Good Clinical Practice: A Question & Answer Reference Guide - May 2017 - 187

Informed Consent
participants could be contacted again in the future (31.7%), whether the materials could be used for genetic
testing (25.2%), and whether the materials could be shared with researchers not on the original research team
(16.5%). In addition, a few studies (12.9%) offered options for participants to designate how their biological
materials could be used in future research-for instance, by specifying whether identifiers may be retained,
or the research topics for which the materials could be used.
* Fifty-eight percent of the studies indicated how materials would be used, with most of these limiting future
research to specific conditions or uses, while the rest placed no limit on future research.
* Although all of the studies described the general right to withdraw from study participation, only 70.5%
described the right to withdraw stored biological materials. The majority of those permitting withdrawal of
the biological materials (69.4%) did so without restriction.
* Sixty-four percent of the studies discussed whether research results would be disclosed to research participants,
with most of these (97.8%) stating that researchers would not provide research results to study participants.
Over one-third of these explained why results would not be disclosed (e.g., the meaning of results would be
unclear, results would not confer a benefit, that tests are experimental, that disclosure of individual results
would be impossible because materials had been de-identified).
5.19 Q. Assume that the consent form signed by the study subject says that urine or blood samples collected
as part of the study will be tested for analytes A, B, and C. In this case, could the previously collected
samples, after being tested for analytes A, B, and C, then also be tested for analytes D or E, or be used in
any additional testing that would not expose the subject to any additional risks?
A. In response to this question, the FDA's Good Clinical Practice Program stated that, "FDA's informed consent
regulations require subjects to be provided with, among other things, 'a statement that the study involves research,
an explanation of the purposes of the research and the expected duration of the subject's participation, a description
of the procedures to be followed, and identification of any procedures which are experimental' (see 21 CFR 50.25(a)
(1)). Thus, if the purpose of the study is to test urine and blood samples for analytes A, B, and C ..., that ought to
be stated in the consent form. If the investigator [later] decided to test for other analytes, the consent form would
need to be modified (or supplemented) to obtain [subjects'] consent for the additional testing (of analytes D or
E)." Depending on the use of the additional analyses and how the data will be used, this could also be a HIPAA
disclosure issue as well.
5.20 Q. If blood and urine samples are anonymized subsequent to collection, and later the investigator or
sponsor wanted to perform previously unanticipated analyses on these anonymized human samples.
Would this be permissible?
A. In an informal response, the FDA's Good Clinical Practice Program stated that, "it does not matter whether the
samples are subsequently anonymized unless as part of the consent process, [the subject is] advised of and agrees
to further unspecified testing of the samples collected. In that case, it is possible that the sponsor or investigator
would, in the consent process, provide some assurance of confidentiality-which could include anonymizing the
sample." In April 2006, FDA issued "Guidance for Sponsors, Institutional Review Boards, Clinical Investigators
and FDA Staff
Guidance on Informed Consent for In Vitro Diagnostic Device Studies Using Leftover Human Specimens that are
Not Individually Identifiable" that "FDA does not intend to object to the use, without informed consent, of leftover
human specimens -- remnants of specimens collected for routine clinical care or analysis that would otherwise have
been discarded -- in investigations that meet the criteria for exemption from the Investigational Device Exemptions
(IDE) regulation at 21 CFR 812.2(c)(3), as long as subject privacy is protected by using only specimens that are not
individually identifiable. FDA also intends to include in this policy specimens obtained from specimen repositories
and specimens that are leftover from specimens previously collected for other unrelated research, as long as these
specimens are not individually identifiable." Under the federal Common Rule, specimens derived from humans but
that are not individually identifiable are considered to be "not human subjects" for purposes of subsequent research.

187
Table of Contents for the Digital Edition of Good Clinical Practice: A Question & Answer Reference Guide - May 2017
