Serum and Plasma Collection: Preanalytical Variables and Standard Operating Procedures in Biomarker Research - Proteomic and Metabolomic Approaches to Biomarker Discovery - page 82

volunteers is beyond the scope of this chapter.
However, here are some common issues to
consider when prospectively collecting speci-
mens or using specimens collected by others.
Specimens that came from a human volun-
teer are usually subject to regulations designed
to protect human subjects participating in
research. In the United States, the primary over-
sight body is the Of

how samples were collected by the other
investigators or institutions sharing biosamples
with fundamental or

translational research

laboratories.
Signi cant changes in biomedical research,

with an emphasis on biospecimen banking,
personalized medicine, and translational ap-
proaches, have prompted changes in regulatory
oversight as well. In the past, blood and
other easily accessible bio

ce of Human Research
Protections (OHRP). OHRP has issued guidance
on biological materials and data collection at
http://www.hhs.gov/ohrp/policy/biodata .
Engaging in a discussion with your local institu-
tional review board (IRB) prior to designing
blood collection protocols or prior to receiving
any specimens from other researchers outside
your institution can prevent problems. Journals
require documentation of compliance with
human subject protections laws and regula-
tions. These laws and regulations specify that
human subjects participating in research (i.e.,
donating blood) are protected according to
regulatory and ethical guidelines,

uids (urine, stool,
saliva, etc.) were used, shared, and kept by
researchers without legal limitations. Recent
concerns and lawsuits over intellectual property
derived from biosamples have created require-
ments for speci c, detailed agreements regard-

ing the use of biosamples by laboratories. Most
institutions now require con

dentiality and
material transfer agreements that are formally
signed by administrative authorities prior to
the release of samples between institutions.
Limits imposed by informed consent documents
or institutional review board proposals must
be stipulated in material transfer agreements. including

TABLE 4 A Selection of Web-Based Resources Regarding Issues in Human Subject Research and Biobanking

URL Topic

http://bioethics.od.nih.gov/humantissue.html Ethical considerations in research with human tissues (including

blood)

http://biospecimens.cancer.gov/practices/ National Cancer Institute Best Practices for biospecimens

and biobanking

http://www.icmje.org/ethical_5privacy.html International Committee of Medical Journal Editors statement

on privacy and con dentiality

http://www.icmje.org/ethical_6protection.html International Committee of Medical Journal Editors statement

on protection of human subjects

http://www.hhs.gov/ocr/privacy/index.html HIPAA rules regarding PHI and future unspeci ed use

of samples

http://www.hhs.gov/ohrp Human subject research protection d regulations regarding

human subjects in U.S. research

http://www.ich.org/products/guidelines/ef c International Conference on Harmonisation (ICH) E6: Good

Clinical Practice standards acy/article/ef cacy-guidelines.html

http://www.hhs.gov/ohrp/policy/biodata OHRP guidance on biospecimens and protecting human subjects

in research