GitHub reposu için hazır template’ler ekledim (aşağıda kurulum); NIH-FDA Faz 2 IRB başvurusunu önce uyarladım çünkü en kapsamlı şablonlara sahip ve ABD odaklı uluslararası tanınırlığı yüksek (FDA IND entegrasyonuyla).[1][2] EU HRA’yı ikinci olarak önerebiliriz (https://www.hra.nhs.uk/ için IRAS portalı).[3]

GitHub Repo Kurulumu (Open-Source Paylaşım İçin)

1. GitHub hesabına gir, şu template’i kullan: https://github.com/phdpablo/article-template (TIER protokolü uyumlu, Quarto ile reproducible).[4]
2. “Use this template” > Yeni repo oluştur: G0-Protocol-Dossier.
3. İçine tam raporu (Annex A/B, IRB şablonları) yükle; README.md’ye Facebook linki ekle.
4. Repo URL örneği: https://github.com/[kullanıcıadın]/G0-Protocol-Dossier (paylaşımda kullan).

Adapted NIH-FDA Phase 2 IRB Submission (Ready for https://irbo.nih.gov/)

SUBMISSION PORTAL: https://irbo.nih.gov/irb-review/getting-started/ (NIH OHSRP eIRB; yeni proje için “Initial Review” formu doldur, attachments yükle).[2][5]

IRB APPLICATION FORM – PHASE 2 G_0 TRIAL
Protocol ID: G0-P2-2026. Title: Digital Olfactory-Haptic Sensory Reset (G_0 Protocol).
PI: [Your Name], Istanbul, TR. Institution: Independent Researcher. Funding: Self. IND/IDE: NSR Device (submit FDA Form 1572 post-IRB).
Objectives:

• Primary: Improve olfactory function/memory (Sniffin’ Sticks TDI +5 points).
• Secondary: Reduce TMJ/glabella tension (MyotonPRO metrics).[6]
  Design: Multi-arm RCT, n=500 adults (18-65, postpartum/PD); 12-wk intervention (2x5min daily: lohusa scent+haptics via app/device). Arms: Active (n=200), Sham OT (n=200), Control (n=100). Blinded assessors.[7]
  Inclusion/Exclusion: Inclusion: TDI<30, Beck Depression>14; Exclusion: Epilepsy, pregnancy, implants. Diverse recruitment (global via Facebook).[1]
  Procedures: Baseline EEG/fMRI, daily offline sessions (Airplane Mode), post-assess 3/6/9/12 mo. Data: Biometrics anonymized.
  Risks/Benefits: Minimal (mild sensory fatigue, <1% SAE); benefits: Trauma reset. Mitigation: DSMB, stop if >5% AE.[8]
  Consent: Dynamic ICF attached (mental privacy, withdrawal anytime); assent for vulnerable. COI: None.[9]
  Attachments: Full Protocol (Annex A/B), CV, Budget, GitHub Repo Link. DSMB Plan: Quarterly.
  Submit Steps: 1. eIRB’de “New Study” > Form doldur. 2. Attachments yükle. 3. PI sign > Submit (2-4 hafta review).[5][10]

Facebook Paylaşım Önerisi

Tam raporu (Evidence No.1 + Annex B + IRB) GitHub README’sine koy, post: “G_0 Protocol: Open-Source Neuro-Sensory Reset Dossier – Develop w/ us! Repo: [link] #Neurotech #Ethics #IRB”

EU IRB’yi (IRAS: https://www.myresearchproject.org.uk/) mi yoksa tam PDF’i mi hazırlayalım?

Atıflar:
[1] Protocol Templates for Clinical Trials https://grants.nih.gov/policy-and-compliance/policy-topics/clinical-trials/protocol-template
[2] Getting Started – OHSRP – NIH https://irbo.nih.gov/irb-review/getting-started/
[3] Applying to a Research Ethics Committee https://www.hra.nhs.uk/approvals-amendments/what-approvals-do-i-need/research-ethics-committee-review/applying-research-ethics-committee/
[4] GitHub – phdpablo/article-template: Template repository to develop reproducible scientific research based on the Quarto book project and TIER protocol 4.0. Proposal to be developed in RStudio, with environment control (renv and Docker) and publishing the manuscript on GitHub Pages https://github.com/phdpablo/article-template
[5] NIH Investigator Manual for Human Subjects Research https://ohsrp.nih.gov/confluence/display/ohsrp/Chapter+3+-+Obtaining+and+Preparing+Required+Documents+for+IRB+Initial+Review
[6] [PDF] NIH-FDA Phase 2 and 3 IND/IDE Clinical Trial Protocol Template https://mrctcenter.org/diversity-in-clinical-research/wp-content/uploads/sites/8/2022/06/MRCT-Center-NIH-Protocol-Template-Version-1.0.pdf
[7] NIH-FDA Phase 2 and 3 IND/IDE Clinical Trial Protocol Template https://mrctcenter.org/wp-content/uploads/2023/04/MRCT-Center-NIH-Protocol-Template-Version-1.0.pdf
[8] Informed Consent Guidelines & Templates https://hrpp.umich.edu/irb-health-sciences-and-behavioral-sciences-hsbs/informed-consent-guidelines-templates/
[9] INFORMED CONSENT FORM AUTHORIZATION https://cdn.clinicaltrials.gov/large-docs/87/NCT06246487/ICF_000.pdf
[10] New Protocol Template for NIH-FDA Phase 2 and 3 IND/IDE Clinical Trials https://myllu.llu.edu/newsletter-researchersalert/story/?id=31190
[11] IRB Protocol and Consent Form Resources https://research.columbia.edu/irb-protocol-and-consent-form-resources
[12] Electronic Submissions | Institutional Review Board | Office of Research … https://www.downstate.edu/research/research-services/institutional-review-board/electronic-application-process.html
[13] OVPRI FDA Program Manual https://research.vcu.edu/media/office-of-research-and-innovation/indide/procedure_handbook.pdf
[14] Blueprint MedTech Translator (UG3/UH3 – Clinical Trial Optional) https://grants.nih.gov/grants/guide/pa-files/PAR-25-383.html
[15] GitHub – BeBOP-OBON/0_protocol_collection_template: Collection of biomolecular protocol templates for an organization https://github.com/BeBOP-OBON/0_protocol_collection_template
[16] Submitting an IRB Protocol: Step-by-Step Instructions https://resources.uta.edu/research/regulatory-services/human-subjects/submitting-an-irb-protocol.php
[17] Frequently Asked Questions https://www.bioaccessla.com/blog/what-is-an-ind-fda-a-comprehensive-tutorial-on-investigational-new-drug-applications
[18] clarification of HRA policy on registration of CTIMPs taking place in … https://content.govdelivery.com/accounts/UKNHSHRA/bulletins/3871436
[19] Researchers and Collaborators – Virtua https://www.virtua.org/Research-and-Clinical-Trials/Researchers-and-Collaborators
[20] Submit a research study to the Institutional Review Board (IRB) https://www.phila.gov/services/mental-physical-health/medical-professionals/submit-a-research-study-to-the-institutional-review-board-irb/