Collection and Distribution of Biospecimens for Novel Research Uses

The level of involvement for each network institution will vary based on the type of specimen
to which they have access (e.g. biofluids, tissues and/or cells) and the category of
collection (remnant specimens that were originally collected for clinical testing and/or
specimens specifically collected for research) in accordance with the institution's elected
preferences.

In most cases, potential participants will be identified and approached upon presenting for
clinical care or recruited specifically for the study using outreach programs. If additional
screening activities are required to determine eligibility criteria, the potential
participant may be presented with the opportunity to participate in these activities as part
of the study. These screening activities will be minimal risk in nature and are described
further below. Should potential participants meet screening criteria, they may then be asked
to provide biospecimens according to current research needs. Individual participants or
groups of participants may be sought according to specific clinical, lifestyle, and/or
demographic characteristics. The providers of these samples may be healthy participants or
participants with a medical condition of interest to the research community but regardless,
all specimens collected under this protocol (whether for screening purposes and for
distribution to researchers) will qualify as minimal risk activities.

Biospecimens may be distributed to researchers at academic institutions, hospitals, clinical
and government laboratories, and corporations including diagnostic, medical device,
biopharmaceutical and biotechnology companies. The types of research studies and testing that
may be performed using the biospecimens will be varied, and it is not possible to provide a
description of all potential studies. Some researchers may perform genetic testing on the
specimens, some may use the specimens to develop cell lines, and some may cryopreserve the
specimens for many years, awaiting a research use. The specimens may also be used for
educational purposes, such as training lab techs on the proper testing of samples or
physicians on the proper reading of stained slides. The iSpecimen consent forms will indicate
a broad scope of possible research and educational uses and activities.

Inclusion Criteria:

- Individual is developmentally aged 7 years old and above for RUO collections (only)

- Individual meets requirements of a current request for research materials from
iSpecimen

- If a blood collection will be performed as part of the screening process or RUO
collection, the individual's health will be assessed by medical staff through medical
record review, clinical exam, and/or the review of an updated medical history as
provided by the participant

- Individual has reviewed and signed a consent form for an RUO specimen collection if
required as part of the research or if a minor or a person with diminished
decision-making capacity, their parent/guardian or Legally Authorized Representative
has reviewed and signed the consent form on their behalf.

- Individual has reviewed and signed a consent form for remnant specimen usage in
research if required as part of the research or if a minor or a person with diminished
decision-making capacity, their parent/guardian or Legally Authorized Representative
has reviewed and signed the consent form on their behalf

Exclusion Criteria:

- Subjects that do not meet the inclusion criteria outlined above.