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Research and Clinical Trials
Policies and guidance
Spectrum Health HRPP administrative policies
- Authority, Jurisdiction, and Responsibilities of the Spectrum Health IRB
- Qualifying “Engagement in Human Subjects Research”
- Investigator Responsibilities
- Research – Policy for Approval
- Training Requirement for Individuals Involved in Human Subjects Research
- Informed Consent and Legally Authorized Representatives for Research
- Conflicts of Interest – Research and Sponsored Programs
- Reportable New Information
Spectrum Health Institutional Review Board policies
Guidance on special topics
- Consenting during a pandemic
- Electronic Communication with Participants
- Case Report Guidance
- Humanitarian Use Device (HUD) FAQs
- Re-consenting Participants
- HIPAA & Research FAQs
- Personalized Medicine
- Protecting Patient Privacy in Research
- QI vs. Research Guidance
- Request for FCOI Information
- Recruitment Advertising
- Submitting Modifications to Exempt Research
- Protocol Deviation Policy Guidance
- Reportable New Information Quick Guide
- Memo: Revised IRB Policy on Adverse Events that Require Reporting to the IRB
- Consenting Limited English Proficiency Subjects
- Required Elements of Informed Consent and HIPAA
- Pregnancy During Participation in Research
- Types of Supporting Material that May Require IRB Review and Approval
- Minor Versus Major Modifications
- Exemption Category Guidance
Investigator manual
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