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14.   References

                  1.    Defining Research Vs Audit. Townsville Hospital and Health Service,  https://www.
                        health.qld.gov.au/__data/assets/pdf_file/0023/641642/define-research-vs-audit.pdf
                        (Accessed on 20th September 2021).
                  2.    Whitaker S (2016).  Scientific Merit Evaluation and Justification. DOI:10.13140/
                        RG.2.2.11155.02083/1.
                  3.    Department of Biosafety (2010). Biosafety Guidelines for Contained Use Activity of
                        Living Modified Organism (LMO).  https://www.biosafety.gov.my/wp-content/up-
                        loads/2021/08/Guidelines-for-Contained-Use-Activity-of-Living-Modified-Organism.
                        pdf (Accessed on 22 November 2021)
                  4.    Declaration of Helsinki (1964), WMA Declaration of Helsinki -  Ethical Principles for
                        Medical Research Involving Human Subjects,  https://www.wma.net/policies-post/
                        wma-declaration-of-helsinki-ethical-principles-for-medical-research-involving-hu-
                        man-subjects/.
                  5.    What  is Research? Hampshire  College,  https://www.hampshire.edu/dof/what-is-re-
                        search (Accessed on 26 July 2021).
                  6.    Preparing a Grant Application (2020) Western Sydney University https://www.west-
                        ernsydney.edu.au/research/researchers/preparing_a_grant_application/dest_defini-
                        tion_of_research (Accessed on 26 July 2021).
                  7.    Personal Health Information Act Section 2, S.O. 2004, Chapter 3, Schedule A, Part I.
                  8.    Protection of Human Subjects (2009). Code of Federal Regulation, Title 45, Subtitle A,
                        Subchapter A, Part 46.102.
                  9.    Integrated Addendum to ICH E6(R1): Guideline for Good Clinical Practice E6(R2), In-
                        ternational Council for Harmonisation of Technical Requirements for Pharmaceuticals
                        for Human Use (ICH), 9 November 2016.
                  10.   National  Pharmaceutical  Regulatory  Agency (NPRA),  Ministry of Health Malaysia.
                        (2018) Malaysian Guideline for Good Clinical Practice. - Fourth Edition,2018, National
                        Committee for Clinical Research (NCCR), ISBN 978-983-42000-1-5
                  11.   Council for International Organizations of Medical Sciences (CIOMS) in collabora-
                        tion  with  the  World  Health  Organization  (WHO).  International  Ethical  Guidelines  for
                        Health-related Research Involving Humans. Geneva 2016.
                  12.   Attachment D: Informed Consent and Waiver of Consent. Office for Human Research
                        Protections. 2013. Code of Federal Regulation, Title 45, Subtitle A, Subchapter A, Part
                        46.116. Available at: <https://www.hhs.gov/ohrp/sachrp-committee/recommenda-
                        tions/2013-january-10-letter-attachment-d/index.html> (Accessed on 26 July 2021).
                  13.    Office for Human Research Protections (2018)  Activities Deemed Not to Be Re-
                        search: Public Health Surveillance 2018 Requirements. Available at: <https://www.
                        hhs.gov/ohrp/regulations-and-policy/requests-for-comments/draft-guidance-activi-
                        ties-deemed-not-be-research-public-health-surveillance/index.html>
                  14.   Clinical Research Malaysia (2015). Malaysian Guideline on the Use of Human Biologi-
                        cal Samples for Research, August 2015.
                  15.   Ministry of Health Malaysia (2007). Malaysian Guidelines for Stem Cell Research and
                        Therapy, Medical Development Division, July 2009, MOH/P/PAK/177.08(GU)
                  16.   Ministry of Health Malaysia (2015). Malaysia Laboratory Biosafety and Biosecurity
                        Policy and Guideline. https://ukkp.usm.my/phocadownload/userupload/julianaar@
                        usm.my/Biosafety_Policy_and_Guideline_2015.pdf (Accessed on 22 November 2021)
                  17.   Ministry of Environment and Water (2021). Contained Use Notice. https://www.bio-
                        safety.gov.my/en/perkhidmatan/pemberitahuan-kegunaan-terkawal/. (Accessed on
                        22 November 2021)




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