TABLE III.
Biomonitoring Decision Matrices for Occupational Health Investigations and Research
| Occupational Health Investigations | Occupational Health Research | |
|---|---|---|
| Is Biomonitoring Appropriate? | (1) Establish whether information gaps exist that biomonitoring can address. | (1) Establish existing information gaps that biomonitoring can address. |
| Will biomonitoring help resolve information gaps? | Will biomonitoring help resolve information gaps? | |
| Will biomonitoring help determine exposures? | Will biomonitoring help determine exposures? | |
| Will biomonitoring help determine adverse health effects? | Will biomonitoring help determine adverse health effects? | |
| Is it likely that biomonitoring will inform decision making? | Could biomonitoring provide answers to questions about the effectiveness of workplace controls or PPE? | |
| Could biomonitoring provide answers to questions about the effectiveness of workplace controls or PPE? | ||
| (2) Determine whether biomonitoring will provide information that is directly applicable, relevant and actionable to emergency responders/remediation workers. | (Not applicable to research) | |
| Will biomonitoring have a direct impact on decision making? | ||
| Will biomonitoring provide information directly applicable to health and safety procedures? | ||
| Will biomonitoring results directly address or improve emergency responder health? | ||
| (3) Establish whether biomonitoring will provide interpretable results. | (Not applicable or necessary for research) | |
| Will the biomonitoring provide information to enable scientifically justified decisions? | ||
| Does the biomonitoring method have sufficient sensitivity and specificity? | ||
| Can a background level be identified that existed before the event? Is a reference range available? | ||
| Is a recognized exposure index or criterion available, or are literature data available to aid in the interpretation of the results? | ||
| Is sufficient information in humans or animals available to establish a relationship between biomonitoring results and either external levels, internal dose, or toxicity? | ||
| (4) Identify and evaluate ethical issues. | (2) Identify and evaluate ethical issues. | |
| Do ethical issues exist that would preclude biomonitoring? | Do ethical issues exist that would preclude biomonitoring? | |
| Are there ethical issues related to interpretation and communication of test results? | Are there issues related to interpretation and communication of test results? | |
| Is Biomonitoring Feasible? | (1) Establish whether there is a validated method for biomonitoring. | (Not applicable; the research itself could involve the development of a biomonitoring method.) |
| Is a published method available to conduct biomonitoring? | ||
| Does the sampling and analytical method provide reproducible and reliable results? | ||
| Has the biomarker been evaluated and is it biologically relevant? | ||
| (2) Determine whether there are significant logistical issues. | Determine whether there are logistical issues. | |
| Can specimens be collected within the required timeframe following exposure? | Can specimens be collected within a sufficient timeframe? | |
| Is the specimen type feasible to be collected (i.e., relatively non-invasive/burdensome)? | Is the specimen type feasible to collect (i.e., relatively non-invasive/burdensome)? | |
| Does the time required to collect, ship and analyze the specimens fit the required timeframe? | Does the time required to collect, ship and analyze the specimens fit the required timeframe? | |
| Is the cost of specimen collection and analysis prohibitive? | Is the cost of specimen collection and analysis prohibitive? | |
| Do multiple specimens need to be collected for optimal interpretation, and if so, is this logistically feasible? | Do multiple specimens need to be collected for optimal interpretation, and if so, is this logistically feasible? | |
| Do other tests/assays need to be conducted to interpret the result (e.g., creatinine, specific gravity)? | Do other tests/assays need to be conducted to interpret the result (e.g., creatinine, specific gravity)? | |
| Have laboratories been identified with sufficient experience to perform the analysis within the required timeframe? | Have laboratories been identified with sufficient experience to perform the analysis within the required timeframe? | |
| Have sufficient personnel been identified to collect the specimens? | ||
| Does the specimen have any specialized collection, shipping or storage requirements? | Does the specimen have any specialized collection, shipping or storage requirements? | |
| Have the types of quality control samples been identified? | Have the types of quality control samples been identified? | |
| Can human IRB approval be obtained within the required timeframe? | Can IRB approval be obtained within the required timeframe?” Is the population accessible and are the Incident Command and workers willing to participate? | |
| “Is the population accessible and are the Incident Command and workers willing to participate? |