While children usually should not be the initial group to be involved in research studies, in some instances, the nature and seriousness of the illness may warrant their participation earlier based on careful risk and benefit analysis. Other special cases justified by the investigator and found acceptable to the review group and the GCRC Director. The exemption must be explicitly stated. Planned enrollment must be viewed in terms of the demographics of the disease in the national population rather than local demographics, referral patterns or convenience samples. Percent distribution of your clinic population or referral base.
Study population Provide a detailed description of the proposed involvement of human subjects.
Describe the characteristics of the subject population, including their age range and health status. Identify the criteria for inclusion or exclusion of any subpopulation. Research materials Identify the sources of research material obtained from living human subjects in the form of specimens, records or data. Recruitment and consent Describe plans for the recruitment of subjects. Describe the consent procedures to be followed, including the circumstances under which consent will be sought and obtained, who will seek it, the nature of the information to be provided to prospective subjects and the method of documenting consent.