Table 5.

Common themes

A. Process of Disclosure
    • The IRB, the researcher, and other appropriate experts are responsible to make the determination about disclosure.
    • Research subjects need to be given an opportunity to decide whether they want to receive the research results.
    • Informed consent process and document should indicate if disclosure is planned or likely and describe the risks associated with disclosure.
    • Only professionals capable of providing genetic counseling should give genetic or genomic research results.
    • Counseling of patients before and after receiving research result is required.
    • Oversight of the disclosure process is required.
B. Conditions for Disclosure
    • Requirement for analytical and clinical validity.
    • Only results from CLIA approved laboratories can be disclosed.
    • Existence of proven medical intervention*.
    • Consideration of positive predictive value and relative risk.
    • Consideration of reproduction factors.
    • Consideration of net benefit to research subject.
  • * This condition was not required by ASHG and some advocacy groups, especially in regards to noncancer diagnosis such as Huntington's Disease, Alzheimer's Disease.