Institut Claudius Regaud

Information and Consent

You have the right to be kept completely informed by health professionals about the different investigations, treatments or preventative actions available, their usefulness, urgency, consequences, frequent or serious risks, possible alternatives and consequences if refused. We are also obliged to inform you later on. Information is provided during a personal appointment with your doctor.

You can also choose to not be kept informed. In this situation, you must tell the doctors who are looking after you so that this request can be stipulated in your medical records.

You have the right to express your consent throughout the care process and can withdraw it at any time after having been informed by the medical team.

Even in situations where it is not compulsory by law, doctors could ask you for written consent.

Designated Person

During your stay you can designate, in writing, a friend or family member to support you during your care. This person will be considered your 'designated person' by the Institute. This person will be consulted or be provided with information if you can no longer express your will. If you want, they can also attend medical appointments with you to help you make decisions. You can choose to no longer have a designated person or change the terms at any time. You must inform this person of the role you want them to take on. [see article L.1111-6 of the Public Health Code]

People requiring special care

In certain situations, when a person's mental or physical faculties are affected by illness, infirmity or old age, to such a degree that their interests are compromised, it is important that certain safety measures are taken.

This is why the Institute commits to providing particularly vulnerable people with special care. This particularly concerns:

• Disabled People (in accordance with law n° 2005-102 dated the 11th February 2005) ;
• Destitute People;
• People deprived of their freedom;
• Protected Adults (temporary guardianship, guardianship, judicial protection).

Special care for minors

Consent: if you are able to express your will and participate in the discussion, your consent must be sought.

Confidentiality: the doctor can provide care without the consent of parents or guardians in the following situations:

• if treatment is required to protect your health;
• the doctor must try and persuade you to consult your parent or guardian;
• if you do not agree, you must be joined by an adult of your choice.

Access to your records: if you are a minor, the right to access your medical records is held by your parent or guardian. You can request that this access be carried out through a doctor.

In all cases, we request that you warn us of any situation that might require special care.

If you would like to find out more about one of these special care options, you can contact the person responsible for user relations by calling 05 61 42 42 48.

Refusal of treatment and discharge against medical advice

You have the right to refuse treatment or care in respect of your individual free will.

If you discharge yourself against medical advice, you will be informed by your doctor of the risks linked to your state of health and administrative formalities for your discharge will be carried out.

In both these situations you must sign a document stating that you are refusing care or are discharging yourself against medical advice. A copy of this document will be kept on your medical record.

If you want to find our more do not hesitate to contact the person in charge of user relations who can answer your queries.

Advance Directives

If they want, any adult can write advance directives in case they are unable to express their will at the end of their life. These directives indicate their wishes in regards to the limitation or discontinuation of treatments. They will be referred to before any medical decisions are made and their content prevails over any other non-medical opinion. Renewable every three years, they can be changed or cancelled at any time. If you would like your directives to be taken into account make sure they are available to the doctor who is in charge of your treatment at the institute: give them to the doctor or give the doctor details of the person who has them.

[see article L.1111-1 1 of the Public Health Code]

Access to Medical Records

Medical records are created at the Institute. They contain information about your health.

It is possible to gain access to these records by putting in a request to management. You can choose to receive them directly or via a doctor. You can also consult your records on site with or without the support of a doctor.

This information will be made available to you between 48 hours and 8 days after you have made your request. If your records are more than five years old it can take up to two months.

It is free for you to look at your records on site. If you want a copy of all or part of your records, costs of creating copies and sending these copies to you must be paid for by you. Your medical records are kept for twenty years after the date of your stay or your last out patient consultation.

[see articles L.1111-7 and R.1111-2 à R.1111-9 of the Public Health Code]

Patient Committee

The role of the Institute's patient committee is to improve information provided, reception, listening and overall care (waiting conditions, hospitalisation conditions, support for hospitalised people, daily life etc.) The committee helps evaluate patient satisfaction and makes recommendations for improvement. It also provides an opinion on documentation given to patients. The committee can approach the Institute about any subject that it deems important to study in relation to care of the sick and their close ones.

The committee has an advisory role and all members are volunteers. Information provided to the committee is done so in secret.

Opinions and analysis provided by the patient committee are free and independent.

Data Protection Act

Law N° 78.17 dated the 6th January 1978 ensures that IT serves everyone and does not affect human identities, human rights, privacy or civil liberties. Through the implementation of article R.61 13-7 of the Public Health Code we inform you that:

• Data about you is dealt with automatically according to conditions set by the law dated the 6th January 1978;
• This data is given to the doctor in charge of the Institute's medical data by the the practitioner in charge of the medical department in which you received your treatment or by the practitioner who created your records. This data is protected by medical confidentiality;
• You have the right to oppose the collection and processing of personal data for a legitimate reason in accordance with the conditions of article 38 of the law dated the 6th January 1978 referred to above;
• Under the provisions of this article, your right to oppose the collection of data can only be exercised if the collection of data is not required by law.

The Commission nationale informatique et libertés (CNIL) is the organisation responsible for ensuring this law is complied with.

Website for the CNIL : www.cnil.fr

Biomedical Research

Whilst being cared for at the Institute, it is possible that your doctor will ask you to participate in biomedical research. The aim of this research is to develop medical knowledge so that in the long term all patients with the same illness as you can benefit.

Depending on the situation, this research could involve:

• a new treatment or a new combination of treatments;
• a new type of treatment for example new radiotherapy methods, diagnostic methods or a new method of measuring blood;
• an innovative piece of equipment.

This type of research is highly regulated and complies with the public health law dated the 9th August 2004. If this type of research is suggested to you, a detailed information booklet explaining the research will be provided to you during an appointment with your doctor. You are free to decide whether you want to participate or not. You agreement is provided by signing a document called 'Informed Consent.' A copy will be given to you. You can withdraw your consent at any time (even during the study.) In some situations, samples (tissue or blood) can be stored to create a sample collection (biological resources centre) adhering to a strict legislative framework. Written consent to be included in this type of collection centre will be requested from you.

Quality and satisfaction

In order to improve the quality of your care, your opinion is vital. At the 'information points' in each department, we have provided suggestion sheets for you to fill in your comments. We also collect patients opinions through surveys. The results of satisfaction surveys can be seen on display boards. Certification is available on the website for the Haute-Autorité Santé.