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Chapter 46 : The Clinical Trial Laboratory: Research Compliance for Clinical Research Microbiologists

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The Clinical Trial Laboratory: Research Compliance for Clinical Research Microbiologists, Page 1 of 2

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Abstract:

There are many aspects of research compliance that impact clinical researchers whose practice is based in academia, private reference laboratories, or hospital-based diagnostic laboratories. This chapter describes the research compliance responsibilities for human subjects protection laws. It explains the key restrictions of the Health Insurance Portability and Accountability Act (HIPAA) and the definition of conflict of interest. Critical components of clinical research include compliance with human subjects protection laws, the HIPAA, conflict of interest policies, good clinical practices (GCPs), and research integrity. The rights of human subjects are protected by a local Human Subjects Protection Program (HSPP) in collaboration with local and/or national institutional review boards (IRBs). The HSPP’s role is to provide administrative support to the IRB and regulatory expertise to the IRB and to investigators. A conflict of interest (COI) is a situation in which there are conflicting incentives with identified potential for injecting inappropriate considerations into a given decision or evaluation—a potential to compromise or jeopardize the integrity or the credibility of a study’s results. GCP encompasses all aspects of clinical trials involving human subjects. Principles of GCP involve ethical aspects of research including risks and benefits to the human subjects, protection of human subjects, informed consent, confidentiality, and the quality of science employed. Good laboratory practice (GLP) is a system of management controls for nonclinical research laboratories and organizations to try to ensure the uniformity, consistency, reliability, reproducibility, quality, and integrity of research.

Citation: Wolk D, Marshall M. 2014. The Clinical Trial Laboratory: Research Compliance for Clinical Research Microbiologists, p 818-831. In Garcia L (ed), Clinical Laboratory Management, Second Edition. ASM Press, Washington, DC. doi: 10.1128/9781555817282.ch46

Key Concept Ranking

Clinical Trials
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Clinical Research
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Analytical Methods
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References

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1. Ackerman, A. B. 2005. Reviewer conflicts of interest should be disclosed. J. Am. Acad. Dermatol. 52(3 Pt 1):538539. [PubMed][CrossRef]
2. Biaggioni, I., 2009. Industry-sponsored clinical research in academia, p. 183188. In R. David, and H. W. Gordon (ed.), Clinical and Translational Science. Academic Press, San Diego, CA.
3. Califf, R. M., 2009. Clinical trials, p. 1337. In R. David, and H. W. Gordon (ed.), Clinical and Translational Science. Academic Press, San Diego, CA.
4. Colecchi, C. H.,, R. Kitterman,, B. N. Hicks,, F. Toneguzzo,, T. Q. Do,, C. Berke,, R. Creeden,, N. Lugn,, C. Gildesgame,, N. Zapol,, and C. Clark,. 2009. Translating science to the bedside: the innovation pipeline, p. 383399. In R. David, and H. W. Gordon (ed.), Clinical and Translational Science. Academic Press, San Diego, CA.
5. Emanuel, E. J.,, D. Wendler,, and C. Grady. 2000. What makes clinical research ethical? JAMA 283(20):27012711. [PubMed]
6.Federal Register. 1978. Nonclinical laboratory studies: good laboratory practice regulations. Fed. Regist. 43:5998560025. [PubMed]
7.Federal Register. 1979. Protection of human subjects; Belmont Report: notice of report for public comment. Fed. Regist. 44: 2319123197. [PubMed]
8.Federal Register. 1998. Protection of human subjects: categories of research that may be reviewed by the Institutional Review Board (IRB) through an expedited review procedure—FDA. Notice. Fed. Regist. 63(Pt 1):6035360356. [PubMed]
9.Federal Register. 2001. Protection of human research subjects. Final rule. Fed. Regist. 66:5677556780. [PubMed]
10. Greco, D.,, and N. M. Diniz. 2008. Conflicts of interest in research involving human beings. J. Int. Bioethique 19(1–2):143. [PubMed]
11. Gunter, K. P. 2002. The HIPAA privacy rule: practical advice for academic and research institutions. Healthc. Financ. Manage. 56(2):5054. [PubMed]
12. Hall, P. A.,, R. Poulsom,, and J. Wixon. How does The Journal of Pathology deal with conflict of interest? J. Pathol. 219(4):396399. [PubMed][CrossRef]
13. Hartmann, K. E.,, E. Heitman,, and N. J. Brown,. 2009. Training basic, clinical and translational investigators, p. 191199. In R. David, and H. W. Gordon (ed.), Clinical and Translational Science. Academic Press, San Diego, CA.
14. Joffe, H. V.,, and M. H. Parks,. 2009. Regulatory environment, p. 401414. In R. David, and H. W. Gordon (ed.), Clinical and Translational Science. Academic Press, San Diego, CA.
15. Koski, G., 2009. Ethical issues in translational research and clinical investigation, p. 415428. In R. David, and H. W. Gordon (ed.), Clinical and Translational Science. Academic Press, San Diego, CA.
16. Macleod, M. R.,, M. Fisher,, V. O'Collins,, E. S. Sena,, U. Dirnagl,, P. M. Bath,, A. Buchan,, H. B. van der, Worp, R. J. Traystman,, K. Minematsu,, G. A. Donnan,, and D. W. Howells. 2009. Reprint: good laboratory practice: preventing introduction of bias at the bench. J. Cereb. Blood Flow Metab. 29(2):221223. [PubMed][CrossRef]
17. Morin, K.,, H. Rakatansky,, F. A. RiddickJr.,, L. Morse,, J. M. O'Bannon,, 3rd, M. S. Goldrich,, P. Ray,, M. Weiss,, R. M. Sade,, and M. A. Spillman. 2002. Managing conflicts of interest in the conduct of clinical trials. JAMA 287(1):7884. [PubMed]
18. Norris, S. L.,, H. K. Holmer,, L. A. Ogden,, and B. U. Burda. 2011. Conflict of interest in clinical practice guideline development: a systematic review. PLoS One 6(10):e25153. [PubMed][CrossRef]
19. Rabinovitch, A. 2004. Financial conflict of interest? Arch. Pathol. Lab. Med. 128(12):1328. [PubMed][CrossRef]
20. Rice, T. W.. 2008. The historical, ethical, and legal background of human-subjects research. Respir. Care 53(10):13251329. [PubMed]
21. Robertson, D.,, and G. H. Williams,. 2009. Clinical and translational science infrastructure, p. 171181. In R. David, and H. W. Gordon (ed.), Clinical and Translational Science. Academic Press, San Diego, CA.
22. Sanford Schwartz, J., 2009. Health services research: translating discovery and research into practice and policy, p. 543561. In R. David, and H. W. Gordon (ed.), Clinical and Translational Science. Academic Press, San Diego, CA.
23. Schwarz, R.P,Jr. 1991. Maintaining integrity and credibility in industry-sponsored clinical research. Control. Clin. Trials 12(6): 753760. [PubMed]
24. Thompson, D. F. 1993. Understanding financial conflicts of interest. N. Engl. J. Med. 329(8):573576. [PubMed][CrossRef]
25. Vermund, S. H.,, and Q. A. Karim,. 2009. Governmental support of research, p. 219236. In R. David, and H. W. Gordon (ed.), Clinical and Translational Science. Academic Press, San Diego, CA.
26. Zgheib, N.,, R. Branch,, and S. Buch,. 2009. Good clinical practice and good laboratory practice, p. 312. In R. David, and H. W. Gordon (ed.), Clinical and Translational Science. Academic Press, San Diego, CA.

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