record through the original submitting institution. The ability to acquire additional data may also be constrained by ethical and legal restrictions, such as privacy laws, as noted briefly below.

Consent from the source might be inadequate for use, permission to recontact might be lacking, or recontact might be prohibitively expensive.

Although the acquisition of additional clinical data for a case may be technically possible, there may be circumstances where it would be prohibited or restricted by ethical or legal issues related to recontact or privacy laws, including the federal Health Insurance Portability and Accountability Act of 1996 (PL 104-191, 110 Stat. 1936, and accompanying regulations). In other situations—especially where a number of years have passed since the data or specimen were collected—it may require extensive research to locate the source individual. Those issues may render specific cases unusable for some types of research. Chapter 3 addresses consent and other ethical, legal, and regulatory aspects of use of the JPC materials for consultative, educational, and research purposes.

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