Alterlab Tr Research Ethics

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:

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.

Door 2 — TİTCK-onaylı Klinik Araştırmalar Etik Kurulu + ayrı TİTCK izni. Studies on human medicinal products, medical devices, cosmetics, stem cells, or bioavailability/bioequivalence (BA/BE) require a committee approved by TİTCK and a separate TİTCK start permit. Per TİTCK, clinical research is conducted "TİTCK tarafından onay verilen Etik Kurulların onayı ve Sağlık Bakanlığının izni ile." A decision from a committee not approved by TİTCK is legally void for clinical research — verify the committee's TİTCK accreditation 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. 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, updated 29 Mar 2023)

The Bilgilendirilmiş Gönüllü Olur Formu must, at minimum, carry the elements in references/consent_minimum_contents.md. Headline items:

• Date, version, and page numbering on every page (and volunteer initials per page for clinical-track forms).
• 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.

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 TİTCK-approved and that a separate TİTCK permit is required.
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.
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 vs TİTCK clinical) and the trigger that put the study there?
• 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?
• 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. 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).
• TİTCK informed-consent minimum contents, updated 29 Mar 2023.
• TR Dizin (TÜBİTAK ULAKBİM) research-and-publication-ethics criteria — ethics-committee approval mandatory for participant data collection in publications from 2020. https://trdizin.gov.tr/

Part of the AlterLab Academic Skills suite.