When applicable, one or more of the following elements of information shall also be provided to each participant:

• Disclosure or non-disclosure of particular studies presented in the planned project. For example, the informed consent for a research study might advise patients in the following way: Over the course of this trial, routine healthcare information, such as [name of test] results and standard blood tests, will be obtained and kept in your medical record.

  The results of these tests may be available to you from your healthcare provider. In addition, trial investigators may collect certain data that are not routine healthcare information, including [for example, assay results name of tests]; these are new [definition] of uncertain significance. The results of these tests will not be released to you.

• Special considerations for children should be addressed explicitly with language such as “parent or legally authorized representative has a right to look at the child’s data.”
• Most research data derived from tissue specimens has not been validated for clinical decision-making and should not be disclosed to the participant under most circumstances. In contrast, aggregate data should be made available to research participants when appropriate or if requested (Proceedings of the Confidentiality, Data Security and Cancer Research Workshop, Bethesda, MD, December 1-2, 1999).