REFERENCES
- American College of Obstetricians and Gynecologists, Committee on Ethics. (ACOG) . September 2007 2007 . “ Research involving women. ACOG Committee Opinion Number 377 ” . September 2007 ,
- Baylis , F. 1996 . Women and health research: Working for change . Journal of Clinical Ethics , 7 ( 3 ) : 229 – 242 .
- Baylis , F. 2010 . Pregnant women deserve better . Nature , 465 ( 10 ) : 689 – 690 .
- Benowitz , I. , Esposito , D.B. , Gracey , K.D. , Shapiro , E.D. and Vázquez , M. 2010 . Influenza vaccine given to pregnant women reduces hospitalization due to influenza in their infants . Clinical Infectious Diseases , 51 ( 12 ) : 1355 – 1361 .
- Bhat , N. , Wright , J.G. , Broder , K.R. , Murray , E.L. , Greenberg , M.E. , Glover , M.J. Likos , A.M. 2005 . Influenza-associated deaths among children in the United States, 2003–2004 . New England Journal of Medicine , 353 : 2559 – 2567 .
- Brent , R.L. 2006 . Risks and benefits of immunizing pregnant women: The risk of doing nothing . Reproductive Toxicology , 21 : 383 – 389 .
- Brent , R.L. 2003 . Immunization of pregnant women: Reproductive, medical and society risks . Vaccine , 21 : 3413 – 3421 .
- Canadian Institutes of Health Research, Natural Sciences and Engineering Research Council of Canada, Social Sciences and Humanities Research Council of Canada. (2010). Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans. www.pre.ethics.gc.ca (http://www.pre.ethics.gc.ca.) (Accessed: 29 June 2011 ).
- Canadian Medical Protective Association. (2011). Fee Schedule for 2011. http://www.cmpa-acpm.ca/cmpapd04/docs/membership/fees/2011cal-e.pdf (http://www.cmpa-acpm.ca/cmpapd04/docs/membership/fees/2011cal-e.pdf)
- Council for International Organizations of Medical Sciences. (2002). International Ethical Guidelines for Biomedical Research Involving Human Subjects. http://www.cioms.ch/publications/layout_guide2002.pdf (http://www.cioms.ch/publications/layout_guide2002.pdf) (Accessed: 29 June 2011 ).
- Dalhousie University. (2011). Pertussis maternal immunization study. Clinicaltrials.gov. http://clinicaltrials.gov/ct2/show/NCT00553228. (http://clinicaltrials.gov/ct2/show/NCT00553228.) (Accessed: 29 June 2011 ).
- DeBruin , D.A. 1994 . Justice and the inclusion of women in medical research . Kennedy Institute of Ethics Journal , 4 ( 2 ) : 117 – 146 .
- Dodds , L. , McNeil , S.A. , Fell , D.B. , Allen , V.M. , Coombs , A. , Scott , J. and MacDonald , N. 2007 . Impact of influenza exposure on rates of hospital admissions and physician visits because of respiratory illness among pregnant women . Canadian Medical Association Journal , 176 ( 4 ) : 463 – 468 .
- Donoghue , v. Stevenson . 1932 . “ A.C. 562 (H.L.) ” .
- Dresser , R. 1992 . Wanted: Single white male for medical research . The Hastings Center Report , 22 ( 1 ) : 24 – 29 .
- Galanis , E. , King , A.S. , Varughese , P. and Halperin , S.A. 2006 . Changing epidemiology and emerging risk groups for pertussis . Canadian Medical Association Journal , 174 ( 4 ) : 451 – 452 .
- Glezen , W.P. 2003 . Session IV. Ethical, liability and regulatory issues . Vaccine , 21 : 3501 – 3502 .
- Goldkind , S.F. , Sahin , L. and Gallauresi , B. 2010 . Enrolling pregnant women in research: Lessons from the H1N1 influenza pandemic . New England Journal of Medicine , 362 ( 24 ) : 2241 – 2243 .
- Grieve , J. , Tordoff , J. , Reith , D. and Norris , P. 2005 . Effect of the pediatric exclusivity provision on children's access to medicines . British Journal of Clinical Pharmacology , 59 ( 6 ) : 730 – 735 .
- Gruslin , A. , Steben , M. , Halperin , S. , Money , D.M. and Yudin , M.H. 2009 . Immunization in pregnancy . Journal of Obstetrics and Gynaecology Canada , 236 Nov : 1085 – 1092 .
- Health Canada. (2008). Prescription drugs labelled for use in pregnancy: The need for a Canadian regulatory framework. http://www.hc-sc.gc.ca/dhp-mps/homologation-licensing/docs/issues-enjeux/issues-enjeux14-eng.php (http://www.hc-sc.gc.ca/dhp-mps/homologation-licensing/docs/issues-enjeux/issues-enjeux14-eng.php) (Accessed: 29 June 2011 ).
- Healy , C.M. and Baker , C.J. 2007 . Maternal immunization . The Pediatric Infectious Disease Journal , 26 ( 10 ) : 945 – 948 .
- Healy , C.M. and Baker , C.J. 2006 . Prospects for prevention of childhood infections by maternal immunization . Current Opinion in Infectious Diseases , 19 : 271 – 276 .
- Hollis , v. and Dow Corning Corporation . 1995 . “ 4 S.C.R ” .
- Jamieson , D.J. , Honein , M.A. , Rasmussen , S.A. and on behalf of the Novel Influenza A (H1N1) Pregnancy Working Group . 2009 . H1N1 2009 influenza virus infection during pregnancy in the USA . Lancet , 374 ( 9688 ) : 451 – 458 .
- Kumar , A. , Zarychanski , R. , Pinto , R. for the Canadian Collaborative H1N1 Critical Care Trials Group . 2009 . Critically ill patients with 2009 influenza A (H1N1) infection in Canada . Journal of American Medical Association , 302 ( 17 ) : 1872 – 1879 .
- Lyerly , A.D. , Little , M.O. and Faden , R.R. 2008a . Pregnancy and clinical research . The Hastings Center Report , 38 ( 6 ) inside back cover
- Lyerly , A.D. , Little , M.O. and Faden , R.R. 2008b . The second wave: Toward responsible inclusion of pregnant women in research . The International Journal of Feminist Approaches to Bioethics , 1 : 5 – 22 .
- Macklin , R. 2010 . Enrolling pregnant women in biomedical research . Lancet , 375 : 632 – 633 .
- Mak , T.K. , Mangtani , P. , Leese , J. , Watson , J.M. and Pfeifer , D. 2008 . Influenza vaccination in pregnancy: Current evidence and selected national policies . Lancet Infectious Diseases , 8 : 44 – 52 .
- McCullough , L.B. , Coverdale , J.H. and Chervenak , F.A. 2005 . A comprehensive ethical framework for responsibly designing and conducting pharmacologic research that involves pregnant women . American Journal of Obstetrics and Gynecology , 193 : 901 – 907 .
- McNeil , S.A. , Dodds , L.A. , Fell , D.B. , Allen , V.M. , Halperin , B.A. , Steinhoff , M.C. and MacDonald , N.E. 2011 . Effect of respiratory hospitalization during pregnancy on infant outcomes . American Journal of Obstetrics and Gynecology , 204 ( 6 Suppl 1 ) : S54 – S57 .
- National Advisory Committee on Immunization (NACI). (2008). Statement on influenza vaccination for the 2008–2009 season. Canada Communicable Disease Report 34: 1–46. http://www.phac-aspc.gc.ca/publicat/ccdr-rmtc/08pdf/acs-3.pdf (http://www.phac-aspc.gc.ca/publicat/ccdr-rmtc/08pdf/acs-3.pdf) (Accessed: 29 June 2011 ).
- National Commission for the Protection of Human Subjects of Biomedical and Behaviorial Research. (1979). The Belmont Report: Ethical Principles and Guidelines for the Protection of Human Subjects of Research. http://ohsr.od.nih.gov/guidelines/belmont.html#gob2 (http://ohsr.od.nih.gov/guidelines/belmont.html#gob2) (Accessed: 12 January 2012 ).
- National Institute of Allergy and Infectious Diseases. (NIAID). (2011). H1N1 vaccine in pregnant women. ClinicalTrials.gov. http://www.clinicaltrials.gov/ct2/show/NCT00963430?term=NCT00963430&rank=1 (http://www.clinicaltrials.gov/ct2/show/NCT00963430?term=NCT00963430&rank=1) (Accessed: 29 June 2011 ).
- Novartis. (2010). Safety and immunogenicity of a group B Streptococcus vaccine in non pregnant and pregnant women 18–40 years of age. Clinicaltrials.gov. http://clinicaltrials.gov/ct2/show/study/NCT01193920 (http://clinicaltrials.gov/ct2/show/study/NCT01193920) (Accessed: 29 June 2011 ).
- Osborne , P.H. 2007 . The Law of Torts , Toronto : Irwin Law Inc .
- Paradiso , P.R. 2002 . Maternal immunization: The influence of liability issues on vaccine development . Vaccine , 20 : S73 – S74 .
- Poehling , K.A. , Szilagyi , P.G. , Staat , M.A. , Snively , B.M. , Payne , D.C. , Bridges , C.B. , Chu , S.Y. , Light , L.S. , Prill , M.M. , Finelli , L. , Griffin , M.R. , Edwards , K.M. and for the New Vaccine Surveillance Network . 2011 . Impact of maternal immunization on influenza hospitalizations in infants . American Journal of Obstetrics and Gynecology , 204 ( 6 Suppl 1 ) : S141 – S148 .
- Santé et Services Sociaux Québec. (2012). Québec's Compensation for Victims of Vaccination Program. http://www.msss.gouv.qc.ca/sujets/santepub/vaccination/index.php?indemnisation_en (http://www.msss.gouv.qc.ca/sujets/santepub/vaccination/index.php?indemnisation_en) (Accessed: 5 January 2012 ).
- Sibbald , B. 1999 . SOGC sounds ALARM on legal pitfalls facing ob/gyns . Canadian Medical Association Journal , 161 ( 5 ) : 565 – 566 .
- Siston , A.M. , Rasmussen , S.A. , Honein , M.A. , Fry , A.M. , Seib , K. , Callaghan , W.M. , Louie , J. on behalf of the Pandemic H1N1 Influenza in Pregnancy Working Group . 2010 . Pandemic 2009 influenza A(H1N1) virus illness among pregnant women in the United States . Journal of American Medical Association , 303 ( 15 ) : 1517 – 1525 .
- Title 45 Code of Federal Regulations, Part 46, Subpart B.
- Trannoy , E. 1998 . Will ethical and liability issues and public acceptance allow maternal immunization? . Vaccine , 16 : 1482 – 1485 .
- U.S. Department of Health and Human Services. (2006a). Guidance for Industry: Considerations for Developmental Toxicity Studies for Preventive and Therapeutic Vaccines for Infectious Disease Indications. http://www.fda.gov/downloads/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/Vaccines/ucm092170.pdf (http://www.fda.gov/downloads/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/Vaccines/ucm092170.pdf) (Accessed: 29 June 2011 ).
- U.S. Department of Health and Human Services. (2006b). What You Need to Know about the National Vaccine Injury Compensation Program (VICP). ftp://ftp.hrsa.gov/vaccinecompensation/84521_Booklet.pdf (http://ftp://ftp.hrsa.gov/vaccinecompensation/84521_Booklet.pdf) (Accessed: 5 January 2012 ).
- U.S. Department of Health and Human Services. (2009a). Coverage under the Public Readiness and Emergency Preparedness (PREP) Act for H1N1 Vaccination. Flu.gov. http://www.flu.gov/professional/federal/vaccineliability.html (http://www.flu.gov/professional/federal/vaccineliability.html) (Accessed: 29 June 2011 ).
- U.S. Department of Health and Human Services. (2009b). Pandemic influenza vaccines—Amendment. Authority: 42 U.S.C. 247d-6d. Federal Register: June 25, 2009 74(121): 30294–30297. http://edocket.access.gpo.gov/2009/E9-14948.htm (http://edocket.access.gpo.gov/2009/E9-14948.htm) (Accessed: 29 June 2011 ).
- Zaman , K. , Roy , E. , Arifeen , S.E. , Rahman , M. , Raqib , R. , Wilson , E. , Omer , S.B. , Shahid , N.S. , Breiman , R.F. and Steinhoff , M.C. 2008 . Effectiveness of maternal influenza immunization in mothers and infants . New England Journal of Medicine , 359 : 1555 – 1564 .