Protocol for Ensuring Insurance Protection of Study Participants

Purpose

The purpose of this Standard Operating Procedure (SOP) is to establish guidelines for providing insurance coverage to participants enrolled in Bioavailability (BA) and Bioequivalence (BE) studies, ensuring their protection against study-related injuries or adverse events.

Scope

This SOP applies to all study personnel involved in participant recruitment, enrollment, and study conduct, including Investigators, Study Coordinators, and Institutional Review Board (IRB) members.

Responsibilities

• The Investigator is responsible for ensuring that participants are informed about insurance coverage options and obtaining their consent for participation in the study.
• The Study Coordinator is responsible for verifying participants’ insurance coverage status, facilitating insurance enrollment if necessary, and maintaining accurate records of insurance information.
• The Institutional Review Board (IRB) is responsible for reviewing and approving the study protocol, including provisions for participant insurance coverage, to ensure participant safety and welfare.
• The Sponsor is responsible for providing insurance coverage or arranging insurance policies to protect participants against study-related injuries, adverse events, or medical expenses.

Procedure

1. Educate study personnel about the importance of insurance coverage for study participants and the ethical principles guiding participant protection in clinical research.
2. Review the study protocol to determine insurance coverage requirements and ensure compliance with regulatory guidelines and sponsor policies.
3. Inform participants about insurance coverage options, including any limitations, exclusions, or conditions associated with the insurance policy.
4. Obtain participants’ consent for enrollment in the study, including acknowledgment of insurance coverage details and potential risks associated with participation.
5. Verify participants’ insurance coverage status and assist participants in enrolling in insurance plans if they are not already covered.
6. Maintain accurate records of participants’ insurance information, including policy details, coverage periods, and contact information for insurance providers.
7. Ensure that insurance coverage extends to study-related injuries, adverse events, medical expenses, and other liabilities arising from study participation.
8. Communicate insurance coverage details to relevant stakeholders, including participants, study personnel, Institutional Review Boards (IRBs), and regulatory authorities.
9. Monitor insurance coverage throughout the study conduct and update insurance information as needed to ensure continuous participant protection.
10. Address any insurance-related inquiries, concerns, or issues raised by participants or study personnel in a timely and transparent manner.

Abbreviations

• SOP – Standard Operating Procedure
• BA – Bioavailability
• BE – Bioequivalence
• IRB – Institutional Review Board

Documents

• Insurance Coverage Information Sheet
• Participant Consent Form
• Insurance Enrollment Forms
• Insurance Policy Documents

Reference

International Council for Harmonisation (ICH) E6 Good Clinical Practice guidelines and relevant regulatory guidelines for participant protection and insurance coverage in clinical research.

SOP Version

Version 1.0