Informed Consent Forms (ICF) and Patient infrormation Sheet: 10 Tips to acheive your goals

If you need to prepare an informed consent for for an ethic committee in France, contact us www.pharmaspecific.com Transcription : Hello everyone, this is Vanessa Montanari from the clinical research blog for Pharmaspecific.

Today, we will talk about consent and the information note I will give you 10 tips to succeed. But first of all, I would like to tell you that through Pharmaspecific training, we have created kits so that you can carry out your consents and information notes in a serene manner.

So, what will you find in these kits? You will find consent models for all types of situations: emergency situations for children, classic situations for an adult … you will have several types and many more besides. Several types of situations. Next, you will find a guide in which we will explain how to write your consent. Paragraphs, examples of sentences to put in your consent, the regulatory texts that must be in your consent and in your information note. You will not find this kit anywhere else, at least not in the French-speaking world. So, now, I am going to give you the 10 tips to make your consent and your information note a success. First of all, at the level of the police.  The font must be easily decipherable and that’s why it must be at least size 12. If it’s about elderly people, you can even go up to 14, that’s my first piece of advice.

My second piece of advice is that the terms used should be simple. If you have technical terms and abbreviations, you should explain everything the first time you use them. The consent and the information note must be clear to the patient.

Third, the letter must be adapted to the category of people you are addressing. If you are writing to a 6-year-old child, you will not be able to speak and write in the same way as a 15-year-old child, or a parent of a child, or an elderly person. So you will have to adapt.

The fourth point is language. It must not be anxiety-provoking. It is preferable that you use the conditional and the subjunctive when you talk about anything that is risky for the patient.

Fifth, the consent form and the information note should be paginated so that the person who is going to open the consent form and the information note will need to know how many pages you have. Therefore, located on the first page of 15 pages, it should be marked 1 out of 15. You must also put the name of the study, the version number, the date of writing of this consent template and the terms informed consent form; if it is an informed consent form; or briefing note; if it is a briefing note. You must indicate this in the footer. Be aware that these documents can be separated. You can either separate them and then paginate them differently, or you can combine them into one document. Then it will be as the footer title of the Informed Consent Form and Briefing Note.

Sixth, you can ask the patient to initial, but it is not always mandatory. Be aware that some Ethic committee in France s ask for it, some require it and some will refuse. You can find this type of information in our kit.

Seventh point, avoid certain formulations that could embarrass the patient. For example, we don’t say if you get pregnant. This word has a negative connotation that is not well perceived in a consent. It is better to use a term such as if you are pregnant. You should also avoid words that refer to a sensation, a feeling. I’ll give you an example. In a sentence such as a needle will be gently inserted into your arm. In reality, you don’t know if the person who is going to take the sample will really be delicate and delicacy is something subjective. So some patients will be in pain, others will not. So you have to avoid all these words of sensation in the informed consent and in the information note.

Eighth point, at the level of the information note. Since it is intended for patients, it is the study physician who addresses the patient. It should be written in the second person. The consent form, on the other hand, is the patient’s attestation. The patient agrees to participate in the study. Therefore, it must be written in the first person. « I understand that … ». So, you should know that to help you write this consent, you can find in the MR001, sample sentences to help you write your consent. The MR001 is the CNIL’s commitment to compliance. It is therefore a document that can also help you.

Tenth piece of advice, make sure you reread your protocol and your observation notebook before reviewing your consent. Make sure that each examination performed is described and that the patient is informed of all the risks. You can also use the Investigator’s Brochure. So, in general, the informed consent form and the training note are written in French. It is mandatory that they be written in French. Sometimes, when you are in an international study, you will receive documents in English. These documents will be translated and you will adapt them to French regulations and to the expectations of the French Ethic committees.

That’s it, so I’m finished for his little advice. I hope that they will help you to write your consent and your information note. See you soon!