Trudo Lemmens

University of Toronto - Faculty of Law

78 and 84 Queen's Park

Toronto, Ontario M5S 2C5

Canada

SCHOLARLY PAPERS

66

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CITATIONS
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41

Scholarly Papers (66)

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 775 (21,447)

Abstract:

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 555 (30,077)

Abstract:

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
Simon Stern and Trudo Lemmens
University of Toronto - Faculty of Law and University of Toronto - Faculty of Law
Downloads 464 (38,278)

Abstract:

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 410 (49,510)
Citation 1

Abstract:

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

5.

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 McGill University Faculty of Law
Downloads 363 (55,366)
Citation 2

Abstract:

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

6.

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 345 (63,446)
Citation 6

Abstract:

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

7.

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 306 (71,192)

Abstract:

8.

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 300 (69,736)
Citation 5

Abstract:

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

9.

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 262 (80,385)

Abstract:

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

10.

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 259 (78,265)

Abstract:

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

11.

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 222 (82,635)
Citation 3

Abstract:

12.

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 208 (108,303)
Citation 1

Abstract:

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

13.

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 195 (118,342)
Citation 1

Abstract:

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

14.

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 188 (121,698)

Abstract:

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

15.

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 168 (135,749)
Citation 1

Abstract:

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

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 162 (124,588)

Abstract:

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

17.

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 157 (143,805)
Citation 1

Abstract:

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

18.

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 137 (161,772)
Citation 1

Abstract:

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

19.

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 134 (144,564)

Abstract:

Clinical Research, Declaration of Helsinki, Human Subjects

20.

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 127 (155,314)

Abstract:

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

21.

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 113 (186,794)
Citation 4

Abstract:

22.

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 95 (210,366)

Abstract:

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

23.

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 83 (222,389)

Abstract:

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

24.

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 77 (238,902)

Abstract:

25.

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 73 (251,956)

Abstract:

technology, innovation, commercialization, medical research

26.

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 67 (179,881)
Citation 1

Abstract:

Research Ethics, International Health, Declaration of Helsinki

27.

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 67 (211,808)

Abstract:

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

28.

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 McGill University Faculty of Law
Downloads 63 (268,252)

Abstract:

29.

"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 63 (270,384)
Citation 1

Abstract:

30.

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 60 (279,420)
Citation 1

Abstract:

31.

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 57 (277,150)
Citation 1

Abstract:

medical research, human research subjects, bioethics

32.

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 56 (284,142)
Citation 1

Abstract:

33.

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 55 (238,902)

Abstract:

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

34.

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 54 (261,922)

Abstract:

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

35.

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 54 (286,464)

Abstract:

Clinical Trials as Topic, Standards, Americas

36.

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 51 (304,045)

Abstract:

Privacy, Property, Ethics, Human Body

37.

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 48 (309,465)

Abstract:

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

38.

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 45 (284,142)

Abstract:

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

39.

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 44 (266,174)

Abstract:

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

40.

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 43 (293,712)

Abstract:

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

41.

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 42 (332,787)
Citation 1

Abstract:

42.

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 40 (335,863)
Citation 1

Abstract:

43.

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 37 (291,239)
Citation 6

Abstract:

44.

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 37 (317,977)

Abstract:

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

45.

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 35 (323,723)

Abstract:

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

46.

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 35 (323,723)

Abstract:

genetic information, genetic testing

47.

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 35 (348,735)

Abstract:

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

48.

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 34 (345,405)

Abstract:

Medical Research, Risk, Research Ethics, Health Law and Policy, Research Regulation, Conflict of Interest, Institutional Review Board, Human Subjects Protection

49.

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 33 (296,243)

Abstract:

pharmacogenomics, pharmaceutical regulation, drug reform, drug policy

50.

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 33 (345,405)
Citation 1

Abstract:

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

51.

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 30 (301,415)

Abstract:

pharmacogenomics, personalized medicine, pharmaceuticals, niche markets

52.

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 29 (345,405)

Abstract:

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

53.

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 - Saint Michael's Hospital, University of Toronto - Saint Michael's Hospital and University of Toronto - Faculty of Law
Downloads 29 (362,782)

Abstract:

Bias, Medical Literature, Libel, Litigation, Editorial Decision Making

54.

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
Downloads 29 (366,510)
Citation 1

Abstract:

55.

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 28 (342,214)

Abstract:

off-label prescribing, pharmaceutical regulation

56.

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
Downloads 21 (390,886)

Abstract:

conflict of interest, medical research, research integrity, protection of human research subjects, finder's fees, recruitment incentives

57.

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
Downloads 15 (395,590)

Abstract:

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

58.

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
Downloads 13 (430,211)

Abstract:

Medical Research, Risk, Research Ethics, Health Law and Policy, Research Regulation, Conflict of Interest, Institutional Review Board, Human Subjects Protection

59.

'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
Downloads 11 (430,211)

Abstract:

emotion, end of life, PVS, art and law, art and bioethics

60.

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
Downloads 7 (450,419)

Abstract:

clinical trials; drug regulation; pharmaceuticals; transparency; research subject protection; data transparency

61.

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

(2015) 8:2 McGill Journal of Law and Health S145
Number of pages: 86 Posted: 07 Jun 2015 Last Revised: 22 Mar 2016
Shannon Gibson and Trudo Lemmens
University of Toronto Faculty of Law and University of Toronto - Faculty of Law
Downloads 3 (430,211)

Abstract:

pharmacogenomics, drug regulation, regulatory reform

62.

Should Assisted Dying for Psychiatric Disorders Be Legalized in Canada?

Canadian Medical Association Journal CMAJ, Forthcoming
Number of pages: 6 Posted: 05 Aug 2016
Scott Y. Kim and Trudo Lemmens
National Institutes of Health and University of Toronto - Faculty of Law
Downloads 0 (182,115)

Abstract:

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

63.

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
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Abstract:

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

64.

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 C. Charland, Trudo Lemmens and Kyoko Wada
Western University, University of Toronto - Faculty of Law and Western University
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Abstract:

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

65.

The Commodification of Gametes: Why Banning Untrammeled Commercialization Matters

Trudo Lemmens, Andrew F. Martin, Cheryl Milne & Ian B. Lee, eds, Regulating Creation: Law, Ethics and Policy of Assisted Human Reproduction (Toronto: University of Toronto Press), Forthcoming
Number of pages: 46 Posted: 20 Mar 2016
Trudo Lemmens
University of Toronto - Faculty of Law
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Abstract:

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

66.

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

Catherine Regis, Lara Khoury & Robert Kouri, eds., Key Conflicts in Health Law, Cowensville: Yvon Blais, 2016, pp. 261-317.
Number of pages: 29 Posted: 26 Feb 2016 Last Revised: 13 May 2016
Trudo Lemmens
University of Toronto - Faculty of Law
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Abstract:

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