Standard Operating Procedure for Obtaining Informed Consent in Clinical Research

Purpose

The purpose of this SOP is to establish the process for obtaining informed consent from participants in clinical trials and clinical studies. This SOP ensures that participants are provided with all necessary information to make an informed decision about their participation.

Scope

This SOP applies to all personnel involved in obtaining informed consent from study participants, including principal investigators, clinical research coordinators, and other research staff.

Responsibilities

• Principal Investigator (PI): Ensures the informed consent process is conducted according to ethical and regulatory standards.
• Clinical Research Coordinators: Conduct the informed consent discussions and obtain signed consent forms.
• Study Team: Assists in providing information and answering participants’ questions.

Procedure

• Preparation:
  • Prepare the informed consent form (ICF) according to study protocol and regulatory guidelines.
  • Review the ICF with the study team to ensure it accurately reflects the study’s risks and benefits.
  • Ensure the ICF is written in clear, non-technical language and is available in the participant’s preferred language.
• Participant Information:
  • Meet with the participant in a private and quiet setting.
  • Provide the ICF and give the participant ample time to read it.
  • Explain the purpose, procedures, risks, benefits, and alternatives of the study.
  • Allow the participant to ask questions and provide answers to their satisfaction.
• Obtaining Consent:
  • Ensure the participant understands the study and their rights.
  • Obtain the participant’s signature on the ICF, along with the signature of a witness if required.
  • Provide a copy of the signed ICF to the participant.
• Documentation:
  • Document the consent process, including the date, time, and details of the discussion.
  • File the original signed ICF in the participant’s study record.
• Ongoing Consent:
  • Monitor the participant’s understanding and willingness to continue in the study throughout its duration.
  • Obtain re-consent if there are significant changes to the study.

Abbreviations Used

• SOP: Standard Operating Procedure
• PI: Principal Investigator
• ICF: Informed Consent Form

Documents

• Informed consent forms (draft and final versions)
• Participant information sheets
• Documentation of informed consent discussions
• Signed informed consent forms

References

• Regulatory guidelines (e.g., FDA, EMA, ICH-GCP)
• Ethics committee regulations
• Institutional policies and procedures

SOP Version

Version: 1.0