When a study includes subjects who may be enrolled in the study only with the consent of the authorized representative (e.g., minors or subjects unable to subject’s legally consent for themselves), the subject should be informed about the study to the extent compatible with the understanding. If capable, the subject should assent and subject’s sign and personally date the written consent form. A separate IRB-approved assent form, describing (in simplified terms) the details of the study, study procedures and risks may be used. Assent forms do not substitute for the consent form signed by the legally acceptable representative. Consult with the institutions policies subject’s regarding enrolling participants who are unable to provide informed consent for themselves. Subjects who are unable to give consent for themselves should not be enrolled in research unless the objectives of the research cannot be met by enrolling only persons who are able to give consent for their participation. The reviewing IRB/IEC must give approval or a favorable opinion on their inclusion. Exclusion of Women, Minorities, and Children (Special Populations) If the study intends to exclude any special populations, justify the exclusion of women, minorities or children in the context of the study design. Subject Confidentiality Include procedures for maintaining subject confidentiality, any special data security requirements, and record retention per the requirements. sponsor’s Subject confidentiality is strictly held in trust by the participating investigators, their staff, and the sponsor(s) and their agents. This confidentiality is extended to cover testing of biological samples and genetic tests in addition to the clinical information relating to participating subjects. The study protocol, documentation, data and all other information generated will be held in strict confidence. No information concerning the study or the data will be released to any unauthorized third party without prior written approval of the sponsor. The study monitor or other authorized representatives of the sponsor may inspect all documents and records required to be maintained by the Investigator, including but not limited to, medical records (office, clinic or hospital) and pharmacy records for the subjects in this study. The clinical study site will permit access to such records.
When a study includes subjects who may be enrolled in the study only with the consent of the subject’s legally authorized representative (e.g., minors or subjects unable to consent for themselves), the subject should be informed about the study to the extent compatible with the subject’s understanding. If capable, the subject should assent and sign and personally date the written consent form. A separate IRB-approved assent form, describing (in simplified terms) the details of the study, study procedures and risks may be used. Assent forms do not substitute for the consent form signed by the subject’s legally acceptable representative. Consult with the institutions policies regarding enrolling participants who are unable to provide informed consent for themselves. Subjects who are unable to give consent for themselves should not be enrolled in research unless the objectives of the research cannot be met by enrolling only persons who are able to give consent for their participation. The reviewing IRB/IEC must give approval or a favorable opinion on their inclusion. Exclusion of Women, Minorities, and Children (Special Populations) If the study intends to exclude any special populations, justify the exclusion of women, minorities or children in the context of the study design. Subject Confidentiality Include procedures for maintaining subject confidentiality, any special data security requirements, and record retention per the sponsor’s requirements. Subject confidentiality is strictly held in trust by the participating investigators, their staff, and the sponsor(s) and their agents. This confidentiality is extended to cover testing of biological samples and genetic tests in addition to the clinical information relating to participating subjects. The study protocol, documentation, data and all other information generated will be held in strict confidence. No information concerning the study or the data will be released to any unauthorized third party without prior written approval of the sponsor. The study monitor or other authorized representatives of the sponsor may inspect all documents and records required to be maintained by the Investigator, including but not limited to, medical records (office, clinic or hospital) and pharmacy records for the subjects in this study. The clinical study site will permit access to such records.