Investigator Manual
Table of Contents
- What is the purpose of this manual?
- What is Human Research?
- What is the Human Research Protection Program?
- Who may be a principal investigator?
- What training do my staff and I need to conduct Human Research?
- What financial interests do my staff and I need to disclose to conduct Human Research?
- What other approvals or notifications are required before initiating Human Research?
- How do I submit new Human Research to the IRB?
- How do I submit a grant project to the IRB?
- How do I submit a request to use a Humanitarian Use Device (HUD) for clinical use?
- Does the IRB charge to review research?
- How can I request an IRB Reliance (Authorization) Agreement?
- Will Northwestern University or its affiliates rely on an external IRB?
- Will Northwestern University’s IRB serve as the IRB of Record for another institution or site?
- How do I write an Investigator Protocol?
- What if my research involves community engagement?
- How do I store Human Research data to protect confidentiality?
- What is a Certificate of Confidentiality?
- Does my research qualify for an automatic Certificate of Confidentiality?
- Should I obtain a Certificate of Confidentiality for my research?
- Am I a mandated reporter of child abuse?
- How do I conduct research using genetic information?
- How do I obtain Institutional Certification for submission of genomic data to an NIH-designated data repository?
- What if I hold the IND for an investigational drug or biologic, or an IDE for an investigational device?
- When should I register my research with ClinicalTrials.gov?
- What is an appropriate recruitment method?
- Do I need IRB review for classroom-based research projects conducted by students?
- Can I recruit my students or people in my employ to participate in my research?
- Can I participate in my research?
- How do I obtain a waiver or alteration of informed consent?
- How do I obtain informed consent from participants?
- Do research participants have to sign a consent document?
- How do I create consent or assent documents?
- How do I document consent or assent (permission)?
- How do I document the Consent Process?
- When am I required to obtain a HIPAA Authorization?
- What if I want to enroll participants with limited English proficiency?
- What supporting documents must I include with my IRB submission?
- What are the different regulatory classifications under which research activities may fall?
- What happens after I submit in eIRB+?
- What are the decisions the IRB can make when reviewing proposed research?
- How does the IRB decide whether to approve Human Research?
- What other state or federal requirements must I meet?
- What will happen after IRB review?
- What are my obligations as Investigator to conduct Human research?
- What are my obligations as the overall study PI where Northwestern is the IRB of Record for a multisite or collaborative study?
- What are my obligations as Investigator when relying on an external IRB?
- How do I submit a modification?
- How do I submit a continuing review?
- How do I close out a study?
- What should I do if something unexpected or non-compliance occurs?
- How long do I keep records, and which records am I required to maintain?
- What should I do if I leave Northwestern University?
- What if I need to use an unapproved drug, biologic, or device and there is no time for IRB review?
- How do I submit a non-emergency expanded access request for an unapproved drug, biologic, or device to the IRB?
- How do I get additional information and answers to questions?
Appendices
- Appendix A-1 Additional Requirements for DHHS-Regulated Research
- Appendix A-2 Additional Requirements for USFDA-Regulated Research
- Appendix A-3 Additional Requirements for Clinical Trials (ICH-GCP)
- Appendix A-4 Additional Requirements for Department of Defense (USDOD) research
- Appendix A-5 Additional Requirements for Department of Energy (USDOE) Research
- Appendix A-6 Additional Requirements for Department of Justice (USDOJ) Research
- Appendix A-7 Additional Requirements for Department of Education (USED) Research
- Appendix A-8 Additional Requirements for Environmental Protection Agency (USEPA) Research
- Appendix A-9 Additional Requirements for Research Subject to EU General Data Protection
Regulations (GDPR) - Appendix A-10 Single IRB Studies