[Code of Federal Regulations]
[Title 38, Volume 1]
[Revised as of January 1, 2007]
From the U.S. Government Printing Office via GPO Access
[CITE: 38CFR1.17]

[Page 14-15]
 
            TITLE 38--PENSIONS, BONUSES, AND VETERANS' RELIEF
 
                CHAPTER I--DEPARTMENT OF VETERANS AFFAIRS
 
PART 1_GENERAL PROVISIONS--Table of Contents
 
Sec.  1.17  Evaluation of studies relating to health effects of dioxin 

and radiation exposure.

    (a) From time to time, the Secretary shall publish evaluations of 
scientific or medical studies relating to the adverse health effects of 
exposure to an herbicide containing 2, 3, 7, 8 tetrachlorodibenzo-p-
dioxin (dioxin) and/or exposure to ionizing radiation in the ``Notices'' 
section of the Federal Register.
    (b) Factors to be considered in evaluating scientific studies 
include:
    (1) Whether the study's findings are statistically significant and 
replicable.
    (2) Whether the study and its findings have withstood peer review.
    (3) Whether the study methodology has been sufficiently described to 
permit replication of the study.
    (4) Whether the study's findings are applicable to the veteran 
population of interest.
    (5) The views of the appropriate panel of the Scientific Council of 
the Veterans' Advisory Committee on Environmental Hazards.
    (c) When the Secretary determines, based on the evaluation of 
scientific or medical studies and after receiving the advice of the 
Veterans' Advisory Committee on Environmental Hazards and applying the 
reasonable doubt doctrine as set forth in paragraph (d)(1) of this 
section, that a significant statistical association exists between any 
disease and exposure to an herbicide containing dioxin or exposure to 
ionizing radiation, Sec.  3.311a or Sec.  3.311b of this title, as 
appropriate, shall be amended to provide guidelines for the 
establishment of service connection.
    (d)(1) For purposes of paragraph (c) of this section a significant 
statistical association shall be deemed to exist when the relative 
weights of valid positive and negative studies permit the conclusion 
that it is at least as likely as not that the purported relationship 
between a particular type of exposure and a specific adverse health 
effect exists.
    (2) For purposes of this paragraph a valid study is one which:
    (i) Has adequately described the study design and methods of data 
collection, verification and analysis;
    (ii) Is reasonably free of biases, such as selection, observation 
and participation biases; however, if biases exist, the investigator has 
acknowledged them and so stated the study's conclusions that the biases 
do not intrude upon those conclusions; and
    (iii) Has satisfactorily accounted for known confounding factors.
    (3) For purposes of this paragraph a valid positive study is one 
which satisfies the criteria in paragraph (d)(2) of this section and 
whose findings are statistically significant at a probability level of 
.05 or less with proper accounting for multiple comparisons and subgroup 
analyses.
    (4) For purposes of this paragraph a valid negative study is one 
which satisfies the criteria in paragraph (d)(2) of this section and has 
sufficient statistical power to detect an association between a 
particular type of exposure and a specific adverse health effect if such 
an association were to exist.
    (e) For purposes of assessing the relative weights of valid positive 
and negative studies, other studies affecting

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epidemiological assessments including case series, correlational studies 
and studies with insufficient statistical power as well as key 
mechanistic and animal studies which are found to have particular 
relevance to an effect on human organ systems may also be considered.
    (f) Notwithstanding the provisions of paragraph (d) of this section, 
a significant statistical association may be deemed to exist between a 
particular exposure and a specific disease if, in the Secretary's 
judgment, scientific and medical evidence on the whole supports such a 
decision.

(Authority: 38 U.S.C. 501; Pub. L. 98-542)

[54 FR 40391, Oct. 2, 1989; 54 FR 46187, Nov. 1, 1989]