SOP for Obtaining Informed Consent Form

Policy

The ethical conduct of clinical investigations is based on the voluntary consent of the subject, who has been appropriately informed about a study’s risks and benefits, and is designed to protect the rights, safety, and well-being of human subjects. It is the responsibility of the investigator to ensure compliance with all ethical standards, guidelines, and federal and state regulations that have been met through the language of the informed consent document and that informed consent itself has been properly obtained from the subject or the subject’s legal representative.

Objective

This SOP gives the procedure for obtaining informed consent from all trial subjects.

Scope

Applicable for all Clinical trials at the site

Definition

Informed Consent: A process by which a subject voluntarily confirms his or her willingness to participate in a particular trial after having been informed of all aspects of the study that are relevant to the subject's decision to participate. Informed consent is documented by means of a written, signed, and dated informed consent form.

PROCEDURE

• All the clinical trial-related ICFs should be obtained in the respective principal investigator OPD.
• Procedure for Obtaining Informed Consent from Volunteers for participation in study
• The subject information sheet and the informed consent form will be given to the subject on the day of screening.
• The study coordinator/designated person will issue a copy of the Institutional Ethics Committee of PHARMAVIGI-approved ‘Subject Information Sheet and Informed Consent Form’ (SIS/ICF) to the subject in the language best understood by him/her.
• The investigator/designated person will give study-related information from the Institutional Ethics Committee of PHARMAVIGI-approved ‘Subject Information Sheet and Informed Consent Form’ to the volunteer.

• The investigator/designated person will inform and explain to the subject the purpose of the study, the study procedure, the risks and discomforts associated with the study procedure and restrictions, the adverse effects of the study drug, the housing period, the total blood loss, the duration of the study, the remuneration, the number of volunteers to be included in the study, voluntary participation, withdrawal from the study, identity confidentiality, etc., from the IEC/approved ‘SIS/ICF’. The name of the subject to whom the SIS/ICF is issued and the signature and date of the person counseling the subject will be documented in the source document.

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• The investigator/designated person will take the informed consent in one-on-one manner. The investigator/designated person will answer all personal queries of the subject or their legal acceptable representative (LAR) or guardian during this session.
• The investigator/designated person will inform the eligible and interested subject or the volunteer’s Legally Acceptable Representative (LAR) that they will have to sign the SIS/ICF’ and if the subject is unable to read and if the Legally Acceptable Representative (LAR) is unable to read, then an impartial witness who is independent of the study will be present during the entire informed consent discussion and will explain the contents of the SIS/ICF to the subject or the volunteer’s legally acceptable representative in the best language understood to the volunteer.
• Each subject will be given sufficient time and opportunity to inquire about the study drug or the study procedure or consult his/her family physician to decide for his/her participation in the study.
• The investigator(s), sponsor, or staff will not coerce or unduly influence the potential volunteer/subject to participate or to continue to participate in the study.

• The investigator/physician/designated person will ensure that the subject as understood all the aspects of the study including the purpose of the study, the study procedure, the risk and discomforts associated with the study procedure and restrictions, the adverse effects of study drug, the housing period, total blood loss, duration of the study, the remuneration, number of volunteers to be included in study, voluntary participation, withdrawal from the study, identity confidentiality, etc., from the Institutional Ethics Committee of PHARMAVIGI-approved ‘SIS/ICF’ and is participating in the study willingly.
• The investigator/designated person will document the name of the subject to whom the SIS/ICF is issued and the name of the investigator/designated person counseling the volunteer in the source document.
• The volunteer/volunteer’s legally acceptable representative (LAR) will write all the details, like his/her name, address, date of birth, qualification, occupation, annual income of the volunteer, name of nominee(s), relation of the nominee with the subject, and address of the nominee, and sign the ICF (declaration) with date.
• In case of the volunteer/legally acceptable representative is unable to read/write then the subject will give the left thumb impression at the appropriate place and the impartial witness will write volunteer’s name and date below the thumb impression and all the respective details as mentioned above in the ICF, with the consent of the volunteer. The impartial witness will write his/her name, address, and contact details, sign and date the declaration for witnessing the entire process of obtaining the informed consent of the volunteer.
• The impartial witness by signing the consent form, attests that the information in the consent form and any other written information is accurately explained and is apparently understood by the subject of the volunteer’s legally representative or the guardian and that the informed consent was freely given by the subject or the volunteer’s legal representative.
• The investigator/co-investigator will sign and date and will put his/her name in the ICF.

• Site coordinator will give a photocopy of signed consent to the subjects/legally acceptable representatives.
• The researcher has an obligation to convey details of how confidentiality will be maintained to the participant.
• After the completion of consent process the study designee record the all protocol related information in sources documents.
• If the patient is literate and unable to write in ICF then LAR can write the details on behalf of the patient and no LAR signature is required to authenticate the same. But reflection of the movement should be recorded in ICF process.

Applicable rules and regulations

• FDA 21 CFR 50.20—General Requirements for Informed Consents
• National Ethical Guidelines for Biomedical and Health Research Involving Human Participants—2017
• HHS 45 CFR 46.116—General Requirements for Informed Consent
• New Drugs and Clinical Trial Rules, 2019

Annexure

Nil

Revision History

Nil

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