Obtaining Informed Consent - SOP 1.3.b

Sist oppdatert: 25.07.2025
Utgiver: NorCRIN
Versjon: 2.0
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Changes from the Previous Version 

CT SOP version no 2.0

 

Main changes from CT SOP version no 1.0: minor changes in wording to reflect ICH GCP R3 and added that information about provisions for data protection is included in a separat document in Norway.

Responsibilities 

The sponsor has overall responsibility for ensuring that this SOP is followed.

 

The sponsor’s responsibilities shall be described in the quality system of the sponsor institution. Tasks are delegated according to SOP Roles and Responsibilities in clinical trials implemented in the institution.

 

Principal investigators (PIs) are responsible for ensuring that written informed consent is obtained prior to participation in a clinical drug trial.

Procedures 

Requirements for informed consent

The information and consent form should be prepared using a template covering all required elements, e.g template provided by the ethics committee that will review the study (for example REK in Norway) and with reference to the SOP Preparing Written Information and Consent Form - SOP. The information and consent form shall be approved by the ethics committee prior to use. The latest approved version should always be used.

 

Informed consent is required from all participants in clinical drug trials.

 

The participants should also be informed about general provisions for data protection. In some countries, the information is included in the informed consent document. In Norway, the information is given in a separat document, see Behandling av dine personopplysninger.

 

The informed consent must be given voluntarily, explicitly and must be documented.

 

The person obtaining consent shall ensure that the consent is given free and voluntarily, without unreasonable influence or any form of coercion. Participants need to know that they can withdraw at any time during the trial, without giving a reason and without any negative consequences or disadvantages for them. 

 

In case of withdrawal, the  investigator should make a reasonable effort to ascertain the reason(s), while fully respecting the participant’s rights. This discussion should focus on the reasons for withdrawal to determine if concerns can be adressed, so that the participant could reconsider their withdrawal without unduly influencing the participant’s decision.

 

Requirements for participants under 18 years

As a general rule, both parents/guardians should sign the consent form on behalf of participants under 18 years in drug trials, if both have parental responsibility.

 

Additonally, appropriate assent information should be provided and assent obtained as appoprate from minors who is capable of forming an opinion and assessing the information given. The process and assent forms must be approved by the Ethics committee. 

 

In Norway there are specific regulations including separate information for children from 12 years old.

 

Care should be taken when asking minors between 12 and 16 years of age to sign an assent form since they are not legally able to consent. 

 

If the minor does not want to participate, the child’s wishes must be respected, as long as it does not have serious consequences for the child's health.

 

Requirements for participants not able to give consent

There are specific requirements for participants who are unable to consent or who are incapable of giving consent due to illness or mental incapacity, see Regulation (EU) No 536/2014 Article 31.

 

In this case  the participant's legally acceptable representative (e.g. next of kin) can give written consent on behalf of the trial participant after they have been properly informed.

 

If the person is not able to give a written consent, oral consent can be obtained after the information is given. Oral consent must be confirmed in writing by an independent witness.

 

If the trial participant becomes able to give consent at a later timepoint, the written information should be provided and the participant should be asked to sign the consent form to confirm willingness to continue in the trial. If trial participants in such cases refuses study participation/written consent, data collected for the subject must be removed from the study database.

 

Responsibility for obtaining consent

PI, investigator, or other qualified person assigned this task by the PI, can provide information and obtain consent on the PI’s behalf. The task can be delegated to, for example, a trial nurse or medical doctor.

 

The delegation of providing information and obtaining consent should be documented in writing in the trial Delegation Log - Template.

 

The trial participant should not be in a dependent relationship to the person taking consent (e.g. treating physician), but information aboout the trial can be provided. In such cases, the consent must be obtained by a different person without dependent relationship. 

 

Persons who have been delegated the  informed consent process should have the necessary knowledge about the clinical trial and the therapeutic area, to be able to perform the task in a satisfactory manner. If this person is not a doctor the participant must always be given the opportunity to speak with a doctor before signing the consent form.

 

Timing of informed consent

Consent must be obtained before any trial related procedures or assessments are performed.

 

Exceptions to this rule are only possible for research in medical emergencies, see Regulation (EU) No 536/2014 Article 35. In emergency medical situations, written consent will be requested as soon as trial participant is able to provide consent.

 

Required information

Participants will be given written information and will have the opportunity to get get all their questions anwered. The participant will be fully informed of all pertinent aspects of the trial.

 

The information should be clear and understandable and unnecessary technical or medical terminology should not be used.

 

The information should be adapted to the age and ability for the participant to understand.

 

The participant should be given sufficient time to ask questions about the trial and all questions should be answered to the satisfaction of the participant.

 

Participants shall have the opportunity to consult with relatives, family doctor or others, before they decide whether or not to participate in the trial.

 

Procedures for persons giving consent

The consent form should be signed and dated in real time by the trial paticipant or the participant’s legally designated representatives, if the participant cannot give consent.

 

The person who had the informed consent discussion and obtained consent must confirm that the information was accurately provided and apparently understood, and consent was freely given by the participant or legal representative by signing and dating the consent form.

 

The trial participant should sign first, the person who informed last. The trial participant should be given a copy of the information sheet and the signed and dated consent form to keep.

 

Procedures for persons not consenting

The person should be thanked for taking the time to consider participation in the trial. It should be emphasised that the person’s refusal to participate will not have any consequences for their further treatment.

 

Trial personnel or the PI should make sure that the person is referred to the appropriate persons for follow-up according to current medical practice. No data should be entered into the CRF.

 

Information to participants during the trial

If important new information becomes available during the course of the trial, especially safety information, that may be relevant to the participant’s willingness to continue in the trial, the PI will inform the participant in a timely manner.

 

The PI shall promptly inform the trial participant if any injury is caused by the trial procedures, or complications which occur as a result of the trial.

 

At the same time the participant should be told how to get compensation. For example in Norway: from Norsk Pasientskadeerstatning (NPE) and any injury should be reported to the Norsk pasientskadeerstatning.

 

The information mentioned in the previous points, must be documented in the patient's medical records.

 

If there are significant changes in a clinical trial, written consent must be re-obtained when the changes are believed to be relevant to the participant’s willingness to continue participation in the trial.

 

The written information and consent form must be updated/revised to also include the new information.

 

When consent has to be renewed the trial participant should receive written information and have the opportunity to ask questions before signing and dating the revised consent form, according to the procedure for obtaining the original consent.

 

Documentation

For partipants who are patients, the process for obtaining consent should be documented in the patient's medical records. The following should recorded:

  • That the trial participant received written information about the trial, got their questions answered and agreed to participate.
  • The date on which the participant signed the consented form.
  • That the trial participant was given a copy of the written information and signed consent form.

 

If the trial participant is under 18 years old, it must be noted that both parents/guardians signed the consent form.

 

All original signed consent forms should be kept in investigator’s site file (ISF), or other specified place. If consent forms are not kept in the ISF, there should be a note in the ISF that gives the location of the consent forms. Refer also to the Location of Document if not in ISF - Template.

 

All consent forms, both those signed by participants who completed the trial and those who withdrew from the trial, should be filed.

 

Signed consent forms will be archived after end of the trial. Refer to the archiving requirements in SOP Completion, Reporting and Archiving – SOP 1.6.b.

 

All participants who consented and were screened will be logged in the trial screening log. Refer to the Screening Log - Template.

 

Participants that consent and are treated will be logged on the list of trial participants. Refer to the Identification & Enrollment Log - Template.

References