| 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
[Waiver of parental permission, assent, mandatory reporting of child abuse and neglect, guardian, ward] | GUI-C24 |
| Parental Permission | GUI-C34 |
Parental Permission for Children in School Based Studies
[Family Educational Rights and Privacy Act (FERPA), Protection of Pupil Rights Amendment (PPRA)] | GUI-45 |
| Risk Level in Pediatric Research | GUI01042 |
| Confidentiality | Confidentiality & Data Protection
[HIPAA/PHI, Certificate of Confidentiality (CoC), Genomic Data Sharing (GDS) Policy, General Data Protection Regulation (GDPR)] | IRB Website |
| 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 |
| 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
[Interpreter, witness, translations] | IRB Website |
| 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 |
| Devices | Digital Health Technologies | IRB Website |
| Frequently Asked Questions About Medical Devices - FDA Information Sheet | FDA |
| Significant Risk and Non-Significant Risk Medical Devices Studies | 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 |
| Expanded Access to Investigational Drugs and Devices | Expanded Access Program
[Compassionate Use, Single Patient IND/IDE] | IRB Website |
| Expanded Access to Drugs/Biologics | IRB Website |
| Expanded Access to Devices | IRB Website |
| Emergency Use of a Test Article | IRB Website |
| Federal Agency Requirements | Other Federal Agency Requirements
[DoD (including Air Force, Navy, Army), ED, DOE, DOJ, EPA, NSF] | IRB Website |
| Human Subject Research | Do I Need IRB Review?
[Why Are IRBs Necessary; What is Human Subject Research; What is Human Subject Research with Drugs/Biologics or Device; Not Human Subjects Research (NHSR) Determination Form; Information about Student Projects, Pilot Studies, Oral History and QA/QI Projects] | IRB Website |
| Research Involving Private Information or Biospecimens: NIH Infographic | NIH |
| Guidance, Coded Private Information or Specimens Use in Research (2008) | OHRP |
When Do External Organizations Need IRB Approval?
[Engaged, primary recipient of federal grant/award, community-engaged research] | IRB Website |
| Quality Assessment & Quality Improvement (QA/QI) | IRB Website |
| CA Laws/Regulations | AID-H18 |
| Is a Pregnant Partner a Research Participant? | GUI-C47 |
| Humanitarian Use (HUD) | Humanitarian Use Device (HUD) | 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 Research | IRB Website |
| Expedited Review Categories | GUI-44 |
| Payment | Payment Considerations
[Reimbursement, compensation, token gifts, incentive, raffle, drawing, sweepstakes, contest, lottery] | IRB Website |
| 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 | Prompt Reporting to the IRB
[Unanticipated problems involving risks to participants or others (UPs), external safety reports, noncompliance, complaint] | IRB Website |
Adverse Event Reporting
[Internal/external events, IND safety reports, possibly related, reasonable possibility, unexpected, suspected adverse reaction, serious AE, SUSAR] | IRB Website |
| Unanticipated Adverse Device Effect (UADE) | GUI-P14 |
| Single IRB (sIRB) | Getting Started with Single IRB (sIRB) | IRB Website |
| Stanford required consent language for sIRB | AID-C57 |
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 |
| Tissue & Samples | Data and Tissue Repositories | GUI |
| Transplantation of Human Fetal Tissue | GUI-2m |
| Training | IRB Training and Education Resources | IRB Website |
| Veterans Affairs (VA) Research | Research Involving VA Studies | CHK-07 |
| Reviewing Veterans Affairs (VA) Research | AID-27m |
| Women | Research Involving Pregnant Women, Fetuses, and Neonates | GUI-8 |
| Women as Subjects in Research | Research Policy Handbook |