss citizens (n=40) were in favour of placing genetic data at disposal for research.25 Focus group discussions convened in the UK showed that just over 50% of the members of the Citizens Council of The National Institute for Health and Care Excellence (NICE) said they would have no concerns about NICE using anonymised data derived from personal care records to evaluate treatments,26 and all participants in one qualitative study were keen to contribute to the National Healthcare Service (NHS)-related research.27Motivations to share dataPatients and public participants expressed similar reasons and motivations for their willingness to share data for health research, including contributing to advancements in healthcare, returning incurred benefits and the hope of future personal health benefits (tables 2â4).View this table:Table 2 Patientsâ views and attitudes towards the sharing of health data for researchView this table:Table 3 Public views and attitudes towards the sharing of health data for researchView this table:Table 4 Patientsâ and public views and attitudes towards the sharing of health data for researchIn the two systematic reviews that addressed this topic, sharing data for âthe common goodâ or âthe greater goodâ was identified as one of the most prevalent motivations.12 14For patients specifically, to help future patients or people with similar health problems was an important reason.14 16 One survey study conducted among German outpatients found that 72% listed returning their own benefits incurred from research as a driver for sharing clinical data.16 Patients with rare disease were also motivated by âgreat hope and trustâ in the development of international databases for health research.19 Among patients, support of research in general,16 the value attached to answering âimportantâ research questions,20 and a desire to contribute to advancements in medicine14 were prevalent reasons in favour of data sharing. Ultimately, the belief that data sharing could lead to improvements in health outcome and care was reported.20Only one original study research paper addressed public motivations. This study found that older citizens mentioned auistic reasons and the greater good in a series of interviews as reasons to share genetic data for research.25 In these interviews, citizens expressed no expectations of an immediate impact or beneficial return but ultimately wanted to help the next generation.Perceived benefits of data sharingPatients and the public perceive that data sharing could lead to better patient care through improved diagnosis and treatment options and more efficient use of resources.
Patients seem to also value the potential of (direct) personal health benefits.Two systematic reviews reported on perceived benefits of data sharing for health research purposes. Howe et al mentioned perceived benefits to research participants or the immediate community, benefits to the public and benefits to research and science.15 Shabani et al also listed accelerating research advancement and maximising the value of resources as perceived benefits.14Surveyed patients perceived that data sharing could help their doctor âmake better decisionsâ about their health (94%, n=3516)28 or result in an increased chance of receiving personalised health information (n=228).21In the original studies reviewed, advantages and potential benefits of data sharing were generally recognised by public and patient participants.22 29 Data sharing was believed to enable the study of long-term treatment effects and rare events, as well as the study of large numbers of people,24 to improve diagnosis25 and treatment quality,20 23 as well as to stimulate innovation30 and identify new treatment options.25 A cross-sectional online survey among patient and citizen groups in Italy (n=280) also identified the perception that data sharing could reduce waste in research.30Perceived risks of data sharingThe most significant risks of data sharing were perceived to results from breaches of confidentiality, commercial use and potential abuse of the data.Systematic reviews report on patientsâ and public concerns about confidentiality in general,13 15 sometimes linked to the risk of reidentification,14 concerns about a party's competence in keeping data secure,12 and concerns that personal information could be mined from genomic data.14 A systematic review by Stockdale et al identified concerns among the public (UK and Ireland) about the motivation a party might have to use the data.14Patients in a UK qualitative study (n=40) perceived âdetrimentalâ consequences of data âfalling into the wrong handsâ, such as insurance companies.22 Respondents from the online patient community PatientsLikeMe were fearful of health data being âstolen by hackersâ (87%, n=3516).28Original research studies flagged data security and privacy as major public concerns.16 18 20 25 26 29â32 More specifically, many studies found that participants worried about who would have access to the data and about risk of misuses or abuses.13 15 18 25 27 33 A large pan-European survey among respondents from 27 EU member states revealed public concerns about different levels of access by third parties (48.9%â60.6%, n=20â882).23 Overall, reviewed papers suggest that patients and the public are concerned about the use of their data for commercial purposes.14 27 For example, the NICE Citizens Council expressed concerns about the potential for data to be sold to other organisations and used for profit and for purposes other than research.26 The Citizens Council also highlighted the need for transparency about how data are used and how it might be used in the future and for ensuring the research is conducted according to good scientific practice and that data are used to benefit society. Concerns about control and ownership of data were identified13 33 and about re-use of data for purposes that participants do not agree on.30 Fear of discrimination, stigmatisation, exploitation or other repercussions as a consequence of data being shared was widely cited by individuals.14 15 18Barriers to share dataStudies showed that patients and the public rarely mention barriers to data sharing in absolute terms.
Rather, acceptance seemed to decrease if data sharing was financially motivated, and if people did not know how and with whom their data would be shared.First, individuals often opposed data sharing if it was motivated by financial gain or profit20 or if the data were shared with commercial/private companies.14 15 In one large pan-European survey (n=20â882), respondents were found to be strongly averse to health insurance companies and private sector pharmaceutical companies viewing their data.23 Second, lack of understanding and awareness around the use of data was viewed as a barrier to data sharing.15 22 Third, lack of transparency and controllability in releasing data were mentioned as factors compromising public trust in data sharing activities.14 22Factors affecting willingness to share dataA wide range of factors were identified from the literature that impacted individualsâ willingness to share data for health research, including geographical factors, age, individual-specific and research-specific characteristics.Geographical factorsMcCormack et al found that European patientsâ expressions of trust and attitudes to risk were often affected by the regulatory and cultural practices in their home countries, as well as by the nature of the (rare) disease the patient participant had.18 Shah et al conducted a survey among patients in four Northern European countries (n=855) and found a significant association between country and attitudes towards sharing of deidentified data.34 Interestingly, Dutch respondents were less likely to support sharing of their deidentified data compared with UK citizens.AgeAmong a sample of surveyed patients with Parkinsonâs disease (UK), a significant association was found between higher age and increased support for data sharing.17 According to a study based on semistructured interviews with older Swiss citizens, generational differences impacted willingness to share.25 With respect to public attitudes towards data sharing, findings of one systematic review suggest that males and older people are more likely to consent to sharing their medical data.27 A systematic review by Shabani et al suggests that patient and public participants with higher mean age are substantially less worried about privacy and confidentiality than other groups.14Individual-specific characteristicsA systematic review into patientsâ and public perspectives on data sharing in the USA suggests that individuals from under-represented minorities are less willing to share data.11 A large multisite survey (n=13â000) among the US public found that willingness to share was associated with self-identified white race, higher educational attainment and lower religiosity.31 In another systematic review, race, gender, age, marital status and/or educational level all seemed to influence how people perceived sensitivity of genomic data and the sharing thereof.14 However, a UK study among patients with Parkinsonâs disease found no clear relationship between data sharing and the number of years diagnosed, sex, medication class or health confidence.17Factors that clearly positively affected attitudes towards data sharing were perceptions of the (public) benefits and value of the research,13 20 fewer concerns and fewer information needs,31 and higher trust in and reputation of individuals or organisations conducting and/or overseeing data sharing.12â14 35 Conversely, willingness decreased with higher privacy and confidentiality concerns11 and higher distrust of the government as an oversight body for (genetic) research data.35Research-specific characteristicsPrivacy measures increased peopleâs willingness to share their data for health research, such as removal of social security numbers (90%, n=3516) and insurance ID (82%, n=3516), the sharing of only summary-level or aggregate data20 and deposition of data in a restricted access online database.29 Expressions of having control over what data are shared and with whom positively affected attitudes towards data sharing.34 In one study, being asked for consent for each study made participants (81%) feel ârespected and involvedâ, and 74% agreed that they would feel that they âhad controlâ.14 With respect to data sharing without prospective consent, participants became more accepting after being given information about the research processes and selection bias.27 Less support was observed for data sharing due to financial incentives25 and, more specifically, if data would be shared with private companies, such as insurance or pharmaceutical companies.11 25Conditions for sharingWidespread willingness to share data for health research very rarely led to participantsâ unconditional support. Studies showed agreement on the following conditions for responsible data sharing. Value, privacy, minimising risks, data security, transparency, control, information, trust, responsibility and accountability.ValueOne systematic review found that participants found it important that the research as a result of data sharing should be in the publicâs interest and should reflect participantsâ values.15 The NICE Citizens Council advocated for appropriate systems and good working practices to ensure a consistent approach to research planning, data capture and analysis.26Privacy, risks and data securityThe need to protect individualsâ privacy was considered paramount11 14 21 34 and participants often viewed deidentification of personal data as a top privacy measure.11 24 30 36 One survey among US patients with cancer found that only 20% (n=228) of participants found linkage of individuals with their deidentified data acceptable for return of individual health results and to support further research.21 Secured access to databases was considered an important measure to ensure data security in data sharing activities.30 34 A systematic review of participantsâ attitudes towards data sharing showed that people established risk minimisation as another condition for data sharing.15 Findings by Mazor et al suggest that patients only support studies that offer value and minimise security risks.20Transparency and controlConditions regarding transparency were information about how data will be shared and with whom,14 35 the type of research that is to be performed, by whom the research will be performed,16 information on data sharing and monitoring policies and database governance,35 conditions framing access to data and data access agreements,24 28 30 and any partnerships with the pharmaceutical industry.19 More generally, participants expressed the desire to be involved in the data sharing process,35 to be notified when their data are (re)used and to be informed of the results of studies using their data.15 Spencer et al identified use of an electronic interface as a highly valued means to enable greater control over consent choices.22 When asked about the use of personal data for health research by the NHS, UK citizens were typically willing to accept models of consent other than the ones they would prefer.37 Acceptance of consent models with lower levels of individual control was found to be dependent on a number of factors, including adequate transparency, control over detrimental use and commercialisation, and the ability to object, particularly to any processing considered to be inappropriate or particularly sensitive.37Information and trustOne systematic review identified trust in the ability of the original institution to carry out the oversight tasks as a major condition for responsible data sharing.14 Appropriate education and information about data sharing was thought to include public campaigns to inform stakeholders about Big Data32 and information communicated at open days of research institutions (such as NICE) to ensure people understand what their data are being used for and to reassure them that personal data will not be passed on or sold to other organisations.26 The informed consent process for study participation was believed to include information about the fact that individualsâ data could potentially be shared,15 30 the objectives of data sharing and (biobank) research, the studyâs data sharing plans,29 governance structure, logistics and accountability.33Responsibility and accountabilityParticipants often placed the responsibility for data sharing practices on the shoulders of researchers.
Secondary use of data collected earlier for scientific research was viewed to require a data access committee that involves a researcher from the original research project, a clinician, patient representative and a participant in the original study.36 Researchers of the original study were required to monitor data used by other researchers.36 In terms of accountability, patient and public groups in Italy (n=280) placed high value on sanctions for misuse of data.30 Information on penalties or other consequences of a breach of protection or misuse was considered important by many.31 35DiscussionIn this study, we narratively reviewed 27 papers on patientsâ and public views on and attitudes towards the use of health data for scientific research. Studies reported a widespreadâthough conditionalâsupport for the linkage and sharing of data for health research. The only outlier seems to be the finding that just over half (n=25) of the NICE Citizens Council answered ânoâ to the question whether they had any concerns if NICE used anonymised data to fill in the gaps if NICE was not getting enough evidence in âthe usual waysâ.26 However, we hasten to point out that the question about willingness to share is different from the question whether people have concerns or not.
In addition, after a 2-day discussion meeting Council members were perhaps more sensitised to the potential concerns regarding data sharing. Therefore, we suggest that the way and context within which questions are phrased may influence the answers people give.Overall, people expressed similar motivations to share their data, perceived similar benefits (despite some variation between patients and citizens), yet at the same time displayed a range of concerns, predominantly relating to confidentiality and data security, awareness about access and control, and potential harms resulting from these risks. Both patient and public participants conveyed that certain factors would increase or reduce their willingness to have their data shared.
For example, the presence of privacy-protecting measures (eg, data deidentification and the use of secured databases) seemed to increase willingness to share, as well as transparency and information about data sharing processes and responsibilities. The identified views and attitudes appeared to come together in the conditions stipulated by participants. Value, privacy and confidentiality, minimising risks, data security, transparency, control, information, trust, responsibility and accountability.In our Introduction, we mentioned that identifying patientsâ and public views and attitudes allows for a better understanding of the elements of a socially sanctioned governance framework.
In other words, what work should our governance framework be doing in order to obtain a social license?. This review urges researchers and institutions to address peopleâs diverse concerns and to make an effort to meet the conditions identified. Without these conditions, institutions lack trustworthiness, which is vital for the proceedings of medicine and biomedical science.
As such, a social license is not a ânice to haveâ but a âneed to haveâ. Our results also confirm that patients and the public indeed care about more than legal compliance alone, and wish to be engaged through information, transparency and control. This work supports the findings of a recent systematic review into ethical principles of data sharing as specified in various international ethical guidelines and literature.38 What this body of research implies is considerable diversity of values and beliefs both between and within countries.The goal of this narrative review was to identify the most internationally dominant, aggregated patient and public views about the broad topic of data sharing for health research.
We deliberately opted for the methodology of a narrative review rather than a systematic review. Most narrative reviews deal with a broad range of issues to a given topic rather than addressing a particular topic in depth.39 This means narrative reviews may be most useful for obtaining a broad perspective on a topic, and that they often are less useful in generating quantitative answers to specific clinical questions. However, because narrative reviews do not require specification of the search and selection strategy and the way of critically appraising literature can be variable, the connection between evidence generated by narrative reviews and (clinical) recommendations is less rigorous and risk of bias exists.
This is something to take into account in this study. A risk of bias assessment was not possible due to the heterogeneity of the findings. We acknowledge that our methodological choices may have affected the discriminative power or granularity of our findings.
For example, there is a difference between sharing of routinely collected health data versus secondary use of health data collected for research purposes. And we can only make loose assumptions about potential differences between patient and public views.In addition, we should mention that this work is centred around studies conducted in Western countries as the whole Big Data space and literature is dominated by Western countries, higher socioeconomic status and Caucasians. However, most of the disease burden globally and within countries is most probably not represented in the âBig Dataâ and so we have to stress the lack of generalisability to large parts of the world.Nevertheless, we believe our findings point towards essential elements of a governance framework for data sharing for health research purposes.
If we are to conclude that the identified conditions ought to act as the pillars of a governance framework, the next step is to identify how these conditions could be practically operationalised. For example, if people value information, transparency and control, what type of consent is most likely to valorise these conditions?. And what policy for returning research results would be desirable?.
Once we know what to value, we can start thinking about the ways to acknowledge that value. A new challenge arising here, however, is what to do when people hold different or even conflicting values or preferences. Discrete choice experiments could help to test peopleâs preferences regarding specific topics, such as preferred modes of informed consent.
Apart from empirical work, conceptual analysis is needed to clarify how public trust, trustworthiness of institutions and accountability are interconnected.ConclusionThis narrative review suggests widespreadâthough conditionalâsupport among patients and the public for data sharing for health research. Despite the fact that participants recognise actual or potential benefits of health research, they report a number of significant concerns and related conditions. We believe identified conditions (eg, social value, data security, transparency and accountability) ought to be operationalised in a value-based governance framework that incorporates the diverse patient and public values, needs and interests, and which reflects the way these same conditions are met, to strengthen the social license for Big Data health research.Ethics statementsPatient consent for publicationNot required.AcknowledgmentsWe thank Susanne Løgstrup (European Heart Network) and Evert-Ben van Veen (Medlaw) for their valuable feedback during various stages in drafting the manuscript..
Choice is probably one of the most where can i buy ventolin over the counter usa often discussed areas in Renova tablet online bioethics, alongside the related concepts of informed consent and autonomy. It is generally, prima facie, portrayed as where can i buy ventolin over the counter usa a good thing. In healthcare, the 2000s saw the UK Prime Minister Tony Blair pursue the âChoice where can i buy ventolin over the counter usa Agendaâ where, âAs capacity expands, so choice will grow.
Choice will fundamentally change the balance of power in the NHS.â1 In a consumerist society giving consumers more choice is seen as desirable. However, choice where can i buy ventolin over the counter usa is not a good in itself, giving people more choice in certain situations can be problematic. I.e.
Consumerism drives economic growth and this has a detrimental effect on the environment. And increasing the range of choices a patient is offered is often not the best way to improve the quality of healthcare provision.2 The assumptions behind the valuing of choice need careful unpacking and this Issue of the Journal of Medical Ethics includes papers that explore choice in a number of areas.This Issue's Editorâs choice is Tom Walkerâs âThe Value of Choiceâ,3 which puts forward a suggestion for the importance of the symbolic value of choice. There are a number of ways of categorising the value of choice in healthcare.
One account sees choice as valuable because it is by choosing that individuals make their life their own. Another account sees choice as valuable for instrumental reasons, people are generally, assuming they are sufficiently informed, the best judge of their own best interests. Walker argues for an additional third reason, the symbolic value of choice, originally proposed by Scanlon.
This sees choice as valuable because being given the option to choose, whether or not one takes it up, not the act of choosing is what makes choice valuable. Being offered the option to choose has a âcommunicative roleâ in that it communicates that the person has standing and, for certain types of choice, being denied the opportunity to choose, âcan be both demeaning and stigmatising.â Walker states that denying someone the opportunity to choose in certain circumstances does not communicate anything untoward, and he goes to explore how we might determine when not allowing someone a choice would be demeaning. Here he stresses the importance of context in making this determination, it is not fixed by the features of a patient, but what being âallowedâ or âdeniedâ the opportunity to make a choice reveals about the healthcare professionalâs view of the patient.
ÂIt communicates that they either see those patients as competent and equal members of society, or that they do not.â Denying a patient the opportunity to choose an ineffective treatment, for example, does not communicate a negative judgement. Walker says his account, âis intended to supplement existing accounts, not replace them. Because choice is valuable for more than one reason no single account can capture everything that matters.âThe importance of pointing to the context of the choice is highlighted in Walkerâs paper and it is only through careful examination of the context of that offering that we can determine if, in fact, this is an area where choice should be offered and to whom.
Such an examination is carried out in Cameron Beattieâs paper,4 which considers the High Court review of service provision at the youth-focussed gender identity Tavistock Clinic. Beattie disagrees with the High Courtâs view that it is âhighly unlikelyâ that under-13s, and âdoubtfulâ that 14â15 years old, can be competent to consent to puberty blocker therapy for gender dysphoria. Beattie argues that having puberty blocker therapy is a choice that minors should be given the opportunity to make.
In principle, children of that age could be competent to make the decision and that the decision is no more complex than other medical decisions that Gillick competence has conventionally been applied to. Children of this age fall into what Walker calls a âtransitionalâ group, âOf particular importance here is the extent to which societal features mean members of some groups find it particularly hard to be recognised as competent and equal members of society. That includes members of groups subject to discriminationâ¦.It also includes those who are in what we might call transitional groups such as teenagers struggling to be recognised as competent.â In the case of denying puberty blockers, the symbolic value of choice is clear.The paper by Zeljka Buturovic5 examines the debate over young childless women requesting sterilisation.
There has been a discussion in the literature that critiques doctorsâ hesitancy to accede to this type of request and Buturovic argues against these criticisms. The argument is that rather than a doctorâs refusal to sterilise a young childless woman or putting up obstacles to this being examples of, variously, inconsistency, paternalism, pronatalist bias and discrimination, it is understandable that doctors should be reluctant to follow this unusual request, and such hesitancy is of potential benefit to the young woman. This hesitancy can act as a filter for women who are not seriously committed to sterilisation.
This, in essence, is the opposite argument to Beattieâs paper, that the barriers put up to prevent people exercising their choice in this case are warranted. Young childless women should have their choice scrutinised and if necessary delayed so that it can be ascertained if the choice is a genuine one, and âto weed out (the) confused and uncommitted.â Ultimately, that choice should be available for young childless woman, but it is a choice, given its long-term consequences and likely lack of reversibility, that should be carefully considered.These papers show that choice is a contextually based, complex and multi-facetted concept and approaches such as Walkerâs, give us tools to think more carefully about the value of choice and what that means in particular situations. A consideration of choice is not complete without thinking about the effects of our choices on others, and this needs to be at the forefront of any ethical analysis.
The âchoice-agendaâ can often be a proxy for an individualistic conception of personal responsibility and a construction of the âgoodâ of the choice as being solely about that individualâs right to exercise a choice, rather than a more nuanced consideration of the wider, or even limited, effects of that choice on others. Although we have well-worn ways of thinking about harm â harm to others and liberty limiting principles6 â how the exercising of individual choice might harm others is often debatable and unclear, and political with a small and large P!. For instance, in July 2021 Boris Johnson, the UK prime minister, announced that mask wearing would now be one of personal choice.
The government would end the legal obligation to wear a face covering, âWe will move away from legal restrictions and allow people to make their own informed decisions about how to manage the ventolin.â Johnson went on to say. ÂGuidance will suggest where you might choose to do so - especially when cases are rising and where you come into contact with people you don't usually meet in enclosed spaces, such as obviously crowded public transport.â7 This mandate for âfreedom-dayâ was criticised in a number of letters in high ranking medical journals,8 9 arguing, âThe narrative of âcaution, vigilance, and personal responsibilityâ is an abdication of the governmentâs fundamental duty to protect public health. ÂPersonal responsibilityâ does not work in the face of an airborne, highly contagious infectious disease.
Infectious diseases are a matter of collective, rather than individual, responsibility.â8 In this case, someoneâs personal choice to not wear a mask on public transport, where social distancing is impossible, conflicts with someone elseâs choice to travel to work as safely as they can. As the critics of this policy and work in public health ethics notes, one personâs choice can have a significant detrimental effect on others, and in situations like this, such as this mask wearing example, where not allowing choice, that is maintaining the legally mandated requirement to wear a face mask (unless there are reasons for an exemption), is an ethically acceptable restriction on âpersonal choice.â In Walkerâs terminology disallowing this choice it is not demeaning or stigmatising, as it applies to everyone, and does not fail to recognise any particular person or group as equal members of society.Choice is often portrayed as a good thing like parenthood and apple pie and the use of choice by politicians to whip up support and bolster their political agendas, as shown by the examples of Blair and Johnson, shows the rhetorical power of the concept. But to really address in what circumstances choices should be offered, to whom and what type of choice, we need theoretical tools to help us understand and be attentive to the wider implications and the papers in this Issue help us to do that.Ethics statementsPatient consent for publicationNot applicable.Ethics approvalThis study does not involve human participants.IntroductionLarge-scale, international data sharing opens the door to the study of so-called âBig Dataâ, which holds great promise for improving patient-centred care.
Big Data health research is envisioned to take precision medicine to the next level through increased understanding of disease aetiology and phenotypes, treatment effects, disease management and healthcare expenditure.1 However, lack of public trust is proven to be detrimental to the goals of data sharing.2 The case of care.data in the UK offers a blatant example of a data sharing initiative gone awry. Criticism predominantly focused on limited public awareness and lack of clarity on the goals of the programme and ways to opt out.3 Citizens are becoming increasingly aware and critical of data privacy issues, and this warrants renewed investments to maintain public trust in data-intensive health research. Here, we use the term data-intensive health research to refer to a practice of grand-scale capture, (re)use and/or linkage of a wide variety of health-related data on individuals.Within the European Union (EU), the recently adopted General Data Protection Regulation (GDPR) (EU 2016/679) addresses some of the concerns the public may have with respect to privacy and data protection.
One of the primary goals of the GDPR is to give individuals control over their personal data, most notably through consent.4 Other lawful grounds for the processing of personal data are listed, but it is unclear how these would exactly apply to scientific research. Legal norms remain open to interpretation and thus offer limited guidance to researchers.5 6 In Recital 33, the GDPR actually mentions that additional ethical standards are necessary for the processing of personal data for scientific research. This indicates a recognised need for entities undertaking activities likely to incite public unease to go beyond compliance with legal requirements.7 Complementary ethical governance then becomes a prerequisite for securing public trust in data-intensive health research.A concept that could be of use in developing ethical governance is that of a âsocial license to operateâ.7 The social license captures the notion of a mandate granted by society to certain occupational groups to determine for themselves what constitutes proper conduct, under the condition that such conduct is in line with societyâs expectations.
The term âsocial licenseâ was first used in the 1950s by American sociologist Everett Hughes to address relations between professional occupations and society.8 The concept has been used since to frame, for example, corporate social responsibility in the mining industry,9 governance of medical research in general8 and of data-intensive health research more specifically.7 10 As such, adequate ethical governance then becomes a precondition for obtaining a social license for data sharing activities.Key to an informed understanding of the social license is identifying the expectations society may hold with regard to sharing of and access to health data. Here, relevant societal actors are the subjects of Big Data health research, constituting both patients and the general public. Identification of patientsâ and public views and attitudes allows for a better understanding of the elements of a socially sanctioned governance framework.
We know of the existence of research papers that have captured these views using quantitative or qualitative methods or a combination of both. So far, systematic reviews of the literature have limited their scope to citizens of specific countries,11 12 qualitative studies only13 or the sharing of genomic data.14 Therefore, we performed an up-to-date narrative review of both quantitative and qualitative studies to explore predominant patient and public views and attitudes towards data sharing for health research.MethodsWe searched the literature databases PubMed (MEDLINE), Embase, Scopus and Google Scholar in April 2019 for publications addressing patientsâ and public views and attitudes towards the use of health data for research purposes. Synonyms of the following terms (connected by âANDâ) were used to search titles and/or abstracts of indexed references.
Research (See box 1 and online supplementary appendix 1). To merit inclusion, an article had to report results from an original research study (qualitative, quantitative or mixed methods) on attitudes of individuals regarding use of data for health research. We restricted eligibility to records published in English and studies performed between 2009 and 2019.
We chose 2009 as a lower limit because we assume that patientsâ and public perspectives might have changed substantially with increasing awareness and use of digital (health) technologies. Systematic reviews and meta-analyses synthesising the empirical literature on this topic also qualified for review. Reports from stakeholder meet-ups and workshops were eligible as long as they included patients or the public as participants.
Since we were only interested in empirical evidence, expert opinion and publications merely advocating for the inclusion of patientsâ and public views in Big Data health research were excluded. Studies that predominantly reported on views of other stakeholdersâsuch as clinicians, researchers, policy makers or industryâwere excluded. Articles reporting on conference proceedings, or views regarding (demographic) data collection in low or middle income countries or for public health and care/quality improvement were not considered relevant to this review.
Despite our specific interest in data sharing within the European context, we broadened eligibility criteria to include studies performed in the USA, Canada, Australia and New Zealand. Additional articles were identified through consultation with experts and review of references in the manuscript identified through the literature database searches. Views and attitudes of patients and the public were identified from selected references and reviewed by means of thematic content analysis.Supplemental materialBox 1 Key search terms(patient* OR public OR citizen*)AND(attitude* OR view* OR perspective* OR opinion* OR interview* OR qualitative* OR questionnaire* OR survey*)AND(âdata sharingâ OR âdata accessâ OR âdata transferâ)ANDResearchResultsStudy characteristicsSearches in PubMed (MEDLINE), Embase, Scopus and Google Scholar resulted in a total of 1153 non-unique records (see online supplementary appendix 1).
We identified 27 papers for review, including 12 survey or questionnaire studies (quantitative), 8 interview or focus group studies (qualitative), 1 mixed methods study and 6 systematic reviews (see table 1). Most records were excluded because they were not relevant to our research question or because they did not report on findings from original (empirical) research studies. Ten studies reported on views of patients, 11 on views of the public/citizens and 6 studies combined views of patients, research participants and the public.View this table:Table 1 Study characteristicsWillingness to share data for health researchReviewed papers suggest widespread support for the sharing of data for health research.Four systematic reviews synthesising the views of patients and the public report that willingness for data to be linked and shared for research purposes is high11â14 and that people are generally open to and understand the benefits of data sharing.15Outpatients from a German university hospital who participated in a questionnaire study (n=503) expressed a strong willingness (93%) to give broad consent for secondary use of data,16 and 93% of a sample of UK citizens with Parkinsonâs disease (n=306) were willing to share their data.17 Wide support for sharing of data internationally18 19 and in multicentre studies20 was reported among patient participants.
Goodman et al found that most participants in a sample of US patients with cancer (n=228) were willing to have their data made available for âas many research studies as possibleâ.21 Regarding the use of anonymised healthcare data for research purposes, a qualitative study found UK rheumatology patients and patient representatives in support of data sharing (n=40).22Public respondents in survey studies recognised the benefits of storing electronic health information,23 and 78.8% (n=151) of surveyed Canadians felt positive about the use of routinely collected data for health research.24 The majority (55%) of a sample of older Swiss citizens (n=40) were in favour of placing genetic data at disposal for research.25 Focus group discussions convened in the UK showed that just over 50% of the members of the Citizens Council of The National Institute for Health and Care Excellence (NICE) said they would have no concerns about NICE using anonymised data derived from personal care records to evaluate treatments,26 and all participants in one qualitative study were keen to contribute to the National Healthcare Service (NHS)-related research.27Motivations to share dataPatients and public participants expressed similar reasons and motivations for their willingness to share data for health research, including contributing to advancements in healthcare, returning incurred benefits and the hope of future personal health benefits (tables 2â4).View this table:Table 2 Patientsâ views and attitudes towards the sharing of health data for researchView this table:Table 3 Public views and attitudes towards the sharing of health data for researchView this table:Table 4 Patientsâ and public views and attitudes towards the sharing of health data for researchIn the two systematic reviews that addressed this topic, sharing data for âthe common goodâ or âthe greater goodâ was identified as one of the most prevalent motivations.12 14For patients specifically, to help future patients or people with similar health problems was an important reason.14 16 One survey study conducted among German outpatients found that 72% listed returning their own benefits incurred from research as a driver for sharing clinical data.16 Patients with rare disease were also motivated by âgreat hope and trustâ in the development of international databases for health research.19 Among patients, support of research in general,16 the value attached to answering âimportantâ research questions,20 and a desire to contribute to advancements in medicine14 were prevalent reasons in favour of data sharing. Ultimately, the belief that data sharing could lead to improvements in health outcome and care was reported.20Only one original study research paper addressed public motivations. This study found that older citizens mentioned auistic reasons and the greater good in a series of interviews as reasons to share genetic data for research.25 In these interviews, citizens expressed no expectations of an immediate impact or beneficial return but ultimately wanted to help the next generation.Perceived benefits of data sharingPatients and the public perceive that data sharing could lead to better patient care through improved diagnosis and treatment options and more efficient use of resources.
Patients seem to also value the potential of (direct) personal health benefits.Two systematic reviews reported on perceived benefits of data sharing for health research purposes. Howe et al mentioned perceived benefits to research participants or the immediate community, benefits to the public and benefits to research and science.15 Shabani et al also listed accelerating research advancement and maximising the value of resources as perceived benefits.14Surveyed patients perceived that data sharing could help their doctor âmake better decisionsâ about their health (94%, n=3516)28 or result in an increased chance of receiving personalised health information (n=228).21In the original studies reviewed, advantages and potential benefits of data sharing were generally recognised by public and patient participants.22 29 Data sharing was believed to enable the study of long-term treatment effects and rare events, as well as the study of large numbers of people,24 to improve diagnosis25 and treatment quality,20 23 as well as to stimulate innovation30 and identify new treatment options.25 A cross-sectional online survey among patient and citizen groups in Italy (n=280) also identified the perception that data sharing could reduce waste in research.30Perceived risks of data sharingThe most significant risks of data sharing were perceived to results from breaches of confidentiality, commercial use and potential abuse of the data.Systematic reviews report on patientsâ and public concerns about confidentiality in general,13 15 sometimes linked to the risk of reidentification,14 concerns about a party's competence in keeping data secure,12 and concerns that personal information could be mined from genomic data.14 A systematic review by Stockdale et al identified concerns among the public (UK and Ireland) about the motivation a party might have to use the data.14Patients in a UK qualitative study (n=40) perceived âdetrimentalâ consequences of data âfalling into the wrong handsâ, such as insurance companies.22 Respondents from the online patient community PatientsLikeMe were fearful of health data being âstolen by hackersâ (87%, n=3516).28Original research studies flagged data security and privacy as major public concerns.16 18 20 25 26 29â32 More specifically, many studies found that participants worried about who would have access to the data and about risk of misuses or abuses.13 15 18 25 27 33 A large pan-European survey among respondents from 27 EU member states revealed public concerns about different levels of access by third parties (48.9%â60.6%, n=20â882).23 Overall, reviewed papers suggest that patients and the public are concerned about the use of their data for commercial purposes.14 27 For example, the NICE Citizens Council expressed concerns about the potential for data to be sold to other organisations and used for profit and for purposes other than research.26 The Citizens Council also highlighted the need for transparency about how data are used and how it might be used in the future and for ensuring the research is conducted according to good scientific practice and that data are used to benefit society. Concerns about control and ownership of data were identified13 33 and about re-use of data for purposes that participants do not agree on.30 Fear of discrimination, stigmatisation, exploitation or other repercussions as a consequence of data being shared was widely cited by individuals.14 15 18Barriers to share dataStudies showed that patients and the public rarely mention barriers to data sharing in absolute terms.
Rather, acceptance seemed to decrease if data sharing was financially motivated, and if people did not know how and with whom their data would be shared.First, individuals often opposed data sharing if it was motivated by financial gain or profit20 or if the data were shared with commercial/private companies.14 15 In one large pan-European survey (n=20â882), respondents were found to be strongly averse to health insurance companies and private sector pharmaceutical companies viewing their data.23 Second, lack of understanding and awareness around the use of data was viewed as a barrier to data sharing.15 22 Third, lack of transparency and controllability in releasing data were mentioned as factors compromising public trust in data sharing activities.14 22Factors affecting willingness to share dataA wide range of factors were identified from the literature that impacted individualsâ willingness to share data for health research, including geographical factors, age, individual-specific and research-specific characteristics.Geographical factorsMcCormack et al found that European patientsâ expressions of trust and attitudes to risk were often affected by the regulatory and cultural practices in their home countries, as well as by the nature of the (rare) disease the patient participant had.18 Shah et al conducted a survey among patients in four Northern European countries (n=855) and found a significant association between country and attitudes towards sharing of deidentified data.34 Interestingly, Dutch respondents were less likely to support sharing of their deidentified data compared with UK citizens.AgeAmong a sample of surveyed patients with Parkinsonâs disease (UK), a significant association was found between higher age and increased support for data sharing.17 According to a study based on semistructured interviews with older Swiss citizens, generational differences impacted willingness to share.25 With respect to public attitudes towards data sharing, findings of one systematic review suggest that males and older people are more likely to consent to sharing their medical data.27 A systematic review by Shabani et al suggests that patient and public participants with higher mean age are substantially less worried about privacy and confidentiality than other groups.14Individual-specific characteristicsA systematic review into patientsâ and public perspectives on data sharing in the USA suggests that individuals from under-represented minorities are less willing to share data.11 A large multisite survey (n=13â000) among the US public found that willingness to share was associated with self-identified white race, higher educational attainment and lower religiosity.31 In another systematic review, race, gender, age, marital status and/or educational level all seemed to influence how people perceived sensitivity of genomic data and the sharing thereof.14 However, a UK study among patients with Parkinsonâs disease found no clear relationship between data sharing and the number of years diagnosed, sex, medication class or health confidence.17Factors that clearly positively affected attitudes towards data sharing were perceptions of the (public) benefits and value of the research,13 20 fewer concerns and fewer information needs,31 and higher trust in and reputation of individuals or organisations conducting and/or overseeing data sharing.12â14 35 Conversely, willingness decreased with higher privacy and confidentiality concerns11 and higher distrust of the government as an oversight body for (genetic) research data.35Research-specific characteristicsPrivacy measures increased peopleâs willingness to share their data for health research, such as removal of social security numbers (90%, n=3516) and insurance ID (82%, n=3516), the sharing of only summary-level or aggregate data20 and deposition of data in a restricted access online database.29 Expressions of having control over what data are shared and with whom positively affected attitudes towards data sharing.34 In one study, being asked for consent for each study made participants (81%) feel ârespected and involvedâ, and 74% agreed that they would feel that they âhad controlâ.14 With respect to data sharing without prospective consent, participants became more accepting after being given information about the research processes and selection bias.27 Less support was observed for data sharing due to financial incentives25 and, more specifically, if data would be shared with private companies, such as insurance or pharmaceutical companies.11 25Conditions for sharingWidespread willingness to share data for health research very rarely led to participantsâ unconditional support. Studies showed agreement on the following conditions for responsible data sharing. Value, privacy, minimising risks, data security, transparency, control, information, trust, responsibility and accountability.ValueOne systematic review found that participants found it important that the research as a result of data sharing should be in the publicâs interest and should reflect participantsâ values.15 The NICE Citizens Council advocated for appropriate systems and good working practices to ensure a consistent approach to research planning, data capture and analysis.26Privacy, risks and data securityThe need to protect individualsâ privacy was considered paramount11 14 21 34 and participants often viewed deidentification of personal data as a top privacy measure.11 24 30 36 One survey among US patients with cancer found that only 20% (n=228) of participants found linkage of individuals with their deidentified data acceptable for return of individual health results and to support further research.21 Secured access to databases was considered an important measure to ensure data security in data sharing activities.30 34 A systematic review of participantsâ attitudes towards data sharing showed that people established risk minimisation as another condition for data sharing.15 Findings by Mazor et al suggest that patients only support studies that offer value and minimise security risks.20Transparency and controlConditions regarding transparency were information about how data will be shared and with whom,14 35 the type of research that is to be performed, by whom the research will be performed,16 information on data sharing and monitoring policies and database governance,35 conditions framing access to data and data access agreements,24 28 30 and any partnerships with the pharmaceutical industry.19 More generally, participants expressed the desire to be involved in the data sharing process,35 to be notified when their data are (re)used and to be informed of the results of studies using their data.15 Spencer et al identified use of an electronic interface as a highly valued means to enable greater control over consent choices.22 When asked about the use of personal data for health research by the NHS, UK citizens were typically willing to accept models of consent other than the ones they would prefer.37 Acceptance of consent models with lower levels of individual control was found to be dependent on a number of factors, including adequate transparency, control over detrimental use and commercialisation, and the ability to object, particularly to any processing considered to be inappropriate or particularly sensitive.37Information and trustOne systematic review identified trust in the ability of the original institution to carry out the oversight tasks as a major condition for responsible data sharing.14 Appropriate education and information about data sharing was thought to include public campaigns to inform stakeholders about Big Data32 and information communicated at open days of research institutions (such as NICE) to ensure people understand what their data are being used for and to reassure them that personal data will not be passed on or sold to other organisations.26 The informed consent process for study participation was believed to include information about the fact that individualsâ data could potentially be shared,15 30 the objectives of data sharing and (biobank) research, the studyâs data sharing plans,29 governance structure, logistics and accountability.33Responsibility and accountabilityParticipants often placed the responsibility for data sharing practices on the shoulders of researchers.
Secondary use of data collected earlier for scientific research was viewed to require a data access committee that involves a researcher from the original research project, a clinician, patient representative and a participant in the original study.36 Researchers of the original study were required to monitor data used by other researchers.36 In terms of accountability, patient and public groups in Italy (n=280) placed high value on sanctions for misuse of data.30 Information on penalties or other consequences of a breach of protection or misuse was considered important by many.31 35DiscussionIn this study, we narratively reviewed 27 papers on patientsâ and public views on and attitudes towards the use of health data for scientific research. Studies reported a widespreadâthough conditionalâsupport for the linkage and sharing of data for health research. The only outlier seems to be the finding that just over half (n=25) of the NICE Citizens Council answered ânoâ to the question whether they had any concerns if NICE used anonymised data to fill in the gaps if NICE was not getting enough evidence in âthe usual waysâ.26 However, we hasten to point out that the question about willingness to share is different from the question whether people have concerns or not.
In addition, after a 2-day discussion meeting Council members were perhaps more sensitised to the potential concerns regarding data sharing. Therefore, we suggest that the way and context within which questions are phrased may influence the answers people give.Overall, people expressed similar motivations to share their data, perceived similar benefits (despite some variation between patients and citizens), yet at the same time displayed a range of concerns, predominantly relating to confidentiality and data security, awareness about access and control, and potential harms resulting from these risks. Both patient and public participants conveyed that certain factors would increase or reduce their willingness to have their data shared.
For example, the presence of privacy-protecting measures (eg, data deidentification and the use of secured databases) seemed to increase willingness to share, as well as transparency and information about data sharing processes and responsibilities. The identified views and attitudes appeared to come together in the conditions stipulated by participants. Value, privacy and confidentiality, minimising risks, data security, transparency, control, information, trust, responsibility and accountability.In our Introduction, we mentioned that identifying patientsâ and public views and attitudes allows for a better understanding of the elements of a socially sanctioned governance framework.
In other words, what work should our governance framework be doing in order to obtain a social license?. This review urges researchers and institutions to address peopleâs diverse concerns and to make an effort to meet the conditions identified. Without these conditions, institutions lack trustworthiness, which is vital for the proceedings of medicine and biomedical science.
As such, a social license is not a ânice to haveâ but a âneed to haveâ. Our results also confirm that patients and the public indeed care about more than legal compliance alone, and wish to be engaged through information, transparency and control. This work supports the findings of a recent systematic review into ethical principles of data sharing as specified in various international ethical guidelines and literature.38 What this body of research implies is considerable diversity of values and beliefs both between and within countries.The goal of this narrative review was to identify the most internationally dominant, aggregated patient and public views about the broad topic of data sharing for health research.
We deliberately opted for the methodology of a narrative review rather than a systematic review. Most narrative reviews deal with a broad range of issues to a given topic rather than addressing a particular topic in depth.39 This means narrative reviews may be most useful for obtaining a broad perspective on a topic, and that they often are less useful in generating quantitative answers to specific clinical questions. However, because narrative reviews do not require specification of the search and selection strategy and the way of critically appraising literature can be variable, the connection between evidence generated by narrative reviews and (clinical) recommendations is less rigorous and risk of bias exists.
This is something to take into account in this study. A risk of bias assessment was not possible due to the heterogeneity of the findings. We acknowledge that our methodological choices may have affected the discriminative power or granularity of our findings.
For example, there is a difference between sharing of routinely collected health data versus secondary use of health data collected for research purposes. And we can only make loose assumptions about potential differences between patient and public views.In addition, we should mention that this work is centred around studies conducted in Western countries as the whole Big Data space and literature is dominated by Western countries, higher socioeconomic status and Caucasians. However, most of the disease burden globally and within countries is most probably not represented in the âBig Dataâ and so we have to stress the lack of generalisability to large parts of the world.Nevertheless, we believe our findings point towards essential elements of a governance framework for data sharing for health research purposes.
If we are to conclude that the identified conditions ought to act as the pillars of a governance framework, the next step is to identify how these conditions could be practically operationalised. For example, if people value information, transparency and control, what type of consent is most likely to valorise these conditions?. And what policy for returning research results would be desirable?.
Once we know what to value, we can start thinking about the ways to acknowledge that value. A new challenge arising here, however, is what to do when people hold different or even conflicting values or preferences. Discrete choice experiments could help to test peopleâs preferences regarding specific topics, such as preferred modes of informed consent.
Apart from empirical work, conceptual analysis is needed to clarify how public trust, trustworthiness of institutions and accountability are interconnected.ConclusionThis narrative review suggests widespreadâthough conditionalâsupport among patients and the public for data sharing for health research. Despite the fact that participants recognise actual or potential benefits of health research, they report a number of significant concerns and related conditions. We believe identified conditions (eg, social value, data security, transparency and accountability) ought to be operationalised in a value-based governance framework that incorporates the diverse patient and public values, needs and interests, and which reflects the way these same conditions are met, to strengthen the social license for Big Data health research.Ethics statementsPatient consent for publicationNot required.AcknowledgmentsWe thank Susanne Løgstrup (European Heart Network) and Evert-Ben van Veen (Medlaw) for their valuable feedback during various stages in drafting the manuscript..
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