Responsibilities: Central IRB and Institutions

InstitutionsSchulman recognizes the need to effectively collaborate with institutions and when applicable, the local IRB.

This sharing of information and responsibilities is vital for the protection of human research subjects and compliant conduct of research. As such, Schulman will assume responsibility for the following IRB activities:

  • Assess investigator qualifications as part of submitted material

  • Assess research education and training documentation for investigators and research staff

  • Maintain registration with FDA and OHRP

  • Notify designated institutional officials of accreditation changes

  • Ensure compliance with ethical standards and regulations in approved research

  • Assume regulatory responsibility for Schulman’s actions as the IRB of record

  • Manage necessary site-specific information for inclusion in the informed consent

  • Approve informed consents that meet the Board’s requirements and maintain review of revisions

  • Provide copies of IRB decisions and rosters

  • Notify institutions of serious or continuing noncompliance determinations, unanticipated problems in research, and suspension or termination of IRB approval

Schuman holds Principal Investigators accountable for specific responsibilities. Similarly, Schulman expects that institutions will fulfill the following responsibilities:

  • Assess investigator qualifications prior to submission to Schulman and report any changes to investigator qualifications that would negatively impact subject safety

  • Require and document research education and training for investigators and appropriate study staff

  • Provide appropriate credentialing of staff

  • Maintain the institution’s approved FWA(s)

  • Conduct security and privacy review of protocol and informed consent as required for HIPAA

  • Ensure investigator compliance and conflict of interest is managed in accordance with Schulman requirements

  • Decide whether to participate in a study or to limit an investigator’s involvement prior to submitting research to Schulman

  • Indicate any relevant state laws or institutional concerns regarding the research (e.g., compensation for research-related injury, institutional contact information, ethical religious directives and costs of participation) in the Schulman submission material

  • Include institution’s assessment of local context in the Schulman submission material to be considered during review of research proposals

  • Report to Schulman any serious or continuing noncompliance, unanticipated problems in research and other compliance issues potentially impacting human subject protections