|
Topic
|
Guidance/Reference |
Doc/
source |
|---|
| Acronyms |
Commonly Used Acronyms |
AID-22 |
| Biosafety (APB) |
Human Gene Transfer
|
Stanford EH&S Web
|
| Genome Editing and Gene Drives and Stanford |
Stanford EH&S Web |
| Infectious Agents: Regulations and Guidelines |
Stanford EH&S Web |
| Children in Research |
Additional Protections - Inclusion of Children (FDA)
Additional Protections - Inclusion of Children (OHRP) |
GUI-9
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 |
GUI-45 |
| Risk Level in Pediatric Research |
GUI01042 |
|
Compassionate Use
|
Humanitarian Use Device HUD |
GUI-36m |
| Expanded Access to Investigational Drugs and Devices |
GUI-19m |
|
Confidentiality
|
Certificates of Confidentiality (COC) - Human Subjects |
NIH |
| Confidentiality - Administrative Panel (IRB) Proceedings |
RPH |
| Privacy and Confidentiality (HRPP Ch 11) |
HRPP 11 |
|
|
Faculty - Policy on Conflict of Commitment & Interest |
RPH |
IRB Members - Conflicting Interests
IRB Members - Conflict of Interest Declaration |
GUI-I5
RPT-I1 |
|
|
Adobe Sign Information and Instructions
|
Office of Research Web |
|
Consent Form Do's & Don'ts (a practical guide)
|
AID-C1 |
|
|
GUI-C27 |
| General Requirements for Informed Consent - OHRP |
GUI-C41 |
| General Requirements for Informed Consent - FDA |
GUI-C42 |
|
|
IRB web |
|
|
APRS web |
| Observation of the Consenting Process - Checklist |
CHK-C15 |
| Parental Permission |
GUI-C34 |
|
|
GUI-C2 |
|
|
GUI-32 |
|
|
GUI-C39 |
|
|
GUI-C47 |
|
|
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 Security - Secure Computing Guidelines
Retention of and Access to Research Data |
ISO web
RPH |
|
|
Clinical Decision Support (CDS) Software – FDA Guidance |
FDA |
| Clinical Decision Support (CDS) Software Determination Graphic – FDA Graphic |
FDA |
|
| FAQs About Medical Devices [FDA] |
FDA |
| 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 |
|
|
Guidelines for Studies Involving Human Volunteers Receiving Potentially Addicting Drugs |
RPH |
| Orphan Drugs |
FDA |
|
Security and Controlled Access Plan for Investigational Drugs and Biologics Maintained and Controlled by a PD
|
SHC Policy |
Supplement to Attachment B of the Security and Controlled Access Plan for
Investigational and Biologics Maintained and Controlled by a Protocol Director |
SHC Policy |
| LCPH Policy on Investigational Drugs and Biologics |
LPCH 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 of a Test Article - Guidance
Emergency Use of a Test Article - Web Page |
GUI-6
IRB web |
| Expanded Access to Investigational Drugs and Devices |
Expanded Access to Investigational Drugs and Devices - Guidance
Expanded Access to Investigational (Test) Articles - Brochure |
GUI-19m GUI-B1m |
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
|
|
DOE - Protection of Personally Identifiable Information (PII) - eProtocol Required Attachment
|
APP-14
|
| 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 web
|
|
|
HIPAA and PHI
HIPAA Privacy Policies at Stanford
Research Privacy Overview
|
GUI-3
University Privacy Offfice Web
Privacy Office PPT presentation
|
| Human Subject Research |
Human Subject Research (HSR) Determination Form |
APP-H8 |
| Does My Project Need IRB Review? |
FLW-H4 |
|
What Qualifies as Human Subject Research
Research Involving Private Information or Biospecimens: NIH Infographic
Guidance, Coded Private Information or Specimens Use in Research (2008)
|
GUI-H12
NIH
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 Device |
GUI-36m |
|
|
Criteria for IRB Approval of Research |
GUI-40 |
| Institutional and Ancillary Reviews |
AID-125 |
| 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 |
| IRB Meeting Schedules |
AID-18 |
| IRB Member Conflict of Interest Declaration |
RPT-I1 |
| IRB Authority |
Charge to Panel on Human Subjects Research-Medical |
CHG-1 |
| Charge to Panel on Human Subjects Research - Nonmedical |
CHG-2 |
| Confidentiality of Panel (IRB) Proceedings |
RPH |
| IRB Rosters |
IRB web |
|
|
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 Web |
| MTA |
Material Transfer Agreements |
OTL |
|
|
Ethical Considerations |
GUI-39 |
| FDA info sheet: Payment and Reimbursement to Research Subjects |
FDA |
| Stanford University Job Aid: Paying Human Subjects |
AID-9 |
|
|
California Penal Code: Section 3501 - 3523 |
GUI-38 |
| OHRP Guidance on Involvement of Prisoners in Research |
GUI-10 |
| Radiation |
Preparing Research Proposals Involving Diagnostic Use of Ionizing Radiation |
APRS web |
| Use of Radiology Devices and Radioactive Materials |
GUI |
| Recruitment |
Advertisements: Appropriate Language - Recruitment Material |
GUI-16 |
| General guidance on participant recruitment |
GUI-33 |
| Use of Employees or Laboratory Personnel as Research Subjects |
RPH |
| Telephone Screening of Potential Subjects |
GUI-15 |
| Non-English Speaking Research Participants |
GUI03H23 |
|
|
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 |
|
|
Data security - Secure Computing Guidelines |
Stanford ISO web |
Short Form
Consent |
Short Form Consent Process - Guidance |
GUI-C39 |
| Short Form Consent Process - Web Page |
IRB web |
| 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 |
RPH |
| 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 |
RPH |
Veterans Administration (VA) Research |
38 CFR 16 |
Department of Veterans Affairs |
| |
Required Questions-VA Research |
APP-1m |
| |
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 |
|
|
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 |
RPH |