Trudo Lemmens

University of Toronto - Faculty of Law

78 and 84 Queen's Park

Toronto, Ontario M5S 2C5

Canada

SCHOLARLY PAPERS

74

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CITATIONS
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Top 14,890

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34

Scholarly Papers (74)

1.

Regulation of Pharmaceuticals in Canada

CANADIAN HEALTH LAW AND POLICY, 3rd ed., J. Downie, T. Caulfield & C. Flood, ed., Toronto. Butterworths, pp. 318-387, 2007
Number of pages: 56 Posted: 15 Nov 2012 Last Revised: 06 Apr 2014
Trudo Lemmens and Ron Bouchard
University of Toronto - Faculty of Law and University of Manitoba - Faculty of Law (deceased)
Downloads 892 (25,205)

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regulation, pharmaceuticals, drugs, policy, health law

2.

Access to Information and the Right to Health: The Human Rights Case for Clinical Trials Transparency

American Journal of Law and Medicine, Vol. 38, pp. 63-112, 2012
Number of pages: 50 Posted: 27 Sep 2011 Last Revised: 06 Mar 2015
Trudo Lemmens and Candice Telfer
University of Toronto - Faculty of Law and Independent
Downloads 747 (32,218)
Citation 3

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drug regulation, drug safety and effectiveness, clinical trials, data secrecy, TRIPS, human rights, right to health, transparency, governance of information

3.

Legal Remedies for Medical Ghostwriting: Imposing Fraud Liability on Guest Authors of Ghostwritten Articles

PLoS Medicine, Vol. 8, No. 8, pp. 1-5, August 2011
Number of pages: 5 Posted: 02 Aug 2011 Last Revised: 01 Nov 2017
Simon Stern and Trudo Lemmens
University of Toronto - Faculty of Law and University of Toronto - Faculty of Law
Downloads 627 (40,766)
Citation 3

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4.

The End of Individual Control over Health Information: Promoting Fair Information Practices and the Governance of Biobank Research

Jane Kaye & Mark Stranger, eds, Governing Biobanks (Farnham (UK): Ashgate, 2009) 243-266
Number of pages: 13 Posted: 05 Feb 2009 Last Revised: 09 Feb 2014
Trudo Lemmens and Lisa M. Austin
University of Toronto - Faculty of Law and University of Toronto - Faculty of Law
Downloads 527 (51,099)
Citation 1

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Privacy, Confidentiality, Health Information, Medical Research, Genetics, Research Ethics, Research Governance

5.

Decision-Making Capacity to Consent to Medical Assistance in Dying for Persons with Mental Disorders

(2016) (open volume) Journal of Ethics in Mental Health 1-14
Number of pages: 14 Posted: 26 May 2016 Last Revised: 09 Jun 2016
Louis Charland, Trudo Lemmens and Kyoko Wada
Western University, University of Toronto - Faculty of Law and Western University
Downloads 507 (53,669)
Citation 4

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Euthanasia; Decisionmaking Capacity; Competency; Physician Assisted Dying; Physician Assisted Suicide; End of LIfe; Mental Health; Informed Consent; Canadian Charter of fundamental rights and freedoms

6.

The Conflict between Open-Ended Access to Physician-Assisted Dying and the Protection of the Vulnerable: Lessons from Belgium's Euthanasia Regime for the Canadian Post-Carter Era

in Catherine Regis, Lara Khoury & Robert Kouri, eds., Les Grands Conflits en Droit de la Santé [Key Conflicts in Health Law] (Cowensville: Yvon Blais, 2016) 261-317.
Number of pages: 29 Posted: 26 Feb 2016 Last Revised: 02 Jun 2017
Trudo Lemmens
University of Toronto - Faculty of Law
Downloads 487 (56,604)
Citation 1

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Euthanasia; Physician Assisted Dying; End of LIfe; Life, Liberty and Security of the Person; Vulnerability; Charter of Rights and Freedoms; Human Rights; Mental Health; Competency; Informed Consent

7.

The Human Subjects Trade: Ethical and Legal Issues Surrounding Recruitment Incentives

Journal of Law, Medicine & Ethics, Vol. 31, No. 3, pp. 398-418, Fall 2003
Number of pages: 21 Posted: 09 Feb 2004 Last Revised: 06 Feb 2014
Trudo Lemmens and Paul B. Miller
University of Toronto - Faculty of Law and Notre Dame Law School
Downloads 427 (66,325)
Citation 4

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Medical research, finder's fees, recruitment incentives, IRB review, research regulation, conflict of interest, legal liability, fiduciary duty

8.

Privacy, Consent, and Governance

NEW CHALLENGES FOR BIOBANKS: ETHICS, LAW AND GOVERNANCE, Kris Dierickx, Pascal Borry, eds., 2009
Number of pages: 14 Posted: 19 Jan 2010
Lisa M. Austin and Trudo Lemmens
University of Toronto - Faculty of Law and University of Toronto - Faculty of Law
Downloads 387 (74,589)

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9.

Leopards in the Temple: Restoring Scientific Integrity to the Commercialized Research Scene

Journal of Law, Medicine & Ethics, Vol. 32, No. 4, pp. 641-657, 2004
Number of pages: 17 Posted: 04 Apr 2005 Last Revised: 06 Apr 2014
Trudo Lemmens
University of Toronto - Faculty of Law
Downloads 381 (75,934)
Citation 7

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Medical research, research ethics, drug regulation, IRB review, conflict of interest, commercialization

10.

Genetics and Insurance Discrimination: Comparative Legislative, Regulatory and Policy Developments and Canadian Options

Health Law Journal, pp. 41-86, 2003
Number of pages: 47 Posted: 24 Feb 2004
Trudo Lemmens
University of Toronto - Faculty of Law
Downloads 377 (76,855)
Citation 6

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Private insurance, genetics, genetic information, insurance law, health law, human rights, comparative law, regulation

11.

Pharmaceutical Knowledge Governance: A Human Rights Perspective

Journal of Law, Medicine and Ethics, Vol. 41(1), pp. 163-184, 2013
Number of pages: 22 Posted: 05 Mar 2013 Last Revised: 16 Feb 2015
Trudo Lemmens
University of Toronto - Faculty of Law
Downloads 338 (87,221)
Citation 3

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pharmaceutical regulation, pharmaceutical law, human rights, knowledge governance, right to health, right to information, access to data, transparency, evidence based medicine, clinical trials, data exclusivity, intellectual property, international trade law, TRIPS, fraud

12.

Selective Justice, Genetic Discrimination, and Insurance: Should We Single Out Genes in Our Laws?

McGill Law Journal, Vol. 45, No. 2, 2000
Number of pages: 66 Posted: 28 May 2008 Last Revised: 17 Feb 2014
Trudo Lemmens
University of Toronto - Faculty of Law
Downloads 330 (89,607)
Citation 6

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13.

The Subjectivity of Objectivity: The Social, Cultural and Political Shaping of Evidence-Based Medicine

THE BRAVE NEW WORLD OF HEALTH, Belinda Bennett, Terry Carney, Isabel Karpin, eds., Federation Press, 2008
Number of pages: 29 Posted: 05 May 2008
Raymond De Vries, Trudo Lemmens and Charles Bosk
University of Michigan at Ann Arbor - Medical School, University of Toronto - Faculty of Law and University of Pennsylvania
Downloads 323 (91,724)

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evidence based medicine, evidence, medical research, bias, pharmaceuticals, drug regulation, pharmaceutical regulation, conflict of interest, obstetrics, home birth, midwivery, medical error

14.

Should Assisted Dying for Psychiatric Disorders Be Legalized in Canada?

(2016) Canadian Medical Association Journal cmaj.160365; doi:10.1503/cmaj.160365
Number of pages: 6 Posted: 05 Aug 2016 Last Revised: 22 May 2017
Scott Y. Kim and Trudo Lemmens
National Institutes of Health and University of Toronto - Faculty of Law
Downloads 292 (102,386)

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Euthanasia, Assisted Suicide, Medical Assistance in Dying, Mental Health, Psychiatry, Criminal Law, End of Life, Competency, Capacity, Consent

15.

Mandatory Clinical Trial Registration: Rebuilding Public Trust in Medical Research

GLOBAL FORUM UPDATE ON RESEARCH FOR HEALTH, Vol. 4: Equitable Access: Research Challenges for Health in Developing Countries, pp. 40-46, London: Pro-Book Publishing, 2007
Number of pages: 7 Posted: 14 Jan 2008 Last Revised: 17 Feb 2014
Trudo Lemmens and Ron Bouchard
University of Toronto - Faculty of Law and University of Manitoba - Faculty of Law (deceased)
Downloads 238 (126,744)

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Clinical trials, clinical trials registration, medical research, results reporting, pharmaceuticals, scientific integrity, intellectual property, patents, competitive advantage, disclosure, research subjects

16.

Revisiting Genetic Discrimination Issues in 2010: Policy Options for Canada

GPS Policy Brief No. 2
Number of pages: 13 Posted: 14 Dec 2010
Trudo Lemmens, Daryl Pullman and Rebecca Rodal
University of Toronto - Faculty of Law, Memorial University of Newfoundland - Faculty of Medicine and University of Toronto - Faculty of Law
Downloads 237 (127,272)

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Human Genome Project, genetic discrimination, GINA, genetic information, discrimination, equality, human rights, genetic testing, regulation of technology, insurance, employment

17.

Commercialized Medical Research and the Need for Regulatory Reform

U Toronto, Legal Studies Research Paper No. 967393, JUST MEDICARE: WHAT'S IN, WHAT'S OUT, HOW WE DECIDE, C. Flood, ed., University of Toronto Press, 2006
Number of pages: 17 Posted: 07 Mar 2007
Trudo Lemmens
University of Toronto - Faculty of Law
Downloads 221 (136,298)

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medical research, research regulation, drug regulation, pharmaceuticals, conflict of interest, research integrity, commercialization, research ethics, clinical trials

18.

Insurance and Human Rights: What Can Europe Learn from Canadian Anti-Discrimination Law?

DISCRIMINATION IN INSURANCE, Herman Cousy, Caroline Van Schoubroeck, eds., Maklu, Academia-Bruylant, 2007
Number of pages: 25 Posted: 20 Feb 2007 Last Revised: 02 Apr 2015
Trudo Lemmens and Yves Thiery
University of Toronto - Faculty of Law and K.U. Leuven University
Downloads 217 (138,730)
Citation 1

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discrimination, equality law, insurance, duty to accomodate, substantive equality

19.

Charter Scrutiny of Canada's Medical Assistance in Dying Law and the Shifting Landscape of Belgian and Dutch Euthanasia Practice

(2018) 85 Supreme Court Law Review (2nd Series) 459-544
Number of pages: 86 Posted: 13 Apr 2018 Last Revised: 12 Jun 2018
Trudo Lemmens
University of Toronto - Faculty of Law
Downloads 203 (147,722)

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Medical Assistance in Dying, Euthanasia, Assisted Suicide, End of Life, Criminal Law, Constitutional Law, Right to Health Care, Vulnerability, Mental Health, Human Rights, Autonomy

20.

Can Insurance Law Accomodate the Uncertainty Associated with Preliminary Genetic Information?

Canadian Bar Review, Vol. 83, pp. 357-409, 2004
Number of pages: 54 Posted: 02 Feb 2005
Trudo Lemmens
University of Toronto - Faculty of Law
Downloads 185 (160,861)
Citation 1

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Insurance law, health law, genetics, genetic discrimination, fairness

21.

The Helsinki Declaration and the Law: An International and Comparative Analysis

HISTORY AND THEORY OF HUMAN EXPERIMENTAION – THE DECLARATION OF HELSINKI AND MODERN MEDICAL ETHICS, pp. 223-252, Andreas Frewer, Ulf Schmidt, eds., Franz Steiner Verlag, 2007
Number of pages: 30 Posted: 14 Nov 2010 Last Revised: 26 Aug 2011
Dominique Sprumont, Sara Girardin and Trudo Lemmens
University of Neuchatel, affiliation not provided to SSRN and University of Toronto - Faculty of Law
Downloads 179 (165,783)

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Declaration of Helsinki, Medical Research Ethics, Drug Regulation, Human Subjects research, Research Governance

22.

The FDA and the Declaration of Helsinki: A New Rule Seems to Be More About Imperialism than Harmonisation

British Medical Journal, Vol. 338, pp. 1157-1158, 2009
Number of pages: 6 Posted: 20 Aug 2011
Dalhousie University, University of Toronto - Faculty of Law, University of Neuchatel and University of Yaounde 1
Downloads 175 (169,155)
Citation 2

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Clinical Research, Declaration of Helsinki, Human Subjects

23.

Cioms' Placebo Rule and the Promotion of Negligent Medical Practice

European Journal of Health Law, Vol. 11, pp. 153-174, 2004
Number of pages: 22 Posted: 02 Nov 2004
University of Toronto - Faculty of Law, University of Neuchatel, KU Leuven, University of KwaZulu-Natal and McGill University
Downloads 171 (172,614)
Citation 2

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Research regulation, human subjects research, research ethics, duty of care, negligence, placebo control, Declaration of Helsinki, CIOMS

24.

The Case for Improved Post-Market Surveillance of Pharmaceuticals

Number of pages: 8 Posted: 20 Oct 2013 Last Revised: 14 Apr 2014
Trudo Lemmens and Shannon Gibson
University of Toronto - Faculty of Law and University of Toronto Faculty of Law
Downloads 169 (174,435)

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pharmaceutical policy, drug regulation, post-market surveillance, adverse drug reactions, off-label prescribing

25.

The Declaration of Helsinki

British Medical Journal, Vol. 335, p. 736, 2007
Number of pages: 7 Posted: 20 Aug 2011
Dalhousie University, Canadian Institute for Health Information and University of Toronto - Faculty of Law
Downloads 157 (185,680)

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Research Ethics, International Health, Declaration of Helsinki

26.

Federal Regulation of REB Review of Clinical Trials: A Modest But Easy Step Towards an Accountable REB Review Structure in Canada

Health Law Review (Special Issue on Research Governance), Vol. 13, Nos. 2-3, pp. 39-50, 2005
Number of pages: 12 Posted: 10 Jun 2008 Last Revised: 09 Feb 2014
Trudo Lemmens
University of Toronto - Faculty of Law
Downloads 154 (188,711)
Citation 2

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Research ethics review, clinical trials, pharmaceutical regulation, commercialization, medical research

27.

Why Canada's Medical Assistance in Dying Legislation Should Be C(h)arter Compliant and What It May Help to Avoid

(2018) 11(1) McGill Journal of Law and Health 61-148
Number of pages: 88 Posted: 21 Mar 2018 Last Revised: 12 Jun 2018
Trudo Lemmens, Heesoo Kim and Elizabeth Kurz
University of Toronto - Faculty of Law, University of Toronto, Faculty of Law, Students and University of Toronto - Faculty of Law
Downloads 130 (216,489)

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End-of-Life, Euthanasia, Medical Assistance in Dying, Canadian Charter of Rights and Freedoms, Constitutional Law, Human Rights, Physician Assisted Suicide, Mental Health

28.

Ethics Review for Sale? Conflict of Interest and Commercial Research Review Boards

Milbank Quarterly, Vol. 78, No. 4, p. 547, 2000
Number of pages: 20 Posted: 07 Jun 2008
Trudo Lemmens and Benjamin Freedman (deceased)
University of Toronto - Faculty of Law and Deceased
Downloads 129 (217,782)
Citation 5

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29.

Decreasing the Data Deficit: Improving Post-Market Surveillance in Pharmaceutical Regulation

McGill Law Journal 2014; 59(4) 943-988.
Number of pages: 46 Posted: 10 Dec 2014
Trudo Lemmens and Shannon Gibson
University of Toronto - Faculty of Law and University of Toronto Faculty of Law
Downloads 111 (243,386)
Citation 1

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Pharmaceutical Regulation; post-marketing surveillance; adverse drug reactions; transparency; clinical trials

30.

7th Revision of the Declaration of Helsinki: Good News for the Transparency of Clinical Trials

Croatian Medical Journal, Vol. 50, pp. 105-110, 2009
Number of pages: 6 Posted: 19 Aug 2011 Last Revised: 24 May 2014
Karmela Krlezˇa-Jeriç and Trudo Lemmens
Canadian Institute for Health Information and University of Toronto - Faculty of Law
Downloads 110 (244,946)

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Medical Ethics, Ethical Principles, Medical Research, Human Subjects, Clinical Trials, Public Interest

31.

The Markingson Case and the Ethics of Institutional Proceduralism

in Trudo Lemmens and Bernadette J. Richards, "Recent Developments: Investigating research and Accessing Reproductive Material" (2014) 11(1) Bioethical Inquiry 11-16 DOI 10.1007/s11673-013-9503-2
Number of pages: 9 Posted: 31 Mar 2014 Last Revised: 07 Apr 2014
Trudo Lemmens
University of Toronto - Faculty of Law
Downloads 107 (249,815)

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clinical trials; undue inducement; coercion; IRB; FDA; research subject protection

32.

The CMA's Chaoulli Motion and the Myth of Promoting Fair Access to Health Care

ACCESS TO CARE, ACCESS TO JUSTICE, C. Flood, K. Roach & L. Sossin, eds., University of Toronto Press, pp. 323-346, 2005
Number of pages: 13 Posted: 18 Feb 2007 Last Revised: 09 Jun 2008
Trudo Lemmens and Tom Archibald
University of Toronto - Faculty of Law and University of Toronto
Downloads 103 (256,509)

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Health care, health insurance, health care systems, conflict of interest, role of professional organizations

33.

Data Collection from Legally Incompetent Subjects: A Paradigm Legal and Ethical Challenge for Population Databanks

Health Law Journal, 2008, U Toronto, Legal Studies Research Paper No. 08-20
Number of pages: 36 Posted: 14 Sep 2008 Last Revised: 11 Feb 2009
Tom Archibald and Trudo Lemmens
University of Toronto and University of Toronto - Faculty of Law
Downloads 99 (263,411)

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Consent, Competency, Research, Research Ethics, Biobanks, Databanks, Genetics, Advanced Directives

34.

The Promise and Peril of Adapting the Regulatory System to the Pharmacogenomic Context

McGill Journal of Law and Health (2015) 8(2): S145-S230
Number of pages: 86 Posted: 26 Nov 2014 Last Revised: 13 Jun 2015
Shannon Gibson and Trudo Lemmens
University of Toronto Faculty of Law and University of Toronto - Faculty of Law
Downloads 96 (268,712)

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pharmacogenomics, pharmaceutical regulation, drug reform, drug policy

35.

Niche Markets and Evidence Assessment in Transition: A Critical Review of Proposed Drug Reforms

Medical Law Review, 2014, Forthcoming
Number of pages: 22 Posted: 12 Apr 2014
Shannon Gibson and Trudo Lemmens
University of Toronto Faculty of Law and University of Toronto - Faculty of Law
Downloads 92 (276,190)
Citation 2

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adaptive licensing, healthcare reform, pharmacogenetics, pharmaceutical regulation, drug reimbursement, risk-sharing agreements, data integrity, transparency, clinical trials

36.

Piercing the Veil of Corporate Secrecy About Clinical Trials

The Hastings Center Report, Vol. 34, No. 5, pp. 14-18, 2004
Number of pages: 5 Posted: 11 Jun 2008
Trudo Lemmens
University of Toronto - Faculty of Law
Downloads 91 (278,114)

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37.

The Commodification of Gametes: Why Prohibiting Untrammelled Commercialization Matters

in Trudo Lemmens, Andrew F. Martin, Cheryl Milne & Ian B. Lee, eds, Regulating Creation: The Law, Ethics, and Policy of Assisted Human Reproduction (Toronto: University of Toronto Press, 2017), 415-460.
Number of pages: 56 Posted: 20 Mar 2016 Last Revised: 02 Jun 2017
Trudo Lemmens
University of Toronto - Faculty of Law
Downloads 85 (290,288)

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Assisted Human Reproduction; health law; criminal law; reproductive rights; exploitation; equality; security of the person; human dignity; gamete donation; surrogacy

38.

Privatizing Biomedical Research - A 'Third Way'

Nature Biotechnology, Vol. 26, No. 1, pp. 31-36, 2008
Number of pages: 6 Posted: 15 Nov 2012 Last Revised: 24 Feb 2014
Ron Bouchard and Trudo Lemmens
University of Manitoba - Faculty of Law (deceased) and University of Toronto - Faculty of Law
Downloads 79 (303,325)
Citation 1

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technology, innovation, commercialization, medical research

39.

Genetics and Life Insurance: A Comparative Analysis

(2004) II-2 GenEdit, 1-14
Number of pages: 15 Posted: 07 Aug 2013
Trudo Lemmens, Yann Joly and Bartha Maria Knoppers
University of Toronto - Faculty of Law, McGill University - Centre for Genomics and Policy and McGill University - Centre for Genomics and Policy
Downloads 78 (305,618)
Citation 1

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40.

Research Involving Humans

CANADIAN HEALTH LAW AND POLICY, SECOND EDITION, J. Downie, T. Caulfield, C. Flood, eds., Toronto: Butterworths, 2002
Number of pages: 43 Posted: 25 Jul 2009 Last Revised: 09 Feb 2014
Kathleen C. Glass and Trudo Lemmens
McGill University and University of Toronto - Faculty of Law
Downloads 78 (305,618)
Citation 1

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medical research, human research subjects, bioethics

41.

Introduction: Global Health Challenges and the Role of Law

Journal of Law, Medicine and Ethics, Vol. 41, No. 1, 2013, 9-15
Number of pages: 7 Posted: 24 May 2013 Last Revised: 07 Jul 2013
Colleen M. Flood and Trudo Lemmens
University of Ottawa - Faculty of Law and University of Toronto - Faculty of Law
Downloads 75 (312,710)
Citation 2

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Global Health, Health Law, Medical Law, Public Health, Right to Health, Health Policy, Health and International Trade

42.

Regulating the Market in Human Research Participants

Public Library of Science Medicine, Vol. 3, iss. 8, p.1237, 2006
Number of pages: 5 Posted: 24 Jul 2008
Trudo Lemmens and Paul B. Miller
University of Toronto - Faculty of Law and Notre Dame Law School
Downloads 73 (317,565)
Citation 3

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43.

"What About Your Genes?" Ethical, Legal, and Policy Dimensions of Genetics in the Workplace

Politics and the Life Sciences, Vol. 16, No. 1, 1997
Number of pages: 19 Posted: 10 Jun 2008
Trudo Lemmens
University of Toronto - Faculty of Law
Downloads 73 (317,565)
Citation 1

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44.

The Challenges of Regulating the Use of Genetic Information

ISUMA, Volume 2, No. 3, pp. 26-37, 2001
Number of pages: 12 Posted: 18 Jul 2012
Trudo Lemmens and Lisa M. Austin
University of Toronto - Faculty of Law and University of Toronto - Faculty of Law
Downloads 66 (335,336)

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genetic information, genetic testing

45.

Should Society Allow Research Ethics Boards to Be Run as For-Profit Enterprises?

Public Library of Science Medicine, Vol. 3, Issue 7, p. 941, 2006
Number of pages: 4 Posted: 25 Jul 2008 Last Revised: 26 Aug 2011
Ezekiel J. Emanuel, Trudo Lemmens and Carl Elliott
Government of the United States of America - Department of Clinical Bioethics, University of Toronto - Faculty of Law and University of Minnesota - Twin Cities
Downloads 66 (335,336)
Citation 3

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46.

Prospective Registration and Results Disclosure of Clinical Trials in the Americas: A Roadmap Toward Transparency

Pan American Journal of Public Health, Vol. 30, No. 1, pp. 87-96, 2011
Number of pages: 10 Posted: 19 Aug 2011 Last Revised: 06 Feb 2014
Canadian Institute for Health Information, University of Toronto - Faculty of Law, affiliation not provided to SSRN, affiliation not provided to SSRN and University of California, San Francisco (UCSF) - School of Pharmacy
Downloads 65 (338,006)

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Clinical Trials as Topic, Standards, Americas

47.

Noninstitutional Commercial Review Boards in North America: A Critical Appraisal and Comparison with IRBs

IRB: A Review of Human Subjects Research, Vol. 23, No. 2, p. 1, 2001
Number of pages: 12 Posted: 14 Jul 2008
Trudo Lemmens and Alison Thompson
University of Toronto - Faculty of Law and affiliation not provided to SSRN
Downloads 65 (338,006)
Citation 2

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48.

Memorandum Re: Health Canada's 'Draft Guidance' on Section 21.1(3)(C) of the Food and Drugs Act

Number of pages: 29 Posted: 28 May 2016
Matthew Herder and Trudo Lemmens
Dalhousie University - Faculties of Medicine and Law and University of Toronto - Faculty of Law
Downloads 64 (340,715)

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Drug Safety, Pharmaceutical Policy, Regulation, Transparency, Intellectual Property

49.

Analysis of Consent Validity for Invasive, Nondiagnostic Research Procedures

IRB: Ethics and Human Research 34(5) Sept-Oct 2012, 1-7
Number of pages: 7 Posted: 06 Jul 2013 Last Revised: 17 Nov 2015
Jonathan Kimmelman, Trudo Lemmens and Scott Y. Kim
McGill University - BioMedical Ethics Unit, University of Toronto - Faculty of Law and National Institutes of Health
Downloads 64 (340,715)

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informed consent, research involving humans, research ethics, nondiagnostic research procedures, consent validity, research risks

50.

Why the Shift? Taking a Closer Look at the Growing Interest in Niche Markets and Personalized Medicine

Gibson, S., Raziee, H. R. and Lemmens, T. (2015), Why the Shift? Taking a Closer Look at the Growing Interest in Niche Markets and Personalized Medicine. World Medical & Health Policy, 7: 3–27. doi: 10.1002/wmh3.131
Number of pages: 25 Posted: 14 Apr 2015 Last Revised: 22 Apr 2015
Shannon Gibson, Hamid Raziee and Trudo Lemmens
University of Toronto Faculty of Law, University of Toronto and University of Toronto - Faculty of Law
Downloads 61 (349,039)

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pharmacogenomics, personalized medicine, pharmaceuticals, niche markets

51.

The Plasticized Pregnant Woman and Legal Rights over Reproductive 'Material'

IMAGINING SCIENCE, pp. 60-62, Timothy Caulfield & Shawn Caulfield, eds., University of Alberta Press, 2008
Number of pages: 3 Posted: 30 Jul 2010 Last Revised: 03 Sep 2013
Trudo Lemmens
University of Toronto - Faculty of Law
Downloads 58 (357,817)

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Privacy, Property, Ethics, Human Body

52.

Clinical Trials Registration and Results Reporting and the Right to Health

in I. Glenn Cohen, ed., The Globalization of Health Care: Legal and Ethical Issues (Cambridge (Mass): Oxford University Press, 213): 255-271
Number of pages: 9 Posted: 04 Jun 2013 Last Revised: 06 Apr 2014
Trudo Lemmens and Candice Telfer
University of Toronto - Faculty of Law and Independent
Downloads 56 (363,916)

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drug regulation, drug safety and effectiveness, clinical trials, access to information, data secrecy, intellectual property, TRIPS, human rights, right to health, transparency, governance of information, clinical trials, trial registration, commercial secret

53.

Governance of Conflicts of Interest in Postmarketing Surveillance Research and the Canadian Drug Safety and Effectiveness Network

Open Medicine, Vol. 4, No. 2, pp. 123-128, 2010
Number of pages: 6 Posted: 14 Nov 2010 Last Revised: 06 Feb 2014
Lorraine E. Ferris and Trudo Lemmens
University of Toronto and University of Toronto - Faculty of Law
Downloads 55 (367,088)
Citation 1

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Pharmaceutical regulation, food and drug regulation, postmarketing surveillance, drug safety and effectiveness, conflict of interest, research governance

54.

Consent for Nondiagnostic Research Biopsies: A Pilot Study of Participant Recall and Therapeutic Orientation

IRB: Ethics & Human Research 2014;36(3):9-15
Number of pages: 7 Posted: 13 May 2014
CUNY, John Jay College of Criminal Justice, McGill University - BioMedical Ethics Unit, McGill University and University of Toronto - Faculty of Law
Downloads 53 (373,302)

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Informed consent, clinical research, biopsy, oncology, therapeutic misconception, voluntariness, comprehension, motivation, research procedures

55.

Financial Conflict of Interest in Medical Research

CAMBRIDGE TEXTBOOK OF BIOETHICS, p. 222, Peter S. Singer & Adrian Viiens, eds., Cambridge University Press, 2007
Number of pages: 10 Posted: 07 Oct 2010
Trudo Lemmens and Lori Luther
University of Toronto - Faculty of Law and affiliation not provided to SSRN
Downloads 52 (376,535)
Citation 1

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conflicts of interest, financial conflicts of interest, medical research, clinician-researchers

56.

Regulating Off-Label Prescribing: The Good, the Bad and the Uncertain

Number of pages: 10 Posted: 20 Oct 2013 Last Revised: 24 Nov 2014
Shannon Gibson and Trudo Lemmens
University of Toronto Faculty of Law and University of Toronto - Faculty of Law
Downloads 50 (383,086)

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off-label prescribing, pharmaceutical regulation

57.

Keeping the GINA in the Bottle: Assessing the Current Need for Genetic Non-Discrimination Legislation in Canada

Open Medicine, Vol. 4, No. 2, pp. 95-97, 2010
Number of pages: 3 Posted: 06 Jan 2011
Daryl Pullman and Trudo Lemmens
Memorial University of Newfoundland - Faculty of Medicine and University of Toronto - Faculty of Law
Downloads 46 (396,784)
Citation 1

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GINA, genetic testing, discrimination, health care, insurance, equality, employment

58.

Structuring the Review of Human Genetics Protocols - Part III: Gene Therapy Studies

IRB: A Review of Human Subjects Research, Vol. 21, No. 2, pp. 1-9,1999
Number of pages: 9 Posted: 13 Jun 2008
McGill University, Dalhousie University, McGill University - Faculty of Medicine, University of Toronto - Faculty of Law, McGill University - Faculty of Medicine, McGill University - Faculty of Medicine and Deceased
Downloads 46 (396,784)
Citation 1

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59.

Structuring the Review of Human Genetics Protocols: Gene Localization and Identification Studies

IRB: A Review of Human Subjects Research, Vol. 18, No. 4, pp. 1-9, 1996
Number of pages: 9 Posted: 12 Jun 2008 Last Revised: 09 Feb 2014
McGill University, Dalhousie University, McGill University - Faculty of Medicine, McGill University - Faculty of Medicine, University of Toronto - Faculty of Law and Pacific School of Religion
Downloads 45 (400,311)
Citation 2

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60.

Integrating Values in Risk Analysis of Biomedical Research: The Case for Regulatory and Law Reform (Intégration des Valeurs Dans L'Évaluation Du Risque Lié À La Recherche Biomédicale: Arguments En Faveur D'Une Réforme De La Réglementation Et Du Droit)

LE DROIT ET LE RISQUE: MEMOIRES DU CONCOURS PERSPECTIVES JURIDIQUES, Commission du Droit du Canada, ed., p. 233, Saint-Nicolas, Québec: Les Presses de l'Université Laval, 2006
Number of pages: 71 Posted: 23 Oct 2010 Last Revised: 18 Apr 2013
Duff Waring and Trudo Lemmens
University of Toronto - Faculty of Law and University of Toronto - Faculty of Law
Downloads 43 (407,589)
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Medical Research, Risk, Research Ethics, Health Law and Policy, Research Regulation, Conflict of Interest, Institutional Review Board, Human Subjects Protection

61.

Individual Researcher Conflict of Interest in Biomedical Research: What Can Be Done About it?

(2013) 1 Deontologie & Tuchtrecht 51-61
Number of pages: 12 Posted: 10 May 2013 Last Revised: 07 Jul 2013
Trudo Lemmens
University of Toronto - Faculty of Law
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conflict of interest, medical research, research integrity, protection of human research subjects, finder's fees, recruitment incentives

62.

How Can Journals Respond to Threats of Libel Litigation

PLoS Med 11(3): e1001615. doi:10.1371/journal.pmed.1001615
Number of pages: 4 Posted: 31 Mar 2014 Last Revised: 14 Apr 2014
Nav Persaud, Thom Ringer and Trudo Lemmens
University of Toronto - Centre for Urban Health Solution, University of Toronto - Saint Michael's Hospital and University of Toronto - Faculty of Law
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Bias, Medical Literature, Libel, Litigation, Editorial Decision Making

63.

Structuring the Review of Human Genetics Protocols Part II: Diagnostic and Screening Studies

IRB: A Review of Human Subjects Research, Vol. 19, Nos. 3-4, pp. 1-13, 1997
Number of pages: 12 Posted: 13 Jun 2008
McGill University, Dalhousie University, University of Toronto - Faculty of Law, McGill University - Faculty of Medicine and McGill University - Faculty of Medicine
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64.

L’accès à l’information et le droit à la santé : La transparence des essais cliniques comme une obligation dans le contexte des droits de l’Homme (Access to Information and the Right to Health: Transparency of Clinical Trials as a Human Rights Obligation)

Louise Lalonde, ed., Le droit, vecteur de la gouvernance en santé? Défis théoriques et enjeux pratiques de l’accès aux soins de la santé (Sherbrooke: Éditions Revue de Droit de L'Université De Sherbrooke, 2012) pp. 131-167
Number of pages: 38 Posted: 09 May 2013
Trudo Lemmens and Candice Telfer
University of Toronto - Faculty of Law and Independent
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drug regulation, drug safety and effectiveness, clinical trials, data secrecy, TRIPS, human rights, right to health, transparency, governance of information

65.

Integrating Values in Risk Analysis of Biomedical Research: The Case for Regulatory and Law Reform

University of Toronto Law Journal, Vol. 52, pp. 249-290, 2004
Number of pages: 22 Posted: 22 May 2013 Last Revised: 15 Mar 2015
Duff Waring and Trudo Lemmens
University of Toronto - Faculty of Law and University of Toronto - Faculty of Law
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Medical Research, Risk, Research Ethics, Health Law and Policy, Research Regulation, Conflict of Interest, Institutional Review Board, Human Subjects Protection

66.

'Talk to Her' or Breaking the Silence of Neglected Bonds

Sean Caulfield, Curtis Gillespie and Timothy Caulfield, eds, Perceptions of Promise: Biotechnology, Society and Art (University of Washington Press, 2011) pp. 9-13
Number of pages: 8 Posted: 07 Aug 2013
Trudo Lemmens
University of Toronto - Faculty of Law
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emotion, end of life, PVS, art and law, art and bioethics

67.

Promoting Transparency of Clinical Trials: How is Canada Doing?

Memorandum for Expert Witness Presentation at the Standing Senate Committee on Social Affairs, Science and Technology 10 May 2012
Number of pages: 7 Posted: 07 May 2014
Trudo Lemmens
University of Toronto - Faculty of Law
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clinical trials; drug regulation; pharmaceuticals; transparency; research subject protection; data transparency

68.

Transparency of Biobank Access in Canada: An Assessment of Industry Access and the Availability of Information on Access Policies and Resulting Research

Journal of Empirical Research on Human Research Ethics, Forthcoming
Number of pages: 28 Posted: 27 Jul 2017
Shannon Gibson, Renata Axler and Trudo Lemmens
University of Toronto Faculty of Law, Odette School of Business and University of Toronto - Faculty of Law
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Biobanks, Data access, transparency, accountability, commercialization, public trust

69.

Introduction

Trudo Lemmens, Andrew Flavelle Martin, Ian Lee & Cheryl Milne (eds), Regulating Creation: The Law, Ethics, and Policy of Assisted Human Reproduction (University of Toronto Press, 2017) 1-20.
Number of pages: 26 Posted: 23 May 2017
Trudo Lemmens and Andrew Flavelle Martin
University of Toronto - Faculty of Law and Dalhousie University - Schulich School of Law
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assisted human reproduction, constitutional law, family law, human rights, children's rights, commodifciation

70.

Restoring the Integrity of the Pharmaceutical Science Record: Two Tales of Transparency

JOTWELL (July 14, 2016) (reviewing J.N. Jureidini et al., 28 Int’l J. Risk & Safety Med. 33 (2016); and J. Le Noury et al. 351 Brit. Med. J. 4320 (2015)
Number of pages: 3 Posted: 27 Apr 2017 Last Revised: 12 Jun 2017
Trudo Lemmens
University of Toronto - Faculty of Law
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pharmaceuticals, transparency, corruption, scientific integrity, marketing, authorship, clinical trials, health law

71.

The Institutional Workers of Biomedical Science: Legitimizing Academic Entrepreneurship and Obscuring Conflicts of Interest

Science and Public Policy (2017) scx075 doi/10.1093/scipol/scx075
Number of pages: 30 Posted: 04 Dec 2017
Odette School of Business, University of Toronto - Institute of Health Policy, Management and Evaluation, Independent and University of Toronto - Faculty of Law
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Entrepreneurial science; academic entrepreneurship; scientific research; conflict of interest; commercialization; health; innovation

72.

Clinical Trial Transparency in the Americas: The Need to Coordinate Regulatory Spheres

(2018) 362 British Medical Journal k2493-8
Number of pages: 5 Posted: 15 Nov 2018
Trudo Lemmens and Carlos Herrera Vacaflor
University of Toronto - Faculty of Law and Universidad Torcuato Di Tella
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Transparency, Clinical Trials, Pharmaceuticals, Governance, Research Ethics, Pan American Health Organization, World Health Organization, Declaration of Helsinki, Commercial Confidential Information, Intellectual Property

73.

Medication Access Via Hospital Admission

Canadian Family Physician May 2017, 63 (5) 344-347
Number of pages: 3 Posted: 26 May 2017 Last Revised: 27 May 2017
Annie Wang, Trudo Lemmens and Nav Persaud
University of Toronto - Faculty of Medicine, Students, University of Toronto - Faculty of Law and University of Toronto - Centre for Urban Health Solution
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74.

Regulation of Health Professions in Ontario: Self-Regulation with Statutory-Based Public Accountability

Revista de Direito Sanitário / Journal of Health Law (2019) Vol 19(3), p124-204
Number of pages: 40 Posted: 14 Jun 2019
Trudo Lemmens and Kanksha Mahadevia Ghimire
University of Toronto - Faculty of Law and University of Toronto, Faculty of Law
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Canada, Health Professions, Health Work Regulation, Public Accountability