Types of Review

All activities, that involve the engagement of Spectrum Health employees or Spectrum Health patient records in the conduct of human subjects research, must be reviewed and approved by the Spectrum Health Institutional Review Board or determined to qualify for exempt status. In general, the activity must meet the definition of “research” and the research must involve “human subjects” to fall within the purview of the Spectrum Health Institutional Review Board.

• Research means a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge. 
• Systematic investigation means a study or examination involving a methodical procedure or plan. 
• Generalizable knowledge means conclusions, facts, or principles derived from particulars (individual subjects, medical records, etc.) that are applicable to or affect a whole category (members of a class, kind, or group, a field of knowledge, etc.) and enhance scientific or academic understanding. 
• Human Subject means a living individual about whom an investigator conducting research: Obtains information or biospecimens through intervention or interaction with the individual, and uses, studies, or analyzes the information or biospecimens; or Obtains, uses, studies, analyzes, or generates identifiable private information or identifiable biospecimens. 
• Intervention includes both physical procedures by which data are gathered (e.g., venipuncture) and manipulations of the subject or the subject's environment that are performed for research purposes. 
• Interaction includes communication or interpersonal contact between investigator and subject. 
• Private information includes information about behavior that occurs in a context in which an individual can reasonably expect that no observation or recording is taking place, and information that has been provided for specific purposes by an individual and that the individual can reasonably expect will not be made public (e.g., a medical record). 
• Identifiable private information is private information for which the identity of the subject is or may readily be ascertained by the investigator or associated with the information. 
• An identifiable biospecimen is a biospecimen for which the identity of the subject is or may readily be ascertained by the investigator or associated with the biospecimen.

The Spectrum Health Institutional Review Board utilizes a pre-review process for all IRB submissions. Each submission in IRBManager is reviewed in detail by an IRB Analyst within the Spectrum Health Institutional Review Board Support Office. This pre-review occurs prior to review by the full IRB or Designated Reviewer. 

The goals of the pre-review process is to evaluate the submission for completeness, compliance with regulations and Spectrum Health policies and procedures. It also guides teams through needed edits to ensure the IRB review can focus on the criteria for approval. 

The intention of the pre-review process is to be comprehensive and create a space for dialogue between the Spectrum Health Institutional Review Board and study teams. During this process, study teams may receive questions for clarifications, requests to provide more details or to correct inconsistencies. Study teams are encouraged to contact their assigned analyst when they need more information or clarification on the rationale behind a request. 

The length of a pre-review process will depend on several factors, including the completeness and quality of an application and the responsiveness from a study team. Only when the pre-review process is complete, will a submission be routed for IRB review. Please note, there may be additional requests for information or corrections resulting from the IRB review.

Amendments to approved research studies must be submitted to the Spectrum Health Institutional Review Board via the Modification xForm in IRBManager, with both the annotated (tracked) and clean versions of revised documents (e.g. protocols, consents, recruitment materials, etc.). 

Changes may not be implemented in approved research until the Spectrum Health Institutional Review Board has reviewed and approved the Modifications, except when these changes are needed to eliminate immediate hazards to participants. If the change has been implemented prior to obtaining Spectrum Health Institutional Review Board approval, the Modification xForm is to be submitted within five business days of the initiation of these changes and must include the rationale for why these actions were taken. The Spectrum Health Institutional Review Board will review this information to determine appropriateness of these changes and ensure the safety and welfare of enrolled participants is continued. 

Upon review of a Modification, the Spectrum Health Institutional Review Board will determine if re-consent of enrolled participants is required and will notify the investigator and study team as such.

The revised Common Rule has modified when continuing review is required for approved research. Unless Spectrum Health Institutional Review Board has determined otherwise, continuing review of research is not required for research subject to the revised Common Rule in the following circumstances: 

• Research eligible for expedited review in accordance with 45 CFR §46.110 
• Research reviewed by the IRB in accordance with limited IRB review in which the Spectrum Health Institutional Review Board has determined continuing review is required 
• Research that has progressed to the point it involves only one or both of the following, which are part of the IRB-approved study: 
• Data analysis, including analysis of identifiable private information or identifiable biospecimens, or 
• Accessing follow-up clinical data from procedures that participants would undergo as part of clinical care 

Spectrum Health Institutional Review Board may determine that continuing review is required when: 

• Required by other applicable regulations (e.g., FDA) 
• The research involves topics, procedures, or data that may be considered sensitive or controversial 
• The research involves particularly vulnerable subjects or circumstances that increase subjects’ vulnerability 
• An investigator has minimal experience in research or the research type, topic, or procedures 
• An investigator has a history of noncompliance 

When the Spectrum Health Institutional Review Board determines that continuing review is required for such research, it will document the rationale in the IRB record and communicate the requirement to the investigator in the IRB determination letter.

The Principal Investigator of an approved research study retains ultimate responsibility for assuring the reporting of new information and adverse or unanticipated events in accordance with the Reportable New Information (RNI) Policy. All RNIs must be reported to the Spectrum Health Institutional Review Board via the RNI xForm in IRBManager within established timelines outlined in the policy.

The Spectrum Health Institutional Review Board is responsible for ensuring compliance with organizational policy, federal requirements and the ethical principles of the Belmont Report. As part of this responsibility, the Spectrum Health Institutional Review Board is expected to provide post-approval monitoring of research. Monitoring is designed to meet this requirement through a pro-active and collaborative process with investigators. The Spectrum Health HRPP has developed the S.A.F.E (Stop, Assess, provide Feedback, Evaluate) Program to conduct routine monitoring. 

The purpose of the S.A.F.E. Program is to provide information to investigators and staff on regulatory compliance and Good Clinical Practice (GCP) Guidelines related to human research participants, data collection and data management; to verify that safeguards protecting the rights and welfare of human research participants are met; verify investigator adherence to the study design in the Spectrum Health Institutional Review Board - approved protocol, and applicable regulatory requirements; and to investigate complaints and/or allegations of noncompliance with research regulations. The review is meant to be a collaborative process whereby the onsite reviewers assess compliance (regulatory, policy, approved protocol, etc.) and help the investigator resolve/correct problems and discrepancies and provide recommendations for process improvements.