Information note and informed consent, the main points

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Information note and informed consent, the main points

You have an information note and a consent form to write and you do not know where to start? You have a consent form to review and you would like to know the essential points to check? You think the CPP will inevitably have a remark about your consent?

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It is true that the regulation on information notes and consent form is vague. The CPPs require, in fact, more information than what is written in the law. This suggests that the assessment will be different according to the CPP which is subjected to the protocol. Here are some tips to know that your information note and your consent are appropriate for the patient population and the CPPs requirements.

  1. In the words of the law.

According to the Law of 9 August 2004 Art. L. 1122-1-1: “No biomedical research may be carried on a person without their free and informed consent, collected after that was delivered to him the information required by Article L. 1122-1. The consent shall be given in writing form or, if not possible, certified by a third party.

And Article 1122-1 says: “Prior to the implementation of biomedical research on a person, the investigator or a physician representing him, let him know in particular:

  • The objective,
  • The methodology,
  • The research duration,
  • The expected benefits,
  • The constraints and foreseeable risks, including in case of termination of the research before expiry,
  • The possible medical alternatives,
  • The terms of medical care planned at the end of research, if such care is necessary in case of premature termination of the research and in situations of exclusion of the research,
  • The opinion of the Committee mentioned in Article L. 1123-1 [The CPP] and permission of the competent authority mentioned in Article L. 1123-12. [ANSM]
  • The right to communication, during or at the end of the research, information concerning his health, that the investigator has,
  • Where necessary, the prohibition to simultaneously participate in another research or the exclusion period covered by the Protocol,
  • His inclusion in the national register [for healthy volunteers or people consenting to a research on a disease different of those they are suffering from]
  • The right to refuse to participate in research or to withdraw his consent at any time without incurring any responsibility or damage as a result.”

“The information provided is summarized in a written document delivered to the person whose consent is sought.”

The information note must also contain the following information, according to the law of January 6, 1978 relating to data and privacy:

  • the purpose of the data processing;
  • individuals or legal recipients of data;
  • the existence of the access right of rectification and opposition.

In reality, the information document must contain more information than those dictated by law.

  1. What CPPs want

If the CPP to which will be made the submission has been designated, you can go on its website to take the temperature. Some CPP have published comprehensive documents on informed consent and the information note.

An article was written by a working group “ethics” in the INSERM clinical investigations centers network. The article is a good tool to give you an overview of the expectations of CPPs.

While your immediate objective is to obtain the agreement of the CPP in the first submission in order to begin the inclusions faster, you must specially think of the patient. He must know his rights and all necessary information to make his decision knowingly. For this, it is legitimate to also specify the type of information:

  • The name of the investigator, contact information, a telephone number to call in case of questions…
  • The name of the promoter
  • The different visits planned,
  • Additional examinations planned for research,
  • The places to which the patient will have to go if necessary (to the hospital…)
  • The modalities of taking experimental drug, the various restrictions,
  • The existence of insurance: the insurer, the right to consult it…
  • Compensation Research / reimbursement of costs by specifying their terms,
  • The right to request the final results of the study, methods to get them…
  1. Tips
  • Re-read the protocol and case report forms before reviewing your consent. Make sure that each review conducted there is described and the patient is well informed of the risks of every one of them.
  • Make sure that the information note is suitable for patients who will be enrolled in the study. For example, for the elderly, often having sight problems, it may be advantageous to use a larger font to facilitate their reading. If information for children, think to add small drawings. This will make the information easier to understand for them.
  • Make sure that patients can understand the contents of the information note. Uses simple terms. If it is necessary to cite scientific terms, explain them upon first use.
  • It is very useful to use examples. For example, to indicate the amount of extra blood taken as part of the study, it is interesting to illustrate this with the number of blood in tablespoons.
  • Avoid some formulations that could interfere with the patient. For example, do not say “If you get pregnant,” this word is a negative connotation that is not well perceived in consent. It is better to use the term “If you are pregnant” or “If you become pregnant.” Moreover, it is best to avoid words denoting a sensation or a feeling. For example, in the sentence “A needle is gently inserted into your arm.” In reality, you do not know if the person who will actually perform the sampling will be really gentle. In addition, the delicacy is subjective; some patients will be in a lot of pain, others not at all.
  • The information note is intended for the patient, the study doctor who speaks to his patient; it must be then written in the second person. The consent form, however, constitutes a certification that the patient agrees to participate in the study, it must be written in the first person (i.e. I understood that…)
  • To help you meet the requirements of the CNIL-France, standard phrases exist in the MR-001 reference methodology. This is a procedure that allows addressing to the CNIL just a commitment to comply with the MR-001 instead of the complete submission, since the study and the promoter meet the criteria described in this document. The requirements of the CNIL relating to patient information are in it.
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These are some basic tips to draft the consent form and the information note. Of course, they are not exhaustive. It is up to you to assure that the consent that you drafted or you review complies with French law and the recommendations of CPP.

For more:

A slide show outlining the regulation about patient information and obtaining consent: x

Assistance in drafting the written document for the information of participant in the BioMedical Research and certification of his informed consent drafted by the working group “ethics” in the Inserm clinical investigations centers network:  x

The methodology of MR-001 Reference: information requirements under the data collection: x

The site of the CPP SudMed 2, rich in tips: x

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Also visit the website of Pharmaspecific, http://www.pharmaspecific.fr and discover our activities. Pharmaspecific is specialized in regulatory submissions for clinical trials and pharmaco-epidemiological studies.
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Sophie Hammer

Je suis Sophie Hammer, attachée de recherche clinique et chef de projet au sein de Pharmaspecific, depuis 3 ans. www.pharmaspecific.fr

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8 thoughts on “Information note and informed consent, the main points

  1. ahlem

    bonjour

    Pour les RIPH2, le consentement est exprès donc possibilité d’un accord oral mais obligation d’information.
    Mais qu’en est il pour les sujets sous protection? L’accord oral du tuteur ou curateur ou personne de confiance suffit t’il? La réglementation precise qu’il doit y avoir un consentement mais ne distingue pas catégorie 1 ou 2 .

    Reply
    1. Vanessa Montanari

      Bonjour,

      Je n’ai pas vérifier vos dires par manque de temps dans loi, Cependant, je voulais vous donner une réponse rapide.
      Personnellement, je prépare un consentement pour les RIPH2 et je vous recommande d’en faire de même. Les écrits restent 🙂

      Bon courage.

      Vanessa

      Reply
  2. eleo

    Bonjour

    j’ai deux interrogations:

    1/Dans le cas des personnes vulnérables majeurs sans protection juridique (donc hors tutelle et curatelle) : Pour les personnes dans l’incapacité physique de donner leur consentement, alors le consentement (spécifique) doit être signé par un membre de la famille ou la personne de confiance (désignée par écrit) ou une personne « entretenant avec l’intéressé des liens étroits et stables ». Il n’y a aucune définition sur ce qu’est une personne entretenant des liens étroits et stables….. comment juger?

    2/Et en tant qu’ARC, si une personne a signé à la place du patient dois je vérifier dans le centre la présence d’un lien de parenté ou de l’accord écrit de designation de personne de confiance? Que faire s’il n’y a rien , puis je remettre en question l’inclusion?

    merci par avance

    eleo

    Reply
    1. Vanessa Montanari

      Bonjour,

      Pour la question 1, je n’ai malheureusement pas le temps de regarder dans les textes, ni de vérifier vos dires. je vous recommande de revoir cela avec le juriste ou le gérant de votre entreprise.
      Pour la question 2, dans tous les cas, il faut avoir une preuve officiel et c’est à voir avec l’investigateur; C’est à lui de la fournir.

      Bon courage.

      Vanessa

      Reply
  3. jeanne

    Bonjour
    Lorsque le premier acte d’une étude est un ECG ou EEG. Peux ton informer un sujet si jamais une particularité est observée sur un signal (ECG, EEG…) avec un gold standard ? (Sachant que le tracé n’est pas analysé par un médecin mais par des experts du signal.) Je trouverais plus éthique d’informer un sujet (s’il a a donné son ok pour être informé) pour qu’il aille faire un contrôle chez un médecin . Les experts n’étant pas médecins est ce légitime de donner cette info?
    Si suite à cela une pathologie est détectée, est ce un évènement indésirable non lié?

    Reply
    1. Vanessa Montanari

      Bonjour,

      C’est à l’investigateur de surveiller cela et d’en parler au patient s’il pense que cela est nécessaire.

      merci

      Vanessa

      Reply
  4. Edery

    Bonjour ayant une schlerose en plaque remittente et n’ayant plus de traitement sous gylenia j’ai 50 ans et diagnostiqué il y a un ans
    Je souhaiterais participer aux essais clinique
    Que faut il faire ?

    Reply
    1. Vanessa Montanari

      Bonjour,

      Les essais cliniques sont réalisés dans les CHU. De grands professeurs en médecine travaillent sur ces recherches. Vous devez dans un premier temps trouver le/les centres de références pour la sclérose en plaques dans votre région, voir dans d’autres régions de France (via internet ou en demandant à votre médecin traitant) et les contacter pour voir avec eux. Ils auront probablement des essais cliniques dans votre pathologie.

      Nous vous souhaitons du courage dans votre combat contre la maladie.

      Vanessa

      Reply

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