Advertisement

Protection of Subjects Participating in Clinical Trials

  • Bram Ramjiawan
  • Angela Ramjiawan
  • Lorie Forbes
  • Paramjit S. Tappia
Conference paper
Part of the NATO Science for Peace and Security Series A: Chemistry and Biology book series (NAPSA)

Abstract

Clinical trials constitute one of the final stages along the testing continuum that is so needed for the introduction of new products, methods, and ground-­breaking technologies. Currently, most economies have recognized the importance clinical trials play as part of the entire value chain from idea to product. While most jurisdictions have developed systems of safeguards for the protection of human subjects involved in clinical trials, there are huge disconnects among jurisdictions, institutions and investigators. This article provides some generally accepted international standards and guidelines in relation to subject protection as it pertains to recruitment, confidentiality, monitoring, data storage and data transfer. The need for all trial protocols to be reviewed by a qualified and registered ethics committee, as well as that all legal requirements are met to ensure patient protection, is also highlighted. Since governments and industry see clinical trials as a critical and necessary step in the product development process, there is a need for more translational research, which will increase the demand for more participation in clinical trials. This article will therefore, also address the importance of patient protection if we are to meet these requirements.

Keywords

Personal Information Ethical Principle Clinical Trial Design Clinical Trial Registration Patient Protection 
These keywords were added by machine and not by the authors. This process is experimental and the keywords may be updated as the learning algorithm improves.

Notes

Acknowledgment 

The authors acknowledge the support of the St. Boniface Hospital Research Foundation.

References

  1. 1.
    World Medical Association Declaration of Helsinki (2012) Ethical principles for medical research involving human subjects. http://www.wma.net/en/30publications/10policies/b3/. Accessed 19 Oct 2012
  2. 2.
    The international conference on harmonisation of technical requirements for registration of pharmaceuticals for human use. http://www.ich.org. Accessed 19 Oct 2012
  3. 3.
    Shuster E (1997) Fifty years later: the significance of the Nuremberg Code. N Engl J Med 337:1436–1440PubMedCrossRefGoogle Scholar
  4. 4.
    Dresser R (2009) First-in-human trial participants: not a vulnerable population, but vulnerable nonetheless. J Law Med Ethics 37:38–50PubMedCrossRefGoogle Scholar
  5. 5.
    US Department of Health and Social Services (1979) Belmont Report. http://www.hhs.gov/ohrp/policy/belmont.html. Accessed 19 Oct 2012
  6. 6.
    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 (2010) http://www.pre.ethics.gc.ca/eng/policy-politique/initiatives/tcps2-eptc2/Default/. Accessed 24 Oct 2012
  7. 7.
    Ministry of Health and Family Welfare (2005) Drugs and cosmetics (II Amendment) rules. http://www.drugscontrol.org/Schedule_Y.pdf. Accessed 19 Oct 2012
  8. 8.
    Nadig P, Joshi M, Uthappa A (2011) Competence of ethics committees in patient protection in clinical research. Indian J Med Ethics 8:151–154PubMedGoogle Scholar
  9. 9.
    Spilker B (1991) Ethical considerations and issues. In: Guide to clinical trials. Raven Press, New York, pp 245–257Google Scholar
  10. 10.
    Srinivasan S (2010) Patient protection in clinical trials in India: some concerns. Perspect Clin Res 1:101–103PubMedGoogle Scholar
  11. 11.
    De Maar EW, Chaudhury RR, Kofi Ekue JM et al (1983) Management of clinical trials in developing countries. J Int Med Res 11:1–5PubMedGoogle Scholar
  12. 12.
    Mahaluxmiwala N (2010) Human subject protection in India: is it adequate? Perspect Clin Res 1:15–20Google Scholar
  13. 13.
    European Parliament Policy Department (2009) Clinical trials in developing countries: how to protect people against unethical practices? http://somo.nl/publications-en/Publication_3035. Accessed 22 Oct 2012
  14. 14.
    Bhatt A (2011) Quality of clinical trials: a moving target. Perspect Clin Res 2:124–128PubMedCrossRefGoogle Scholar
  15. 15.
    Slade KL, Carreau NA, Heald P (2012) Ethics of clinical trials in dermatology. Clin Dermatol 30:226–230PubMedCrossRefGoogle Scholar
  16. 16.
    Irwin RS (2007) Clinical trial registration promotes patient protection and benefit, advances the trust of everyone, and is required. Chest 131:639–640PubMedCrossRefGoogle Scholar
  17. 17.
    Miller FG, Brody H (2005) Professional integrity industry-sponsored clinical trials. Acad Med 80:899–904PubMedCrossRefGoogle Scholar

Copyright information

© Springer Science+Business Media Dordrecht 2013

Authors and Affiliations

  • Bram Ramjiawan
    • 1
    • 2
  • Angela Ramjiawan
    • 1
  • Lorie Forbes
    • 1
  • Paramjit S. Tappia
    • 1
  1. 1.Office of Clinical Research, Asper Clinical Research InstituteSt Boniface Hospital Research CentreWinnipegCanada
  2. 2.Departments of Pharmacology and Therapeutics, Faculty of MedicineUniversity of ManitobaWinnipegCanada

Personalised recommendations