Table 3.

Summaries of Institutional Review Board (IRB) recommendations.

Recommendations from IRBs at ≥2 Sites

Language in consent documents must be easily readable and understandable for all

Materials must be provided to ensure that individuals with low English literacy can understand study information prior to consent

Investigators must define the point in time for participants that study findings can be withdrawn, and clarify that following results disclosure, results cannot be removed from a participant’s health record

Mention protections afforded by GINA, potential impact on long-term care and disability insurance

Determine which genes are associated with medically actionable conditions in pediatric populations, and which are specific to adult onset conditions

Include loss of privacy and potential insurance discrimination as risks

Consider counseling participants regarding the sharing of genetic test results with family members

Consider providing a gene list to the study participants

Specific IRB Recommendations (Limited to IRBs at 1 Site)

Consider mentioning that current federal protections for pre-existing conditions may have an uncertain future—Returned results may be considered to be pre-existing conditions

Consider describing the low likelihood of receiving positive test results

Explain that results from samples not obtained under CLIA are considered research findings and may not be as meaningful as clinical tests

Consider educational resources for participants and their healthcare providers that describe in greater detail the proposed genome sequencing techniques.

Consider using an alternative method of communicating, such as in-person, for both the actionable and the negative genetic results with participants