Attachment 5 - Human Subjects Review Board Memo

NIOSH 0920-0566 Reinstatement Attachment 5.docm

Use of a Reader Response Postcard for Workers Notified of Results of Epidemiologic Studies Conducted by the National Institute for Occupational Safety and Health (NIOSH)

Attachment 5 - Human Subjects Review Board Memo

OMB: 0920-0566

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Attachment 5

Human Subjects Review Board Memo Waiving Review

TO: Frank Stern, M.S.

Through: Associate Director for Science, DSHEFS_____ _____(R12)

Chief, IWSB, DSHEFS_____ _____(R13)

Chief, RCA, IWSB, DSHEFS_____ _____(R13)


Report of NIOSH HSRB


NIOSH Protocol “Use of a Reader Response Form by Workers Notified of Results of Epidemiologic Studies Conducted by NIOSH”


January 18, 2002


General Comments and IRB Actions


In reviewing the subject application, it appears that the primary purpose of the activity is to evaluate the effectiveness of the NIOSH program designed to notify distinct worker populations, through specifically tailored communications, of health risks associated with their work. After consulting the CDC document “Guidelines for Defining Public Health Research and Public Health Research”, I have concluded that the proposed activity constitutes a public health program evaluation. It is not a research activity and therefore does not require HSRB approval.

Protocol Issues


None


Consent Form Issues


None


Addenda Issues (Scripts, questionnaires, brochures, etc.)


None


End of report



Michael J. Colligan, Ph.D.

Chair, NIOSH HSRB





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