51 9 COLLABORATIVE AGREEMENTS ................................................................................. 52 9.1 Agreement Type ............................................................................................................. 52 10 HUMAN SUBJECTS PROTECTIONS ............................................................................... 52 10.1 Rationale For Subject Selection ................................................................................. 52 10.1.1 Inclusion of Women and Minorities ....................................................................... 52 10.1.2 Exclusions ............................................................................................................... 52 10.2 Participation of Children ............................................................................................ 52 10.3 Evaluation of Benefits and Risks/Discomforts ........................................................... 53 10.4 Consent and Assent Process and Documentation ....................................................... 53 10.4.1 Telephone (Re- )Consent Procedure ........................................................................ 53 10.4.2 Informed Consent of Non-English Speaking Subjects ........................................... 54 11 PHARMACEUTICAL INFORMATION .............................................................................