INFORMED CONSENT FORM

INFORMED CONSENT FORM

• Before the enrollment of a patient in a clinical trial and beginning of any trial-related procedures, a voluntary written, study-specific informed consent is obtained from the patients (participants) for protection of the:Rights of the participantsSafety and well-being of the participantsInterests of the participants

PURPOSE OF INFORMED CONSENT FORM

• Purpose of informed consent form (ICF) is not only to get a participant’s signature, but also to provide the participants with the information related to a clinical trial

• Informed consent means that the purpose of the clinical trial is explained to the potential participants, including what their role would be and how the trial will be conducted

REGULATORY REQUIREMENT OF ICF

• In obtaining and documenting informed consent, the investigator should comply with the applicable regulatory requirement(s), and should adhere to GCP and to the ethical principles that have their origin in the Declaration of Helsinki (as per ICH E6 guidelines)

ELEMENTS OF INFORMED CONSENT FORM (ICF)• To meet the regulatory requirements, following elements

should be included in ICF:The study involves research and purpose of researchDuration of participation and approximate number of participantsDescription of the procedures that will be completed during

enrollment of the participantExperimental procedures that will be completed during the

clinical trial

Description of any foreseeable risks or discomforts that could occur as a result of the research

Any possible benefits to the participants Alternative procedures or treatment (if any) that might benefit the

participant Participant’s responsibilities

ELEMENTS OF INFORMED CONSENT FORM (ICF) (contd.)

Extent of confidentiality of records and personal identification information

Compensation and treatments in case of injury Statement that participation is voluntary Participants may have a right to refuse treatment or withdraw

without any loss of benefits for which they are entitled Additional costs, if any, to the participant

ELEMENTS OF INFORMED CONSENT FORM (ICF) (contd.)

ELEMENTS OF INFORMED CONSENT FORM (ICF) (contd.) Foreseeable circumstances and/or reasons why participant may end

involvement with the study Termination procedures Premature termination or suspension of a trial Signatures and date

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