How to create a research protocol

The protocol is a statement of the researcher's project design and a description of his/her responsibilities toward the human subjects inolved in the research. Please note that your protocol should not be more than 3 pages-single spaced or 1500 words.

Every researcher planning to conduct research involving human subjects is required to submit a protocol describing the research to the IRB The research protocol should contain the following elements:

1. A brief description of the purpose and methods.
2. A statement of the benefits of the research to the human subjects, if any, and of the benefits to humanity and/or scientific knowledge.
3. A detailed explanation of how the subjects will give informed consent.
4. A description of the risks and discomforts, if any, to the subjects. Such deleterious effects may be physical, psychological, or social. If the research involves more than minimal risks or greater than those encountered in daily life then, a thorough description of the means taken to minimize the deleterious effects must be discussed. 
5. A description of how to ensure privacy and confidentiality of subjects. If any identification information will be released, specify the recipient of the information. Describe and explain how confidentiality of data will be maintained.