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This is the home – based cohort of the PCSIG trial

Participant Information and Informed Consent for the Home Sampling Group of “A Study to Understand the Influence of Blood Sampling Approaches on Clinical Trial Recruitment and Retention Based on Sample Collection in a Clinical Setting, or in the Home”

26 February 2021

Version – 1.0

Thank you for your interest in this study. We are looking at the amount of alcohol that people from the general population drink, as well as the practical feasibility of collecting this information. This will be achieved by the collection of blood samples from volunteers and measuring the amount of phosphotidylethanol (PEth), an established indicator of alcohol consumption, which remains in the blood for a longer period than alcohol itself.

Taking part in this study is entirely voluntary and you can drop out at any time you wish to with no costs or consequences (although please let us know using the email below).

What will happen if I participate in the study?

• Three devices for collecting blood samples will be sent to your home, along with instructions for their use.
• You will need to provide a blood sample from yourself on 3 separate occasions, approximately 10 days apart. This will use a device that you will place on your upper arm, as illustrated in the video below. This process should take approximately 10 minutes on each of the 3 blood sampling occasions. The amount of blood collected on each occasion will be a few drops (approximately 100 µL).

• You will record the collection of the sample in the website or smartphone app provided for the purpose.
• You will package the collected blood samples following the instructions provided and will return them to the study center as soon as possible in the regular mail, using the packaging provided. Postage will be be pre-paid.
• At the end of the study, you will be e-mailed a brief questionnaire on your experiences. This questionnaire should take no more than 5 minutes to complete.
• The results of your tests will be available through either, a confidential website using a unique code / or via an e-mail. It may take up to 2 months after the last sample is collected to get the results back to you, because we are analysing all the samples together at the end of the study. Please be assured that the results will be returned and so you will get to find out what your own alcohol consumption is and how this compares to other participants in the study.

Am I eligible to participate in the study?

People who are aged 21 and above, are located in the United States of America, are not pregnant, or breastfeeding and weigh at least 110 pounds (50 kg) are allowed to take part. Participants must have access to the internet. Prisoners and those with diminished decision making capacity, or a member of a vulnerable group are not able to take part in the study.

What will happen to my information?

The data collected will be the information you enter into the system, as well as your test results. The people who will see this information will be restricted to yourself and the research team. If results from the study are published, this will be done on grouped data across all participants and there will be no way for someone to identify you.

Your blood samples will not be stored after the end of the study and no genetic information will be collected from them.

Will I be compensated for taking part?

You will not be compensated for taking part. The study itself should not cost you anything. However, if you need to drive anywhere because of your involvement in the study, or incur costs in any other way, these will not be reimbursed.

There is no commitment to provide any compensation for research-related injury whilst taking part in this study.

If you have any questions, or want extra information please just let us know: <<insert email address>>.

What are the benefits and risks of taking part?

You will get a unique and confidential insight into your own blood alcohol levels that you can use to support your own healthcare.

Taking the blood sample may cause some discomfort, sensitivity and / or a small mark at the sampling site on the upper arm.

Consent to participate in the study

To take part, please answer the following questions and click ‘Join’ at the bottom.

• I confirm that I have read the information above, have had the opportunity to ask additional questions if I have wanted to, and understand what will happen in this study.
• I understand that my participation is voluntary and that I am free to withdraw at any time without giving a reason.
• I understand that the information collected about me will be seen by the research team and myself. If published this will be done so anonymously.
• I understand that this study was approved by an independent medical ethics committee and that this study will be conducted according to the appropriate international guidelines.
• I confirm that I am located in the United States of America.
  • Please provide your postal / ZIP code.
• I confirm that I am a male / female aged 21-44 / 45-65 / over 65 years.
• I confirm that I am not pregnant, or breastfeeding.
• I confirm that I weigh more than 110 pounds (50 kg).
• I confirm that I am not in prison.
• I confirm that I am not of diminished decision making capacity or a member of a vulnerable group.

Big button at the bottom saying ‘Join’