IRB # (if known):
Study Title:
Principal Investigator:
Version Date:
SPECIMEN COLLECTION OR TESTING;
RADIATION EXPOSURE SUPPLEMENT
*Fill in header information.
Key:
Type in text (as appropriate)
Instructions:
 Complete this form if you will be collecting or testing either new or existing human
specimens (including blood).
 Complete this form if your study will involve radiation exposure.
1. Blood Draws
1.1. Will blood be drawn for research purposes?
Yes  Answer questions 1.1.1. – 1.1.4.
No  Skip to section 2: Specimens.
1.1.1. Specify the amount of blood to be drawn for research. In your answer,
indicate the volume (including a conversion to lay language in parentheses
(e.g., one teaspoon)) and the scheduling of all research blood draws. If the
volume or schedule of research blood draws differs among study groups (e.g.,
cases vs. controls), please also differentiate between the groups.
Investigator Help:
Sample answer: Cases: 2mL (less than one teaspoon) of blood will be drawn at the
Screening Visit, Day 0, Day 1, and the Final visit.
Controls: 2mL (less than one teaspoon) will be drawn at the Screening visit.
1.1.2. To be considered minimal risk, the amount of blood drawn for research may
not exceed the lesser of 50mL OR 3 mL per kg in an 8 week period and
collection may not occur more frequently than 2 times per week. If you will
exceed these limitations, justify why this is necessary. In your answer,
comment on the risks of the required blood volume loss and the steps taken to
minimize these risks.
Investigator Help:
Sample answer: The minimal risk blood volume limitations are exceeded for some
patients. These blood draw volumes exceed the Seattle Children’s blood draw limits
by blood volume (or by frequency). We will add a statement in our consent form to
explain that smaller patients who have all blood draws might have a risk of needing
transfusion which is a new risk for patients who have not had a transfusion before.
The following statement has been added to the consent documents, “The amount of
blood that will be taken from small children (weighing less than 55 pounds) may
Human Specimen/Radiation Supplement (long)
March 2014
Page 1 of 4
IRB # (if known):
Study Title:
Principal Investigator:
Version Date:
increase the chance that you will need a red blood cell transfusion. You should
discuss this risk with your doctor.” Of note, it would be extremely unlikely for a
patient with recurrent, not curable cancer to have never received a prior blood
transfusion.
1.1.3. Explain if the blood taken for research requires needle pokes or placement of
intravenous lines. If blood cannot be drawn from existing lines or at the time
of a clinically indicated blood draw, then explain the steps to minimize risks
(e.g., use of numbing cream, limit on number of pokes allowed).
Investigator Help:
Sample answers:
 All blood will be drawn when the participant is having blood drawn for their
standard rheumatology care.
 Blood for this study cannot be drawn at the same time of clinically indicated blood
draw. Numbing cream will be offered to all participants and the study nurse will
limit attempts to obtain blood to 2 pokes.
 It is possible that participating in the extra blood draws may require additional
pokes. If patients choose to do optional blood draws then they may require IVs if
they do not have an indwelling central line in place. Whenever possible, extra
blood is taken when required labs or draws are done in order to avoid extra
pokes; however, this is not always possible. As with all pokes, measures will be
taken to minimize pain and injury. Most often we use j-tips which are painless
and do not require extra time as EMLA cream does.
1.1.4. Are the research blood draws and their associated risks described in the
consent form?
Yes
No  Please Explain.
2. Specimens
Note: Blood is also considered a specimen. Therefore, you may need to provide
answers in this section in addition to the above section if your study involves collection
of blood.
2.1. Does the research involve either the collection of new (prospective) or the use of
existing (stored, archived) biological specimens?
Yes  Answer questions 2.1.1. - 2.1.6.
No  Skip to section 3: Radiation.
2.1.1. The specimens used in this research are:
Collected prospectively (new); or
Existing (stored, archived) specimens.
Human Specimen/Radiation Supplement (long)
March 2014
Page 2 of 4
IRB # (if known):
Study Title:
Principal Investigator:
Version Date:
2.1.2. What is the source of specimens (e.g., patients undergoing surgery at Seattle
Children's; archived specimens stored in Children's Laboratory)?
Investigator Help:
Sample answer: Cases: Tissue specimens will be obtained from study participants
at study visit.
Controls: Archived anonymous tissue specimens will be obtained from Dr. X’s
repository.
2.1.3. Are you using tissue from Seattle Children’s patients (either tissue collected
prospectively or archived tissue)?
Yes  The use must be reviewed and approved by the Department of Laboratory
(Pathology) at Children’s. The form for applying to use tissue from Children’s
patients is available on the IRB Web site.
No  Skip to section 2.1.5.
2.1.4. If you are using archived specimens, did the donors of the specimens consent
to their use for such research?
Yes
No
2.1.5. Will any of the specimens be stored for future research (“banking”)?
Yes  Complete the Banking Supplement.
No
3. Radiation
3.1. Will participants be exposed to radiation (e.g., x-rays, radiopharmaceuticals,
radiation therapy) as a result of taking part in this research project?
Yes  Answer question 3.1.1.
No  You are finished with this supplement.
3.1.1. Are the procedures involving radiation exposure investigational, experimental,
or with greater frequency or intensity than required for the standard care for
the patient’s condition?
Yes  The project will require review by the Radiation Safety Committee (RSC).
If the procedures involving radiation exposure are being done at Seattle Children’s,
submit a copy of the IRB-ITHS application and a cover letter explaining the use of
radioactive materials to Marguerite Parisi, MD, MS Chairman of the Radiation Safety
Committee, Department of Radiology, 5C-1. If the procedures involving radiation
exposure are being done at the University of Washington, contact Matt Asay,
Compliance Analyst, Radiation Safety Committee at (206) 543-0463
3.1.1.1. Has the RSC approved the project?
Yes  Please attach copy of approval.
No*  Please explain (is pending, etc.):
*Obtaining this approval will most likely be an IRB contingency if not
obtained prior to IRB review.
Human Specimen/Radiation Supplement (long)
March 2014
Page 3 of 4
IRB # (if known):
Study Title:
Principal Investigator:
Version Date:
No
Note: If the procedures involving radiation exposure will be performed in girls
12 years-of-age and older, a pregnancy test must be performed prior to the
exposure.
Human Specimen/Radiation Supplement (long)
March 2014
Page 4 of 4