Research Ethics Committee

You may need to modify the application if you want to make changes to it or if the Research Ethics Committee has set conditions for the study that need to be fulfilled.

1. We will return the application for editing in ETIS.
   This will make the form editable again – you will be able to upload new documents and modify the contents of the form fields. ETIS will send a corresponding procedural notification to the principal investigator.
2. For the changes made, please add a free‑form cover letter documenting how you have fulfilled the conditions set by the Research Ethics Committee. Guidance on how to mark changes in the electronic ETIS application form is available here: Marking Changes in the Research Ethics' Electronic Application Form.
3. Upload the cover letter describing the changes under the “Additional documents” tab.
4. If you make changes in an additional document, upload both a clean revised version and a version with tracked changes.
   If only a minor detail in an additional document is updated (e.g., contact email), the tracked-changes version may be replaced by noting the change directly in the cover letter. Note: It is important to indicate in the titles of the additional documents that they are revised versions.
5. Confirm the application.
6. We will assess the fulfilment of the conditions through a simplified procedure, meaning the application does not need to be submitted to a new committee meeting for discussion.

All researchers have the right to apply to the Research Ethics Committee. Research may be conducted by a researcher from a research institution, university, or higher education institution. Research may also be conducted by a hospital, a public sector institution, a company dealing with research, an NGO, or another organisation. 

There can be several reasons to apply to the Research Ethics Committee, including: 

1. Legal obligation: secondary use of health data, processing special categories of personal data without consent (Personal Data Protection Act § 6), all human gene studies (new Human Genes Research Act); 
2. Funding requirement: European Commission, ETAG, other funders; 
3. Publisher requirement: some journals require ethics committee approval as a condition for publication; 
4. Disciplinary good practice: professional ethical principles, codes, or other agreements foresee the need for ethics committee approval; 
5. Institutional requirement: the organisation has established internal rules requiring approval from an ethics committee; 
6. Researcher’s own responsibility: voluntary submission to an ethics committee. 

If any of the above reasons apply, submitting an application to the ethics committee is necessary. Some research institutions have established their own ethics committees under the new Organisation of Research and Development and Innovation Act – researchers from such institutions may turn to their institutional committee, which will guide them if needed. All other researchers can apply only to the Research Ethics Committee of Estonian Research Council.

Applications are submitted and the entire review process takes place in the Estonian Research Information System (ETIS) through a dedicated electronic form. To submit an application, both the researcher and the responsible institution must have an ETIS account, and the institution must approve the application. The form can be accessed after logging in to ETIS. 

Information on creating an account is available on the ETIS webpage.

The form is electronic and uses dynamic elements, like control questions (yes/no) which display or hide questions according to the applicant’s needs. 

Unlike before, the applicant must have an ETIS account (anyone can create one), but all other researchers or institutions listed in the application do not need to have ETIS accounts. The ETIS account is required for access so all team members can review or edit the application before submission. 

Institutional approval requires only a single confirmation click by the designated representative. If multiple institutions (including foreign institutions) are involved in the study, it is sufficient to upload a separate written confirmation from each. 

ETIS contains built-in help questions and guidance texts. Additional guidance materials are being developed and will be published on the Estonian Research Council’s website. 

You may always seek assistance from the research ethics & integrity coordinator or the head of the unit of research integrity, and for technical questions from the ETIS team. 

The researcher submits one application, and the appropriate subcommittee is assigned during the review process. Applicants may indicate a preferred subcommittee based on the content of the application and field of the study. However, the application will be processed independent of the choice of subcommittee and the researcher doesn't need to worry about the choice - the final decision concerning the subcommittee is made by the Research Ethics Committee. 

The processing time is about 30 days, but the exact time may vary. If the application must be corrected or improved, the application may be discussed at the next meeting which can extend the time by additional 30 days. However, minor corrections can be solved without an additional meeting.

According to the regulation § 4 lg 12 the maximum review time is 90 days for complex cases.

The Committee evaluates the ethical acceptability of studies, weighing the benefits and risks, and fulfilling other legal tasks. It evaluates both ethical acceptability and justification for requesting personal data from registers. 

The Committee may give three types of assessments: 

1. Research complies with ethical principles. 
2. Research complies with ethical principles if conditions set by the Committee are met.
3. Research does not comply.

The fulfilment of the conditions will be assessed in a simplified procedure before the next meeting. In this case, the application does require improvement, but obtaining the assessment does not require waiting for the next subcommittee meeting. 

The results will be communicated via ETIS no later than five working days after the meeting. All issued approvals are automatically published on the ETIS website, where general information about the research is provided. In the electronic processing environment, it is possible to set up automatic notifications that are sent to the email address linked to the ETIS user account. In addition to the final assessment, notifications will also be sent via ETIS regarding whether the application has been taken into processing or if additional questions have arisen concerning the application. 

Although the default assumption is that the principal investigator is the person who initiates the ethics committee application in ETIS, it is also possible to authorize another person to initiate and submit the application in ETIS on their behalf. To do this, the principal investigator must log in to ETIS, select the ‘Authorize’ option from the left-hand menu under the researcher role, search for the desired person, and specify the authorization period. To avoid errors in ETIS, the authorization should be granted for all available actions. Since the authorization covers all activities performed in ETIS, delegating rights to another person is a reasonable and suitable solution primarily when the principal investigator is not an active ETIS user or fully trusts the authorized person. The authorized person can thereafter click on their name in the upper right corner, switch their role, and select the role of the person who granted the authorization. 

Because ETIS sends automatic notifications regarding the process to the principal investigator, the email address to which notifications are sent should also be updated when granting authorization. This can be done by changing the email address in the principal investigator’s ETIS CV. Inevitably, this means that all ETIS notifications will from then on be sent to the new email address, so before granting authorization it is important to consider whether forwarding notifications to the new address is suitable and appropriate.