The Ulutas Medical Journal p-ISSN 2149-0430 e-ISSN 2149-388X

How to get ethics committee approval

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Ethics approval is not a formality added at the end. International guidance and this journal both expect research with human participants, their samples or their data to be reviewed by an independent ethics committee before it starts. This guide explains which studies need approval, which committee to apply to in Türkiye, how to prepare the application and what to write in your manuscript. Rules and committee names change, so always check your own institution's current procedures.

Which studies need approval

The Declaration of Helsinki, the World Medical Association's statement of ethical principles, covers medical research involving human participants, including research using identifiable human material or data. It says the research protocol must be submitted to the relevant research ethics committee for consideration and approval before the research begins. It also says that where consent is impossible or impracticable, secondary research on stored data or biological material may be done only after a research ethics committee has considered and approved it.

ICMJE asks authors to obtain approval from an independent local, regional or national review body, such as an ethics committee or institutional review board, and to be ready to provide documentation if editors ask. This journal's Informed Consent page states that studies involving human participants must have been approved by an appropriate ethics committee and conducted according to the Declaration of Helsinki.

In practice this includes:

  • clinical trials of drugs, devices or procedures;
  • prospective observational studies, surveys and interviews;
  • retrospective reviews of patient files, images or laboratory records;
  • studies on stored blood, tissue or other samples.

If you believe your study does not need approval, the journal asks you to explain why in the ethics statement; ask your ethics committee for its view in writing rather than deciding alone.

Clinical and non-interventional committees

In Türkiye, the Turkish Medicines and Medical Devices Agency (TİTCK) states on its clinical research page that clinical trials are carried out with the permission of the Ministry of Health and the approval of ethics committees approved by the agency. The page also mentions an electronic application system and an e-mail contact for investigators who have no company sponsor.

Several Turkish universities also run a separate non-interventional clinical research ethics committee (girişimsel olmayan klinik araştırmalar etik kurulu). Istanbul Medipol University's directive, for example, defines non-interventional research as all research that does not require a physician's direct intervention on a person, and lists observational studies (other than observational drug studies), surveys, retrospective reviews of files and images, and research on routinely obtained samples.

The dividing line between the two is set by current legislation and your institution's directive, so read your committee's own page before you choose where to apply.

Preparing the application

Each committee has its own forms and checklist, and these take precedence. As a practical starting point, prepare:

  • a protocol with the background, objectives, design, setting, participants, variables, sample size and statistical plan (the STROBE, CONSORT or other relevant checklist is a useful outline);
  • the names, roles and CVs of the investigators, and the responsible investigator's signature;
  • informed consent forms in plain Turkish, or a reasoned request for a consent waiver for record-based studies;
  • data collection forms and a description of how data will be de-identified and stored;
  • permission from the institution or department where data will be collected, if your committee asks for it;
  • funding information and any conflicts of interest.

Apply early. The Declaration of Helsinki requires approval before the research begins, and clinical trials must also be registered in a public database before the first participant is recruited. This journal asks for the registration number of clinical trials in the abstract (see the Instructions for Authors).

Official university and ministry pages

Use official pages and the latest version of each form.

  • Your university or hospital – the ethics committee page of your own institution, with its current directive, forms and meeting calendar.
  • TİTCK clinical research page – for trials of medicines and other studies within the agency's remit: titck.gov.tr.
  • Legislation – the current text of regulations is published on the official legislation portal: mevzuat.gov.tr.
  • International principles – the WMA Declaration of Helsinki: wma.net.

Ethics statement in the manuscript

This journal asks for an ethics statement under Declarations at the end of the main text, giving the name of the ethics committee, the approval number and the date, or a statement explaining why approval was not required. If the committee waived informed consent, for example in a retrospective study, the Methods must say so, again with the committee's name and approval number. Written informed consent from participants must also be stated in the Methods.

Example (replace with your own details):

"The study was approved by the [full committee name] (approval number [number], date [day month year]). Because the study used existing anonymised records, the committee waived the requirement for informed consent. The study was conducted in accordance with the Declaration of Helsinki."

Keep the approval letter; ICMJE notes that editors may ask for documentation, and editors may form their own judgement about whether the research was done appropriately.

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