Guidance A-Z
Main content start
A | B | C | D | E | F | G | H | I | J | K | L | M | N | O | P | Q | R | S | T | U | V | W | X | Y | Z
You can also use "Ctrl+F" to search this page by keyword. If you are having trouble accessing these documents, please email IRB Education or call 650-724-7141.
| Topic | Guidance/Reference [specific topics and key words] | Source |
|---|---|---|
| Children in Research | Children in Research [Permitted Categories of Research with Children, Parental Permission, Assent Process] | IRB Website |
| School-Based Research [School Collaborations, Family Educational Rights and Privacy Act (FERPA), Protection of Pupil Rights Amendment (PPRA)] | IRB Website | |
| Confidentiality | Confidentiality & Data Protection [HIPAA/PHI, Certificate of Confidentiality (CoC), Genomic Data Sharing (GDS) Policy, General Data Protection Regulation (GDPR)] | IRB Website |
| Consent | Consent Process | IRB Website |
| Short Form Consent Process [Interpreter, witness, translations] | IRB Website | |
| 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 | |
| Waiver/Alteration of Consent Requirements | GUI-C2 | |
| Research Surrogate Decision Makers | GUI-32 | |
| 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 Guidance | IRB Website |
| Drugs and Devices | Research with Drugs/Biologics [IND, IND Exempt, Security & Controlled Action Plan (SCAP)] | IRB Website |
| Research with Medical Devices [IDE, IDE Exempt, Significant vs. Non-Significant Risk devices] | IRB Website | |
| Sponsor-Investigator Research (SIR) Requirements | IRB Website | |
| Humanitarian Use Device (HUD) Program | IRB Website | |
| Digital Health Technologies | IRB Website | |
| 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 Flowchart | 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 | |
| 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 | |
| Special Considerations about Risks in Behavioral and Social Sciences Research | GUI-14n | |
| Evaluating Sound Study Design | GUI-17 | |
| 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) | Who Can Be a Protocol Director? | 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, unanticipated adverse device effect (UADE)] | IRB Website |
| Adverse Event Reporting [Internal/external events, IND safety reports, possibly related, reasonable possibility, unexpected, suspected adverse reaction, serious AE, SUSAR] | IRB Website | |
| Single IRB (sIRB) | Getting Started with Single IRB (sIRB) | IRB Website |
| Stanford required consent language for sIRB | AID-C57 | |
| Students | Student Research Projects | IRB Website |
| 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 |
Page updated July, 2026