Attachment 9 Privacy Act memo

Attachment 9
NIH Privacy Act Memo

#

,:

DEPARTMENT OT HEALTH & HUI}TAN SDRVICES

Public Health Service

National lnstitutes of Health
Bethesda. Maryland 20892

DATE:

June 10,2011

TO:

Christine D. Berg, M.D., Project Officer
National Cancer Instifute

FROM:

NIH Privacy Act Officer

SUBJECT: Applicability of the Privacy Act: "Prostate, Lung, Colorectal and Ovarian Cancer Screening
Trial (PLCO) (NCI)"
NCI submission to OMB to continue the collection of data for the PLCO Screening Trial
to evaluate the effect of screening on the reduction of cancer specific mortality from four targeted sites. NCI
seeks to increase the value of PLCO as a resource to intra- and extramural researchers by continuing to collect
follow up behavioral data, morbidity and mortality outcomes and tumor tissue using one, rather than ten data
collection centers.
I have reviewed the

data collection which involves the collection of
personally identifiable information such as participant name, participant ID, date of birth, social security

I have determined that the Privacy Act will apply to this

number (SSN), telephone number, current marital status, religion at birth, ethnicity, race, etc. Basic
demographic, socioeconomic, occupational, and risk factor information collected from the participants at
baseline will be used to assure comparability between the screening and control groups and stored in a
database. For subsequent annual information collections, information previously supplied by the participant is
pre-populated and sent to him/her for confirmation (e.g., name and address of primary care physician and
tracing contacts).
completed hard copy data forms are kept in locked filing facilities. Data collected in automated
information systems are physically separate from other institutional systems. Access to files is through the use
of a password known only to authorized staff. Names and SSNs are encrypted and stored in files separate
from other data and linked only by the participant ID. Data collected are maintained until the study is
completed or until no longer required for research.

All

This data collection is covered by NIH Privacy Act Systems of Record 09-25-0200, "Clinical, Basic and
Population-based Research Studies of National Institutes of Health (NIH), HHSA'{IH/OD."

If you have any questions, please contact my office at (3 0 I ) 402-6201 .

/4*-

F(o-

Kbren M. Pl6

cc: Vivian Horovitch-Kelley, PRAiOMB Project Clearance Liaison