Human Research Protection Program: Policy
Research with Coded Information and Specimens
Adopted
By: All Campus IRB
Adoption
Date: January 5, 2006
Revised: May 1, 2008
Purpose: This document establishes UW-Madison policy as to when research
involving coded private information or coded biological specimens must be
submitted to a UW-Madison Institutional Review Board (IRB) for review. The document is in response to the 2004 guidance
issued by Office of Human Research Protections (OHRP) that excepts certain
kinds of research with coded private information or coded biological specimens
from IRB review on the ground that it does not fit the Common Rule definition
of human subjects research (45 CFR Part 46). The OHRP guidance also recommends
that institutions determine when this research requires IRB review.
Policy
I. The UW-Madison requires all research with coded
private information or coded biological specimens to be submitted to a
UW-Madison IRB for review. The IRB will determine whether such research
requires an IRB protocol and whether any additional ethical issues should be
addressed before the research is approved.
Even when research with coded private information
or coded biological specimens does not meet the Common Rule definition of human
subjects research, such research can raise ethical issues, such as
appropriateness of specimen sources, that make IRB review prudent.
Procedure
II. UW-Madison IRBs require that the UW-Madison
investigator submit either an application for initial review or an application
for exemption to one of the UW-Madison IRBs for
all research involving coded private information or coded biological specimens,
as described below:
Case 1:
Application for Initial Review.
A
UW-Madison investigator is asked to analyze coded specimens, data or images
that are provided to the investigator by a non-UW-Madison investigator and that
were obtained by the non-UW-Madison investigator through an interaction with
living individuals under the current research protocol.
Although the
specimens, data or images are coded, the UW-Madison investigator is “engaged in
human subjects research” and must submit an application for initial review.
Case 2:
Exemption Application
UW-Madison
investigator is asked to analyze coded specimens, data or images that are
provided to the investigator by a non-UW-Madison investigator but that were
previously collected under a separate IRB-approved protocol.
As long as
the UW-Madison investigator cannot readily identify the individuals from whom
the specimens, data or images were obtained, the UW-Madison investigator is not
“engaged in human subjects research” and must submit an application for
exemption.
For forms and
electronic submission information, see, UW-Madison’s Human Research Protection
Program website (http://info.gradsch.wisc.edu/research/hrpp/index.html).
III. Even if an investigator indicates on a National
Institutes of Health (NIH) grant proposal cover sheet that research involving
coded private information or coded biological specimens does not involve human
subjects, as instructed by NIH’s Office of Extramural Research[1],
the investigator must indicate on the UW-Madison Extramural Support Transmittal
Form (T-Form) that the project does involve human subjects and must submit the
project to a UW-Madison IRB for review as described above.
IV. This guidance document does not cover research
projects involving certain publicly available datasets pre-approved by the
UW–Madison IRBs under the Existing Datasets Policy. To determine
when publicly available datasets may be used without prior IRB approval, see, Existing Datasets Policy.
