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Skillsalterlab-tr-research-ethics

alterlab-tr-research-ethics

Writing & research

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Updated 10-15 19:56

About this skill

TR Research Ethics — Turkish Etik Kurul & Onam Form Scaffolder

The Turkey-specific counterpart to alterlab-research-ethics. Given a study description, it answers the first question every Turkish researcher faces — which etik kurul (ethics committee) do I need? — then scaffolds the bilingual dossier (başvuru formu, dilekçe, onam formu) and lints the consent form against the TİTCK minimum-content checklist. Glossary on first use: etik kurul = ethics committee; onam / olur formu = informed-consent form; dilekçe = formal cover petition; TİTCK = Türkiye İlaç ve Tıbbi Cihaz Kurumu (Turkish Medicines and Medical Devices Agency); öz = abstract.

This skill scaffolds and routes. It does not grant approval, and a draft it produces is not a substitute for your institution's own committee templates, which always take precedence.

When to Use This Skill

Use it when the request is about Turkish human-subjects ethics review:

IEU anket çalışması için etik kurul başvurusu hazırla
Bu cihaz çalışması için TİTCK onayı / klinik araştırma etik kurulu gerekir mi?
Draft a Turkish bilgilendirilmiş onam (informed consent) form for an interview study
Which ethics committee do I need for a focus-group study at a Turkish university?
Check my olur formu against the TİTCK minimum-content rules

Does NOT Trigger

Route adjacent requests to the correct sibling skill instead of firing here:

Request Route to
US/EU IRB, Belmont Report, HIPAA, GDPR, non-Turkey ethics board alterlab-research-ethics
KVKK-compliant data management plan, anonymization, VERBIS, açık rıza data basis alterlab-kvkk-dmp
TÜBİTAK Veri Yönetim Planı, Aperta deposit, open-access mandate alterlab-aperta
Drafting the TÜBİTAK ARDEB 1001/1002-A proposal narrative alterlab-tubitak-proposal
Survey instrument design / item wording (not the ethics dossier) alterlab-survey-design
Qualitative interview/focus-group method design alterlab-qualitative-methods
Pre-registration of hypotheses & analysis plan alterlab-open-science
Checking a journal's TR Dizin indexing status alterlab-trdizin
Docentlik (associate-professorship) eligibility / point math alterlab-docentlik-eligibility
Akademik teşvik (academic-incentive) scoring alterlab-akademik-tesvik

The boundary with alterlab-kvkk-dmp matters: ethics review (this skill) and KVKK data protection (that skill) are two separate legal tracks for the same study. A full project usually needs both — scaffold the etik kurul dossier here, then hand off to alterlab-kvkk-dmp for the data plan.

The Routing Rule (do this first)

Turkish ethics review has two doors, and sending a study to the wrong one wastes a review cycle. Route by what the study does, per references/etik_kurul_routing.md:

Door 1 — Üniversite Girişimsel Olmayan (non-interventional) Etik Kurulu. Triggered by the TR Dizin/ULAKBİM rule (mandatory for publications from 2020): any study collecting data from participants via survey (anket), interview (görüşme), focus group (odak grup), observation (gözlem), or experiment (deney) needs ethics-committee approval. For non-clinical social/behavioral/education research this is the researcher's own university non-interventional committee. Two rules keep studies out of the wrong door: a study with no direct intervention still needs ethics approval (TİTCK SSS 72, citing Helsinki), and a TİTCK Klinik Araştırmalar Etik Kurulu may not review surveys, retrospective record studies, or other non-interventional work outside its remit (Yönetmelik Art. 61/11; TİTCK SSS 70). Those go to the university committee (TİTCK SSS 73: "müdahalesiz çalışmalar etik kurulu, bilimsel araştırmalar etik kurulu vb.").

Door 2 — TİTCK-regulated research: a designated committee, usually plus a permit. Per TİTCK, clinical research is conducted "TİTCK tarafından onay verilen Etik Kurulların onayı ve Sağlık Bakanlığının izni ile." Which committee and which permit depend on the product (Yönetmelik Art. 61/11–12; TİTCK Klinik Araştırmalar SSS 2, 8, 70):

Study Ethics committee Permit
Drug (beşeri tıbbi ürün) clinical trial or low-risk scientific study TİTCK-approved Klinik Araştırmalar Etik Kurulu TİTCK Klinik Araştırmalar Dairesi
Observational study of a medicinal product Klinik Araştırmalar Etik Kurulu only None — no TİTCK permit
Medical-device clinical investigation or post-market study (R.G. 8/7/2022, No. 31890) Klinik Araştırmalar Etik Kurulu TİTCK Tıbbi Cihaz Onaylanmış Kuruluş ve Klinik Araştırmalar Dairesi
Stem cells (SHGM Genelge 2018/10) or human tissue/cell products (R.G. 4/9/2025, No. 33007) Klinik Araştırmalar Etik Kurulu TİTCK for tissue/cell products; confirm the stem-cell permit route
Bioavailability/bioequivalence (BA/BE) TİTCK-approved BY/BE Çalışmaları Etik Kurulu only TİTCK Klinik Araştırmalar Dairesi
Cosmetics tested on people (R.G. 20/9/2015, No. 29481) A committee on TİTCK's Kozmetik Klinik Etik Kurul list TİTCK Kozmetik Ürünler Dairesi

Only a committee on TİTCK's approved list can approve these studies: TİTCK calls BA/BE decisions from any other committee void ("geçersizdir"), and observational drug studies cannot be approved by any committee other than a Klinik Araştırmalar Etik Kurulu. Check TİTCK's "Etik Kurul Faaliyet Durumu" list before you submit.

Governing instrument: Beşeri Tıbbi Ürünlerin Klinik Araştırmaları Hakkında Yönetmelik (Regulation on Clinical Research of Human Medicinal Products), mevzuat.gov.tr MevzuatNo 40207 (R.G. 27/5/2023, No. 32203; amended by R.G. 29/12/2023, No. 32414 and R.G. 5/6/2025, No. 32921). See references/etik_kurul_routing.md for the full decision tree, edge cases (retrospective record review, secondary data, minors/vulnerable groups), and source citations.

Some studies hit both doors (e.g. a device trial that also runs a patient survey). When in doubt, the clinical track governs and you escalate to Door 2.

What It Produces

A bilingual (Turkish primary, English gloss) dossier skeleton. Pull the templates from references/dossier_templates.md:

  1. Etik Kurul Başvuru Formu — application form skeleton: title, PI/araştırmacı roster, aim & rationale (öz), design, population & sample, instruments, risk/benefit, data-handling summary (with a pointer to the KVKK plan), and the informed-consent procedure.
  2. Başvuru Dilekçesi — the formal cover petition addressed to the committee.
  3. Bilgilendirilmiş Gönüllü Olur Formu — the participant-facing consent form, built to satisfy the TİTCK minimum-content checklist (below).
  4. Ek/CV bundle checklist — instruments, measurement tools, researcher CVs, data-collection-permission letters, and any institutional annexes.

Always tell the user that their own university committee's official form overrides this skeleton where the two differ.

Consent-Form Minimum Content (TİTCK KAD-DD-13)

The Bilgilendirilmiş Gönüllü Olur Formu must, at minimum, carry the elements in references/consent_minimum_contents.md, taken from TİTCK's "BGOF'de Bulunması Gereken Asgari Bilgiler" (KAD-DD-13). Headline items:

  • Date, version, and "page X of Y" numbering on every page (and, for clinical-track forms, volunteer initials on every page except the signature page).
  • Plain-language statement of purpose, procedures, expected duration, and what participation involves.
  • Foreseeable risks/discomforts and benefits, stated honestly.
  • A 24-hour contact for problems or questions.
  • An explicit statement that participation is voluntary and the participant may withdraw at any time without penalty.
  • An explicit no-coercion statement.
  • For clinical-track studies: insurance, alternative treatments, and the sponsor/contact chain as the regulation requires.
  • A signature block with the volunteer's and the informing researcher's name, signature, and date (plus witness / parent or legal guardian where needed).

Lint a draft consent form

uv run python skills/turkish-academia/alterlab-tr-research-ethics/scripts/consent_form_check.py \
    path/to/olur_formu.md

The linter (scripts/consent_form_check.py, standard-library only) scans a draft for the required elements above (in Turkish or English) and prints a per-element PASS / MISSING table plus an overall verdict. It is a completeness aid, not a legal sign-off: a PASS means the checklist elements are present, not that the wording satisfies the committee. Run it, read the JSON/table, and report the MISSING items to the user with the exact element name.

Workflow

  1. Classify the study → run the routing rule. State which door (committee type) applies and why, citing the trigger (e.g. "collects interview data → non-interventional committee" or "tests a medical device → TİTCK clinical committee + permit").
  2. Flag the clinical-track gate when Door 2 applies: remind the user to confirm the committee is on TİTCK's approved list for that study type and whether a TİTCK permit is required (yes for trials and BA/BE; no for observational drug studies).
  3. Scaffold the dossier from references/dossier_templates.md, filled with the study's specifics; keep Turkish as the primary language with an English gloss. If generative AI (ÜYZ) is used anywhere in the study, the application must say so: YÖK's Üretken Yapay Zekâ Kullanımına Dair Etik Rehber (Mayıs 2024) asks for the tool, its version, and when and at which stage it is used, and states that AI must not stand in for real participants ("Gerçek katılımcılar yerine ÜYZ kullanılması doğru değildir").
  4. Build & lint the consent form against the TİTCK checklist; run scripts/consent_form_check.py and surface MISSING elements.
  5. Hand off the data-protection half to alterlab-kvkk-dmp and (if funded / open-access) the deposit half to alterlab-aperta.
  6. Disclaim: outputs are drafts; the institution's official forms and the committee's own decision are authoritative. Caps, forms, and checklists change — verify against the current TİTCK / university committee documents before submission.

Self-Check Before Reporting

  • Did I name the specific committee type (non-interventional, Klinik Araştırmalar, BY/BE, or cosmetics) and the trigger that put the study there, and did I say whether a TİTCK permit is needed (not for observational drug studies)?
  • For any clinical-track study, did I flag the TİTCK-approval + separate permit requirement and the "non-approved committee = legally void" rule?
  • Did I run the consent linter and report MISSING elements by name, not just a pass/fail?
  • Did I route data-protection to alterlab-kvkk-dmp rather than improvising KVKK advice here?
  • If the study uses generative AI, does the dossier state the tool, version, stage, and purpose (YÖK ÜYZ Etik Rehberi, 2024)?
  • Did I state that institutional forms override the skeleton and that figures/rules must be verified against current sources?

References

  • references/etik_kurul_routing.md — full two-door decision tree, trigger list, edge cases, and primary-source citations.
  • references/consent_minimum_contents.md — the TİTCK minimum-content checklist the linter enforces, element by element.
  • references/dossier_templates.md — bilingual başvuru formu, dilekçe, and olur formu skeletons plus the annex checklist.

Primary sources

  • TİTCK — Klinik Araştırmalar, incl. the SSS (FAQ) and approved-committee lists. https://www.titck.gov.tr/faaliyetalanlari/ilac/klinik-arastirmalar
  • Beşeri Tıbbi Ürünlerin Klinik Araştırmaları Hakkında Yönetmelik — mevzuat.gov.tr MevzuatNo 40207 (R.G. 27/5/2023, No. 32203; amended R.G. 29/12/2023, No. 32414 and R.G. 5/6/2025, No. 32921).
  • TİTCK KAD-DD-13, "BGOF'de Bulunması Gereken Asgari Bilgiler" (informed-consent minimum contents), linked from the TİTCK clinical-research page.
  • YÖK, Yükseköğretim Kurumları Bilimsel Araştırma ve Yayın Faaliyetlerinde Üretken Yapay Zekâ Kullanımına Dair Etik Rehber (Mayıs 2024).
  • TR Dizin (TÜBİTAK ULAKBİM) research-and-publication-ethics criteria — ethics-committee approval mandatory for participant data collection in publications from 2020; the article must give the committee name, date, and decision number in the method section and on the first or last page. https://trdizin.gov.tr/kriterler/

Part of the AlterLab Academic Skills suite.