Download English - Clinical Trials Laboratory Services

CTLS
CONFIDENTIAL
Procedure No: C663
Issue No: 9
CLINICAL TRIALS LABORATORY SERVICES
Unit 3 Acorn Centre, 30-34 Gorst Road
London NW10 6LE
Tel: 0208 965 4913
0208 965 2347
Information on Collection of Body Fluids
for Genetic Studies
Fresh human blood / saliva / urine are required for research purposes by Clinical Trials
Laboratory Service’s (CTLS) clients. These clients use the blood / saliva / urine to help with basic
research into various diseases, as well as for teaching/training future workers during medical
related field of study. Please note that genetic research (DNA genotyping studies) may be
performed using these blood samples. Any remaining unused blood product will be discarded
once a specific piece of work has been completed. However, in a few instances processed
samples may be stored for later subsequent research, by clients who have necessary approval
from UK Human Tissues Authority. The fluids collected are NOT for use in Humans or for
clinical diagnosis. Safe handling within national rules including HTA compliance is the
responsibility of the end user.
You are being asked to give consent for your blood / saliva / urine to be used by scientists for
teaching/training or research purposes. To protect your privacy under the Data Protection Act
your sample will be labelled (or “coded”) only with a subject number, not your name or any other
personal identifier. Some information (e.g. donor gender and age) may also be supplied with
your sample in a similarly coded fashion to the scientists. Only CTLS’s authorised Blood
Donation Unit staff will have access to the link between your subject number and your name. In
this way, your identity will not be divulged to the scientists who receive your blood sample.
Your blood / saliva / urine will be tested for evidence of HIV, Hepatitis B and C infection. These
results will be held in the CTLS Blood Donation Unit and kept confidential. You will be
informed of any abnormality and invited to a consultation with your GP for assessment and
advice should this be necessary.
There is minimal risk or discomfort from donating blood. Occasional minor bruising or irritation
may follow a blood donation around the site of the puncture. In very rare cases there may be local
infection. Please note that all the materials used for collecting blood are sterile and used only
once, it is not possible to contract HIV (AIDS) or Hepatitis B or C by donating your blood.
Your participation is voluntary; you are free to withdraw consent and leave the Volunteer Panel at
any time without explanation.
After each donation you will be reimbursed for your inconvenience and time.
The results of any research might be valuable for commercial and/or intellectual property
purposes (patenting for example). If you decide to become a volunteer, you are giving your
sample to CTLS’s clients who will retain sole ownership of any such research results and of any
use or development of the research records (including your sample) consistent with this consent.
You will not receive any financial benefit that might come from the research results.
CTLS
CONFIDENTIAL
Procedure No: C663
Issue No: 9
Volunteer Barcode No: __________________
VOLUNTEER CONSENT FORM (For Genetic Studies)
A copy of this Consent Form must be signed and dated.
My signature below indicates that:
1.
I have read and understand this form and all the information given to me.
2.
I have been given the opportunity to discuss the donation and ask questions.
3.
I am satisfied with the answers.
4.
I wish to be part of the CTLS blood / saliva / urine Donation Volunteer Panel.
5.
I understand that my blood / saliva / urine will be used for teaching, training or genetic
research purposes.
6.
I understand that I will not be able to receive the results of any research.
7.
I will have no ownership of the research results or the research records. I agree that CTLS’s
clients may apply for and use patents relating to the research results, records and
developments or for teaching and training.
8.
I give consent for my blood / saliva to be tested for HIV, Hepatitis B and C.
9.
I give consent to donate blood / saliva / urine for teaching, training and research purposes.
10.
I understand that participation in this research is voluntary and I may withdraw my consent
at any time.
I do give consent to take up to 500ml of blood / or saliva / or urine.
VOLUNTEER’S DETAILS (Please print)
Signature of Volunteer
Date
_______________________
________________
Name: ______________________________________________
Sex: _________________
Birth Date: __________________________________
Age: _________________
Contact no: ____________________ E-mail ID: _______________________________________
Address (Residence):
_____________________________________________________________________________________
GP DETAILS & EMERGENCY CONTACT:
GP Name: ________________________________
GP Address: _______________________________________________________________________
In emergency Contact No: _________________________ Relationship: ______________________
PRE SCREENING QUESTIONS
Last Donating Date: _______________________
Last time of taking meal: ____________________
Please inform us if you have suffered from any of the following illness in the last 3 months.( Yes or No)
Malaria, Jaundice _____________________
Major Surgery, Immunisation _________________
Viral Infection, ______________________
Drug Addiction Alcohol intake _______________
Any blood Transfusion taken _______________ Fever, Cold, T B,___________________________
Diabetes, Cancer ____________________
Other Infectious Disease: _____________________
Volunteer is fit for blood donation.
Screening Staff: ____________________________
Signature and Date:________________________
Witness Name: ____________________________
Signature and Date:________________________
CTLS
CONFIDENTIAL
Procedure No: C663
Issue No: 9