1-Research and Development

Sub-module 3.1-Research and Development

Objective

To develop the ability to perform research in an area of relevance to nuclear medicine physics either individually or as a member of a multi- disciplinary research team.

Pre-requisites

None An understanding of processes of scientific research including the role

Competencies

of ethics review, statistical analysis, and the publication process.

Addressed

The ability to carry out research and development in nuclear medicine physics in cooperation with nuclear medicine physicians, diagnostic medical physicists, radiation oncology medical physicists and other professionals .

Core

(1) Understanding of

Knowledge

• The role of ethics in research involving human and animal subjects

including radiation related subjects

• The application of statistics to experimental design, formulation of hypotheses, and data analysis (including ROC analysis where appropriate)

• The format of scientific papers • The peer-review process of research grant applications and

scientific publications (2) Awareness of appropriate international journals in nuclear

medicine, medical physics, and associated fields of research

Recommended

Design a research project including:

elements of

• Identify an area for research, including the specific question which

training

is being asked, in consultation with other professionals such as nuclear medicine physicians.

• Formulate hypotheses. • Review the literature in the area effectively and critically, using

appropriate databases e.g., MedLine, PubMed and Scorpus, and provide this in a written report (including the clinical benefits of the research or development).

• Continually monitor current advances in research and development

in the chosen area of research. • Determine a plan for a research project including milestones,

necessary experiments, and analysis. • Consult with statistician or epidemiologist as required. • Evaluate the ethical issues involved against national criteria,

including radiation issues, and make the necessary application to an appropriate ethics committee (also known as a human studies committee [HSC] or institutional review board [IRB]) if necessary.

• Evaluate required resources including time, personnel, and

equipment. Manage a budget for a small research project Peer review of results: • Present and defend results at the departmental level • Present results at national or international conference • Publish in a peer-reviewed journal Building on research initiatives • Write a simple research grant application in conjunction with

nuclear medicine physicians or other experienced staff, including a response to comment from the review process.

• Participate in a multidisciplinary research team by contributing medical physics knowledge and skills, such as providing dosimetry support.

• Provide dose calculations and risk estimates, including comparisons to other risks from ionizing radiation, for use by the ethics committee (HSC or IRB) for a proposed project involving medical internal radiation dosimetry to human subjects.

Knowledge

[1] AMERICAN ASSOCIATION OF PHYSICISTS IN MEDICINE,

Sources

Quality assurance for clinical trials: A primer for Physicists, AAPM Rep. 86, New York (2005). http://www.aapm.org/pubs/reports/rpt_84.PDF.

[2] ARPANSA, Code of Practice for the Exposure of Humans to Ionizing Radiation for Research Purposes, Radiation Protection Series Rep. 8, ARPANSA. http://www.arpansa.gov.au/rps8.htm.

[3] ICH/CPMP, Good Clinical Practice : Consolidated Guidelines, International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use Rep. E6 (R1) (1996). http://www.ich.org/cache/compo/276-254- 1.html.

[4] ICH/CPMP, Statistical Principles for Clinical Trials, International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use Rep. E9 (1998). http://www.ich.org/cache/compo/276-254-1.html.

[5] http://www.nhmrc.gov.au/ethics/human/issues/trials.htm [6] http://www.tga.gov.au/docs/html/ich13595.htm. [7] RAVINDRAN, C., Ethics in Biomedical Research, Calicut

Medical Journal 6 2 (2008). [8] WOODWORD, M., Epidemiology: Study Design and Data Analysis, 2nd edn, Chapman & Hall/CRC (2005). [9] WOOLFE, J., How to write a PhD Thesis, http://www.phys.unsw.edu.au/~jw/thesis.html [10] WORLD HEALTH ORGANIZATION, Operational Guidelines for Ethics Committees That Review Biomedical Research, Geneva (2000).

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