Document that you have the right to access the information. Describe the criteria and procedure used to select research participants from the pool of all possible participants. If selection is to be accomplished on the basis of document review, provide assurance that the researcher will not have unauthorized access to private or confidential files. If selection is to be accomplished on the basis of primary data collection, this must be made clear to the subjects during the initial consent process. Include appropriate debriefing information for individuals removed from the research and an additional consent form for those remaining as subjects in the research project.
Benefits Describe the benefits to the subjects or larger community.
State clearly the importance of expected knowledge to be gained from this research project. Describe any potential reactive effects of the instrumentation as well as the treatment. Describe how confidentiality will be maintained. Describe measures ensuring professional intervention in the event of adverse effects to the subjects. Address issues of privacy and potential coercion for research involving vulnerable subjects.