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Every complete research protocol must contain the relevant elements summarized below:
Include an evaluative review of the state of current knowledge in the area of the research and indicate how the study builds on or extends this body of information.
The review should clearly place the research in context to form the basis for its rationale.
Present the results of any pilot studies.
State the hypotheses.
State in concise, concrete terms what you intend to accomplish.
Discuss in detail the experimental design and procedures. Include a clear description of all steps and procedures, including timetable, for the study.
Specify inclusion/exclusion criteria. Identify the criteria for inclusion or exclusion of any sub-population. Explain the rationale for the involvement of special classes of the subjects, such as fetuses, pregnant women, children, prisoners, or others who are likely to be vulnerable. The principle of justice requires fairness in the exclusion and inclusion criteria. Federal regulations require, when appropriate, the enrollment of women, children and minorities in research. A valid justification for excluding these populations must be included in the protocol.
Describe the characteristics of the subject population, including their anticipated number, age range, and health status.
Identify the sources of research material obtained from individually identifiable living human subjects in the form of specimens, records, or data. Indicate if the material will be obtained exclusively for research or as part of standard clinically indicated care.
Describe the source for participant recruitment and the recruitment mechanism. Describe the informed consent process including who will seek consent and the nature of the information to be provided to subjects, and the method of documenting consent.
Describe the potential physical, psychological, social, or legal risks and assess their likelihood and seriousness. Describe how the potential risks will be minimized, including the protection of the participants' confidentiality. Describe alternatives to participation in this study.
Describe the provisions for monitoring the data collected to ensure the safety and confidentiality of the participants.
Explain why the risks to participants are reasonable in relation to the anticipated benefits to participants and relative importance of the knowledge that may reasonably be expected to result.
Discuss how the data collected will be analyzed.
Describe the statistical methods that will be used to test the hypotheses or determine if the objectives have been achieved.
Specify in detail how the results will be evaluated.
Include a bibliographic list of all references included in the protocol.
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