Table 3.

Comparison of positions on disclosure

CategoryNAPBC, 1999NBAC, 1999ASHG, 1996OPRR, 1993NHLBI, 2006
Position on disclosure of research resultsYes, except in certain circumstances (see Table 4).No, except in rare circumstances.Maybe, depends on study. Respect right to know, and right not to know research results.No, except when a treatment exists to improve the diagnosis.Yes, if they meet certain criteria (see Table 4).
Responsible party to decide to discloseIRBResearchers and IRB. IRB should require researchers to justify disclosure (or not) and a management plan.ResearchersResearcher and IRB. Researcher to indicate in consent conditions for disclosure.IRB and Researcher
Individual to give the resultsGenetic counselor or geneticistAppropriate medical advice or referral should be provided.Only by persons able to provide genetic counselingTrained genetic counselorGenetic counselor, or training and experience in genetic counseling
Pre- and post-test counseling requiredYesYesYesYesYes. + referrals for medical and psychological care. Subjects responsible for the cost.
Risks defined in informed consent process/documentYes. Economic, social, psychological harm. No disclosure of misidentified parentage.Yes, risks along with clear statement whether research results will be disclosed.Yes, medical risk, carrier status, risk to offspring; family dynamics, stigmatization, discrimination; psychosocial harmYes, psychosocial, familial relationships, potential to compromise insurability or employabilityYes. Psychosocial issues, reproductive implications, uncertainty of disease prediction and severity; insurance and employment discrimination
OversightRequired. Monitor ongoing clinical relevance.Required. IRB to develop guidelines for disclosure.Required. Extend IRB review to those not covered by federal regulationsSuggested. IRBs to address implications of research result disclosure and require investigators to think through these issues.Required. Standard guidelines should be developed. Education for nongenetic members of research team.