A researcher who collects data without obtaining ethics committee approval cannot later submit their article to any journal. However, completing the technical sections of an ethics committee application can be unexpectedly difficult for clinicians.
What Do Ethics Committees Look For in the Technical Section?
Ethics committees evaluate not only patient safety but also the scientific quality of the research. A methodologically weak study means exposing patients to unnecessary risk.
Focus points in the technical section evaluation:
- Is the research question clear and answerable?
- Can the chosen method answer this question?
- Is the sample size justified?
- How will personal data be protected?
- Is there a risk of harm to participants, and how will it be minimized?
Research Summary Section
This section should be brief but focused. Follow this structure:
Objective: One sentence. "This study aims to investigate the effect of intervention Y on outcome Z in patients with X."
Design: Cross-sectional, cohort, case-control, RCT. With a brief rationale.
Population: Inclusion/exclusion criteria. Age range, diagnostic criteria, specific exclusions.
Data collection method: Is it a retrospective archive review, a prospective survey, or image analysis?
Sample Size
This field cannot be left blank. At a minimum, write the following:
"According to the power analysis calculated using G*Power 3.1, accepting α=0.05 and power=0.80, it was determined that [N] participants are required for the expected [effect size]. Adding %[X] for loss to follow-up, a total of [N_total] participants was planned."
Statistical Analysis Plan
"Statistical analyses will be performed with SPSS" is not sufficient. The tests to be used must be specified:
"Continuous variables will be summarized as mean ± standard deviation, and categorical variables as percentages. In between-group comparisons, the assumption of normal distribution will be checked with the Shapiro-Wilk test; when the assumption is met, the independent samples t-test will be used, and when it is not met, the Mann-Whitney U test will be used. For the primary outcome, [name of analysis] will be applied. The statistical significance threshold was accepted as p < 0.05."
Data Security and KVKK
The vast majority of ethics committees in Turkey now explicitly ask about KVKK compliance.
Answer these questions:
Will personal data be collected?
In retrospective studies, if a protocol number will be used instead of the patient name, state this.
Where will the data be stored?
Even "in an encrypted folder on the researcher's computer" is acceptable, but it must be written.
Who will be able to view the data?
If it will not be shared with anyone outside the research team, commit to this.
Confidentiality at the publication stage:
No information that would allow the identification of an individual patient will be published.
Facilitators in Retrospective Studies
In retrospective studies involving archive review:
- Informed consent is generally requested to be waived; mark this on the form and write the justification
- There is no intervention per patient, only record review; define the risk as low
- After ethics committee approval is obtained, institutional management approval may also be required to access the data
Request a free consultation for the technical section of your ethics committee application.
Where Do People Get Stuck Most in This Analysis?
- A sample size calculation is requested, but your study is exploratory and a formal power analysis cannot be applied.
- In the KVKK section, you do not know what to write from a technical standpoint for the "where will the data be stored" question.
- The ethics committee form was rejected, and it is unclear which section needs to be revised.