Table 2.
Fixed-response survey item scores (n=95).
| Mean Score (1-5) |
Standard Deviation |
|
|---|---|---|
| LIABILITY | ||
| Q1: How important do you think it is to clarify and improve the law surrounding liability issues in genomics research and clinical care? | 3.83 | 0.91 |
| How important do you think it is to address the following issues? | ||
| Q2: Failure to create appropriate informed consent procedures and documents | 3.73 | 1.01 |
| Q3: Negligent performance of genomic analysis | 3.84 | 0.97 |
| Q4: Negligent interpretation of results | 4.20 | 0.91 |
| Q5: Failure to inform research participants or patients about primary, secondary, or incidental findings | 3.81 | 0.92 |
| Q6: Establishing the standard of care for clinical use of genomics in assessing risk, in diagnosing, and guiding prescribing and other treatment | 4.10 | 0.75 |
| Q7: Defining the duty to re-interpret data due to changes in genomic knowledge | 3.88 | 0.90 |
| Q8: Hospital or other organizational failure to adopt procedures, acquire equipment, or hire personnel for genomic analysis and integration into clinical care | 3.32 | 1.12 |
| Q9: Health insurer/payer failure to pay for genomic testing | 4.02 | 0.99 |
| QUALITY | ||
| Q1: How important do you think it is to clarify and improve the law surrounding quality issues? | 3.82 | 0.97 |
| How important do you think it is to address the following issues? | ||
| Q2: Ensuring adequate validity and reliability of results | 4.08 | 0.90 |
| Q3: Ensuring consistency of interpretation and results across laboratories | 4.04 | 0.93 |
| Q4: Determining when use of a CLIA-certified laboratory is needed | 3.74 | 1.12 |
| Q5: Ensuring adequate quality in biospecimen repositories | 3.48 | 1.09 |
| Q6: Ensuring adequate quality in data archives | 3.54 | 1.01 |
| Q7: Determining the appropriate role of regulatory agencies such as the FDA, CDC, CMS, and NIST |
3.96 | 0.86 |
| Q8: Determining the appropriate role of and standards from professional societies such as CAP, AMP, ACMG, ASHG, and NSGC | 3.78 | 0.95 |
| Q9: Harmonizing international standards | 3.24 | 0.92 |
| PRIVACY AND ACCESS | ||
| Q1: How important do you think it is to clarify and improve the law surrounding privacy and access issues? | 4.01 | 0.95 |
| How important do you think it is to address the following issues? | ||
| Q2: Determining who should have access to raw genomic data (e.g., patient or research participant, family, clinicians, others) | 3.90 | 0.99 |
| Q3: Determining who should have access to interpreted genomic data | 4.01 | 0.94 |
| Q4: Defining how much control individuals should have over how data about them is used--in research, quality control, or public health | 3.81 | 0.96 |
| Q5: Determining how to handle access to genomic data and results after the patient’s death | 3.63 | 0.98 |
| Q6: Determining data sharing rules and practices | 4.05 | 0.89 |
| Q7: Clarifying the law related to using de-identified data and biospecimens in research | 3.65 | 1.06 |
| Q8: Determining how to prevent and penalize re-identification | 3.63 | 1.10 |
| Q9: Addressing employer access to genomic results | 4.09 | 1.00 |
| Q10: Addressing insurer access to genomic results | 4.18 | 0.98 |
| Q11: Controlling potential use of genomic results in other contexts (e.g., to determine parentage, in forensic contexts, in adoption) | 3.63 | 1.11 |
| FRAMEWORK | ||
| Q1: How important do you think it is to clarify and improve the law surrounding the framework question of when clinical rules vs. research rules apply? | 3.91 | 0.93 |
| How important do you think it is to address the following issues? | ||
| Q2: Determining when the laws and norms governing human subjects research should apply in genomics | 3.62 | 1.01 |
| Q3: Determining when laws and norms governing clinical care should apply in genomics (e.g., malpractice liability, robust duty of clinical care) | 3.83 | 1.03 |
| Q4: Determining when genomics researchers have duties to offer return of primary, secondary, or incidental findings | 3.96 | 0.96 |
| Q5: Determining what laws and norms should apply to research with de-identified data or specimens that were not collected for the research | 3.61 | 1.08 |
| Q6: Developing appropriate approaches for translational genomics that combine research and clinical care | 3.97 | 1.01 |
| Q7: Determining when genomics researchers need to seek an investigational device exemption from the FDA | 3.53 | 1.08 |
| Q8: Clarifying the law governing genomic research by private companies | 3.45 | 0.98 |
| Q9: Determining what laws and norms should apply to companies offering direct-to-consumer (DTC) genomic testing services and research | 3.92 | 1.06 |
| Q10: Determining what law applies when research crosses states or countries | 3.36 | 1.15 |
Note:The 3 highest Mean Scores across all categories are bolded. The 3 lowest Mean Scores are italicized.