An ideal format of Informed Consent Form should have following three sections - Introduction, Information Sheet & Certificate of Consent
The investigator must provide information about the study to the prospective subjects who are willing to participate in the study. This information should be provided to the subject through verbal and audio visual aids. The details of the trial should also be provided in a written document, patient information sheet. The patient information sheet is called ICF or Informed Consent Form.
The Informed Consent Form contains details of processes and procedures involved in the trial, the potential risk and benefit that the subject may obtain by participating in the study in a language that is non-technical and easily understandable by the study subject. The Subject's consent to participate in the study must be obtained in writing using the Informed Consent Form. The informed consent form should be written to a format to comply with international ethical and regulatory requirements.An ideal format of Informed Consent Form should have following three sections namely,
- Introduction - To provide information on the investigator, organisation & sponsor involved in the study
- Information Sheet - To share information about the research with the subject
- Certificate of Consent - For declaration and signatures, if the subject agree to take part in the study
I. The "Introduction" section of an Informed Consent FormThe following information should be provided in the introduction section of the Informed Consent Form.
- Name of Principal Investigator
- Name of Organization
- Name of Sponsor
- Proposal and its version
II. The "Information" section of an Informed Consent FormThe section on information of an Informed Consent Form provided to prospective subjects participating in a study contains two types of elements
- Essential elements
- Additional elements
- Statement that the study involves research
- Explanation of the purpose of the research
- Expected duration of the subject's participation
- Description of the procedures to be followed, including all invasive procedures and identification of any procedures which are experimental
- Description of any reasonably foreseeable risks or discomforts to the subject participating in the study
- Description of criteria for participant selection in the study, Inclusion and exclusion criteria
- Statement that participation of the subject in the study is voluntary
- Statement that the subject can withdraw from the study at any time and that refusal to participate will not involve any penalty or loss of benefits to which the subject is otherwise entitled to
- Information on the study drug [Name of Drug] to be used in the study
- Expected side effects with the study drug(s) to be used in the study
- Studies of investigational articles (drugs, biologics or devices) should include a statement that a purpose of the study includes an evaluation of the safety of the test article. Studies that involve efficacy should also include the effectiveness of the test article, as a study purpose, but should not make claims of effectiveness.
- Study treatment schedule(s) and the probability for random assignment to each treatment (for randomization and placebo control studies)
- A description of any reasonably foreseeable risks or discomforts to the subject
- Processes and procedures involved in the study as described in the protocol
- Description of any benefits to the subject or others reasonably expected from research. If no benefit is expected subject should be made aware of this.
- Disclosure of specific appropriate alternative procedures or therapies available to the Subject if any, that might be advantageous to the subject.
- Statement describing the extent to which confidentiality of records identifying the subject will be maintained and who will have access to subject’s medical records
- An explanation about whom to contact for answers to pertinent questions about the research and research subjects rights, and whom to contact in the event of a research-related injury to the subject
- The anticipated prorated payment, if any, to the subject for participating in the study
- Rights of subjects and in the event of any injury
- Statement describing the financial compensation and medical management as under:
- In the event of an injury occurring to the clinical study subject, such subject shall be provided free medical management as long as required
- In the event of a study related injury or death, the sponsor or his representative, whosoever has obtained permission from the licensing Authority for conduct of the clinical study, shall provide financial compensation for the injury or death
- Statement of anticipated circumstances under which the subject's participation may be terminated by the Investigator without the subject's consent.
- Additional costs to the subject that may result from participation in the study.
- The consequences of a subject’s decision to withdraw from the research and procedures for orderly termination of participation by subject.
- Statement that the subject or subject's representative will be notified in a timely manner if significant new findings develop during the course of the research which may affect the subject's willingness to continue participation will be provided.
- A statement that the particular treatment or procedure may involve risks to the subject (or to the embryo or foetus, if the subject is or may become pregnant), which are currently unforeseeable.
- Approximate number of subjects enrolled in the study
III. The "Certificate of Consent section" of an Informed Consent FormThe section on Certificate of Consent of an Informed Consent Form provided to prospective subjects participating in a study should contain
- Questions to test if the subject understood the verbal, audio visual presentation and the information consent form in its entirety
- Confirmation by the subject that he had opportunity to ask questions (and if asked, were answered) about study to the Principal Investigator or appropriate individual
- Statement of acknowledge that the subject has read and understood the information consent form
- Declaration of consent by the subject to participate in the study
- Provision for signature of the subject in section on Certificate of Consent of the information consent form
An audio-visual recording of the informed consent process should also be performed. Both the written and audio visual documentation of subject consent to participate in the study should be preserved adhering to the principles of confidentiality.
Tags: ClinicalTrials, DCGI, Regulatory