All individuals who are involved in the design, conduct or management of human subject research within Spectrum Health must complete required human subjects research protections (HSRP) training. The completion of the Basic Couse - Biomedical Research provided by the Collaborative Institutional Training Initiative (CITI) meets this requirement. HIPAA rules as they relate to research activity are included in this module, as well. Documentation of completed HSRP training must be on file with the Spectrum Health IRB prior to committee consideration of a research submission. IRB submissions will not be processed until the CITI Basic Course is completed by all research personnel listed on the application. This requirement also applies to subcontractors, consultants, students and all other non-Spectrum Health personnel involved in research being conducted at Spectrum Health. Good Clinical Practice (GCP) training is required for all NIH-supported clinical trials. For clinical trials, is highly recommended that individuals involved in the conduct, management and/or oversight of a clinical trial complete the GCP CITI Program modules.
All research personnel who remain engaged in human research at Spectrum Health are required to complete continuing education every three years from the date the Basic Couse - Biomedical Research provided by the Collaborative Institutional Training Initiative (CITI) was completed.
An email reminder of upcoming expirations is sent by the CITI to the email address specified when originally registering. The email reminder will include a link directly to the CITI Refresher Course.
Research personnel who do not complete this continuing education requirement will be placed on the IRB restricted research personnel list. New IRB approvals will not be granted, active protocols may be suspended, and further engagement in research activities may no longer be permitted for individuals placed on the IRB restricted research personnel list. You can be removed from the IRB restricted research personnel list by completing the continuing education requirement.
Spectrum Health requires, at a minimum, annual disclosures from employees, physicians and affiliates involved in research and/or other sponsored programs overseen and managed by the Spectrum Health Office of the Institutional Review Board (IRB) as well as Spectrum Health’s Office of Sponsored Programs (OSP). Individuals fitting into any of these categories are required to disclose certain financial and other interests on an annual basis.
Completing the required disclosure supports our core value of integrity and fulfills the requirements of the Spectrum Health Conflicts of Interest – Research and Sponsored Programs Policy (SH-ADMIN-RES-020). In addition to an annual disclosure, any new and/or updated financial interests must be disclosed under certain circumstances (refer to "WHEN must disclosures be made?" section of the policy for detailed information on these circumstances).
Note: The IRB cannot process any proposal until all identified personnel have completed and/or are current with COI training and disclosure. Further, the IRB cannot grant final approval to any project where an individual on the project has a positive disclosure until a final determination from the Spectrum Health Conflict of Interest Committee has been reviewed and accepted by the IRB (more detailed information available in the conflict of interest policy).