1. United States Federal Government. Code of Federal Regulations, Title 45, Public Welfare, Subtitle A, Department of Health and Human Services, Subchapter A, General Administration, Part 46, Protection of Human Subjects. July 19, 2018. Available at
https://www.ecfr.gov/cgi-bin/retrieveECFR?gp=&SID=83cd09e1c0f5c6937cd9d7513160fc3f&pitd=20180719&n=pt45.1.46&r=PART&ty=HTML
. Accessed 15 Jan 2019.
2. The National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research: The Belmont Report. Ethical Principles and Guidelines for the Protection of Human Subjects of Research. Department of Health, Education and Welfare Publication No. (OS) 78-0012; (30 September 1978); United States Government Printing Office, Washington, D.C.
3. United States Federal Government. Code of Federal Regulations, Title 21, Food and Drugs, Chapter I, Food and Drug Administration, Department of Health and Human Services, Subchapter A—General. December 20, 2018. Available at
https://www.ecfr.gov/cgi-bin/text-idx?SID=1397a97a9e6c26b4e58857b25fcddcc2&mc=true&tpl=/ecfrbrowse/Title21/21cfrv1_02.tpl#0
. Accessed 15 Jan 2019.
4. World Medical Association. WMA Declaration of Helsinki – Ethical Principles for Medical Research Involving Human Subjects. July 9, 2018. Available at
https://www.wma.net/policies-post/wma-declaration-of-helsinki-ethical-principles-for-medical-research-involving-human-subjects/
. Accessed 15 Jan 2019.
5. Whitney SN. Consent in biomedical research. In: Whitney SN, editor. Balanced ethics review: a guide for institutional review board members. New York: Springer; 2016. p. 47–56.