The good clinical practice (GCP) related laws, regulations, guidance and standard operating procedures (SOP), are derived products of the 1964 World medical association’s Declaration of Helsinki (ASCO. 2008). The World medical association developed the Helsinki Declaration from the principles of the Nuremberg code of 1947. Consequently the Helsinki and the Nuremberg code were the principle architectures of the international conference on harmonization-good clinical practice (ICH-GCP) guidelines (ASCO.2008). Hence, the principle objective of the GCP-related laws, regulations, guidance and SOP is to ensure that the conduct of quality clinical trial is an obligation that researchers or principal investigators (PIs) must have in maintaining meaningful and safe trials (ASCO.2008). In addition, compliance to the ICH-GCP related laws and guide ensures that data generated in a clinical trial is accurate, verifiable, reproducible, and most importantly provide public assurance that the rights, safety, well-being and personal health information of participating human subjects in a clinical trial are protected at all times (ASCO. 2008). Therefore, the objective of this review is to analyze how the GCP-related laws, regulations, guidance and standard operating procedures (SOP) reflect the influence of the ICH “Guideline for Good Clinical Practice E6 (R1)”.
GCP-Related Laws, Regulations, Guidance, and Standard Operating Procedures
The principle of the 1996 ICH-GCP: E6 (R1) guidelines laid down critical guides in section 2 (page 8) of the document and emphasized key elements that are needed in fulfilling the need for an ethical conduct in any clinical research studies involving human subject participants (ICH.1996). In the advent of the ICH-GCP guidelines, many countries and regulatory agencies have embedded the GCP guidelines in drafting laws and regulations relating to medical clinical research involving human subjects and making sure that any clinical trial is adhering to but not limited to the 13 basic principles of the ICH-GCP guidelines (Vijayananthan, & Nawawi, 2007). In addition, sponsors has also increased their resources and vigilance in making sure that they are abiding or in compliance with the ICH-GCP guidelines (Woodin, Schneider, Kelly, & Pillemer, 2012).
In the US, for instance, the strictness of the 1996 HIPAA Act regarding research and medical care such as the protected health information (PHI), health service research, research repositories and database, institutional review board (IRB) and privacy board’s privacy rules were strongly influenced by recommendations of the GCP guidelines (NIH, 2004). In Europe, the commission directives 2005/28/EC, is an essential document that derived its principles from the ICH-GCP guidelines in an attempt to mandate the initial ICH-GCP guidelines into a legal binding clinical research practices (EU. 2005). Furthermore, the Asia-pacific nations using the ICH-GCP frameworks advocate for medical ethical awareness, improve trial method, encourage better trial concept, mitigate public safety concerns, avoid fraud and accident in trial, increase competition, enhance mutual recognition of data and new market structure in conducting an ethical clinical research; drafted comprehensive guides and regulations on ethical principles in conducting a clinical research (Vijayananthan, & Nawawi, 2007).
The use of standard operating procedures (SOP) is an organizational based scientific or non-scientific procedural guidelines on how to perform a specific task or function (Woodin, Schneider, Kelly, & Pillemer, 2012). SOP is a vital non-legal binding component of scientific protocol that ensure and outline systematic and sequential order to which a scientific conduct is to be operated. In addition, it is a framework that ensure that experiments are conducted in a uniform and reproducible manner (Woodin, Schneider, Kelly, & Pillemer, 2012). Furthermore, by following a given SOPs in clinical trials, it ensures that a data or result generated in a clinical can be “verifiable”, an elemental criterion that is very critical and in sync with the ICH-GCP guidelines. Moreover, for regulatory aspect, following a written SOP is usually the base of the inspection and compliance measures that most regulatory agency’s monitoring teams evaluate to ensure that sponsors or researchers are not deviating from the stipulated protocol and SOP (Woodin, Schneider, Kelly, & Pillemer, 2012).
On the other hand, guidance is more advance form of SOP that may reflect global, national or institution’s principles. Thus, guidance has no limited compliance barrier within a single organization or institution. However, guidance just like an SOP is not a legally binding document (Woodin, Schneider, Kelly, & Pillemer, 2012).
ASCO.(2008). Good clinical practice research guidelines, reviewed emphasis given to responsibilities of investigators: second article in series. JOP, 4 (5 )233-235. doi: 10.1200/JOP.0854601
European Union. (2005). Commission Directive 2005/28/EC. (2005). Official Journal-European Union Legislation L, 48(91), 13–19. Retrieved from http://eur-lex.europa. eu/LexUriServ/LexUriServ.do?uri=OJ:L:2005:091:0013:0019:EN:PDF
Grimes, D., Hubacher, D., Nanda, K., Schulz, K., Moher, D., & Altman, D. (2005). The good clinical practice guideline: A bronze standard for clinical research. Lancet, 366(9480), 172–174. Retrieved from http://ezp.waldenulibrary.org/login? url=http://search.ebs cohost.com/login.aspx? direct=true&db=a9h&AN=17540289&site=ehost-live&scope=site .
International Conference on Harmonization Expert Working Group. (1996). Guideline for good clinical practice E6(R1). Retrieved from http://www.ich.org/fileadmin/Public _Web_Site/ICH_Products/ Guidelines/Efficacy/E6_R1/Step4/E6_R1__Guideline.pd.
International Conference on Harmonization. (2012). Initiation of ICH. Retrieve from http://www.ich.org/about/history.html.
Mueller, J., Scheflenberg, D., & Owens, S. (2007). Third-World barriers: Getting past consent and ethical issues endemic in underserved populations to ensure quality GCP. Applied Clinical Trials, 16(10), 58–64. Retrieved from http://ezp.waldenulibrary.org/login? url=http://search.ebscohost.com/login.aspx? direct=true&db=a9h&AN=2 7063452&site=ehost-live&scope=site .
National Institute of Health. (2004). Clinical research and the hipaa privacy rule. Retrieve from http://privacyrul eandresearch.nih.gov/clin_research.asp.
Vijayananthan, A., & Nawawi, O. (2007). The importance of good clinical practice guidelines and its role in clinical trials. Retrieve from http://www.biij.org/2008/1/e5/e5.pdf.
Woodin, K., Schneider, J., Kelly, M., & Pillemer, S. (2012). Regulation and good clinical practice. Retrieve from https://class.waldenu.edu/webapps/portal/frameset.jsp? tab_tab_group_id=_2_1&url=%2Fwebapps%2Fblackboard%2Fexecute%2Flauncher %3Ftype%3DCourse%26id%3D_1342087_1%26url%3D.