Table 4.

Specific criteria for disclosing individual research results

I. National Action Plan on Breast Cancer (NAPBC, 1999)
    Access to experimental data except when:
        a. Information is obtained under a promise of confidentiality, is about another person, or would cause harm to another;
        b. Access to information may endanger life or physical safety of participant;
        c. Access would break the masking of the study;
        d. Research results are of unproven clinical validity;
        e. IRB has judged there is no benefit to research subjects
II. National Bioethics Advisory Commission (NBAC, 1999)
    Access (to research results) in exceptional circumstances, when all the following apply:
        a. Findings are scientifically valid and confirmed;
        b. Findings have significant implications for subject’s health concerns;
        c. A course of action to ameliorate/treat concerns is readily available
III. National Heart Lung and Blood Institute Working Group (NHLBI, 2006)
    Must meet all of the following criteria:
        a. Established clinical validity (and the test is done in a CLIA certified laboratory); if test is only available in a research laboratory it should be run by two different methods and under the supervision of a CLIA certified laboratory to confirm results.
        b. Associated risk for the disease is replicable and significant (e.g., RR >2.0); prioritize variants with greater penetrance or associated with younger age of onset;
        c. Disease has important health implications (e.g., premature death; substantial morbidity)
        d. Proven therapeutic or preventive interventions are available
        e. Research results that affect reproductive decisions or carry reproductive risk should be considered for reporting to subjects
IV. Working Group on Incidental Findings (ref. 11): Net Benefit to Subject
    A. Strong Net Benefit: Should Disclose
        i. Condition or risk of condition is life threatening or grave that can be avoided or ameliorated.
        ii. Reproductive decision-making, to avoid a significant risk to offspring of life-threatening/grave condition or ameliorate a condition likely to be life threatening or grave.
    B. Possible Net Benefit: May Disclose
        i. Nonfatal condition likely to be grave or serious, but cannot be ameliorated or avoided, when subject deems information important.
        ii. Reproductive decision-making as in A.
    C. Unlikely Net Benefit: Do Not disclose
        i. Condition or risk not likely to be of serious health or reproductive importance or in which the importance cannot be ascertained.