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Guidances

Guidances

To see the most frequently used guidances, visit the Laminates page [1]. 

NOTE:  If you are having trouble accessing these documents, please ask IRB Education (email [2] or call 650-724-7141) to have them sent to you.

Use "Ctrl+F" to search this page.

Topic

 Guidance/Reference Doc/
source
Acronyms Commonly Used Acronyms [3] AID-22
Biosafety (APB)

Human Gene Transfer [4]

Stanford EH&S Web
Genome Editing and Gene Drives and Stanford [5] Stanford EH&S Web
Infectious Agents: Regulations and Guidelines [6] Stanford EH&S Web
Children in Research Additional Protections - Inclusion of Children (FDA) [7]
Additional Protections - Inclusion of Children (OHRP) [8]		 GUI-9
GUI-1
Research Involving a Placebo Arm [9] (implications of March 2013 FDA final rule, subpart D) IRB memo
Children Involved as Subjects in Research - "407" Review Process [10] OHRP
Consent for Children and Consenting Minors [11] GUI-C24
Parental Permission [12] GUI-C34
Parental Permission for Children in School Based Studies [13] GUI-45
Risk Level in Pediatric Research [14] GUI01042
Compassionate Use
 Humanitarian Use Device HUD [15] GUI-36m
Expanded Access to Investigational Drugs and Devices [16] GUI-19m
Confidentiality
 Certificates of Confidentiality (COC) - Human Subjects  [17] NIH
Confidentiality - Administrative Panel (IRB) Proceedings [18] RPH
Privacy and Confidentiality (HRPP Ch 11) [19] HRPP 11
Conflict of Interest
 Faculty - Policy on Conflict of Commitment & Interest [20] RPH
IRB Members - Conflicting Interests [21]
IRB Members - Conflict of Interest Declaration [22] [21]		 GUI-I5
RPT-I1
Consent

Adobe Sign Information and Instructions [23]

 Office of Research Web

Consent Form Do's & Don'ts [24] (a practical guide)

 AID-C1
GUI-C27
General Requirements for Informed Consent - OHRP [26] GUI-C41
General Requirements for Informed Consent - FDA [27] GUI-C42
IRB web
APRS web
Observation of the Consenting Process [30] - Checklist CHK-C15
Parental Permission [12] GUI-C34
GUI-C2
GUI-32
GUI-C39
GUI-C47
Data & Safety Monitoring

Data and Safety Monitoring [35] - Guidance
DSM Plan [36] - eProtocol Help & Hints

GUI-P20

DMSB in Phase I/II Cell and Gene Transfer Clinical Trials [37]

AID-59

DSMP vs DSMB [38]

GUI-P46
Data Security
 Data Security - Secure Computing Guidelines [39]
Retention of and Access to Research Data [40]		 ISO web
RPH
Devices
 FAQs About Medical Devices [FDA] [41] FDA
Frequently Asked Questions About Medical Devices  [42] - FDA Information Sheet FDA
Significant Risk and Non-Significant Risk Medical Devices Studies [43] - Stanford Guidance GUI-7m
Significant Risk and Nonsignificant Risk Medical Device Studies [44] - FDA Information Sheet FDA
Special Considerations for the Oversight of Research Protocols in FDA-regulated Drug or Device Studies [45] GUI-26m
Sponsor-Investigator Research when the STANFORD Investigator holds the IDE [46] GUI-5m
STANFORD investigator is the sponsor on a nonsignificant risk (NSR) device study [47] GUI-41m
Drugs
 Guidelines for Studies Involving Human Volunteers Receiving Potentially Addicting Drugs [48] RPH
Orphan Drugs [49] FDA

Security and Controlled Access Plan for Investigational Drugs and Biologics Maintained and Controlled by a PD [50]

 SHC Policy
Supplement to Attachment B of the Security and Controlled Access Plan for
Investigational and Biologics Maintained and Controlled by a Protocol Director [51]		 SHC Policy
LCPH Policy on Investigational Drugs and Biologics [52] LPCH Policy
Special Considerations for the Oversight of Research Protocols in FDA-regulated Drug or Device Studies [45] GUI-26m
Sponsor-Investigator Research when the STANFORD Investigator holds the IND [53] GUI-3m
Emergency Use
 Emergency Use of a Test Article [54] - Guidance
Emergency Use of a Test Article [55] - Web Page		 GUI-6
IRB web
Expanded Access to Investigational Drugs and Devices Expanded Access to Investigational Drugs and Devices [16] - Guidance
Expanded Access to Investigational (Test) Articles [56] - Brochure		 GUI-19m GUI-B1m
Federal Agency Requirements
[DoD, DON, DOE, etc.]		 Other Federal Agencies - Additional Requirements [57]:
    DoD, DON, ED, DOE, DOJ, EPA, NSF, PHS		 GUI-42

DoD Reporting Requirements [58]

GUI-46

DOE - Protection of Personally Identifiable Information (PII) [59] - eProtocol Required Attachment

APP-14
VA - Reviewing VA Research [60] AID-27m
Genomic Data Sharing
(NIH grant info)
 NIH Genomic Data Sharing for NIH Grant Submission [61]

GUI-G01
FAQs for Genomic Data Sharing [62]

IRB web
HIPAA

HIPAA and PHI [63]

HIPAA Privacy Policies at Stanford [64]

 

Research Privacy Overview [65]

GUI-3

University Privacy Offfice Web

Privacy Office PPT presentation
Human Subject Research Human Subject Research (HSR) Determination Form [66] APP-H8
Does My Project Need IRB Review? [67] FLW-H4

What Qualifies as Human Subject Research [68]

 

Research Involving Private Information or Biospecimens: NIH Infographic [69]

 

Guidance, Coded Private Information or Specimens Use in Research (2008) [70]

GUI-H12

 

NIH

 

OHRP

Determining When an Organization is Engaged [71]

 AID-H15

Engagement of Institutions in Human Subjects Research [72]

 OHRP
Quality Assessment & Quality Improvement (QA/QI) [73] AID-H16
CA Laws/Regulations [74] AID-H18

Humanitarian Use

 Humanitarian Use Device [15] GUI-36m
IRB Review
 Criteria for IRB Approval of Research: Medical [75]
Criteria for IRB Approval of Research: Nonmedical [76]		 GUI-40
GUI-40n
Institutional and Ancillary Reviews [77] AID-125
Exempt Review Categories [78] GUI-4
Expedited Review Categories [79] GUI-44
Obtaining Additional Expertise or an Expert Consultant [80] GUI-12
Guidelines for IRB Members on Conflicting Interests [21] GUI-I5
IRB Meeting Schedules [81] AID-18
IRB Member Conflict of Interest Declaration [22] RPT-I1
IRB Authority Charge to Panel on Human Subjects Research-Medical [82] CHG-1
Charge to Panel on Human Subjects Research - Nonmedical [83] CHG-2
Confidentiality of Panel (IRB) Proceedings [18] RPH
IRB Rosters [84] IRB web
International Research
 International Compilation of Human Research Protections [85] (OHRP) - laws, regulations, guidelines on human subjects research in over 100 countries; standards (international, regional) OHRP

Guide to Conducting Research in India [86]
  General Data Protection Regulation (GDPR) [87] IRB Web
MTA Material Transfer Agreements [88] OTL
Payment
 Ethical Considerations [89] GUI-39
FDA info sheet: Payment and Reimbursement to Research Subjects [90] FDA
Stanford University Job Aid: Paying Human Subjects [91] AID-9
Prisoners
 California Penal Code: Section 3501 - 3523 [92] GUI-38
OHRP Guidance on Involvement of Prisoners in Research [93] GUI-10
Radiation Preparing Research Proposals Involving Diagnostic Use of Ionizing Radiation [29] APRS web
Use of Radiology Devices and Radioactive Materials [94] GUI
Recruitment Advertisements: Appropriate Language - Recruitment Material [95] GUI-16
General guidance on participant recruitment [96] GUI-33
Use of Employees or Laboratory Personnel as Research Subjects [97] RPH
Telephone Screening of Potential Subjects [98] GUI-15
Non-English Speaking Research Participants [99] GUI03H23
Reporting
 Events and Information that Require Prompt Reporting to the IRB [100] GUI-P13
Unanticipated Adverse Device Effect (UADE) [101] GUI-P14
Risk Special Considerations about Risks in Behavioral and Social Sciences Research [102] GUI-14n
Security
 Data security - Secure Computing Guidelines [39] Stanford ISO web
Short Form
Consent		 Short Form Consent Process [33] - Guidance GUI-C39
Short Form Consent Process [103] - Web Page IRB web
Single IRB (sIRB) Stanford required consent language for sIRB [104] AID-C57
STANFORD SOPs FOR RELYING ON A SINGLE IRB (sIRB) [105] GUI-H24
Sponsor-Investigator
Research (SIR)		 Requirements for New, Continuing Review and Final Report [106]

AID-23m
Requirements for Sponsor-Investigators who hold their own IND/IDE (Memo from Ann Arvin, MD) [107] MEM-1m

When the STANFORD Investigator holds the IDE [46]

GUI-5m
When the STANFORD Investigator holds the IND [53] GUI-3m
When the STANFORD Investigator is the sponsor on a nonsignificant risk (NSR) device study [47] GUI-41m
SIR Self-Assessment Checklist - IND/IDE [108] AID-58m
Students Special Considerations about Risks in Behavioral and Social Sciences Research [102] GUI-14n
Use of Human Subjects in Student Projects, Pilot Studies, Oral Histories and QA/QI Projects [109] RPH
Study Design Evaluating Sound Study Design [110] GUI-17
Terminology Clinical Trials Terms [111] AID-20m
Tissue & Samples Data and Tissue Repositories [112] GUI
Transplantation of Human Fetal Tissue [113] GUI-2m
Training Training in the Protection of Human Subjects in Research [114] RPH
Veterans Administration (VA) Research
 38 CFR 16 [115] Department of Veterans Affairs
  Required Questions-VA Research [116] APP-1m
  Research Involving VA Studies [117] CHK-07
  Reviewing Veterans Affairs (VA) Research [60] AID-27m
  VHA Directive 1058 Research Compliance Reporting Requirements [118] VHA
  VHA Directive 1200.05 Requirements for the Protection of Human Subjects in Research [119] VHA
  VHA Program Guide 1200.21 VHA Operations Activities That May Constitute Research [120] VHA
Waivers
 Regulations for Waiver or Alteration of Consent Requirements [31] GUI-C2
Women Research Involving Pregnant Women, Fetuses, and Neonates [121] GUI-8
Women as Subjects in Research [122] RPH

 

Source URL: https://researchcompliance.stanford.edu/panels/hs/policies/guidances

Links
[1] https://researchcompliance.stanford.edu/panels/hs/policies/guidances/laminates
[2] mailto:IRBeducation@stanford.edu
[3] https://stanfordmedicine.box.com/shared/static/ujcj7g1l52o0sjtepb31by8709083brh.pdf
[4] https://ehs.stanford.edu/manual/biosafety-manual/human-gene-transfer
[5] https://ehs.stanford.edu/forms-tools/genome-editing-and-gene-drives-stanford
[6] https://ehs.stanford.edu/manual/biosafety-manual/tissue-culture-human-and-primate-tissue
[7] https://stanfordmedicine.box.com/shared/static/0dubjxalejn6hp380s6yhwf06a6erjug.pdf
[8] https://stanfordmedicine.box.com/shared/static/zcijgpiswcf7x004hvjnb8eq0dq3j4uk.pdf
[9] https://stanfordmedicine.box.com/shared/static/z8f1dm1mtle8mhapsq1v7v7somq7r8ox.pdf
[10] http://www.hhs.gov/ohrp/policy/populations/guidance_407process.html
[11] https://stanfordmedicine.box.com/shared/static/tnxkpep2r6fzptdglt6jkgibopype0zt.pdf
[12] https://stanfordmedicine.box.com/shared/static/xrq3q46pfuly7a71uaugc1zyyl1bmi6k.pdf
[13] https://stanfordmedicine.box.com/shared/static/3r9vf7bskru9flgac6hlodqmx4udz4zc.pdf
[14] https://stanfordmedicine.box.com/shared/static/lzmd6crqxji03x6oe74cmv4lqs2btixv.pdf
[15] https://stanfordmedicine.box.com/shared/static/89y403mrzuv784l065ib5jy6cvwm8uuu.pdf
[16] https://stanfordmedicine.box.com/shared/static/zwucoebcma8w5rb4m5dn8ut382829uz5.pdf
[17] https://grants.nih.gov/policy/humansubjects/coc.htm
[18] http://doresearch.stanford.edu/policies/research-policy-handbook/committees-and-panels-support-research/confidentiality
[19] https://stanfordmedicine.box.com/shared/static/l2u7ynl9ixc2trf39ku796jjgzkcxsgf.pdf
[20] https://doresearch.stanford.edu/policies/research-policy-handbook/conflicts-commitment-and-interest/faculty-policy-conflict-commitment-and-interest
[21] https://stanfordmedicine.box.com/shared/static/pc13ckamitvsps473vj2sh8ehmckdrbb.pdf
[22] https://stanfordmedicine.box.com/shared/static/syiaxdr6hun8fufi6cu7nxfy903walm1.doc
[23] https://med.stanford.edu/researchoffice/resources/services/adobesign.html
[24] https://stanfordmedicine.box.com/shared/static/htaj9twheowi56dzuznte6whbp86bfhp.pdf
[25] https://stanfordmedicine.box.com/shared/static/efb7eagptdvfp4j6ih6bfs438iaewss2.pdf
[26] https://stanfordmedicine.box.com/shared/static/abnw9zaduffrrj48okqf0bdsue8m83iz.pdf
[27] https://stanfordmedicine.box.com/shared/static/u5c2bg2cl9ue11n8ebjtmuf62osmhdg3.pdf
[28] https://researchcompliance.stanford.edu/panels/hs/forms/definitions
[29] https://ehs.stanford.edu/manual/radiation-protection-guidance-hospital-staff/guidance-preparing-research-proposals-involving
[30] https://stanfordmedicine.box.com/shared/static/azmq9212ujg6cmhjmmrix8fleeho8df7.doc
[31] https://stanfordmedicine.box.com/shared/static/6s5bimwuqdan2k5zxr3kbzdghctjgbx8.pdf
[32] https://stanfordmedicine.box.com/shared/static/wetqr16ycb7u0yoe5tvbaggexfp9wnew.pdf
[33] https://stanfordmedicine.box.com/shared/static/ndrm3md49uenu2qhqbx17rm1whgm270b.pdf
[34] https://stanfordmedicine.box.com/shared/static/1ifcnhrrvzobv4wgwi5z3w8en018d0qw.pdf
[35] https://stanfordmedicine.box.com/shared/static/hlrwxofivx8eib7i7ubrgb67yoaywa70.pdf
[36] https://humansubjects.stanford.edu/ephelp/ephelp_dsmp.html
[37] https://stanfordmedicine.box.com/shared/static/5re0w8fvya5j5gze0uvqnlwyxodcmofq.pdf
[38] https://stanfordmedicine.box.com/shared/static/48cqrjusqugwb9lpucrqwzeqiytdc3di.pdf
[39] http://www.stanford.edu/group/security/securecomputing/iso-guidelines.html
[40] http://doresearch.stanford.edu/policies/research-policy-handbook/conduct-research/retention-and-access-research-data
[41] http://www.fda.gov/oc/ohrt/irbs/irbreview.pdf
[42] http://www.fda.gov/downloads/RegulatoryInformation/Guidances/UCM127067.pdf
[43] https://stanfordmedicine.box.com/shared/static/jzxwygvlgyxfpi1aa47aaprcser1kfiy.pdf
[44] http://www.fda.gov/downloads/RegulatoryInformation/Guidances/UCM126418.pdf
[45] https://stanfordmedicine.box.com/shared/static/kfyni1hnmx891w8vcf3mmkfmauordq5i.pdf
[46] https://stanfordmedicine.box.com/shared/static/ixuqw2sr58u8s3hjwqr4uytkiqzsot94.pdf
[47] https://stanfordmedicine.box.com/shared/static/fm381h2zz7h1ygkkg5zwssblwbgano35.pdf
[48] https://doresearch.stanford.edu/policies/research-policy-handbook/human-subjects-and-stem-cells-research/guidelines-studies
[49] https://stanfordmedicine.box.com/shared/static/fpwq4m80ujk6uuh5yup8w2p9fwdkp2h3.pdf
[50] https://stanfordmedicine.box.com/shared/static/h1xm3yzfr6um7bhs6nwhy6y77a84uv4c.pdf
[51] https://stanfordmedicine.box.com/shared/static/aembtzmhu5a3xnl5es1w7f2ugbus3wh0.pdf
[52] https://stanfordmedicine.box.com/shared/static/4d7fl1gppd4wc82hua8jj1pchdfeami7.pdf
[53] https://stanfordmedicine.box.com/shared/static/ax6kc67z5ff549gh14jlfmk9gci8tjb4.pdf
[54] https://stanfordmedicine.box.com/shared/static/5cridy8s1dvs1na2jawanp3b9zcpvdlf.pdf
[55] https://researchcompliance.stanford.edu/panels/hs/forms/emergency
[56] https://stanfordmedicine.box.com/shared/static/w0myy68uz345g2g3df83goifgjj2ih6j.pdf
[57] https://stanfordmedicine.box.com/shared/static/tuw133jlboffsox877ot2li43gzfectr.pdf
[58] https://stanfordmedicine.box.com/shared/static/v0bt30nqo2o5jdb60od0f8sq64qly5aa.pdf
[59] https://stanfordmedicine.box.com/shared/static/ibb09kek42xmucngtu6zxocp08ivdbq3.docx
[60] https://stanfordmedicine.box.com/shared/static/20xhu8go436rp3dxe5rwc051w8qrioie.pdf
[61] https://stanfordmedicine.box.com/shared/static/hkgnu37c6ihl6lcfyiw26reqtvrszugr.pdf
[62] https://researchcompliance.stanford.edu/panels/hs/forms/forms-templates/faqs#gds
[63] https://stanfordmedicine.box.com/shared/static/nodcdo1dq3y0gncfyv74kc3d78zi6ww6.pdf
[64] https://privacy.stanford.edu/policies/hipaa-privacy-policies
[65] https://stanfordmedicine.box.com/shared/static/74m1dinxu3z4kdgss4iji0h37nmoms9u.pptx
[66] https://stanfordmedicine.box.com/shared/static/jm5gac2qyhz80glrmds8uas32fwn87ce.pdf
[67] https://stanfordmedicine.box.com/shared/static/vqeuewr5axycjpu8h0wat77vqdpua9ru.pdf
[68] https://stanfordmedicine.box.com/shared/static/ay0l6dewep46o49qm696g4llf3vpx0u9.pdf
[69] https://grants.nih.gov/grants/policy/hs/private-information-biospecimens-flowchart.pdf
[70] https://www.hhs.gov/ohrp/regulations-and-policy/guidance/research-involving-coded-private-information/index.html
[71] https://stanfordmedicine.box.com/shared/static/1v6p5iy6x189dbfxb5i451l2wanda8g6.docx
[72] https://www.hhs.gov/ohrp/regulations-and-policy/guidance/guidance-on-engagement-of-institutions/index.html
[73] https://stanfordmedicine.box.com/shared/static/nvuzhf3pjqsrzx4890jax7uwbglbxcp4.pdf
[74] https://stanfordmedicine.box.com/shared/static/fbqr8ok5y5qq2j4ojb13m7va8ukhmdb1.docx
[75] https://stanfordmedicine.box.com/shared/static/qgftz5i38gi4ycntsv37ey4qawkzqf3i.pdf
[76] https://stanfordmedicine.box.com/shared/static/0xxxr7nza4fc7je0xuhcstklxgk85r4m.pdf
[77] https://stanfordmedicine.box.com/shared/static/2hukpmgrja5ytq5rai74jt5720ywk68f.docx
[78] https://stanfordmedicine.box.com/shared/static/ase46ixmatdeahj7qdfgp4ydmy5qc3ei.pdf
[79] https://stanfordmedicine.box.com/shared/static/uzm5fctlrur2nm4b2zvmra21mluh0rt5.pdf
[80] https://stanfordmedicine.box.com/shared/static/kxuabdk1rqzdms7m62b9d2fk2lr7pr2h.pdf
[81] https://researchcompliance.stanford.edu/rco/meetings
[82] https://stanfordmedicine.box.com/shared/static/3q09ufhom3ufq4adsqe69wlnrzh7idyh.pdf
[83] https://stanfordmedicine.box.com/shared/static/6leg7m0ub0nelyt6vas95k62krkfl5jl.pdf
[84] https://researchcompliance.stanford.edu/panels/hs/about/rosters
[85] https://www.hhs.gov/ohrp/sites/default/files/2019-International-Compilation-of-Human-Research-Standards.pdf
[86] https://stanfordmedicine.box.com/shared/static/2a0movzdcbmidturft5wnr7e1em0n3g4.pdf
[87] https://researchcompliance.stanford.edu/panels/hs/forms/forms-templates/faqs#gdpr1
[88] https://ico.sites.stanford.edu/mtas
[89] https://stanfordmedicine.box.com/shared/static/gpbjsk4avx04zqhtynetytiyi1o9py59.pdf
[90] https://www.fda.gov/RegulatoryInformation/Guidances/ucm126429.htm?utm_campaign=Payment%20for%20Research%20Subjects%20Information%20Sheet&utm_medium=email&utm_source=Eloqua
[91] https://stanfordmedicine.box.com/shared/static/h8u6r38mvkp14cbugfkyl6j5cc111a82.pdf
[92] https://stanfordmedicine.box.com/shared/static/a6zw687aef5nk96ts6nb3u97nuy3h885.pdf
[93] https://stanfordmedicine.box.com/shared/static/i4qdk5crjaselaohvshvrcnu6iowuny2.pdf
[94] https://stanfordmedicine.box.com/shared/static/a1r0x5ertuu3e67gc0itx03yuy6cu3bd.pdf
[95] https://stanfordmedicine.box.com/shared/static/bslih2a9odsgfauvblzxdluf06nbykkt.pdf
[96] https://stanfordmedicine.box.com/shared/static/8uebsdjrrqjyauanjp9i9d0gm1i480co.pdf
[97] https://doresearch.stanford.edu/policies/research-policy-handbook/human-subjects-and-stem-cells-research/use-employees-or-laboratory
[98] https://stanfordmedicine.box.com/shared/static/lnlt88zaqxhw7dulvkx2um8grtgxmvi5.pdf
[99] https://stanfordmedicine.box.com/shared/static/4aj1fth309551do70wg6t06pukl98as6.pdf
[100] https://stanfordmedicine.box.com/shared/static/qbsi8u8h47qsotxhdpuzz50xlrqa0sgo.pdf
[101] https://stanfordmedicine.box.com/shared/static/k9wzjz2cfiw3679fe081r2ddtb4cupmy.pdf
[102] https://stanfordmedicine.box.com/shared/static/lolfrimbs34jq2serfo5bsoye2t46o3p.pdf
[103] https://researchcompliance.stanford.edu/panels/hs/consent/forms/short-form-consent-process
[104] https://stanfordmedicine.box.com/shared/static/nrvyyq8mn4yqbnl2uvo61chk65awf313.pdf
[105] https://stanfordmedicine.box.com/shared/static/dd8tug3acklexmndzmkzzo2s9jysjak3.pdf
[106] https://stanfordmedicine.box.com/shared/static/gyp8xpp1wtznmv83w4eucg25k1wu82av.pdf
[107] https://stanfordmedicine.box.com/shared/static/s3rx27hoc363gclja1wm2hvzweh1p5h7.pdf
[108] https://stanfordmedicine.box.com/shared/static/ecw0rxnkx1qgrx2mfvvcdpknmg1kz4xl.docx
[109] https://doresearch.stanford.edu/policies/research-policy-handbook/human-subjects-and-stem-cells-research/use-human-subjects-student
[110] https://stanfordmedicine.box.com/shared/static/rg6ysufs4gwtovd5s4shceghqbh1wbsz.pdf
[111] https://stanfordmedicine.box.com/shared/static/war1ui5kbqi26t4l3juig76dujx0wti8.pdf
[112] https://stanfordmedicine.box.com/shared/static/5gh071342lxwriqrinu5szv5mrvizenr.pdf
[113] https://stanfordmedicine.box.com/shared/static/ma7e50oqmx5eu8oppndl2wzbsnplpqt6.pdf
[114] https://doresearch.stanford.edu/policies/research-policy-handbook/human-subjects-and-stem-cells-research/training-protection-human-subjects-research
[115] https://www.govinfo.gov/app/details/CFR-2002-title38-vol1/CFR-2002-title38-vol1-part16
[116] https://stanfordmedicine.box.com/shared/static/0s2mcovurpg20ok0d31a0p8g9rgrwxjq.doc
[117] https://stanfordmedicine.box.com/shared/static/y0iewqaeeq7lcgk19t28krxspqu0qk4v.docx
[118] https://www.va.gov/oro/oropubs.asp
[119] https://www.va.gov/vhapublications/ViewPublication.asp?pub_ID=8171
[120] https://www.research.va.gov/resources/policies/ProgramGuide-1200-21-VHA-Operations-Activities.pdf
[121] https://stanfordmedicine.box.com/shared/static/jdoze0z8zhiw8cabn8aw7b1055cifero.pdf
[122] https://doresearch.stanford.edu/policies/research-policy-handbook/human-subjects-and-stem-cells-research/women-subjects-research