Complaints

If at any point during the research, or soon after, you experience any health problems that may be because you took part in the study, contact the researchers immediately.

Researchers must tell you about any risks or potential problems before you agree to take part in the research. They should also have in place arrangements for compensation in the event of any problems. If you feel that you were not told about the risks or you have sufferered harm you may want to complain or ask for compensation.

If you are not satisfied with their explanation or actions, you should contact a member of the Patient Advice and Liaison Service (PALS) and their role is to:

• Act as independent & impartial advisors for patients, relatives, staff and visitors to the hospital
• Listen to your concerns, issues or problems that you may have with the service the hospital provides
• Try to find a resolution to your problems by supporting you, contacting and informing the hospital and working with you to improve our services
• Inform you about the formal complaints procedure and, with your agreement, help you to make a formal complaint and support you through the process where necessary & appropriate

Insurance

If you are harmed or injured as a result of taking part in a research you may be entitled to compensation. If the study is sponsored by a pharmaceutical company, the company will have an agreement to compensate research subjects who are harmed because of a drug or treatment involved in their study.

Confidentiality

The researchers will have made arrangements to make any information they hold about you is kept confidential but you may want to ask how they will do this. The Data Protection Act 1998 gives you the right to expect that your personal details will be kept secure and confidential. All researchers must comply with this act and respect the confidentiality of your information. Members of the research team should be able to answer the following questions:

• What information will be kept about you?
• Who will be responsible for keeping this information confidential?
• What arrangements will the researchers make to prevent information about you being given to other people?
• Do the researchers plan to share the information with any one else? (this could be researchers at another hospital or university)
• Have the researchers asked you if they can tell your GP that you are taking part in the research?

Informed consent

Once you have been given all the information about the study, you will be ready to decide whether you want to take part. If you do decide to go ahead you will be asked to sign a consent form. No one can include you in a research study without fully discussing it with you first. The doctor, nurse or other researcher must always ask your permission, and if you do not give your consent they cannot enter you into the trial.

It is important that you are satisfied that you know enough about the trial to make an informed decision. You should feel free to ask any questions that may help you to reach a decision. You should also feel satisfied that you have been given enough time to think about the study and what it would mean to you, before you decide.

1. Have you read and understood the patient information sheet and had the chance to ask questions?
2. Have you been given enough time to make a decision?
3. Do you understand that taking part is voluntary and that you can withdraw from the study at any time without giving a reason?
4. Do you understand the aims of the study, side effects, risks and benefits, and also the alternative treatments available.

A copy of the form should be given to you to keep. If you are not asked to sign a form you should speak to the researcher about this.

This page was last modified on Wed May 02 2012