VCOM Institutional Policy and Procedure Manual

VCOM Policy and Procedure

Policy #R004

Where research is covered by 45CFR46.406 and 46.407, permission is to be obtained from both parents unless one parent is deceased, unknown, incompetent or not reasonably available, or when only one parent has legal responsibility for the care and custody of the child. Per 45CFR46.408(c), in addition to the normal waiver requirements, the IRB may waive the parental permission requirement if it determines that a research protocol designed for conditions or a subject population for which parental or guardian permission is not a reasonable requirement to protect the subjects. This waiver might apply to studies involving neglected or abused children, or older adolescents presenting in medical situations wherein a parental consent requirement might deter the child from seeking needed care (e.g., seeking care at an STD clinic). If parental permission is waived, the IRB must be sure that an appropriate mechanism for protecting the children is substituted. The choice of an appropriate mechanism would depend on the nature and purpose of activities in the protocol, the risk and benefit to the subject, and their age, maturity, status, and condition. 14.5. Stored Samples & Genetic Testing The consent form and process for maintaining human specimens in a repository for future research uses must inform the subjects explicitly about the unspecified possible future use of the specimens and related personal information. The consent process must include the following: • The sample will be stored and possibly used in future research studies. • A description of any personal information about the specimen source will be maintained (this may or may not include identifiers). • If no personal identifiers will be used for labeling the stored samples (i.e., if it is impossible for the sample to be linked with the subject), the consent form should so state. • If personal identifiers are to be used that will allow future matching of the subject to the collected sample, the consent form should describe how they will be used, how privacy and confidentiality will be protected, whether and under what circumstances identifying information would be disclosed. • Future research using the samples will be reviewed by the IRB prior to additional use of the samples. • Whether and how researchers may contact individuals whose specimens are in the repository. • A statement about any potential commercialization and that there are no plans for subjects to share in financial proceeds that may accrue from products derived from the specimens. • Whether and under what circumstance and how any results from research studies using the specimens would be communicated to or available to the human subjects, if, for example, the information gathered also applied to family members. • If specimens are individually identifiable, how the specimens and associated data may be withdrawn from the repository. If the specimens are not individually identifiable, a statement that they may not be withdrawn for that reason.

VCOM Institutional Review Board Policies and Procedures

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