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

forGenetic 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.

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.

  1. I give consent for my blood / saliva to be tested for HIV, Hepatitis B and C.
  2. I give consent to donate blood / saliva / urine for teaching, training and research purposes.
  3. 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:______