| Institutional Biosafety Committee (IBC) | Human Gene Transfer | EH&S Website |
| Genome Editing and Gene Drives and Stanford | EH&S Website |
| Infectious Agents: Regulations and Guidelines | EH&S Website |
| Children in Research | Additional Protections - Inclusion of Children (FDA) | GUI-9 |
| Additional Protections - Inclusion of Children (OHRP) | GUI-1 |
| Research Involving a Placebo Arm (implications of March 2013 FDA final rule, subpart D) | IRB memo |
| Children Involved as Subjects in Research - "407" Review Process | OHRP |
| Ethical Considerations for Clinical Investigations of Medical Products Involving Children – FDA Guidance | FDA |
| Consent for Children and Consenting Minors | GUI-C24 |
| Parental Permission | GUI-C34 |
Parental Permission for Children in School Based Studies
(FERPA, PPRA) | GUI-45 |
| Risk Level in Pediatric Research | GUI01042 |
| Confidentiality | Certificates of Confidentiality (COC) - Human Subjects | NIH |
| Privacy and Confidentiality (HRPP Ch 11) | HRPP Policy Manual |
| Conflict of Interest | Faculty - Policy on Conflict of Commitment & Interest | Research Policy Handbook |
| Consent | Adobe Sign Information and Instructions | Office of Research Website |
| Consent Form Do's & Don'ts (a practical guide) | AID-C1 |
| Basic Research Consent Requirements | GUI-C27 |
| General Requirements for Informed Consent - OHRP | GUI-C41 |
| General Requirements for Informed Consent - FDA | GUI-C42 |
| Glossary of Lay Terms for use in Consent Forms | IRB Website |
| Diagnostic Use of Ionizing Radiation - Consent Form Language | EH&S Website |
| Observation of the Consenting Process - Checklist | CHK-C15 |
| Parental Permission | GUI-C34 |
| Waiver/Alteration of Consent Requirements | GUI-C2 |
| Research Surrogate Decision Makers | GUI-32 |
| Short Form Consent Process | GUI-C39 |
| Is a Pregnant Partner a Research Participant? | GUI-C47 |
| Data & Safety Monitoring | Data and Safety Monitoring - Guidance
DSM Plan - eProtocol Help & Hints | GUI-P20 |
| DMSB in Phase I/II Cell and Gene Transfer Clinical Trials | AID-59 |
| DSMP vs DSMB | GUI-P46 |
| Data Scraping | Data Scraping | IRB Website |
| Data Security | Data Security - Secure Computing Guidelines | ISO Website |
| Retention of and Access to Research Data | Research Policy Handbook |
| Devices | Clinical Decision Support (CDS) Software – FDA Guidance | FDA |
| Clinical Decision Support (CDS) Software Determination Graphic – FDA Graphic | FDA |
| Digital Health Technologies | IRB Website |
| Frequently Asked Questions About Medical Devices - FDA Information Sheet | FDA |
| Significant Risk and Non-Significant Risk Medical Devices Studies - Stanford Guidance | GUI-7m |
| Significant Risk and Nonsignificant Risk Medical Device Studies - FDA Information Sheet | FDA |
| Special Considerations for the Oversight of Research Protocols in FDA-regulated Drug or Device Studies | GUI-26m |
| Sponsor-Investigator Research when the STANFORD Investigator holds the IDE | GUI-5m |
| STANFORD investigator is the sponsor on a nonsignificant risk (NSR) device study | GUI-41m |
| Drugs | Guidelines for Studies Involving Human Volunteers Receiving Potentially Addicting Drugs | Research Policy Handbook |
| Orphan Drugs | FDA |
| Security and Controlled Access Plan for Investigational Drugs and Biologics Maintained and Controlled by a PD | SMHC Policy |
Supplement to Attachment B of the Security and Controlled Access Plan for
Investigational and Biologics Maintained and Controlled by a Protocol Director | SMHC Policy |
| SMHC Policy on Investigational Drugs and Biologics | SMCH Policy |
| Special Considerations for the Oversight of Research Protocols in FDA-regulated Drug or Device Studies | GUI-26m |
| Sponsor-Investigator Research when the STANFORD Investigator holds the IND | GUI-3m |
| Emergency Use | Emergency Use of a Test Article - Web Page | IRB Website |
| Expanded Access to Investigational Drugs and Devices | Expanded Access Program | IRB Website |
| Expanded Access to Drugs/Biologics | IRB Website |
| Expanded Access to Devices | IRB Website |
Federal Agency Requirements
[DoD, DON, DOE, etc.] | Other Federal Agencies - Additional Requirements
(DoD, DON, ED, DOE, DOJ, EPA, NSF, PHS) | GUI-42 |
| DoD Reporting Requirements | GUI-46 |
| VA - Reviewing VA Research | AID-27m |
Genomic Data Sharing
(NIH grant info) | NIH Genomic Data Sharing for NIH Grant Submission | GUI-G01 |
| FAQs for Genomic Data Sharing | IRB Website |
| HIPAA | HIPAA and PHI | GUI-3 |
| HIPAA Privacy Policies at Stanford | University Privacy Office Website |
| Research Privacy Overview | Privacy Office PPT presentation |
| Human Subject Research | Human Subject Research (HSR) Determination Form | APP-H8 |
| Do I Need IRB Review? | IRB Website |
| What Qualifies as Human Subject Research | GUI-H12 |
| Research Involving Private Information or Biospecimens: NIH Infographic | NIH |
| Guidance, Coded Private Information or Specimens Use in Research (2008) | OHRP |
| Determining When an Organization is Engaged | AID-H15 |
| Engagement of Institutions in Human Subjects Research | OHRP |
| Quality Assessment & Quality Improvement (QA/QI) | AID-H16 |
| CA Laws/Regulations | AID-H18 |
| Humanitarian Use | Humanitarian Use Device | GUI-36m |
| International Research | International Compilation of Human Research Protections (OHRP) - laws, regulations, guidelines on human subjects research in over 100 countries; standards (international, regional) | OHRP |
| Guide to Conducting Research in India |
| General Data Protection Regulation (GDPR) | IRB Website |
| IRB Review | Criteria for IRB Approval of Research | GUI-40 |
| Institutional and Ancillary Reviews | IRB Website |
| Exempt Review Categories | GUI-4 |
| Expedited Review Categories | GUI-44 |
| Obtaining Additional Expertise or an Expert Consultant | GUI-12 |
| Guidelines for IRB Members on Conflicting Interests | GUI-I5 |
| MTA | Material Transfer Agreements | OTL |
| Payment | Ethical Considerations | GUI-39 |
| FDA info sheet: Payment and Reimbursement to Research Subjects | FDA |
| Stanford University Job Aid: Paying Human Subjects | AID-9 |
| Prisoners | California Penal Code: Section 3501 - 3523 | GUI-38 |
| OHRP Guidance on Involvement of Prisoners in Research | GUI-10 |
| Protocol Director (PD) | Protocol Director (PD) Guidelines | IRB Website |
| Radiation | Preparing Research Proposals Involving Diagnostic Use of Ionizing Radiation | EH&S Website |
| Use of Radiology Devices and Radioactive Materials | EH&S Guidance |
| Recruitment | Advertisements: Appropriate Language - Recruitment Material | GUI-16 |
| General guidance on participant recruitment | GUI-33 |
| Use of Employees or Laboratory Personnel as Research Subjects | Research Policy Handbook |
| Telephone Screening of Potential Subjects | GUI-15 |
| Non-English Speaking Research Participants | GUI03H23 |
| Reporting | Events and Information that Require Prompt Reporting to the IRB | GUI-P13 |
| Unanticipated Adverse Device Effect (UADE) | GUI-P14 |
| Risk | Special Considerations about Risks in Behavioral and Social Sciences Research | GUI-14n |
| Security | Data security - Secure Computing Guidelines | Stanford ISO Website |
Short Form
Consent | Short Form Consent Process - Guidance | GUI-C39 |
| Short Form Consent Process - Web Page | IRB Website |
| Single IRB (sIRB) | Stanford required consent language for sIRB | AID-C57 |
| STANFORD SOPs FOR RELYING ON A SINGLE IRB (sIRB) | GUI-H24 |
Sponsor-Investigator
Research (SIR) | Requirements for New, Continuing Review and Final Report | AID-23m |
| Requirements for Sponsor-Investigators who hold their own IND/IDE (Memo from Ann Arvin, MD) | MEM-1m |
| When the STANFORD Investigator holds the IDE | GUI-5m |
| When the STANFORD Investigator holds the IND | GUI-3m |
| When the STANFORD Investigator is the sponsor on a nonsignificant risk (NSR) device study | GUI-41m |
| SIR Self-Assessment Checklist - IND/IDE | AID-58m |
| Students | Special Considerations about Risks in Behavioral and Social Sciences Research | GUI-14n |
| Use of Human Subjects in Student Projects, Pilot Studies, Oral Histories and QA/QI Projects | Research Policy Handbook |
| Student Research Projects | IRB Website |
| Study Design | Evaluating Sound Study Design | GUI-17 |
| Terminology | Clinical Trials Terms | AID-20m |
| Tissue & Samples | Data and Tissue Repositories | GUI |
| Transplantation of Human Fetal Tissue | GUI-2m |
| Training | Training in the Protection of Human Subjects in Research | Research Policy Handbook |
| Veterans Affairs (VA) Research | 38 CFR 16 | Department of Veterans Affairs |
| Research Involving VA Studies | CHK-07 |
| Reviewing Veterans Affairs (VA) Research | AID-27m |
| VHA Directive 1058 Research Compliance Reporting Requirements | VHA |
| VHA Directive 1200.05 Requirements for the Protection of Human Subjects in Research | VHA |
| VHA Program Guide 1200.21 VHA Operations Activities That May Constitute Research | VHA |
| Waivers | Regulations for Waiver or Alteration of Consent Requirements | GUI-C2 |
| Women | Research Involving Pregnant Women, Fetuses, and Neonates | GUI-8 |
| Women as Subjects in Research | Research Policy Handbook |