When Are Health Studies Appropriate To Do?

Some ATSDR Guidelines

One of the major roles of ATSDR is to assess the health hazards of communities that might be exposed to hazardous substances from specific Superfund sites or from environmental releases. Health studies are used to identify people at health risk and to evaluate relationships between exposures and adverse health effects. The knowledge gained from health studies can be used to prevent or reduce the human health hazards for the community studied, as well as other communities with similar environmental hazards. The decision to perform a study at a hazardous waste site or when an environmental exposure occurs depends on circumstances such as the substances released, exposure pathways, levels of exposure, health outcomes, and the populations at risk. Existing knowledge of the exposure and health outcome relationship will also influence the need for and the type of health study that might be done.

Community Involvement

When reviewing the options for health studies or other public health activities, ATSDR initiates a process of public involvement and coordination with the appropriate stakeholders, including community residents, community representatives, tribal representatives, local and state health agencies, and other state or federal agencies. This process allows ATSDR to understand and respond to community needs and health concerns, discuss agency activities and possible options, and coordinate actions among the different government agencies that might be involved. The goal is to have the community and local and state health agencies informed fully and involved early. It is very important to explain to the community the differences between the possible options for health studies and other public health activities. The community also needs an explanation of what can be studied scientifically, and the limitations of any proposed activities.

Questions

Before a health study can be recommended for a particular site, the following questions need to be considered by both the community and ATSDR:

1. Is there sufficient information to support the proposed study? When answering this question, the hazard to human health, the toxicity of the contaminant, type and level of exposure, health outcome, population size and susceptibility, ability to prevent or mitigate exposure or human health outcomes, and relevance to other sites must be considered.
2. .Is there the ability to involve community residents and representatives? Is there a clear understanding of community health concerns? Does the community understand the approach and limitations of the proposed activities? Does the community support conducting the proposed study?
3. What is the scientific importance of the study? Does it provide new knowledge or information, allow new laboratory tests or study methods to be used or evaluated, or confirm or provide additional support for a preliminary hypothesis or theory?
4. How helpful will the study results be in providing useful information related to specific exposure-outcome relationships?
5. Will there be sufficient resources to meet the needs of the proposed health study?
6. How will the proposed health study address the program goals of the agency?
7. Are the local, state, and federal health agencies that are involved able to support or provide technical assistance, and to address community issues and health concerns?

Criteria

Once the preceding questions have been answered, certain criteria must also be met. There should be: (1) sufficient ability to characterize the environmental contaminants by type, media, and concentration levels; (2) evidence of human exposure, or a high likelihood of health risk if sufficient levels of exposure can be shown to exist; (3) limited knowledge about the relationship between exposure and specific adverse health outcomes that require further study; and (4) when known, a documented excess of adverse human health outcomes.

Attributes

To ensure the highest possible quality of a study effort, the following attributes should also be present: (1) a reasonable ability to document and characterize exposure in the target area, or to document and characterize individual exposure; (2) an adequate size population for the type of study recommended; (3) an ability to identify and locate participants and records; (4) appropriate comparisons for rates of occurrence; (5) an ability to document or validate human health outcomes; (6) availability of an appropriate control or comparison population; (7) an ability to understand confounding factors and minimize biases; and (8) an ability to determine the influence of environmental, behavioral, or other factors.

To carefully consider these questions, criteria, and attributes, preliminary concept proposals are developed. The agency can then determine the appropriateness of the proposal before undertaking the health study.

When Health Studies Should Not Be Done

Health studies should not be done when: (1) there is insufficient information or other existing factors that would severely limit ATSDR's ability to provide new and useful information on the health or exposure status of the community; or (2) other factors exist that would severely affect ATSDR's ability to evaluate specific exposure-outcome relationships.