Questions commonly asked by researchers. If your question is not answered here, please contact the Clinical Trials Committee (CTC) Coordinator so that the page can be updated.
Why is the Principal Investigator (PI) the only one who can submit a protocol or study documents to the CTC for review and approval?
Effective February 19, 2014, any member of a study team can initiate an ethics application through IRISS on behalf of the PI. The PI, however, is still responsible for submitting the application. By submitting the application the Principal Investigator is affixing his or her electronic signature and accepting responsibility for the application.
The CTC holds the PI responsible for all correspondence to the CTC. As such, the CTC expects that the Principal Investigator has read, is fully aware of, and accountable for all documentation submitted.
Do all subjects under the age of 18 have to have a parent sign the consent form?
With respect to obtaining consent, the CTC agreed that:
- If a minor is able to understand the nature and consequences of the study (the “mature minor” concept) – a standard form should be used.
- If a minor is able to only partially understand the nature of the study, the parent/guardian must sign the standard form, phrased in 2nd /3rd person (you/your child). The minor must sign an assent. It is implied that should the minor refuse to sign the assent, participation in the study would not be permitted regardless of the parent/guardian signing a consent form.
- If a minor is unable to understand the nature and consequences of the study, the parent/guardian must sign the standard form, phrased in 2nd/3rd person (you/your child). No assent is required.
What must be included in the consent form if there is a concern about the female partner of a male research subject becoming pregnant?
If there is a concern about the female partner of a male research subject becoming pregnant, you should provide justification in the consent form. In addition, if a male subject’s partner becomes pregnant and the pregnancy is to be followed, the consent must state that permission will be sought to follow the pregnancy (e.g. Your partner will be asked for her permission to follow the pregnancy and birth of your child.)
What must be included in the consent form about visit procedures and expected length of visit?
Each visit should be clearly identified (e.g. Screening Visit, Visit 1, Visit 2, etc) and include the procedures that will be performed at that visit with the approximate length of time that the subject can expect to spend at the visit.
What must be included in the Confidentiality section regarding access to subject records?
You must state that the HREBA-Clinical Trials Committee will have access to the subject’s medical records. Please refer to the CTC Reviewer Form for a list of items required for this section.
Is it mandatory to have a witness sign the Informed Consent Form?
From a research ethics policy perspective, there is no ethical requirement to have a witness sign the consent form. Some investigators, however, may wish to do so. If this is the case, the person who serves as the witness is up to the discretion of the investigator.
For your information, this topic is also touched on in the ICH Harmonised Tripartite Guideline on Good Clinical Practice Section 4.8.9.
Can the consent process be delegated?
According to the ICH GCP Guidelines, obtaining informed consent from a subject is a task that may be delegated.
Section 4.8.5 states:
The investigator, or a person designated by the investigator, should fully inform the subject or, if the subject is unable to provide informed consent, the subject’s legally acceptable representative, of all pertinent aspects of the trial including the written information given approval/favourable opinion by the IRB/EIC.
Section 4.8.7 states:
Before informed consent may be obtained, the investigator, or a person designated by the investigator, should provide the subject or the subject’s legally acceptable representative ample time and opportunity to inquire about details of the trial and to decide whether or not to participate in the trial. All questions about the trial should be answered to the satisfaction of the subject or the subject’s legally acceptable representative.
The CTC must stress, however, that although the investigator can delegate the provision of information for the consent, the investigator retains ultimate legal and ethical responsibility for ensuring the patient:
- is provided with all appropriate information (for each individual patient);
- understands the information;
- has had all questions adequately addressed; and
- has the capacity to consent.