Corewell Health Lakeland Institutional Review Board

All activities, that involve the engagement of Corewell Health employees or Corewell Health patient records in the conduct of human subjects research, must be reviewed and approved by the Corewell Health Lakeland Hospitals 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 Corewell Health Lakeland Hospitals Institutional Review Board.

Key definitions

• 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

Amendment (Modification)

Amendments to approved research studies must be submitted to the CH Lakeland IRB for review.

Changes may not be implemented in approved research until the CH Lakeland IRB reviewed and approved the modifications, except when these changes are needed to eliminate immediate hazards to participants. The CH Lakeland IRB 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 CH Lakeland IRB will determine if re-consent of enrolled participants is required and will notify the investigator and study team as such.

Continuing review

The revised Common Rule has modified when continuing review is required for approved research. Unless CH Lakeland IRB 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 CH Lakeland IRB 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

CH Lakeland IRB 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 CH Lakeland IRB 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 Approval letter.

Reportable new information

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 CH Lakeland IRB.