Skip to main content

Clinical Development Resources

Browse our clinical development resources to find the latest articles, blogs, brochures, and videos from our experts. See the latest content below.

Informed Consent SOP Considerations

When you are creating an SOP for the Informed Consent process, you should keep in mind that:

  • The most recent IRB-approved version of the Informed Consent Form (ICF) will be used to obtain informed consent from potential research subjects.
  • The most current version of the Informed Consent Form will be identified by a version date.
  • The person obtaining informed consent will introduce themselves to the potential subject and/or legally authorized representative (if applicable).
  • The ICF must to be adapted per subject age and written in an accessible format.
  • The ICF will include: 
    • Explanation of what clinical research is and why you are approaching them.
    • Explanation of why people generally volunteer to participate in research.
    • Explanation of what they can expect (risk and benefits) if they choose to participate in clinical research (general).
    • Explanation of how participating affects their regular care and relationship with their primary care provider.
    • Ethical rights of subjects’ and whom to contact for their rights and in case of any injury.
  • After explaining the general principles of research, the person obtaining informed consent will ask the potential subject (or legally authorized representative) if they want to hear the details about the research study. 
  • The potential subject, or legally authorized representative, will be given ample time to completely read and listen to the consent form being read to them and ask any questions.
  • All questions will be answered fully by the authorized person obtaining informed consent, Principal Investigator, or Sub-Investigator.
  • The person obtaining informed consent will acknowledge that the potential subject/legal representative verbalized understanding of the research and research related procedures.
  • The subject/legally authorized representative will initial each page of the informed consent form and sign and date the appropriate page(s) of the consent form.
  • The person obtaining informed consent will sign and date the appropriate page(s) of the consent form.
  • A copy of the fully signed consent form will be given to the subject/legal representative and original will be filed in the subject’s medical records and research file. 
  • Discussion on ICF process conducted by the site staff should be documented in the subject’s source notes which includes the entire consenting process (what was discussed, who discussed, what questions were asked by subject/LAR, what answers were provided etc).
  • Written informed consent must be obtained before any research related procedures are performed.
  • If during the research trial, the informed consent form is revised, subjects will be re-consented using the revised IRB approved.
  • It is critical to consider that local regulations may have specific requirement, it is critical to reflect the process requirements that may affect it.