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SOP on Informed Consent Procedure for Clinical Research Studies

 Title: Informed Consent Procedure for Clinical Research Studies

Introduction and Purpose:

Informed consent is a fundamental component of ethical clinical research, ensuring that participants voluntarily agree to participate with full awareness of the study's purpose, procedures, and potential risks. This Standard Operating Procedure (SOP) outlines the procedures for obtaining and documenting informed consent for clinical research studies conducted at [Institution Name]. It is essential to adhere to federal regulations, including the Department of Health and Human Services Common Rule (45 CFR §46) and the U.S. Food and Drug Administration (FDA) regulations (21 CFR §50), as well as the International Council on Harmonization (ICH) Good Clinical Practice (GCP) guidelines, which provide guidance on obtaining informed consent.

This SOP applies to all clinical research studies that require informed consent as outlined in 45 CFR §46 and 21 CFR §50 and do not fall under consent without signature or opt-out consent models approved by the Institutional Review Board (IRB).


Definitions and Acronyms:

  • Clinical Research: Encompasses all research involving human participants, excluding secondary studies using existing biological specimens or data collected without identifiers or publicly available data.
  • Clinical Trial: Refers to clinical research studies involving human participants assigned to an intervention designed to evaluate the effect(s) of the intervention on the participant and the effect being evaluated is a health-related biomedical or behavioral outcome.
  • Legally Authorized Representative (LAR): An individual or judicial or other body authorized under applicable law to consent on behalf of a prospective subject to the subject’s participation in the study.
  • CFR: Code of Federal Regulations
  • ERICA: Electronic Research Integrity and Compliance Administration program
  • FDA: United States Food and Drug Administration
  • GCP: Good Clinical Practice
  • ICF: Informed Consent Form
  • ICH: International Council on Harmonization
  • IRB: Institutional Review Board
  • PI: Principal Investigator
  • SOP: Standard Operating Procedure


Procedure:

Delegation of Authority:

  • The Principal Investigator (PI) is responsible for ensuring that informed consent is administered appropriately and effectively to all study subjects before enrollment.
  • The PI may delegate the task of obtaining informed consent, or parts of it, to a qualified Sub-Investigator or study staff member. This delegation must be documented in the study records.
  • Delegated staff must receive appropriate training in the informed consent process and be added to the IRB application with consent privileges.

IRB Approval:

  • Consent forms must be submitted to and approved by the IRB before obtaining informed consent from study subjects.
  • Any changes made to the consent forms after initial IRB approval must also be submitted to the IRB for review and approval before use.
  • The consent form must be presented to the subject in a language they can understand. For non-English-speaking subjects, an IRB-approved translated consent form or short form must be used.
  • No subject should be asked to sign a consent form in a language they do not understand.

Types of Consent Forms:

  • The type of consent form required depends on the subject's age and specific circumstances. Typically, the following forms are required:
  • Informed Consent Form (ICF) for adult subjects age 18 or older or emancipated minors.
  • Parental Permission Form (PPF) for subjects under the age of 18, signed by a parent or guardian. The IRB may require both parents to sign the PPF in specific cases.
  • Assent Form, in addition to the PPF, for subjects aged 7-17 or as required by the IRB for adults with diminished decision-making capacity.
  • Additional consent forms may be necessary for supplemental information, specimen repository/tissue banking, or optional sub-study consents.

Obtaining Informed Consent:

  • No study procedures should occur before obtaining the required consent(s) unless exempted by the IRB. Procedures performed before consent must be standard of care and allowed by the protocol.
  • The PI or delegated personnel will meet with the prospective subject or their legally authorized representative (LAR) to explain the study and discuss each section of the consent form.
  • To ensure up-to-date consent forms are used, the consent form should be retrieved directly from the electronic IRB ERICA application for each new subject.
  • For studies where direct retrieval from ERICA is not feasible (e.g., eConsents, community settings), an alternate process should be implemented to ensure accurate versions of consent forms are used.
  • Subjects should be given adequate time to read the consent form(s) and have their questions answered before signing.
  • During the consent discussion, subjects must be informed that participation is voluntary, and they can withdraw at any time.
  • If the subject agrees to participate, they should sign and date the consent form(s) and answer any additional questions included in the form.
  • If study procedures are performed on the same day as consent, the consent's timing should be documented on the form.
  • The person obtaining consent will verify that all sections of the form are complete, all pages are present, and the subject's signature block is correctly signed and dated.
  • Any errors on the form should be corrected with a single line through the incorrect information, the correct information, initials, date of correction, and a reason for the change (if necessary).
  • After the subject or LAR signs and dates the form, and it is verified as complete, the person obtaining consent will sign, date, and, if applicable, timestamp the form.
  • If the investigator's signature is required on the form, it should be obtained on the day of consent or as soon as possible. Delays in obtaining the PI's signature should be explained in the consent process note.
  • Subjects/LARs must always receive a copy of the consent form. For studies following GCP guidelines, subjects should receive a copy of the fully executed signed consent form(s).
  • Remote consenting may be conducted if approved by the IRB.

Documenting the Consent Process:

  • In addition to the completed and signed ICF, the consent process should be documented in a consent process note or study flowsheet. Documentation should include details such as the provision of a copy to the subject, attendees during the discussion, questions and answers, consent timing, use of a translator or witness, and any unique details.
  • Some studies may be exempt from individual consent process notes due to their nature (e.g., large, low-risk trials).
  • No extraneous information should be added to the consent form(s) except for corrections. Any needed clarifications should be included in the consent process note.
  • Some departments may require specific templates for consent process notes, while others may allow free text or alternative documentation methods.

Filing Consent Documents and Notes:

  • Original signed and dated consent forms should be retained in the subject's research chart along with the consent process note.
  • Inclusion of the informed consent form and consent process note within the participant's medical records is allowed but not mandatory. Factors such as clinical relevance, sensitivity of consent, and Certificates of Confidentiality (CoC) should be considered when deciding whether to include these documents in medical records.
  • Re-consenting subjects may be required when there are changes to the consent form that affect risks, procedures, treatment, or other relevant information. Re-consent should be obtained within a timely manner, typically no later than 60-90 days after IRB approval of the changes.
  • Additional considerations apply to specific subject populations, including non-English speaking subjects, blind or illiterate subjects, subjects using an LAR, remote location/telephone consents, children, and prisoners. Detailed guidance can be found on the IRB website or within departmental guidelines.

Materials Required:

  • Current IRB Approved Consent Form(s)
  • IRB Witness Signature Page (if applicable)
  • Delegation of Authority log
References:

  • 21 CFR Part 50 Subpart B: Protection of Human Subjects
  • 45 CFR Part 46: Protection of Human Subjects
  • ICH Guidance for Industry E6(R2): Good Clinical Practice
  • IRB Telephone Consent Process to Obtain a Signed Consent Form
  • IRB Investigator Guidance Series
  • IRB Forms: Consent Process Models
  • IRB SOP
  • IRB Investigator Guidance, Certificates of Confidentiality

Document Approval:

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