It's not (just) about privacy: a new perspective on health databases.Introduction
Low-cost computing power has made possible the storage and analysis of large quantities of health data. Individual electronic health records (EHRs) offer the potential for major improvements both in patient care and in the extent and quality of data available for population health research. The Canadian government has committed more than $1 billion in infrastructure funds for the so-called Canada Health Infoway Canada Health Infoway is a strategic investor working with Canadian jurisdictions to accelerate the development of electronic health records. According to their website, it is an independent, not-for-profit organization whose Members are Canada's 14 federal, provincial and , with a specific mandate to accelerate the development of EHR (Electronic Health Records) Computerized medical records that bring patient care into the digital age and save time, money and lives. The push to adopt comprehensive electronic documentation between doctors' offices and hospital settings intensified after the RAND systems across Canada Across Canada was an afternoon program that formerly aired on The Weather Network. The segment ran from early 1999 until mid 2002. The show ran from 3:00PM ET until 7:00 PM ET. . Several provincial governments are actively supporting complementary initiatives. (1) In addition to facilitating secondary uses of data that were gathered in the course of providing and financing health care, the 'information revolution' facilitates multiple, low-cost analyses of data gathered for research purposes. The proposed Canadian Lifelong Health Initiative (CLHI) relies on this capability. This longitudinal prospective research program would involve both an early birth cohort and an aging cohort. Health status information, information related to various social determinants of health Social determinants of health are the economic and social conditions under which people live which determine their health. Virtually all major diseases are primarily determined by specific exposures to these conditions. , and biological materials would be collected and maintained as a "research platform" to support multiple individual research studies, over a period of decades. (2) A larger scale study in the UK (Biobank) will collect baseline data and blood samples from 500,000 people aged 45-69 years, who will be followed for at least 10 years. (3) Such projects offer unprecedented opportunities to study interactions between genetic variations and environmental variables, which can and should be defined in the broadest sense, and to provide an evidence base for policies and interventions to improve population health.
Somewhat belatedly, legislative and policy attention has focussed on the ethical and social implications of these new technological capabilities. In the United States United States, officially United States of America, republic (2005 est. pop. 295,734,000), 3,539,227 sq mi (9,166,598 sq km), North America. The United States is the world's third largest country in population and the fourth largest country in area. , the main national response has been a health information privacy rule under the Health Insurance Portability and Accountability Act The Health Insurance Portability and Accountability Act (HIPAA) was enacted by the U.S. Congress in 1996.
According to the Centers for Medicare and Medicaid Services (CMS) website, Title I of HIPAA protects health insurance coverage for workers and their families when (HIPAA (Health Insurance Portability & Accountability Act of 1996, Public Law 104-191) Also known as the "Kennedy-Kassebaum Act," this U.S. law protects employees' health insurance coverage when they change or lose their jobs (Title I) and provides standards for patient health, ) of 1996. (4) In Canada, legislation governing commercial users of health information and federally regulated industries--the Protection of Personal Information and Electronic Documents Act (5)--which came fully into force in January 2004, complementing a variety of existing federal and provincial privacy statutes. (6) However, this article is concerned not with the content and implementation of these requirements, but rather with a key omission in the underlying ethical and public policy rationale.
Privacy, and Beyond
At least in the Anglo-American countries, ethical analysis of research involving health data is highly individualistic. It tends to focus on potential encroachments on individual privacy; on preventing unauthorized or inappropriate access to data related to the health status of a particular, identifiable individual; and (when data are gathered specifically for research purposes) on the nature of the process by which consent is obtained from research participants. (7) If confidentiality can be assured, then many ethical problems are considered solved, even if data were originally collected with no indication that they would subsequently be used for research purposes. For instance, the Tri-Council Policy Statement (TCPS TCPS Tissue Culture Polystyrene
TCPS Transportable Collective Protection Shelter
TCPS Telemetry and Command Processing System
TCPS Tcp for Ssl ) that provides guidelines for ethics review of federally funded research in Canada states that secondary use of data "becomes of concern only when data can be linked to individuals." (8) Commentators often presume that a legitimate tradeoff exists between individuals' wishes to control use of information they have provided and society-wide benefits in the form of improved health system performance or improved understanding of the determinants of health. (9) When data are gathered specifically for research, ethical debate tends to focus on the question of whether and how the process of obtaining consent can take into account uses of data that might not be envisioned at the time the participant is originally recruited, and the circumstances under which renewed or amended consent should be sought. (10) Somewhat paradoxically, this has the effect of setting a more demanding ethical standard when individuals are clearly informed that data are being gathered for research purposes than for research involving administrative and clinical data gathered in the course of providing health care or other services.
Ethics analysis of research uses of health data, whether or not they were gathered for research purposes, generally ignores harms or benefits that may result for individuals not because they are personally identified, but because of shared characteristics: they are part of a population whose interests and well-being are affected by the research or by its subsequent dissemination and use. A partial exception to this generalization involves literature on population genetics Population genetics
The study of both experimental and theoretical consequences of mendelian heredity on the population level, in contradistinction to classical genetics which deals with the offspring of specified parents on the familial level. , where some authors acknowledge that potential harms to individuals, by virtue of their identification as members of a definable group or community (e.g., with high genetic vulnerability to a particular condition), should be considered when choices are made about such matters as how research is explained to participants and how consent is obtained. (11) The issue of "group consent", however, remains contentious. (12)
As important as they are, privacy and confidentiality are only part of the ethics equation. Justice is one of the canonical "four principles" of bioethics bioethics, in philosophy, a branch of ethics concerned with issues surrounding health care and the biological sciences. These issues include the morality of abortion, euthanasia, in vitro fertilization, and organ transplants (see transplantation, medical). , at least in its North American North American
named after North America.
North American blastomycosis
see North American blastomycosis.
North American cattle tick
see boophilusannulatus. version. (13) Crucially, justice includes distributive justice DISTRIBUTIVE JUSTICE. That virtue, whose object it is to distribute rewards and punishments to every one according to his merits or demerits. Tr. of Eq. 3; Lepage, El. du Dr. ch. 1, art. 3, Sec. 2 1 Toull. n. 7, note. See Justice. , and should (in the author's view) incorporate special concern for populations disadvantaged by one or more of the interacting gradients of power and powerlessness (class, gender, education, (dis)ability, stigmatization stigmatization /stig·ma·ti·za·tion/ (stig?mah-ti-za´shun)
1. the developing of or being identified as possessing one or more stigmata.
2. the act or process of negatively labelling or characterizing another. ) that characterize contemporary society.
The central argument of this article is that ethical analysis and institutional approval of population health research must be explicitly concerned with avoiding harms to subordinated or marginalized populations. Terminology is important here: 'population' is preferable to 'community' or 'group,' since each of these implies an element of self-recognition and internal cohesion. (14) The descriptors 'subordinated' and 'marginalized,' although imperfect, are pre- ferable to 'vulnerable.' Vulnerability connotes lack of agency and a need for paternalistic pa·ter·nal·ism
A policy or practice of treating or governing people in a fatherly manner, especially by providing for their needs without giving them rights or responsibilities. protection, and references to vulnerable populations in bioethics often address individual inability to provide fully informed consent for legal or other reasons, which is not the issue here. Suggestions for improvement are invited.
The argument made here was, in fact, noted but not elaborated upon in a recent compilation of case studies on secondary use of personal information published by the Canadian Institutes of Health Research Canadian Institutes of Health Research (CIHR) is the major federal agency responsible for funding health research in Canada. It is the successor to the Medical Research Council of Canada. (CIHR CIHR Canadian Institutes of Health Research
CIHR Cambodian Institute of Human Rights ): "While the right to privacy is essentially recognized in law as an individual human right, collecting, using and linking personal information about many individuals, then analyzing that information and drawing generalizable conclusions from it may sometimes result in potential discriminatory harm to communities of individuals in certain circumstances." (15) So far, the problematique has been stated in abstract terms those which express abstract ideas, as beauty, whiteness, roundness, without regarding any object in which they exist; or abstract terms are the names of orders, genera or species of things, in which there is a combination of similar qualities.
See also: Abstract . Its importance can be illustrated with reference to three scenarios. These are distinctive in that none of them involves genetic information. Debate continues about whether the collection, storage and use of genetic information in population health research raise truly distinctive ethical issues ("genetic exceptionalism Genetic exceptionalism is a genetic policy approach taken by state legislatures to safeguard genetic information in the United States. The approach builds upon the existing protection required of general health information provided by such regulations as Health Insurance Portability and "). (16) Thus, one can remain agnostic on this point while nevertheless acknowledging the existence and importance of a range of ethical issues that go beyond privacy.
What's Wrong with These Pictures?
Scenario 1 -- A record linkage Record linkage (RL) refers to the task of finding entries that refer to the same entity in two or more files. Record linkage is an appropriate technique when you have to join data sets that do not have a unique database key in common. study is designed to document health status differences among workers in the health care sector, investigate predictors of long-term disability claims for musculoskeletal musculoskeletal /mus·cu·lo·skel·e·tal/ (-skel´e-t'l) pertaining to or comprising the skeleton and muscles.
Relating to or involving the muscles and the skeleton. and mental health disorders, and identify characteristics of the health care workplace that are associated with increased risk of these disorders. The study links a database maintained by the benefits provider for health care workers with data on health service use obtained by the provincial Ministry of Health, and with workers' compensation workers' compensation, payment by employers for some part of the cost of injuries, or in some cases of occupational diseases, received by employees in the course of their work. claims. (17). Published results subsequently show that workers older than 45 are more likely than their younger, but otherwise comparable counterparts, to file long-term disability claims.
Scenario 2 -- Using either a pre-post or RCT RCT Randomized Controlled Trial
RCT Regimental Combat Team (infantry regiment with their own artillery, engineers, medical and tanks)
RCT Rollercoaster Tycoon
RCT Randomized Clinical Trial
RCT Rhondda Cynon Taff design (the distinction is not important for purposes of this article), chart audits are used in a program evaluation Program evaluation is a formalized approach to studying and assessing projects, policies and program and determining if they 'work'. Program evaluation is used in government and the private sector and it's taught in numerous universities. to assess the effect of introducing mobile mental health crisis teams in one or more mid-size cities on use of hospital emergency rooms, which are routine 'last resort' ports of call for people with certain psychiatric diagnoses. Because only anonymized data are used in the study, ethics review is expedited and individual consent to the research use of chart data is not required. (18) Reductions in the outcome of interest are identified, but these are not statistically significant at conventional 95 percent confidence levels. Citing this negative result and its commitment to evidence-based service planning, the health authority responsible for funding priorities decides not to fund mobile crisis teams in the future, and to terminate the funding for existing teams.
Scenario 3 -- Data from a national survey of health and household characteristics are used to assess the relations among children's activities, obesity, and family characteristics. Published results identify a negative correlation Noun 1. negative correlation - a correlation in which large values of one variable are associated with small values of the other; the correlation coefficient is between 0 and -1
indirect correlation between household income and obesity, and also identify growing up in a single-parent household as a risk factor for obesity in childhood and adolescence. The lead investigator explains the connection to the media: "The more convenient television or video game thing serves as a very good surrogate to a partner that keeps the kids safe and quiet and so forth." (19)
Each scenario raises important ethical issues that have nothing to do with privacy, and points to the importance of integrating concern for differentials in power and privilege into both the design and anticipated use of research studies. In the first scenario, employers might well use the results of the research as a basis for favouring younger employees in the recruitment process, for reasons that would be justifiable on the basis of 'bottom-line' considerations: limiting workers' compensation premiums and costs for privately provided long-term disability insurance. This choice might also be impermissible im·per·mis·si·ble
Not permitted; not permissible: impermissible behavior.
im under anti-discrimination statutes, but meeting a legal standard of proof with respect to discrimination, especially age discrimination, is always expensive and time-consuming. Since mental health disorders constitute one of the studied categories of disability claims, various considerations related to the stigmatization of people living with mental illness (20) are also an issue.
The second scenario demands considerations of how 'negative' results are defined and interpreted. Emergency room usage, although relevant to institutional and financial concerns, may not be the most meaningful or patient-centred indicator of therapeutic effectiveness. Perhaps the intervention's apparent lack of effectiveness was due to exogenous factors beyond the control of researchers, such as the introduction of more demanding eligibility criteria for disability benefits or the repeal of rent controls, leading to a drastic increase in housing costs at the bottom end of the rental market. The value dimension involved in the choice of a threshold of statistical significance, and the potential for competing interpretations of 'conservatism' in drawing conclusions about cause and effect, has been extensively discussed in the context of environmental policy; (21) it is also relevant to research on the effectiveness of health and social service interventions. (22)
Unlike the first two, the third scenario involves data collected specifically for research purposes. It is nevertheless troubling, especially because it contains no hypothetical elements. Neither in the article reporting on the research nor in the interview given to Canada's national public broadcaster did the researchers specifically acknowledge the time pressures on single parents, or how those pressures can be compounded by poverty or lack of adequate child care. In 1994, the year in which the data were gathered, 53 percent of all single parent households lived on incomes below Canada's national Low-Income Cutoff; for households headed by single mothers, the overwhelming majority of such households, the figure was 56.4 percent. (23) Income-related contextual factors may also be important in explaining the study findings: downtown neighbourhoods with narrow sidewalks and high levels of vehicle traffic, or high-rise buildings adjacent to multi-lane suburban arterial routes, do not offer the safe and convenient opportunities for outdoor physical activity available in manicured suburban culs-de-sac. (24) Risk of criminal victimization victimization Social medicine The abuse of the disenfranchised–eg, those underage, elderly, ♀, mentally retarded, illegal aliens, or other, by coercing them into illegal activities–eg, drug trade, pornography, prostitution. may also be an issue in some neighbourhoods.
It is unrealistic to state--as do the authors of the most comprehensive study of consent requirements for population-based genetic research--that "the burden of considering group implications falls primarily on the participants themselves," (25) and this position is of course inapplicable in·ap·pli·ca·ble
Not applicable: rules inapplicable to day students.
in·ap to studies involving secondary uses. Discriminatory or otherwise ethically impermissible use of published or unpublished results may be preventable, if at all, only at prohibitive cost to those adversely affected. The example of mental health services research Health services research is the multidisciplinary field of scientific investigation that studies how social factors, financing systems, organizational structures and processes, health technologies, and personal behaviors affect access to health care, the quality and cost of health care, provides an especially dramatic illustration of how discrepant dis·crep·ant
Marked by discrepancy; disagreeing.
[Middle English discrepaunt, from Latin discrep life situations of researchers and the people they study (26) may create a gap that confounds even the best intentioned and most reflective researchers. As Donna Haraway This article or section is written like a personal reflection or and may require .
Please [ improve this article] by rewriting this article or section in an . writes, "there is good reason to believe vision is better from below the brilliant space platforms of the powerful." (27)
Considerations of equity or distributive justice suggest that ethics review should not be restricted to issues of privacy and confidentiality, although those remain crucially important. Rather, it should provide a deliberative de·lib·er·a·tive
1. Assembled or organized for deliberation or debate: a deliberative legislature.
2. Characterized by or for use in deliberation or debate. context for considering a broader range of harms to all individuals comprising a particular subordinated or marginalized population, whether or not they are participants or data subjects (28) in a particular study. It also needs to take into account potential benefits to the populations of greatest concern. For example, a study of the effects of user charges for prescription drugs in Quebec's provincial drug insurance plan made use of the province's administrative databases on health service utilization and prescriptions filled. It identified substantial negative impacts, including reduced use of essential drugs and an increase in the number of emergency department visits, among the poor and elderly beneficiaries of the plan. (29) Both logistical considerations and response bias would have limited the value of a survey-based approach: "people who are willing to fill out a questionnaire and send it back are likely to be in better health than those who do not. If the researchers had used only the results of surveys to evaluate the impact of the new drug cost-sharing policy, they would have falsely concluded that the drug plan had a very minor impact on these groups of individuals ... " (30) Thus, it cannot be emphasized too strongly that the argument made here is not 'anti-research.' Rather, it is for a more inclusive approach to assessing both potential harms and potential benefits--an approach that, in the case of research on determinants of health at the population level, may have the additional advantage of generating richer, more policy-relevant research designs.
Guidelines for ethics review could be amended to specify create the necessary deliberative context. As noted, the TCPS now appears to foreclose fore·close
v. fore·closed, fore·clos·ing, fore·clos·es
a. To deprive (a mortgagor) of the right to redeem mortgaged property, as when payments have not been made.
b. such deliberation in many cases, so long as privacy and confidentiality are protected. Devising operational definitions of a subordinated or marginalized population is not easy, but any worthwhile definition would include several categories identified in the scenarios (workers injured or made ill by their employment, people with serious mental illness, low-income single parents) as well as, e.g., people living with HIV/AIDS HIV/AIDS Human Immunodeficiency Virus/Acquired Immune Deficiency Syndrome . Alternatively, researchers might be asked to demonstrate the absence of economic or power differentials between themselves and research participants or data subjects sufficient to trigger a review that went beyond considerations of privacy and confidentiality.
Not enough research has been conducted on the operation of the research ethics Research ethics involves the application of fundamental ethical principles to a variety of topics involving scientific research. These include the design and implementation of research involving human participants (human experimentation); animal experimentation; various aspects of boards (REBs) that are responsible for implementing the TCPS and its predecessor guidelines. The lead author of the most recent national study of this topic (31) laments the lack of research on research ethics, and is also highly critical of many aspects of the ethics review process: "Canadian regulators are distracted and generally inattentive in·at·ten·tive
Exhibiting a lack of attention; not attentive.
inat·ten to the ethical challenges of health research" (32) and "all the major actors (including research sponsors, institutions, and regulators) behave as if REB approval is all that there is the ethical conduct of research involving human subjects." (33) Until more is known about REBs and how they function, and until REBs are provided with adequate resources at least to carry out clearly specified existing duties, (34) judgments of feasibility must be set aside even if its concluded that more expansive ethics review is desirable.
A proactive response to the issues raised here, which is more in keeping with the long time frame anticipated for research programs like CLHI, would actively seek out knowledge and experience from outside the research community, by empowering research participants, data subjects and similarly situated similarly situated adj. with the same problems and circumstances, referring to the people represented by a plaintiff in a "class action," brought for the benefit of the party filing the suit as well as all those "similarly situated. individuals. The Social Sciences and Humanities Research Council The Social Sciences and Humanities Research Council of Canada (SSHRC) is an arm's length Canadian federal funding agency. Offering numerous funding programs with a 2006-2007 budget of CAN$306 million for grants and scholarships, and CAN$538 overall, of Canada's Community-University Research Alliance (CURA) funds ongoing collaborations between university researchers and community-based organizations. This innovative model could be applied to many kinds of population health research; indeed, many CURA projects deal either with health directly or with key determinants of health. (35) Members of subordinated or marginalized populations, or advocates for those populations such as labour unions or organizations of psychiatric consumer/survivors, (36) could serve on advisory boards for individual studies. They could also be recruited for the boards or management committees of institutions mandated to manage administrative databases and research platforms, and for the boards and advisory councils of agencies such as CIHR. (37) Representativeness will always be an issue, but imperfect or even inconveniently strident representation is preferable to the silencing of important voices. Agencies like CIHR might award additional points for, or even require: involvement of members of affected populations in defining outcome variables; participatory action models that incorporate multiple perspectives into the design of research projects before protocols are finalized; and, for larger scale research projects, governance structures that specify and formalize the roles of members of vulnerable populations through advisory and steering committees. (38) One or more university-based research centres could compile and maintain a national database of organizational templates for equity-oriented approaches to research design and governance.
This article has suggested, in necessarily generic terms, the need for creativity and innovation in responding to the ethical challenges presented by power imbalances and divergences of perspective between health researchers and members of subordinated or marginalized populations. Some researchers are likely to be sceptical of the need for adding to ethics review requirements that may already be considered burdensome. Others will recognize the proposals made here as part of the evolution of bioethics away from a primary focus on the clinic and the laboratory and toward a broader concern with the social context of health, illness and health research. (39) Prudential considerations are also relevant, especially for funding agencies. Large scale population health research that links a variety of data sources can generate evidence in support of a range of preventive policies and interventions, but it also carries with it the possibility of large scale (and very expensive) failure. This could happen if public mistrust results either in active policy opposition or bias in recruitment of participants--for example, under-representation of precisely those populations whose health is placed most at risk by their social and economic situation. As noted, the scenarios outlined in this article do not involve genetic information, although its collection is integral to the design of research platforms like Biobank and CLHI. Heightened public sensitivities about possible (mis)uses of health information, and the likelihood that those sensitivities will increase during the long time frame contemplated for such studies, mean that scientific researchers and funding agencies committed to such projects are well advised to 'go the extra mile' (or two, or three) to anticipate and address both matters of public perception and genuine ethical problems such as those identified here.
1. Canada Health Infoway, Annual Report 2003 (Toronto, 2003), online: Canada Health Infoway <http://www.canadahealthinfoway.ca/pdf/2003_CHI_AnnualReport.pdf>; David Ticoll "Electronic health records offer big payoff" The Globe and Mail (11 September 2003) B12; Mark Weitz et al., "In Whose Interest? Current Issues in Communicating Personal Health Information: A Canadian Perspective" (2003) 31 J.L. Med. & Ethics 292.
2. Canadian Institutes of Health Research "The Canadian Lifelong Health Initiative--A CIHR Cross Cutting Initiative", online: Canadian Institutes of Health Research <http://www.cihr-irsc.gc.ca/e/strategic/18542.shtmh>>.
3. Virginia Barbour, "UK Biobank UK Biobank is a large long-term study in the United Kingdom (UK) which is investigating the respective contributions of genetic predisposition and environmental exposure (including nutrition, lifestyle, medications etc.) to the development of disease. It began in 2007. : A Project in Search of a Protocol?" (2003) 361 Lancet 1734.
4. 67 Fed. Reg. 53182 (2002).
5. S.C. 2000, c. 5.
6. Patricia Kosseim, ed., A Compendium of Canadian Legislation Respecting the Protection of Personal Information in Health Research (Ottawa: Public Works and Government Services Canada Public Works and Government Services Canada, also referred to as Department of Public Works and Government Services, is the department of the government of Canada with responsibility for the government's internal servicing and administration. , 2000), online: Canadian Institutes of Health Research <http://www.cihr-irsc.gc.ca/e/publications/compendium_e.pdf>; Privacy Commissioner of Canada The Privacy Commissioner of Canada is a special ombudsman and an officer of parliament who reports directly to the House of Commons and the Senate.
The Privacy Commissioner has the authority to investigate complaints filed by Canadian citizens, and report on whether there , Report to Parliament Concerning Substantially Similar Provincial Legislation (Ottawa: Minister of Public Works and Government Services Canada, 2003), online: Privacy Commissioner of Canada <http://www.privcom.gc.ca/legislation/leg-rp_e.asp>.
7. In this article, the term 'research participant' is used to describe individuals from whom data are gathered primarily or exclusively for research purposes, and 'data subject' describes individuals about whom data are gathered for non-research purposes in the course of providing or financing care but are subsequently used for research.
8. Tri-Council Policy Statement on Ethical Conduct for Research Involving Humans (Ottawa: Public Works and Government Services Canada, 2003) at 3.4.
9. Nick Black, "Secondary Use of Personal Data for Health and Health Services Research: Why Identifiable Data are Essential" (2003) 8 J. Health Services Research & Plcy. S1:36; Lawrence Gostin, "Health Information: Reconciling Personal Privacy with the Public Good of Human Health" (2001) 9 Health Care Analysis 321; Nigel Rawson, "Ethical Issues in Pharmacoepidemiologic Research Using Saskatchewan Administrative Health Care Utilization Data" (2001) 10 Pharmacoepidemiology and Drug Safety 607.
10. See e.g. Laura M. Beskow et al., "Informed Consent for Population-Based Research Involving Genetics" (2001) 286 J. Am. Med. Assn. 2315.
11. Ibid.; Charles Weijer & Ezekiel Emmanuel, "Protecting communities in biomedical research Biomedical research (or experimental medicine), in general simply known as medical research, is the basic research or applied research conducted to aid the body of knowledge in the field of medicine. " (2000) 289 Science 1142; Richard R. Sharp & Morris W. Foster, "Involving Study Populations in the Review of Genetic Research" (2000) 28 J.L. Med. & Ethics 41; Charles Weijer, "Protecting Communities in Research: Philosophical and Pragmatic Challenges" (1999) 8 Cambridge Quarterly of Healthcare Ethics 501.
12. Eric T. Juengst, "Groups as Gatekeepers to Genomic Research: Conceptually Confusing, Morally Hazardous, and Practically Useless" (1998) 8 Kennedy Institute Kennedy Institute may mean any of the following:
13. Tom L. Beauchamp & James Childress James Franklin Childress (born 4 October 1940) is a philosopher and theologian mainly concerned with ethics, particularly biomedical ethics. Currently he is the John Allen Hollingsworth Professor of Ethics at the Department of Religious Studies at the University of Virginia. , Principles of Biomedical bi·o·med·i·cal
1. Of or relating to biomedicine.
2. Of, relating to, or involving biological, medical, and physical sciences. Ethics, 5th ed. (New York New York, state, United States
New York, Middle Atlantic state of the United States. It is bordered by Vermont, Massachusetts, Connecticut, and the Atlantic Ocean (E), New Jersey and Pennsylvania (S), Lakes Erie and Ontario and the Canadian province of : Oxford University Press, 2001).
14. Weijer & Emmanuel, supra A relational DBMS from Cincom Systems, Inc., Cincinnati, OH (www.cincom.com) that runs on IBM mainframes and VAXs. It includes a query language and a program that automates the database design process. note 11.
15. Canadian Institutes of Health Research, Secondary Use of Personal Information in Health Research: Case Studies (Ottawa: Public Works and Government Services Canada, 2002) at 111, online: Canadian Institutes of Health Research <http://www.cihr-irsc.gc.ca/e/publications/case_studies_nov2002_e.pdf> [Case Studies].
16. Lawrence Gostin & J.G. Hodge, "Genetic Privacy and the Law: An End to Genetics Exceptionalism ex·cep·tion·al·ism
1. The condition of being exceptional or unique.
2. The theory or belief that something, especially a nation, does not conform to a pattern or norm. "  Jurimetrics 21; Laurie F. Ross, "Genetic Exceptionalism vs. Paradigm Shift A dramatic change in methodology or practice. It often refers to a major change in thinking and planning, which ultimately changes the way projects are implemented. For example, accessing applications and data from the Web instead of from local servers is a paradigm shift. See paradigm. : Lessons from HIV HIV (Human Immunodeficiency Virus), either of two closely related retroviruses that invade T-helper lymphocytes and are responsible for AIDS. There are two types of HIV: HIV-1 and HIV-2. HIV-1 is responsible for the vast majority of AIDS in the United States. " (2001) 29 J.L. Med. & Ethics 141; Zita Lazzarini, "What Lessons Can We Learn from the Exceptionalism Debate (Finally)?" (2001) 29 J.L. Med. & Ethics 149; Sonia M. Suter, "The Allure and Peril of Genetics Exceptionalism: Do We Need Special Genetics Legislation?" (2001) 79 Wash. U.L.Q. 669.
17. This is a condensed con·dense
v. con·densed, con·dens·ing, con·dens·es
1. To reduce the volume or compass of.
2. To make more concise; abridge or shorten.
a. version of the description of an actual British Columbia British Columbia, province (2001 pop. 3,907,738), 366,255 sq mi (948,600 sq km), including 6,976 sq mi (18,068 sq km) of water surface, W Canada. Geography
study in Case Studies, supra note 15 at 120-123.
18. The author was employed on a similar study, which used a pre-post design to evaluate the introduction of a mental health crisis worker in a hospital emergency room in a mid-sized Ontario city, before relocating to another province; the study is still in progress.
19. M.S. Tremblay & J.D. Willms, "Is the Canadian childhood obesity childhood obesity Public health Overweight in a child, an average BMI of ≥ 85% for age and sex; ≥ 95% for age and sex is very obese. See Body-mass index, Obesity. Cf Adult obesity. epidemic related to physical inactivity physical inactivity A sedentary state. Cf Physical activity. ?" (2003) 27 Int. J. Obesity & Related Metabolic Disorders 1100; "Sask Study Confirms TV, PCs Mean Overweight Kids" Canadian Broadcasting Corporation “Radio-Canada” redirects here. For the French language TV arm of the CBC, see Télévision de Radio-Canada.
The Canadian Broadcasting Corporation (CBC), a Canadian crown corporation, is the country’s national public radio and television broadcaster. (15 August 2003), online: Canadian Broadcasting Corporation <http://sask.cbc.ca/regional/servlet/View?filename=overweight030814>.
20. Stephen P. Hinshaw and Dante Cichetti, "Stigma and mental disorder mental disorder
Any illness with a psychological origin, manifested either in symptoms of emotional distress or in abnormal behaviour. Most mental disorders can be broadly classified as either psychoses or neuroses (see neurosis; psychosis). Psychoses (e.g. : Conceptions of illness, public attitudes, personal disclosure, and social policy" (2000), 12 Development & Psychopathology psychopathology /psy·cho·pa·thol·o·gy/ (-pah-thol´ah-je)
1. the branch of medicine dealing with the causes and processes of mental disorders.
2. abnormal, maladaptive behavior or mental activity. 555.
21. Talbot Page, "A Generic View of Toxic Chemicals and Similar Risks" (1978) 7 Ecology L.Q. 207; Beverly Paigen, "Controversy at Love Canal" (1982) 12:3 Hastings Center Report 29; Ted Schrecker, "Using Science in Environmental Policy: Can Canada Do Better?" in Edward A. Parson ed., Governing the Environment: Persistent Challenges. Uncertain Innovations (Toronto: University of Toronto Research at the University of Toronto has been responsible for the world's first electronic heart pacemaker, artificial larynx, single-lung transplant, nerve transplant, artificial pancreas, chemical laser, G-suit, the first practical electron microscope, the first cloning of T-cells, Press, 2001) 31.
22. Ted Schrecker et al., "The Ethics of Social Risk Reduction in the Era of the Biological Brain" (2001) 52 Social Science and Medicine 1677.
23. National Council of Welfare, Child Poverty Profile 1998 (Ottawa, 2001), online: National Council of Welfare <http://www.ncwcnbes.net/htmdocument/reportchildpoverty98/reportchildpoverty98.html>.
24. For a summary of some of the factors that make child and adolescent obesity and its medical sequelae sequelae Clinical medicine The consequences of a particular condition or therapeutic intervention conditions of disadvantage rather than of affluence, see e.g. David Barboza "Rampant Obesity, a Debilitating de·bil·i·tat·ing
Causing a loss of strength or energy.
Weakening, or reducing the strength of.
Mentioned in: Stress Reduction Reality for the Urban Poor" New York Times (26 December 2000) F5; M.P. Galvez, T.R. Frieden & P.J. Landrigan, "Obesity in the 21st century" (2003) 111 Environmental Health Perspectives A684. Much more extensive scientific documentation is available from the author.
25. Beskow et al., supra note 10 at 2319.
26. In 2002 the maximum income provided under the province of Ontario's disability income support program (ODSP ODSP Ontario Disability Support Program (Canada)
ODSP Optical Digital Signal Processing ) was $11,763: National Council of Welfare, Welfare Incomes 2002 (Ottawa, 2003) at 16, online: National Council of Welfare <http://www.ncwcnbes.net/htmdocument/reportwelfinc02/Welfare2002.htm>. By comparison, at least two of the author's mental health research colleagues were earning salaries of over $100,000 in that year (a matter of public record; see Ontario Ministry of Finance, Disclosure for 2002 under The Public Sector Salary Disclosure Act, 1996: Hospitals (Toronto, 2003); Ontario Ministry of Finance, Disclosure for 2002 under The Public Sector Salary Disclosure Act, 1996: Universities (Toronto, 2003). This is like living on two different planets.
27. Donna Haraway, "Situated Knowledges: The Science Question in Feminism and the Privilege of Partial Perspective" (1988) 14 Feminist Studies 575 at 583.
28. See supra note 7.
29. Robyn Tamblyn et al., "Adverse Events Associated With Prescription Drug Cost-Sharing Among Poor and Elderly Persons" (2001) 285 J. Am. Med. Assn. 429.
30. Case Studies, supra note 15 at 88.
31. Michael McDonald et al., The Governance of Health Research Involving Human Subjects (HRIHS HRIHS Health Research Involving Human Subjects (Canada) ) (Ottawa: Law Commission of Canada, 2000), as summarized in Michael McDonald, "Canadian Governance of Health Research Involving Human Subjects: Is Anyone Minding the Store Minding the Store is a 2005 reality TV show starring Pauly Shore. The show is based around Shore trying to revitalize his acting career and run the family business, The Comedy Store. ?" (2001) 9 Health L.J. 1.
32. McDonald, ibid. at 7.
33. Ibid. at 9.
34. See McDonald et al., supra note 31 at 216-219.
35. Social Sciences and Humanities Research Council of Canada The Social Sciences and Humanities Research Council of Canada (French: (le) conseil de recherches en sciences humaine en Canada) (SSHRC/CRSH) is a Canadian federal agency which supports university-based training and research and training in the humanities and social , Community-University Research Alliances (CURA) Backgrounder (Ottawa, 2001), online: SSHRC SSHRC Social Sciences and Humanities Research Council of Canada <http://www.sshrc.ca/web/apply/background/cura2001_backgrounder_e.pdf>.
36. The term "consumer/survivor" is contentious, but widely recognized; see e.g. J. Campbell, "How Consumers/survivors Are Evaluating the Quality of Psychiatric Care" (1997) 21 Evaluation Review 357; Barbara Everett, "Something is Happening: The Contemporary Consumer and Psychiatric Survivor Movement in Historical Context" (1994) 15 J. Mind & Behavior 55; V. Sharma et al., "R, Preferred Terms for Users of Mental Health Services health services Managed care The benefits covered under a health contract among Service Providers and Recipients" (2000) 51 Psychiatric Services 203.
37. The National Breast Cancer Coalition The National Breast Cancer Coalition (NBCC) is a grassroots membership organization, comprised of hundreds of member organizations and tens of thousands of individuals dedicated to ending breast cancer through action and advocacy. has been influential in setting research priorities in the United States, partly because it has established a science training program to enable advocates to contribute the priority-setting process more effectively: J.H. Platner et al., "The Partnership between Breast Cancer Advocates and Scientists" (2002) 39 Environmental and Molecular Mutagenesis mutagenesis /mu·ta·gen·e·sis/ (mu?tah-jen´e-sis)
1. the production of change.
2. the induction of genetic mutation.
n. pl. 102.
38. Ted Schrecker, Joan Bishop & Evelyn Vingilis, "Pluralist Mental Health Systems Research for the Post-institutional Era" (Paper presented to the conference on Making Gains in Mental Health and Addiction, Niagara Falls, Ontario Niagara Falls is a Canadian city of 82,184 residents<ref name="2006CensCommun" /> on the Niagara River in the Golden Horseshoe region of south-central Ontario. It lies across the river from Niagara Falls, New York, and was incorporated on June 12, 1903. , September 2003), online: Canadian Mental Health Association--Ontario <http://www.ontario.cmha.ca/docs/makinggains2003/makinggains2003_schrecker.pdf>.
39. See e.g. Dan Brock, "Broadening the Bioethics Agenda" (2000) 10 Kennedy Institute of Ethics J. 21; Ellen Wright Clayton, "The Complex Relationship of Genetics, Groups, and Health: What it Means for Public Health" (2002) 30 J.L. Med. & Ethics 290; Helen B. Holmes, "When Health Means Wealth, Can Bioethicists Respond?" (2001) 9 Health Care Analysis 213; Sandra D. Lane et al., "Towards a Public Health Approach to Bioethics" (2000) 925 Annals of the New York Academy of Science 25; Colin L. Soskolne, "Ethical, Social, and Legal Issues Surrounding Studies of Susceptible Populations and Individuals" (1997) 105 Environmental Health Perspectives 837; Leigh Turner, "Bioethics, Public Health, and Firearms-Related Violence: Missing Links Between Bioethics and Public Health" (1997) 25 J.L. Med. & Ethics 42.
Ted Shrecker is a Research Associate at the Saskatchewan Population Health and Evaluation Research Unit, University of Saskatchewan The University of Saskatchewan (U of S) is a coeducational public research university located on the east side of the South Saskatchewan River in Saskatoon, Saskatchewan, Canada. The University is celebrating its centennial year in 2007. , Saskatoon Saskatoon (săskətn`), city (1991 pop. 186,058), S central Sask., Canada, on the South Saskatchewan River. , Saskatchewan. The author acknowledges Bartha Maria Knoppers who encouraged the articulation of these ideas in article form. All views expressed are exclusively those of the author.