About Studies at ProImmune

In order to perform studies of human health and disease, or to assess the potential effects of new drugs, ProImmune needs to use human blood samples taken from healthy volunteers. You are asked to register as a potential donor, so that we may later ask you to donate your blood for use in research studies performed by ProImmune.

 

Registering as a Donor

To register as a donor, please email us and provide the following information:

  • First name
  • Family name
  • Street address
  • City
  • Postcode
  • Date of birth
  • Gender
  • Mobile number
  • Email
  • Allergies
  • Permission to add you to the blood donation register
  • Permission to contact you for blood donations

We will then contact you to confirm that you have been placed on our donor register.

 

Your Information

If you agree to take part in any study, you will be asked to complete some forms. These will include a consent form, and personal information including your name, date of birth, gender, address, telephone number and email address.  In order to comply with the Human Tissue Act (2004) and the Human Tissue Authority Code of Practice 1 (Consent), you will need to complete a form giving informed consent for the sample to be taken.

Your personal information will not be available to the scientists who work with your blood, but will be retained separately for legal archival purposes only. ProImmune will not release your personal information to any third party without your approval.

Once you have registered, ProImmune will retain your contact details on our donor database, and if you match the criteria for a study we are performing then we will contact you to see if you are willing to make a donation.

 

What will happen during your donation

You will be asked to attend an appointment at ProImmune’s facility in the Oxford area, where a qualified phlebotomist will take a blood sample from you. The volume of blood you are asked to donate will depend on the study you are participating in, and you will be told how much blood we would like to take when we contact you to make an appointment for donation.

Each donation should take no more than 15 minutes. Donation of blood for experimental use is purely voluntary and you will not be placed under any pressure to donate.

You will receive £50 compensation for your time and inconvenience.

You will be provided with a consent form explaining the study and will be given an opportunity to ask questions before deciding whether to participate. If you are happy to participate in the study, you will be asked to sign the consent form before your donation.

The blood sampling procedure involves the following:

  • A pressure cuff will be put around your upper arm and the donation area cleaned with an antiseptic wipe.
  • A needle attached to a blood collection tube will then be inserted into a vein in your arm and blood will be taken.
  • The needle will then be removed and a dressing applied.

After the donation, you will be given the opportunity to rest, and offered a snack and a drink.

 

Results of the Study

Other than as stated below, ProImmune will not provide you with the results of any lab tests involving use of your samples, or any other research data or results. These results will, in general, be experimental and provide no diagnostic relevance to any medical condition.  In many cases, additional research may be necessary to determine whether these results are meaningful.

By donating blood, you agree that your blood may be tested for infectious diseases such as HIV and Hepatitis B and C. [Note that this testing will not be performed on all donated samples. If you are concerned about your health then please visit your doctor for a diagnostic test].

 

Risks of the Study

Blood donations are very safe, and side effects are rare.

To minimise the likelihood of any adverse reactions we always employ an experienced phlebotomist. Pain and bruising may occur at the needle placement sites. Temporary lowering of the blood pressure may develop, and lightheadedness, dizziness, or fainting may occur.  In extremely rare cases, following any procedure, there may be nerve damage or infection at the needle placement sites.

Unknown Risks

You might have side effects or discomforts that are not listed in this form. Some side effects may not be known yet. New ones could happen to you. Tell the study staff right away if you have any problems.

Safety

If evidence suggests that donating blood could potentially harm you, then to protect your safety we ask you not to donate.

 

Who Can’t Give Blood For A Study?

You should not give blood for this study if any of the following apply to you:

Medication

  • You have taken any steroidal anti-inflammatory medication (e.g. cortisone cream) in the 7 days prior to donation, or non-steroidal anti-inflammatory medication (e.g. ibuprofen, aspirin or diclofenac) in the 3 days prior to donation

Pregnancy

  • You are breastfeeding, are pregnant, have given birth in the last 6 months, think that you may be pregnant, or are trying to get pregnant. There may be risks to you or your baby that are not known at this time.

Recent Blood Donation

  • You’re a male donor who has given blood in the last 12 weeks.
  • You’re a female donor who has given blood in the last 16 weeks.

Illness

  • You are unwell at the moment or have been unwell within the past 4 weeks
  • You are anaemic or receiving treatment for anaemia or iron deficiency.
  • You are on any type of blood coagulation therapy, immunosuppressive therapy or other experimental therapy.
  • Your doctor has told you that you may not give blood.
  • You know you are, or think you might be, infected with Hepatitis B Virus (HBV), HTLV (Human T – lymphotropic virus), Hepatitis C Virus (HCV), Syphilis or HIV (AIDS associated virus).
  • You’ve had a serious illness or major surgery in the past or are currently on medication. Please discuss this with your doctor before volunteering to give blood, as the reason you’re taking medicines may prevent you from donating.

Recent Treatment

  • You’ve had complicated dental work. Simple fillings are OK after 24 hours, as are simple extractions after 7 days.

Recent Travel

  • You have visited a malarial area in the last 6 months

Age and Blood Volume

  • You are under 18 years of age.
  • You weigh less than 50kgs (7st 12lb).
  • If you are female, aged under 20 years old and weigh under 65kg (10st 3lbs) and are under 168cm (5’ 6”) in height, we need to confirm your estimated blood volume is over 3500ml, to minimize the risk of fainting.

 

What to do if you change your mind:

If you have registered as a donor you can inform us at any time that you wish to be removed from our register. There is no obligation to participate in any study.  If you have donated blood for a study and given consent, you can withdraw your consent at any time.  ProImmune will do its best to identify and withdraw your sample from use.  However due to the way that samples are anonymised by the company, it may not be possible to positively identify your sample and withdraw it from further work. To contact us please call 08700 427279 or email donor@proimmune.com