IRB Guidelines

IRB Standard Operating Procedure (SOP): Communication with Potential Research Participants

Introduction

This procedure establishes the communication protocol for inviting potential participants to research studies approved by the Austin Peay State University (APSU) Institutional Review Board (IRB). It ensures transparency and aligns with ethical principles concerning informed consent.

Initial Invitation

1. The Office of Research and Sponsored Programs (ORSP) will send the initial invitation to participate in research on behalf of the Principal Investigator (PI) for studies with approved APSU IRB applications.
2. The invitation will be sent a maximum of two times from the “research_survey@apsu.edu” email account to maintain consistency and clarity.
3. All invitation requests must be submitted to the IRB Chair via email. The IRB Chair holds sole authority for approving invitations for participation. Unauthorized deviations may result in immediate revocation of IRB approval at the IRB Chair's discretion.

Subsequent Invitations

1. Any follow-up invitations to participate must be sent directly by the PI, as identified in the approved IRB application. This supports direct communication and personalized interaction between the PI and potential participants.
2. All follow-up invitations should be sent using the PI's email address listed in the IRB application.

Rationale

This procedure is designed to:

1. Maintain a clear and consistent communication channel for initial research invitations.
2. Allow for personalized interaction between the PI and potential participants following the initial contact.
3. Uphold ethical standards of informed consent, ensuring participants can directly contact the PI with questions or concerns.

Recordkeeping

1. The ORSP will maintain records of all initial invitations sent on behalf of the PI.
2. The PI is responsible for documenting all subsequent communication with potential participants.

Procedural Revisions

1. This procedure may be revised to reflect updates in IRB regulations or best practices.

Contact Information: For questions regarding this procedure, please contact:

1. The Office of Research and Sponsored Programs (ORSP)
2. The APSU Institutional Review Board (IRB)

Ethical and Legal Aspects of Human Subjects Research in Cyberspace

Inclusion of Children as Participants in Research

Inclusion of Persons with Questionable Capacity for Decision

IRB Review of Human Subjects Protocols in Grant Applications