Additional Requirement – 17: Peer and Technical Reviews of Final Reports of Health Studies – ATSDR

Comprehensive Environmental Response, Compensation, and Liability Act of 1980 (CERCLA), as amended by Superfund Amendments and Reauthorization Act of 1986 (SARA), Section 104 (I)(13), and [42 U.S.C. 9604 (I)] requires all studies and results of research (other than public health assessments) that ATSDR carries out or funds in whole or in part will be peer reviewed by ATSDR. The ATSDR peer review process for final reports requires that:

1. Studies must be reported or adopted only after appropriate peer review.
2. Studies shall be peer reviewed within a period of 60 days to the maximum extent practical.
3. Studies shall be reviewed by no fewer than three or more than seven reviewers who:
   • Are selected by the Assistant Administrator, ATSDR;
   • Are disinterested scientific experts;
   • Have a reputation for scientific objectivity; and
   • Who lack institutional ties with any person involved in the conduct of the study or research under review.

ATSDR encourages rapid reporting and interpretation of laboratory results and reference ranges back to individual participants. However, if summary tables or distribution of laboratory results are prepared using the study data, this is considered a preliminary finding and will require ATSDR technical and peer review prior to release.

When, in the opinion of the investigator(s), a public health concern exists requiring the release of summary study statistics prior to the completion of the study, the investigator must obtain concurrence from ATSDR prior to releasing the summary statistics. A request for ATSDR concurrence for the release of information must be documented in a letter to ATSDR and should outline the public health concern, the investigator’s interpretation of the concern and recommended response, and the draft document proposed for release by the investigator. ATSDR will provide a technical review and peer review within ten working days to the maximum extent possible. At sites where ATSDR must coordinate with another Federal agency, this requires additional time. Summary statistics may be released only after peer review. The release of summary statistics does not preclude the requirement for a final report.

By statute, the reporting of preliminary studies and preliminary research results to the public is not acceptable without prior review by ATSDR. This includes manuscripts prepared for publication, presentations at scientific meetings and reporting of preliminary findings to the community or the media.

Final Report:

1. The final report for every study should include a detailed description of the problem, hypothesis, methods, results, conclusions, and recommendations that constitute a complete performance record of the study. A copy of the suggested format for the final report will be supplied by ATSDR to the investigator.
2. ATSDR is responsible for the technical and peer review of the draft final reports of any study that it funds prior to the submission of the final report. This will allow the recipient to incorporate technical and peer review comments into the final report. Responses to all ATSDR required technical and peer review comments should be summarized in a letter to ATSDR. This letter should also include the investigator’s response to each comment and a rationale for those responses. Based upon the comments of the technical and peer reviewers, modifications in the study report may result. The modified study report should accompany the letter to ATSDR.
3. Following the steps outlined above, a final report of all studies and results of research carried out or supported by ATSDR must be submitted to the Office of Grants Services with a copy furnished to ATSDR.

All requirements, including peer review, technical review, and cost recovery, are applicable to award recipients and any subcontractors employed by the award recipient. Failure to comply with these requirements could adversely affect future funding.