Human Participants
Address the following points in the Participants section (using a numbered outline is okay but not required).
Describe the characteristics of the subject population, including their anticipated number, age range, and health status.
Identify the criteria for inclusion or exclusion of any sub population.
Explain the rationale for the involvement of vulnerable populations, such as pregnant women, children, institutionalized individuals, or others who may be considered vulnerable populations.
The inclusion of women and members of minority groups and their sub populations must be addressed in developing a research design appropriate to the scientific objectives of the study. Describe the composition of the proposed study population in terms of sex/gender and racial/ethnic group, and provide a rationale for selection of such subjects. Such a plan should contain a description of the proposed outreach programs for recruiting women and minorities as participants.
Describe any potential risks (physical, psychological, social, legal, or other) and assess their likelihood and seriousness to the subjects. Describe planned procedures for protecting against or minimizing potential risks, including risks to confidentiality. Where appropriate, discuss plans for ensuring necessary medical or professional intervention in the event of adverse effects to the subjects.
