IRB Survival Handbook

• Administrative Regulation 7:4 (formerly III-4.0-6) Human Research Subject Protection and Institutional Review Boards
• Administrative Regulation 7:1 (formerly II-4.0-2) Research Misconduct
• Administrative Regulation 7:2 (formerly II-4.0-4) Research Conflict of Interest and Financial Disclosure Policy
• Administrative Regulation 7:9 Institutional Conflicts of Interest Involving Research
• Administrative Regulation 10:1 Use of Technology Resources

• NIAAA:  Recommended Council Guidelines on Ethyl Alcohol Administration in Human Experimentation [T2.0000]
• NACDA Guidelines for Administration of Drugs to Human Subjects [T3.0000] (PDF)
• NACDA Guidelines for Substance Abuse Research Involving Children and Adolescents [T29.0000] (PDF)

• UK Advance Research Recommendations
• UK Center for Applied Artificial Intelligence
• UK College of Medicine Artificial Intelligence in Medicine (AIM) Alliance
• AI Bill of Rights
• Considerations for IRB Review of Research Involving Artificial Intelligence- Secretary’s Advisory Committee on Human Research Protections (SACHRP)
• Artificial Intelligence (AI) Types and Use in Biomedical Research, National Institutes of Health (NIH)
• FDA Digital Health Policy Navigator to determine if AI/ML Software/Algorithm is subject to FDA Oversight and Regulatory Requirements
• CITI Webinar Artificial Intelligence (AI) and Human Subject Protection. 
  • See the instructions for accessing the webinar from the Optional Course menu on CITI.

• UK Research Biospecimen Bank Guidance [D129.0000](PDF)
• UK Research Registry Guidance [D130.0000](PDF)
• Sample Repository/Registry/Bank Consent [F1.0170](.doc)
• Summary and Guidance Regarding the Genetic Information Nondiscrimination Act of 2008 (GINA) [D101.0000](PDF)
• Guidance on the NIH Genome Data Sharing (GDS) Policy [D104.0000](PDF)
• OHRP Guidance on Research Involving Coded Private Information or Biological Specimens [T27.0000]
• NIH Decision Chart for Research Involving Private Information or Biological Specimens [T65.0000](PDF)
• IRB Application Guidelines and materials to submit for “Form EE” (Institutional Biosafety Committee (IBC)) [F1.2300]
• IBC/IRB/ORI Coordination SOP [C6.0100](PDF)
• DHHS - The Genetic Information Nondiscrimination Act of 2008 - Information for Researchers and Health Care Professionals [D106.0000](PDF)
• Human Genetic Research -- OHRP: IRB Guidelines, Chapter 5, Section H [T14.0000](PDF)
• OHRP Guidance for Investigators and IRBs Regarding Research Involving Human Embryonic Stem Cells, Germ Cells and Stem Cell-Derived Test Articles [D74.0000](PDF)
• FDA’s "Guidance on Informed Consent for In Vitro Diagnostic Device Studies Using Leftover Human Specimens that are Not Individually Identifiable" [T12.0000](PDF)
• FDA Blood & Blood Products
• UK Guide for Determining When Protocols Involving Coded Private Information or Biological Specimens Meet the Federal Definition of “Human Research” [D117.0000](PDF)
• HIPAA and Research Repositories
• NIH Genomic Data Sharing (GDS) Policy

• Markey Cancer Center/IRB/ORI Coordination SOP [C6.0400](PDF)
• NCI CIRB SOP (NIH Pediatrics Cooperative Group Trials) [C3.0400](PDF)
• IRB Application "Form G" (Department of Health and Human Services (DHHS)-approved protocols) [F1.0450]

Research Involving Children - Comprehensive webpage that provides additional tools and information on research involving children.

• IRB Application “Form W” (Children in Research) [F1.1750](PDF)
• IRB Application Instructions for Vulnerable Populations - Children [F1.1775]
• IRB Application Instructions for Assent (Informed Consent/Assent Process) [Medical F1.0225; Nonmedical F2.0250]
• Informed Consent SOP [C3.0050](PDF)
• Protection of Vulnerable Subjects SOP [C3.0100](PDF)
• Guidance for Enrolling K-12 Students as Research Subjects [D79.0000](PDF)
• UK ORI Parent Permission Sample (PDF)
• OHRP Special Protections for Children as Research Subjects
• OHRP FAQs on Research with Children
• UK IRB Policy on Children in Research [D22.0000](PDF)
• U.S. Dept. of Education/Protection of Pupil Rights Amendment (PPRA) [D60.0000](PDF)
• Summary of Children Regulations (Subpart D) [D61.0000](PDF)
• Family Educational Rights and Privacy Act (FERPA) Guidance [D31.0000](PDF)
• UK ORI Children's Online Privacy Protection Act (COPPA) Guidance (PDF)

• What you need to know for conducting clinical trials
• Research Participants
• Definition of clinical research vs. clinical trial
• OSPA Clinical Trial Agreements Information Site
• OSPA ClinicalTrials.gov Guidance and General Information
• Non-Indemnification Policy/Risk Management Committee (RMC)
• Center for Clinical and Translational Sciences (CCTS)

• Community-Engaged and Community-Based Participatory Research Frequently Asked Questions [D115.0000](PDF) 
• NIH Community-Based Participatory Research (CBPR) Program
• UK Cares Community Engaged Research Training
• K-12 Teacher & Support Staff Human Subject Protection (HSP) Training

• Contact ORI
• Subject Concerns/Complaints SOP [C2.0500](PDF)
• Noncompliance SOP [C2.0550](PDF)

• Privacy vs. Confidentiality - What's the Difference? [D32.0000](PDF)
• UK/ORI Certificate of Confidentiality Frequently Asked Questions (FAQs) [D56.0000](PDF)
• Methods for De-identification for Honest Brokers
• UK Confidentiality and Data Security Guidelines for Electronic Data [D105.0000](PDF)
• UK Information Technology Services Information Security Policy & Procedures
• UK General Data Protection Regulation (GDPR) Guidance(PDF)
• HIPAA in Human Research
• Family Educational Rights and Privacy Act (FERPA) Guidance [D31.0000](PDF)
• IRB Review and Digital Data Considerations [D131.0000](PDF)
• Considerations for Protocol Design Concerning Digital Data [D132.0000](PDF)
• UK ORI Children's Online Privacy Protection Act (COPPA) Guidance(PDF)

• DHHS Financial Conflict of Interest Guidance: Financial Relationships and Interests in Research Involving Human Subjects [D73.0000]
• IRB Member Conflict of Interest:
  • IRB Member and Consultant Conflict of Interest SOP [C1.0200](PDF)
  • IRB Member Conflict of Interest Statement [F17.0000](PDF)
  • Consultant Conflict of Interest Statement and Confidentiality Agreement(PDF)
• Investigator Conflict of Interest
  • UK Administrative Regulations (AR) 7:2 Financial Conflicts of Interest in Research(PDF)
  • Investigator Conflict of Interest/OSPA/IRB Coordination SOP [C6.0650](PDF)
  • Office of Sponsored Projects Administration (OSPA) Resources on Financial Conflict of Interest

Continuation Review (CR)/Annual Administrative Review (AAR) - Comprehensive webpage that provides additional tools and information on developing a Continuation Review application and the Continuation Review process.

Select Forms/Guidance:

• Sample CR Report Form [F14.0000] (PDF)
• Continuation/Annual Administrative Review SOP [C2.0250] (PDF)
• Time-Saving Tips for Continuation Review of an IRB Approved Study [D40.0000]
• OHRP Guidance on Continuing Review of Research [T5.0000]
• IRB Continuing Review After Clinical Investigational Approval (FDA Info Sheets 2000) [T6.0000] (PDF)
• IRB Continuation Review: Primary Reviewer Checklist [F28.0000] (PDF)

• ORI Resources for Data and Safety Monitoring [D24.0000]
• Data and Safety Monitoring Plan SOP [C3.0350] (PDF)

Debriefing and Permission to Use Data Form [F1.0365] (.doc)

Recommended Readings:

• Seiber, Joan E. Planning Ethically Responsible Research: A Guide for Students and Internal Review Board. Vol. 31, SAGE Publications, 1992, pp. 64-74.
• Sieber, Joan E, and Martin Tolich. Planning Ethically Responsible Research. 2nd ed., SAGE, 2013.
• Sieber, Joan E. “Deception in Social Research I: Kinds of Deception and the Wrongs They May Involve.” IRB: Ethics and Human Research, vol. 4, no. 9, Nov. 1982, pp. 1–5.
• Sieber, Joan E. “Deception in Social Research II: Evaluating the Potential for Harm or Wrong.” IRB: Ethics and Human Research, vol. 5, no. 1, Jan. 1983, pp. i-3.

• What Does the Department Chairperson's Assurance Statement on the IRB application mean? [D17.0000] (PDF)
• EVPR Memo:  Department Chairperson’s Assurance Statement on Institutional Review Board Applications [D16.0000] (PDF)
• IRB Application Form Z (Signature Assurance Sheet) [F1.2000] (PDF)
• IRB Application Guidance for Form Z [F1.2050]

• IRB Application “Study Device Form” (Use of Any Device Being Tested in Research) [F1.1100] (PDF)
• IRB Application Instructions for Study Device [F1.1150]
• UK ORI Food and Drug Administration (FDA) Interactive Flow Chart: Medical Device Trials
• FDA Digital Health Policy Navigator Tool for determining if a Mobile App or Software is an FDA-regulated medical device
• Medical Device Clinical Investigations, Compassionate Use, and Treatment IDE SOP [C3.0150] (PDF)
• Humanitarian Use Device SOP [C3.0200] (PDF)
• Summary of FDA Requirements for Investigators Who Are Also Considered Sponsors of New Devices [D45.0000] (PDF)
• Summary of FDA Regulations on Investigational Device Exemptions (IDE) and Exemption from IDE Requirements [D97.0000] (PDF)
• Flow Charts for Applications of FDA IND and IDE Regulations [D127.0000] (PDF)
• Food and Drug Administration (FDA) Resources [D116.0000] (PDF)
• IRB Review of Medical Device Research [D110.0000] (PDF)
• IRB Summary - Humanitarian Use Devices [21 CFR Parts 20 and 814 Subpart H] [D54.0000] (PDF)