Monitoring Human Tissues for Toxic Substances (1991) / Chapter Skim
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7. Program Design and Management Issues
7. Program Design and Management Issues
Pages 143-166
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From page 143... ...
. This chapter concludes with discussion of the importance of timely data analysis and reporting; the importance of cooperation and information transfer with other organizations; timely production and dissemination of reports to enable researchers, policy-makers, etc.; access to and descriptive analysis of the data; and the need for an orderly transition to prevent further deterioration and loss of institutional memory.
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From page 144... ...
EPA staff have argued that the NHMP is primarily an environmental monitoring effort and that EPA has both the most appropriate mission and the greatest capability to manage such a program. If a strong and sufficiently independent Bureau of Environmental Statistics (or equivalent)
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From page 145... ...
The committee is also concerned that ATSDR is still rather new, growing and evolving rapidly, and perhaps suffering from the "growing pains" inherent in newness and growth. Centers for Disease Control Advantages of this choice include strength in epidemiologic research, as well as biomedical and chemical surveillance; demonstrated ability in supporting national monitoring efforts such as NHANES and blood-lead surveys; inhouse capability for chemical analyses; and a substantial research focus.
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From page 146... ...
A location that is geographically close to other programs and laboratories active in the relevant technical disciplines would facilitate important exchanges about methods, as well as followup of findings. Funding The critical resources in a program of monitoring human tissues include funding and expertise in appropriate scientific fields.
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From page 147... ...
The chance of that seems remote, except possibly for ATSDR, but it is not clear that ATSDR in its present phase of rapid growth, development, and consolidation can spare the top management attention needed for a successful monitoring program. The committee urges that EPA consider termination of human-tissue monitoring only under the most compelling circumstances, and even then only after the fullest exploration of ways to ensure an orderly transfer to some other appropriate agency in less straitened circumstances.
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From page 148... ...
We have not undertaken detailed cost analyses, but study of EPA's own history and the operations of other tissue monitoring programs suggests that $5 million per year could support a substantial flow of high-quality, policy-relevant information about chemical burdens in human tissue and that the two special problems just mentioned maintaining a critical mass of scientific talent and ensuring stability of essential core funding during hard times for the agency—could be solved. It is still not munificent support.
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From page 149... ...
However, such allocations do not seem feasible now, so their implications are not explored here. Whatever budgetary level is chosen, agency staff, in consultation with the scientific advisory body, should pay continuing attention to the competing demands of adequate sample size (within a context of periodic redesign of the sample to meet changing conditions and needs)
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From page 150... ...
Research activities should be developed in close consultation with other monitoring programs. Examples of subjects that will need research are improved methods for specimen collection and storage, and chemical analytic methods.
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From page 151... ...
We are dubious of relying on a general advisory committee; such a committee probably could not devote enough time to a special topic, such as monitoring of human tissues, to make a useful contribution to the program. The committee concludes that numerous criteria—including cost, breadth and depth of review, objectivity, program stability, timeliness of response, and a continuing need for fresh ideas point strongly to a standing outside scientific advisory body to provide advice and program oversight to management levels of the program and EPA.
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From page 152... ...
However the charge is drafted, we believe that the outside scientific advisory body should have no other major responsibilities related to the program. We envision a schedule that initially calls for quarterly meetings, but tapers rapidly to perhaps annual meetings, so that committee assignment ~11 not be seriously burdensome.
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From page 153... ...
It therefore seems prudent to organize a human-tissue monitoring program in such a way that new activities can be smoothly added and so that the most critical core activities can be maintained even when other activities are, for good cause, curtailed, suspended, or even terminated. For example, some panels of chemical tests might be identified as critical for collection every other year, but less critical for annual collection.
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From page 154... ...
As was discussed in some detail in preceding sections covering statistical design, sample collection, chemical analysis, and data analysis, the conditions that govern design choices m11 inevitably change. For example, demographic and environmental changes can affect the appropriateness of the sampling network, the list of chemical agents included or potentially measurable in the analytic scheme used, the possible choices of tissues based on analytic constraints, and costs.
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From page 155... ...
General ethical concerns regarding environmental testing have been outlined elsewhere; some of them depend on the types of tests done to monitor exposures (Belmont Report, 1979; NRC, 1987~. One of the important ethical issues to be considered in a monitoring program that uses human tissues is patient confidentiality with respect to the collected and reported data.
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From page 156... ...
Those requirements and guidelines for human research not only apply to research supported by NIH, but also are used generally by institutional review boards (human-use committees) at academic institutions and in industry when such organizations review experimental protocols dealing with humans or with human tissues.
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From page 157... ...
The issues associated with the commercial use of human tissues are extremely complex and not easily solved, but may in the long run inhibit the availability of human tissues for noncommercial research or environmental monitoring, whether because of donor reluctance to provide tissues that might be used commercially or because of legislation that might inhibit the collection of tissues. ANALYSIS AND REPORTING OF DATA lopes of Data Analysis and Reporting The production of data sets that characterize nationally representative average tissue concentrations of specific chemicals is a necessary goal, but not in itself sufficient for a national tissue-based monitoring program.
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From page 158... ...
Reporting of those should be systematized, but this will require close collaboration of the statistical analysts with persons providing the other information. Comparison data, especially reports of tissue concentrations of chemical agents, should be sought continuously in the scientific literature and in technical reports from complementary programs, such as NHANES.
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From page 159... ...
At a minimum, an annual report of level 1 analyses should be produced within a year of completion of the collection of samples. Additional reports addressing more specific questions regarding exposures or trends among chemicals or population groups, or more fundamental issues of exposure assessment, should also appear frequently, but perhaps with a little more lead time.
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From page 160... ...
The program should have a specific outreach component that is the primary responsibility of at least one person. It is warranted because of the multiuse nature of the program, the wide-ranging interest in the resulting data, and the clear indications that more passive or low-key approaches to publicizing program reports have failed to reach some critical target groups.
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From page 161... ...
For example, if the FOG program identifies a chemical in human tissue, rapid information exchange will permit an expeditious search of the chemical in human tissues of the U.S. population.
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From page 162... ...
Taken together, those points indicate that the present program will be of sufficient value to its successor to merit temporary continued support at a level consistent with its functions of several years ago. The presence of a complete gap of a year or longer even several months would risk major damage to public and legislative support, to internal support (if funds, once reallocated, cannot be recaptured)
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From page 163... ...
Funding eider should be increased enough to support a useful prim team or be elimi''ate~ Elimination of the program would be preferable to seriously inadequate support. However, such an action would risk the likelihood that no comprehensive, coordinated program would be developed elsewhere, the skilled staff would be lost along with institutional memory, and specimens that have been banked and saved might be destroyed.
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From page 164... ...
Scientific Advisory Committee Numerous criteno, u~c~g cost, breads and depth of review, objec~vi~, program st~ibili~, timeliness of response, and a cor~inuirlg need for new ideas, point to a Banding outside scier:~;fic advisory committee. The body should be outside EPA; nearly all members should be knowledgeable about one or more scientific and technical disciplines important to the program; and the body should be constituted to facilitate a substantial two-way flow of information and ideas.
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From page 165... ...
Data reporting should be systematic and conducted with close collaboration between statistical analysts and persons providing other relevant information. Comparison data should be sought continuously from scientific literature and complementary programs.
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