Skip navigation

References

  1. Secretariat for National Committee for Clinical Research, Ministry of Health Malaysia. Malaysian Guideline on the use of Human Biological Samples for Research [Internet]. Ministry of Health Malaysia; 2015. Available from: http://www.crc.gov.my/wp-content/uploads/2016/07/Guideline_on_Human_Tissue_in_Clinical_Research.pdf
  2. Office of the Commissioner. Recruiting Study Subjects [Internet]. U.S. Food and Drug Administration. 2019 [cited 2019 Jun 6]. Available from: http://www.fda.gov/regulatory-information/search-fda-guidance-documents/recruiting-study-subjects
  3. e-CFR (Revised Common Rule) [Internet]. United States Electronic Code of Federal Regulations. Sect. Part 46—Protection of Human Subjects Jul 19, 2018. Available from: https://www.hhs.gov/ohrp/regulations-and-policy/regulations/45-cfr-46/index.html
  4. National Committee for Clinical Research (NCCR). Malaysian Guideline for Good Clinical Practice Fourth Edition (Mar 2018) [Internet]. Ministry of Health Malaysia; [cited 2019 Jan 8]. Available from: http://www.nccr.gov.my/index.cfm?menuid=6&parentid=17
  5. NHS Health Research Authority, UK Medical Research Council. Home - Consent and Participant information sheet preparation guidance. [Internet]. [cited 2019 Jan 15]. Available from: http://www.hra-decisiontools.org.uk/consent/index.html
  6. SUPPORT Study Group. Target Ranges of Oxygen Saturation in Extremely Preterm Infants. New England Journal of Medicine. 2010 May 27;362(21):1959–69. Available from: https://doi.org/10.1056/NEJMoa0911781
  7. SUPPORT Study Group. Protocol: The SUrfactant Positive Airway Pressure and Pulse Oximetry Trial in Extremely Low Birth Weight Infants (The SUPPORT Trial) [Internet]. The Eunice Kennedy Shriver NICHD Neonatal Research Network; 2004 [cited 2019 Jan 16]. Available from: https://www.nih.gov/sites/default/files/institutes/foia/support-protocol.pdf
  8. Carlo W, Ambalavanan N. Participant information sheet: The Surfactant Positive Airway Pressure and Pulse Oximetry Trial in Extremely Low Birth Weight Infants [Internet]. National Institute of Child Health and Development (NICHD); 2014 [cited 2019 Jan 16]. Available from: https://www.nichd.nih.gov/sites/default/files/about/Documents/2013-04-08_All_Consent_SUPPORT.pdf#search=SUPPORT-trial
  9. Lantos JD. Vindication for SUPPORT. New England Journal of Medicine. 2015 Oct 8;373(15):1393–5. Available from: https://doi.org/10.1056/NEJMp1510876
  10. Furlow B. SUPPORT controversy’s lessons for informed consent. The Lancet Respiratory Medicine. 2015 Dec 1;3(12):928–9. Available from: https://www.thelancet.com/journals/lanres/article/PIIS2213-2600(15)00417-8/abstract
  11. United States District Court for Northern District of Alabama. Looney v. Moore, Case No.: 2:13-cv -00733-KOB [Internet]. 2014. Available from: https://www.govinfo.gov/content/pkg/USCOURTS-alnd-2_13-cv-00733/pdf/USCOURTS-alnd-2_13-cv-00733-0.pdf
  12. U.S. Department of Health and Human Services. OHRP: General Informed Consent Requirements [Internet]. 2010. Available from: https://www.youtube.com/watch?v=URo4x4pv68A&t=0s&index=12&list=PL-PYqw3Y3NFsy9-3McTUQakPqqfVIslnb
  13. Medical Research and Ethics Committee (MREC). Malaysian Guidelines for health research involving minors [Internet]. Malaysia National Institute of Healh; 2011. Available from: http://nih.gov.my/mrec/wp-content/uploads/2014/11/Guidelines-for-Minors1.pdf
  14. A Clinical Drug Study at the University of Minnesota Department of Psychiatry: The Dan Markingson Case (Special Review) [Internet]. Minnesota: Office of the Legislative Auditor, State of Minnesota; 2015 Mar [cited 2019 Jan 17]. Available from: https://www.auditor.leg.state.mn.us/sreview/markingson.pdf
  15. Clinical Trial Protocol - Tranexamic acid for the treatment of significant traumatic brain injury:  an international randomised, double blind placebo controlled trial [Internet]. Clinical Trials Unit, London School of Hygiene & Tropical Medicine; 2018 [cited 2018 Dec 31]. Available from: https://crash3.lshtm.ac.uk/resources-for-collaborators/protocol-v2-2-english/
  16. Zulfiqar A. Bhutta. Beyond informed consent. Bulletin of the World Health Organization. 2004 Oct;82(10):771–7. Available from: https://www.who.int/bulletin/volumes/82/10/771.pdf
  17. UK Health Research Authority, UK Medicines and Healthcare Products Regulatory Agency. Joint statement on seeking consent by electronic methods [Internet]. 2018. Available from: https://www.hra.nhs.uk/documents/1588/hra-mhra-econsent-statement-sept-18.pdf
  18. U.S. Department of Health and Human Services. Use of Electronic Informed Consent: Questions and Answers (Guidance for Institutional Review Boards, Investigators, and Sponsors) [Internet]. Food and Drug Administration; 2016. Available from: https://www.fda.gov/downloads/drugs/guidances/ucm436811.pdf
  19. Wong M-L, Chan R, Tan HH, Yong E, Lee L, Cutter J, et al. Sex Work and Risky Sexual Behaviors among Foreign Entertainment Workers in Urban Singapore: Findings from Mystery Client Survey. J Urban Health. 2012 Dec;89(6):1031–44. Available from: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3531347/
  20. Office for Protection from Research Risks. Exculpatory Language in Informed Consent [Internet]. HHS.gov. 1996 [cited 2019 Jan 16]. Available from: https://www.hhs.gov/ohrp/regulations-and-policy/guidance/exculpatory-language-in-informed-consent-documents/index.html