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  • 1.
    Evers, Kathinka
    et al.
    Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Public Health and Caring Sciences, Centre for Research Ethics and Bioethics.
    Stjernschantz Forsberg, Joanna
    Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Public Health and Caring Sciences, Centre for Research Ethics and Bioethics.
    Eliason, James F.
    What are your views on commercialization of tissues for research?2012In: Biopreservation and Biobanking, ISSN 1947-5535, E-ISSN 1947-5543, Vol. 10, no 6, p. 476-478Article in journal (Refereed)
  • 2.
    Evers, Kathinka
    et al.
    Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Public Health and Caring Sciences, Centre for Research Ethics and Bioethics.
    Stjernschantz Forsberg, Joanna
    Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Public Health and Caring Sciences, Centre for Research Ethics and Bioethics.
    Hansson, Mats
    Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Public Health and Caring Sciences, Centre for Research Ethics and Bioethics.
    Commercialization of Biobanks2012In: Biopreservation and Biobanking, ISSN 1947-5535, E-ISSN 1947-5543, Vol. 10, no 1, p. 45-47Article in journal (Refereed)
    Abstract [en]

    Biobank policy and regulations profoundly vary between different societies. One area with profound differences in culture and tradition concerns commercialization, and the possibility of using the human body as a capital resource. In the United States there is acceptance of this possibility, whereas European law is based on principles that categorically prohibit selling parts of the human body. We suggest that questions of commercialization in the area of biobanking must be considered in relation to different ethical values, notably the principle of best possible use of collected biobank materials for the benefit of vital patient interests.

  • 3.
    Forsberg, Joanna Stjernschantz
    Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Public Health and Caring Sciences, Centre for Research Ethics and Bioethics.
    Comments on the Role of Consent and Individual Autonomy in the PIP Breast Implant Scandal2013In: Public Health Ethics, ISSN 1754-9973, E-ISSN 1754-9981, Vol. 6, no 2, p. 223-226Article in journal (Other academic)
    Abstract [en]

    The featured case discussion on the role of consent and individual autonomy in the PIP breast implant scandal raises interesting and important questions regarding the right of patients (and individuals in general) to decide whether to have their personal data included in medical registries and used for research. The fate of the National Breast Implant Registry, following the introduction of a policy that demanded formally recorded informed consent, is particularly enlightening. Combined with the (ex post) fact that reliable and comprehensive data would have been useful in this specific case, it clearly illustrates the dangers of overemphasizing individual autonomy in observational research. The issue is timely, as the European Commission has recently proposed a new Data Protection Regulation (European Commission, 2012) that may have serious implications for registry based research. In this commentary, I will first discuss two aspects of the regulatory framework that arguably contribute to the problematic situation and then offer an alternative view on why requiring consent should not be the default position in this kind of research.

  • 4.
    Forsberg, Joanna Stjernschantz
    et al.
    Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Public Health and Caring Sciences, Centre for Research Ethics and Bioethics.
    Hansson, Mats G.
    Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Public Health and Caring Sciences, Centre for Research Ethics and Bioethics.
    Eriksson, Stefan
    Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Public Health and Caring Sciences, Centre for Research Ethics and Bioethics.
    Biobank Research and Consent: Authors' reply to Sheehan2011In: The BMJ, E-ISSN 1756-1833, Vol. 343, p. d6901-Article in journal (Refereed)
  • 5.
    Forsberg, Joanna Stjernschantz
    et al.
    Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Public Health and Caring Sciences, Centre for Research Ethics and Bioethics.
    Inoue, Yusuke
    Beware Side Effects of Research Ethics Revision2013In: Science, ISSN 0036-8075, E-ISSN 1095-9203, Vol. 341, no 6152, p. 1341-1342Article in journal (Other academic)
  • 6.
    Forsberg, Joanna Stjernschantz
    et al.
    Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Public Health and Caring Sciences, Centre for Research Ethics and Bioethics.
    Soini, Sirpa
    A big step for Finnish biobanking2014In: Nature reviews genetics, ISSN 1471-0056, E-ISSN 1471-0064, Vol. 15, no 1, p. 6-6Article in journal (Other academic)
  • 7.
    Hansson, Mats G.
    et al.
    Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Public Health and Caring Sciences, Centre for Research Ethics and Bioethics.
    Gattorno, Marco
    Stjernschantz Forsberg, Joanna
    Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Public Health and Caring Sciences, Centre for Research Ethics and Bioethics.
    Feltelius, Nils
    Martini, Alberto
    Ruperto, Nicolino
    Ethics bureaucracy: a significant hurdle for collaborative follow-up of drug effectiveness in rare childhood diseases2012In: Archives of Disease in Childhood, ISSN 0003-9888, E-ISSN 1468-2044, Vol. 97, no 6, p. 561-563Article in journal (Refereed)
  • 8.
    Hansson, Mats G
    et al.
    Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Public Health and Caring Sciences, Centre for Research Ethics and Bioethics.
    Simonsson, Bengt
    Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Medical Sciences, Haematology.
    Feltelius, Nils
    Forsberg, Joanna Stjernschantz
    Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Public Health and Caring Sciences, Centre for Research Ethics and Bioethics.
    Hasford, Joerg
    Medical registries represent vital patient interests and should not be dismantled by stricter regulation2012In: Cancer Epidemiology, ISSN 1877-7821, E-ISSN 1877-783X, Vol. 36, no 6, p. 575-578Article in journal (Refereed)
    Abstract [en]

    BACKGROUND:

    Medical registries serve patients as beneficiaries of quality standards and new treatment opportunities. However, it has been argued that registries threaten patient privacy interests and should therefore be more strictly regulated.

    METHODS AND RESULTS:

    With the European Treatment and Outcome Study for Chronic Myeloid Leukemia as a concrete example we identify and describe how four of the major arguments put forward for stricter regulation fail.

    CONCLUSION:

    We conclude that medical registries should be promoted both for research and quality control, and that the regulatory bureaucratic burden should be reduced.

  • 9.
    Stjernschantz Forsberg, Joanna
    Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Public Health and Caring Sciences, Centre for Research Ethics and Bioethics.
    Biobank Research: Individual Rights and Public Benefit2012Doctoral thesis, comprehensive summary (Other academic)
    Abstract [en]

    The aim of this thesis is to investigate the relationship between individuals and society in the context of healthcare and medical research, more specifically concerning the rights and duties of individuals in regard to biobank-based research. My starting point is that we all have a strong vested interest in improved healthcare, and therefore the possibilities to conduct important research should be optimized. In the first article, I investigate whether individual results from research using samples in large-scale biobanks should be returned. I conclude that there is good reason not to implement such policies, and instead to allocate available resources to pursuing medical advances. In the second article, I compare consent for using stored samples in research with consent for organ donation, whereby many countries have adopted opt-out strategies in order to increase the number of organs available. I claim that the default position should be changed in biobank research as well, i.e. it should be presumed that individuals want to contribute rather than that they do not. In the third article, I argue that safeguarding autonomy by requiring informed consent for using samples in research not only defeats the interests of society but also runs counter to the interests of the individuals the policy purports to protect. Finally, in the fourth article I suggest that it is reasonable to view participation in medical research from the perspective of a social contract, built on our mutual need for medical advances, and that this implies that there is a moral duty to adhere to the contract by allowing one’s samples to be used in research. A central conclusion in this thesis is that biobank research should be viewed as a natural part of healthcare, like quality control, method development and teaching, and that as such, it ought to be endorsed and facilitated.

    List of papers
    1. Changing perspectives in biobank research: from individual rights to concerns about public health regarding the return of results
    Open this publication in new window or tab >>Changing perspectives in biobank research: from individual rights to concerns about public health regarding the return of results
    2009 (English)In: European Journal of Human Genetics, ISSN 1018-4813, E-ISSN 1476-5438, Vol. 17, no 12, p. 1544-1549Article in journal (Refereed) Published
    Abstract [en]

    During the past decade, various guidelines that imply a duty for researchers to disclose information obtained through research to participants have emerged. The character and extent of this obligation have been debated extensively, with much attention devoted to the decisiveness of the validity and utility of the results in question. The aim of this paper is to argue that individual results from research on materials stored in large-scale biobanks, consisting of samples taken within the healthcare system or of altruistically donated materials, should not be returned. We will defend the thesis that medical research on these biobanks should be viewed as a collective project to improve public health, and that available resources should be utilized to pursue this goal. We argue that there is a need for a change of perspectives. Medical research should not primarily be viewed as a danger that individuals must be protected from, but rather be recognized as constituting a necessary defense against current and future diseases. Research that bears the prospect of advancing medicine and that can be carried out at no risk to individuals should be endorsed and facilitated. This calls for a shift of focus from autonomy and individual rights toward collective responsibility and solidarity.

    Keywords
    biobanks, returning results, solidarity, public health, altruism
    National Category
    Medical and Health Sciences
    Research subject
    Bioethics
    Identifiers
    urn:nbn:se:uu:diva-120631 (URN)10.1038/ejhg.2009.87 (DOI)000271911700004 ()19471310 (PubMedID)
    Available from: 2010-03-15 Created: 2010-03-15 Last updated: 2017-12-12
    2. Changing defaults in biobank research could save lives too
    Open this publication in new window or tab >>Changing defaults in biobank research could save lives too
    2010 (English)In: European Journal of Epidemiology, ISSN 0393-2990, E-ISSN 1573-7284, Vol. 25, no 2, p. 65-68Article in journal, Editorial material (Refereed) Published
    Abstract [en]

    In an effort to increase the amount of organs available for transplantation, many countries have implemented presumed consent for organ donation. Presuming a wish to contribute to medical advances through biobank research on previously taken tissue samples could similarly improve health and wellbeing. In this article we analyze common arguments for and against presumed consent for organ donation and assess their relevance in the context of biobank research. In spite of obvious differences between biobank research and organ transplantation the cases for implementing presumption of a positive attitude appear quite analogous. It has repeatedly been shown that a majority of the general population supports these projects and selecting informed consent as the default position decreases the amount of organs and samples available and thus reduces the prospect of promoting health. We conclude that instead of presuming that individuals do not wish to contribute to the advancement of healthcare through biobank research on previously taken samples, ethics committees should presume that they do.

    Keywords
    Biobank, Consent, Ethics, Organ donation
    National Category
    Medical and Health Sciences
    Identifiers
    urn:nbn:se:uu:diva-120633 (URN)10.1007/s10654-009-9413-0 (DOI)000274461600001 ()19957020 (PubMedID)
    Available from: 2010-03-15 Created: 2010-03-15 Last updated: 2017-12-12
    3. Biobank research: who benefits from individual consent?
    Open this publication in new window or tab >>Biobank research: who benefits from individual consent?
    2011 (English)In: The BMJ, E-ISSN 1756-1833, Vol. 343, no Oct 4, p. d5647-Article in journal (Refereed) Published
    Abstract [en]

    Requiring informed consent for research on stored tissue samples and associated data safeguards the autonomy rights of donors. But Joanna Stjernschantz Forsberg, Mats Hansson, and Stefan Eriksson argue that this policy not only defeats the interest of society but also runs counter to the interests of the individuals it purports to protect.

    Keywords
    Biobanks, informed consent, human rights, public good, Biobanker, informerat samtycke, rättigheter, allmänintresse
    National Category
    Ethics
    Research subject
    Bioethics
    Identifiers
    urn:nbn:se:uu:diva-164607 (URN)10.1136/bmj.d5647 (DOI)000295779300002 ()21972296 (PubMedID)
    Available from: 2011-12-21 Created: 2011-12-21 Last updated: 2023-08-28
    4. Why participating in (certain) scientific research is a moral duty
    Open this publication in new window or tab >>Why participating in (certain) scientific research is a moral duty
    2014 (English)In: Journal of Medical Ethics, ISSN 0306-6800, E-ISSN 1473-4257, Vol. 40, no 5, p. 325-328Article in journal (Refereed) Published
    Abstract [en]

    Our starting point in this article is the debate between John Harris and Iain Brassington on whether or not there is a duty to take part in scientific research. We consider the arguments that have been put forward based on fairness and a duty to rescue, and suggest an alternative justification grounded in a hypothetical agreement: that is, because effective healthcare cannot be taken for granted, but requires continuous medical research, and nobody knows what kind of healthcare they will need, participating in research should be viewed from the perspective of a social contract, based on our mutual need for medical advances.

    National Category
    Medical Ethics
    Research subject
    Bioethics
    Identifiers
    urn:nbn:se:uu:diva-171897 (URN)10.1136/medethics-2012-100859 (DOI)000334614100010 ()
    Available from: 2012-03-28 Created: 2012-03-28 Last updated: 2017-12-07
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  • 10.
    Stjernschantz Forsberg, Joanna
    et al.
    Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Public Health and Caring Sciences, Centre for Research Ethics and Bioethics.
    Eriksson, Stefan
    Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Public Health and Caring Sciences, Centre for Research Ethics and Bioethics.
    Presumed consent and taking organs from the unwilling2011In: The BMJ, E-ISSN 1756-1833Article in journal (Other (popular science, discussion, etc.))
  • 11.
    Stjernschantz Forsberg, Joanna
    et al.
    Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Public Health and Caring Sciences, Centre for Research Ethics and Bioethics.
    Eriksson, Stefan
    Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Public Health and Caring Sciences, Centre for Research Ethics and Bioethics.
    Hansson, Mats G
    Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Public Health and Caring Sciences, Centre for Research Ethics and Bioethics.
    Changing defaults in biobank research could save lives too2010In: European Journal of Epidemiology, ISSN 0393-2990, E-ISSN 1573-7284, Vol. 25, no 2, p. 65-68Article in journal (Refereed)
    Abstract [en]

    In an effort to increase the amount of organs available for transplantation, many countries have implemented presumed consent for organ donation. Presuming a wish to contribute to medical advances through biobank research on previously taken tissue samples could similarly improve health and wellbeing. In this article we analyze common arguments for and against presumed consent for organ donation and assess their relevance in the context of biobank research. In spite of obvious differences between biobank research and organ transplantation the cases for implementing presumption of a positive attitude appear quite analogous. It has repeatedly been shown that a majority of the general population supports these projects and selecting informed consent as the default position decreases the amount of organs and samples available and thus reduces the prospect of promoting health. We conclude that instead of presuming that individuals do not wish to contribute to the advancement of healthcare through biobank research on previously taken samples, ethics committees should presume that they do.

  • 12.
    Stjernschantz Forsberg, Joanna
    et al.
    Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Public Health and Caring Sciences, Centre for Research Ethics and Bioethics.
    Hansson, Mats G.
    Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Public Health and Caring Sciences, Centre for Research Ethics and Bioethics.
    Eriksson, Stefan
    Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Public Health and Caring Sciences, Centre for Research Ethics and Bioethics.
    Biobank research: who benefits from individual consent?2011In: The BMJ, E-ISSN 1756-1833, Vol. 343, no Oct 4, p. d5647-Article in journal (Refereed)
    Abstract [en]

    Requiring informed consent for research on stored tissue samples and associated data safeguards the autonomy rights of donors. But Joanna Stjernschantz Forsberg, Mats Hansson, and Stefan Eriksson argue that this policy not only defeats the interest of society but also runs counter to the interests of the individuals it purports to protect.

  • 13.
    Stjernschantz Forsberg, Joanna
    et al.
    Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Public Health and Caring Sciences, Centre for Research Ethics and Bioethics.
    Hansson, Mats G
    Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Public Health and Caring Sciences, Centre for Research Ethics and Bioethics.
    Eriksson, Stefan
    Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Public Health and Caring Sciences, Centre for Research Ethics and Bioethics.
    Changing perspectives in biobank research: from individual rights to concerns about public health regarding the return of results2009In: European Journal of Human Genetics, ISSN 1018-4813, E-ISSN 1476-5438, Vol. 17, no 12, p. 1544-1549Article in journal (Refereed)
    Abstract [en]

    During the past decade, various guidelines that imply a duty for researchers to disclose information obtained through research to participants have emerged. The character and extent of this obligation have been debated extensively, with much attention devoted to the decisiveness of the validity and utility of the results in question. The aim of this paper is to argue that individual results from research on materials stored in large-scale biobanks, consisting of samples taken within the healthcare system or of altruistically donated materials, should not be returned. We will defend the thesis that medical research on these biobanks should be viewed as a collective project to improve public health, and that available resources should be utilized to pursue this goal. We argue that there is a need for a change of perspectives. Medical research should not primarily be viewed as a danger that individuals must be protected from, but rather be recognized as constituting a necessary defense against current and future diseases. Research that bears the prospect of advancing medicine and that can be carried out at no risk to individuals should be endorsed and facilitated. This calls for a shift of focus from autonomy and individual rights toward collective responsibility and solidarity.

  • 14.
    Stjernschantz Forsberg, Joanna
    et al.
    Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Public Health and Caring Sciences, Centre for Research Ethics and Bioethics.
    Hansson, Mats G.
    Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Public Health and Caring Sciences, Centre for Research Ethics and Bioethics.
    Eriksson, Stefan
    Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Public Health and Caring Sciences, Centre for Research Ethics and Bioethics.
    The Risks and Benefits of Re-Consent2011In: Science, ISSN 0036-8075, E-ISSN 1095-9203, Vol. 332, no 6027, p. 306-306Article in journal (Refereed)
  • 15.
    Stjernschantz Forsberg, Joanna
    et al.
    Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Public Health and Caring Sciences, Centre for Research Ethics and Bioethics.
    Hansson, Mats G.
    Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Public Health and Caring Sciences, Centre for Research Ethics and Bioethics.
    Eriksson, Stefan
    Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Public Health and Caring Sciences, Centre for Research Ethics and Bioethics.
    Why participating in (certain) scientific research is a moral duty2014In: Journal of Medical Ethics, ISSN 0306-6800, E-ISSN 1473-4257, Vol. 40, no 5, p. 325-328Article in journal (Refereed)
    Abstract [en]

    Our starting point in this article is the debate between John Harris and Iain Brassington on whether or not there is a duty to take part in scientific research. We consider the arguments that have been put forward based on fairness and a duty to rescue, and suggest an alternative justification grounded in a hypothetical agreement: that is, because effective healthcare cannot be taken for granted, but requires continuous medical research, and nobody knows what kind of healthcare they will need, participating in research should be viewed from the perspective of a social contract, based on our mutual need for medical advances.

  • 16.
    Stjernschantz Forsberg, Joanna
    et al.
    Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Public Health and Caring Sciences, Centre for Research Ethics and Bioethics.
    Hansson, Mats G.
    Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Public Health and Caring Sciences, Centre for Research Ethics and Bioethics.
    Evers, Kathinka
    Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Public Health and Caring Sciences, Centre for Research Ethics and Bioethics.
    International guidelines on biobank research leave researchers in ambiguity: why is this so?2013In: European Journal of Epidemiology, ISSN 0393-2990, E-ISSN 1573-7284, Vol. 28, no 6, p. 449-451Article in journal (Refereed)
  • 17.
    Svensson, Anna C.
    et al.
    Karolinska Inst, Dept Publ Hlth Sci, SE-17177 Stockholm, Sweden..
    Stjernschantz Forsberg, Joanna
    Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Public Health and Caring Sciences, Centre for Research Ethics and Bioethics. Stockholm Cty Council, Ctr Epidemiol & Community Med, Stockholm, Sweden..
    Seblova, Dominika
    Karolinska Inst, Dept Publ Hlth Sci, SE-17177 Stockholm, Sweden.;Stockholm Cty Council, Ctr Epidemiol & Community Med, Stockholm, Sweden..
    Lager, Anton
    Karolinska Inst, Dept Publ Hlth Sci, SE-17177 Stockholm, Sweden.;Stockholm Cty Council, Ctr Epidemiol & Community Med, Stockholm, Sweden..
    Residential area and physical activity: A multi-level study of 68,000 adults in Stockholm County2017In: Scandinavian Journal of Public Health, ISSN 1403-4948, E-ISSN 1651-1905, Vol. 45, no 1, p. 25-32Article in journal (Refereed)
    Abstract [en]

    Aim: To determine whether there are systematic differences in physical activity between residential areas after extensive control for sociodemographic factors at the individual level. Methods: Multi-level regressions of walking/bicycling, sedentary activities, household work and exercise were carried out in a representative sample of 68,303 adults in 39 residential areas in Stockholm County, first adjusting at the individual level for country of birth, sex, age, education, occupational class and income. The type of housing was then considered at the individual level or, for walking/bicycling and exercise, at both the individual and area levels (as a measure of area density). Results: After adjustment for sociodemographic factors, differences between residential areas remained in walking/bicycling, corresponding to 0.27 SD, or 50 min/week between the most and least active areas. Forty per cent of this difference could be explained by the type of housing at the area level. For sedentary activities and household work, respectively, much of the variation that remained after adjustment for sociodemographic factors was, in turn, explained by the type of housing at the individual level, leaving a difference of 0.16 SD (80 min/week) and 0.13 SD (60 min/week), respectively. For exercise, the corresponding difference was 0.11 SD (11 min/week, not sensitive to housing). Conclusions: Area level factors may influence walking/bicycling. High area density was associated with more activity. However, high density also comes with a type of housing (apartments) that is associated with less household work and, surprisingly, more sedentary activities, introducing a challenging trade-off. The differences in exercise were smaller than for all other types of activities.

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