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  • Expressions of Concern ::: Expressions of Solidarity
    • Expression of Concern – U.S. Centers for Disease Control and Prevention [CDC] Bars Liaison Organizations from ACIP [Advisory Committee on Immunization Practice] Work Groups – 31 July 2025
    • Expression of Concern :: HHS – Elimination of SACHRP [Secretary’s Committee on Human Research Protections] – 23 April 2025
    • Expression of Concern :: U.S. Vaccine/Immunization Science & Policy – 08 March 2025
    • Expression of Concern :: US CDC – ACIP: Commitment to Established Rigorous Evidence Evaluation and Vaccine Recommendation Processes – Issued 25 Sep 2025
    • Expression of Concern: HHS Removal/Retirement of all ACIP Voting Members – 09 June 2025
    • Expression of Concern: Meeting of the CDC ACIP [Advisory Committee on Immunization Practices] 18-19 Sep 2025 [Docket No. CDC-2025-0454]
    • Expression of Concern: U.S. Rejection of 2024 Amendments to IHR [2005]
    • Expression of Solidarity – AAP and ACOG – Issuance of Independent, Evidence-based Immunization Recommendations – Issued 05 September 2025
  • GE2P2 Global Foundation
    • RFI :: Project Documentation – Report Drafts/Final Versions et al
    • GE2P2 Global Foundation :: Global Consultation Submission – Draft UNESCO Recommendation on Ethics of Neurotechnology – 12 July 2024
    • NYAS – Gene Therapies – Bioethics Challenges and Solutions – 10 October 2019
      • Bioethics Issues in Somatic and Germline Gene Editing: Key Content
    • GE2P2 Global Foundation – Board Documentation
    • ICGEN :: Life Cycle Documentation
    • requiem for integrity :: Project Content Repository
      • Lullabies and Cradle Songs
    • Contracts/Concept Notes/RFP-Bid Responses Repository
      • OSIC
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      • Art Caplan
      • Anne Cropp
      • Lisa Kearns
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      • Tom Watson
    • Center for Informed Consent Integrity Call Log
    • Fundraising 990 Respository
    • Patients, Politics, Pressure :: Pharma Stays Steady [Mostly] In Russia Sanctions Context
  • Global Forum for Research Ethics & Integrity [GFREI]
    • GE2P2 Global – Public Comment on  FDA Docket No. FDA-2023-D-5470: Real-World Evidence: Considerations Regarding Non-Interventional Studies for Drug and Biological Products; Draft Guidance for Industry – 18 June 2024
    • Global Forum for Research Ethics & Integrity [GFREI] – Oxford Bioethics Conference Workshop :: Resource Page
    • Global Forum for Research Ethics and Integrity [GFREI]-GE2P2 Global :: Public Comment on Declaration of Helsinki – 2024 Revision: Phase 2 – 24 June 2024
    • GE2P2 Global Foundation/Global Forum on Research Ethics and Integrity [GFREI] Working Group :: Public Consultation Submissions
      • GFREI Public Consultation Submission at 22 July 2023 :: WHO Guidance for Global Practices for Clinical Trials – Draft (19 July 2023)
      • GFREI Public Consultation Submission at 05 September 2023 :: ICH E6(R3) GCP  Principles, Annex 1 – Draft. (19 May 2023)
      • GFREI Public Consultation Submission at 03 August 2022 :: NIH RFI – Promoting Equity in Global Health Research [May 20, 2022]
      • GFREI Public Consultation Submission at 11 April 2022 :: CIOMS Working Group XI draft report – Patient Involvement in the development, regulation and safe use of medicines, 28 February 2022.
    • GE2P2 Global – GFREI :: Public Comment – Draft WHO Principles for human genome access, use, and sharing – May 2023
    • GFREI Public Consultation Submission at 02 April 2024 :: VolREthics initiative :: DRAFT – Global Ethics Charter for the Protection of Healthy Volunteers in Clinical Trials
    • GE2P2 Global – GFREI Public Comment Submission :: Key Information and Facilitating Understanding in Informed Consent; Draft Guidance for Sponsors, Investigators, and Institutional Review Boards – 30 April 2024
  • Public Consultation Watch Digest
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    • Bioethics Program – Initiative 2.0
      • Bioethics Initiative 10.0
        • Advisory Case Documentation :: IBAC
      • Bioethics Initiative 11.0
      • Bioethics Initiative 13.0
      • Bioethics Initiative 6.0
      • Bioethics Initiative 7.0
      • Bioethics Initiative 8.0
    • IBAC Advisory Program – Initiative 1.0
      • GE2P2 Global – Initiative 4.0
        • GFREI Content
      • Initiative 1.0 :: Key Work Products
    • Initiative File 3.0
      • RFPS-NYH-2019-503076
    • Bioethics Initiative 12.0
      • Case Documentation
    • GE2P2 Global Advisory Services pbc_Board Documentation
    • OSIC Project Page
    • Advisory Case :: 2020-F
    • Bioethics Initiative 5.0
  • Contact

Bioethics Initiative 11.0

GSK – Compassionate Use Policy Development [Feb, 2020]

Key Documentation

Program Case Cover Sheet :: GSK-GE2P2 IBAC_Program Case Cover Sheet_Treatment Use Policy advice

GSK PPT Case Overview/IBAC Call of 14 Feb 2020 ::  GSK_EA Policy Case_Jan 2020_Treatment Use of Unapproved Medicines

GSK CU Policy [at Feb 2020] :: GSK_EAP Policy Case_POL_87186 DRAFT v8 (002)AF

GSK SOPs [at Feb 2020]
GSK_Importation SOP_2018_00000631294
GSK_CU SOP_2018_00000454971

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