Ethical and regulatory issues related to pregnancy registries and their outcomes

Author:

French Jacqueline A.,Meador Kimford,Cnaan Avital,Gilliam Frank,Conway Jill,Araojo Richardae,Feibus Karen

Publisher

Elsevier BV

Subject

Behavioral Neuroscience,Neurology (clinical),Neurology

Reference14 articles.

1. Guidance for industry: establishing pregnancy exposure registries. U.S. Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research, Center for Biologics Evaluation and Research; 2002 August. Available at: http://www.fda.gov/cber/gdlns/pregexp.htm.

2. Birth defects after prenatal exposure to antiepileptic drugs;Perucca;Lancet Neurol,2005

3. The Belmont Report: ethical principles and guidelines for the protection of human subjects of research. National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. 1979 April 18. Available at: http://ohsr.od.nih.gov/guidelines/belmont.html.

4. Code of Federal Regulations title 45 public welfare Department of Health and Human Services Part 46 protection of human subjects Revised June 23, 2005. Available at http://www.hhs.gov/ohr/humansubjects/guidance/45cfr46.htm#46.10.

5. Guidelines for the conduct of research involving human subjects at the National Institutes of Health: U.S. Department of Health and Human Services Public Health Services, National Institutes of Health. 5th Printing: August 2004. Available at: http://ohsr.od.nih.gov/guidelines/GrayBooklet82404.pdf.

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