Consent for Pluripotent Cell Use for Therapy

Author:

Jonlin Erica C.

Publisher

Springer Science and Business Media LLC

Subject

Cell Biology,Developmental Biology,Genetics,Molecular Biology

Reference37 articles.

1. Lund TC, Boitano AE, Delaney CS, Shpall EJ, Wagner JE. Advances in umbilical cord blood manipulation—from niche to bedside. Nat Rev Clin Oncol. 2014. doi: 10.1038/nrclinonc.2014.215 . Published online 16 December 2014.

2. Pluripotent stem cells in translation: early decisions. NIH/FDA conference. March 21–22, 2011.

3. Code of Federal Regulations, Title 45 Department of Health and Human Services Part 46: protection of human subjects. Subpart A, basic HHS policy for protection of human research subjects. Revised January 15, 2009; Effective July 14, 2009. Available from: http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.html .

4. Code of Federal Regulations, Title 21 Food and Drug Administration, Department of Health and Human Services Part 50: protection of human subjects. Subpart B, informed consent of human subjects. Revised as of April 1, 2014 Available from: http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?CFRPart=50 .

5. Guidance for Industry E6 good clinical practice: consolidated guidance. International Conference on Harmonization (ICH) E6 Available from: http://www.fda.gov/downloads/Drugs/Guidances/ucm073122.pdf . April 1996.

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