ABSTRACT
Engaging in research activities can be an enriching aspect of one's professional career.
Research serves to advance the knowledge base from which clinical decisions are founded
and is the responsibility of all who provide clinical services. That is, developing
and advancing this knowledge base is everyone's responsibility, whether as consumers
of research or as direct contributors of research. Understanding the ethical issues
that embrace the research enterprise is a complementary responsibility of professionals.
Conducting research within an ethical framework is essential to maintaining integrity
and credibility in science. Opportunities to promote scientific integrity are particularly
relevant when conducting or examining research involving children. Therefore, the
purpose of this article is to provide an overview of the role of research in clinical
practice, particularly in an environment with pediatric populations. The article will
unfold with three major themes: (1) understanding the value of research in the clinical
environment, (2) describing factors that contribute to sound ethical practices, and
(3) promoting integrity in research conducted with pediatric populations.
KEYWORDS
Research - scientific integrity - research ethics - children - ethical guidelines
REFERENCES
- 1 Levine R J. The nature, scope, and justification for clinical research. In: Emanuel E J,
Grady C, Crouch R A, Lie R K, Miller F G, Wendler D, eds. The Oxford Textbook of Clinical
Research Ethics. New York, NY: Oxford University Press; 2008: 211-221
- 2 NIH policy and guidelines on the inclusion of children as participants in research
involving human subjects. March 6, 1998. Available at: http://grants.nih.gov/grants/guide/notice-files/not98-024.html Accessed October 12, 2011
- 3 Steneck N H. ORI: Introduction to the responsible conduct of research. Rockville,
MD: U.S. Department of Health and Human Services. 2007. [Online monograph]. Available
at: http://ori.hhs.gov/education/products/RCRintro/ Accessed October 12, 2011
- 4 The Nuremberg Code. In: Trials of War Criminals before the Nuremberg Military Tribunals
under Control Council Law No. 10, Vol. 2. Washington, DC: U.S. Government Printing
Office; 1949: 181–182. Available at: http://ohsr.od.nih.gov/guidelines/nuremberg.html Accessed October 12, 2011
- 5 World Medical Association .Code of ethics of the world medical association: Declaration
of Helsinki: Ethical principles for medical research involving human subjects. Helsinki,
Finland: WMA; June 1964. Available at: http://ohsr.od.nih.gov/guidelines/helsinki.html Accessed October 12, 2011
- 6 Fleischman A R, Collogan L K. Research with children. In: Emanuel E J, Grady C,
Crouch R A, Lie R K, Miller F G, Wendler D, eds. The Oxford Textbook of Clinical Research
Ethics. New York, NY: Oxford University Press; 2008: 446-459
- 7 The National Commission for the Protection of Human Subjects of Biomedical and Behavioral
Research .The Belmont Report: Ethical principles and guidelines for the protection
of human subjects of research. Washington, DC: DHEW Publication; 1978. Available at:
http://ohsr.od.nih.gov/guidelines/belmont.html Accessed October 12, 2011
- 8
Emanuel E J, Wendler D, Grady C.
What makes clinical research ethical?.
JAMA.
2000;
283
2701-2711
- 9 Department of Health and Human Services, National Institutes of Health, and Office
for Human Research Protections .The common rule, title 45, code of federal regulations,
part 46 (Protection of Human Subjects). June 23, 2005. Available at: http://www.hhs.gov/ohrp/humansubjects/commonrule/index.html Accessed October 12, 2011
- 10 American Speech-Language-Hearing Association .Code of Ethics [Ethics]. 2010. Available
at: http://www.asha.org/docs/html/ET2010-00309.html Accessed October 12, 2011
- 11 Mustain W. ASHA's code of ethics modified to address research ethics. ASHA Leader
April 2003. [Online]. Available at: http://www.asha.org/practice/ethics/code_changes_research.htm Accessed October 12, 2011
- 12 American Speech-Language-Hearing Association .Guidelines for the responsible conduct
of research: ethics and the publication process [Guidelines]. 2009. Available at:
http://www.asha.org/docs/html/GL2009-00308.html Accessed October 12, 2011
- 13 American Speech-Language-Hearing Association .Conflicts of professional interest
[Issues in Ethics]. 2004. Available at: http://www.asha.org/docs/html/ET2004-00169.html Accessed October 12, 2011
- 14 American Speech-Language-Hearing Association .Ethics in research and scholarly
activity [Issues in Ethics]. 2008. Available at: http://www.asha.org/docs/html/ET2008-00299.html Accessed October 12, 2011
- 15 American Speech-Language-Hearing Association .Protection of human subjects [Issues
in Ethics]. 2005. Available at: http://www.asha.org/docs/html/ET2005-00176.html Accessed October 12, 2011
- 16 Valiela I. Doing Science: Design, Analysis, and Communication of Scientific Research.
2nd ed. New York, NY: Oxford University Press; 2009: 278-289
- 17
Woodgate R L, Edwards M.
Children in health research: a matter of trust.
J Med Ethics.
2010;
36
211-216
- 18
Ghosh P.
UK science head backs ethics code.
BBC News, York, 2007
- 19 IOM .Ethical conduct of clinical research involving children. In: Field M J, Behrman R E,
eds. Committee on Clinical Research Involving Children. Washington, DC: The National
Academies Press; 2004: 58-92
- 20
Thompson R A.
Behavioral research involving children: a developmental perspective on risk.
IRB.
1990;
12
1-6
- 21
Freedman B.
Scientific value and validity as ethical requirements for research: a proposed explication.
IRB.
1987;
9
7-10
- 22
Merlo D F, Knudsen L E, Matusiewicz K, Niebrój L, Vähäkangas K H.
Ethics in studies on children and environmental health.
J Med Ethics.
2007;
33
408-413
- 23 CIOMS .International ethical guidelines for biomedical research involving human
subjects. Geneva, Switzerland: Council for International Organizations of Medical
Sciences, November 2002: 23–69. Available at: http://www.cioms.ch/publications/layout_guide2002.pdf Accessed October 12, 2011
- 24 Wendler D S. Evaluating the worry. In: The Ethics of Pediatric Research. New York,
NY: Oxford University Press; 2010: 47-73
- 25 Shamoo A E, Resnik D B. Protecting vulnerable human subjects in research. In: Responsible
Conduct of Research. 2nd ed. New York, NY: Oxford University Press; 2009: 265-288
Sharon E MossPh.D.
Office of Research Oversight, Department of Veteran Affairs
810 Vermont Avenue NW, Washington, DC 20420
eMail: Sharon.moss2@va.gov