А. At the Stage of Planning a Scientific Research/Experimental Development/Clinical Trial (SR/ED/CT)
Within 2 months of initiating a research project (approval of the technical assignment), the following documents must be submitted for review:
1. Application from the head of the scientific research/experimental development/clinical trial (SR/ED/CT) for conducting a bioethical review.
2. Full text of the SR/ED/CT project
For research involving patients (healthy volunteers):
3. Application for project review with a detailed description and attachments.
For research involving experimental animals:
3. Application for permission to use laboratory animals in experimental studies.
В. At the Stage of Approving the Dissertation Research Topic
Within 2 months of approving the dissertation research topic, the following documents must be submitted for review:
1. Application from the scientific advisor/consultant and the PhD/postdoctoral student for conducting a bioethical review of the dissertation research.
2. Abstract of the dissertation research program.
3. Extract from the department/scientific council meeting protocol confirming the approval/refinement of the research topic.
4. Copy of the previous bioethical expert opinion (if the research is conducted within an SR/ED/CT that has already received an expert opinion)
For research involving patients (healthy volunteers):
5. Application for the review of the dissertation research project with a detailed description and attachments.
For research involving experimental animals:
5. Application for permission to use laboratory animals in the dissertation research.
С. Request for Clarification or Expansion of the Scientific Research/Experimental Development/Clinical Trial
1. Application from the head of the scientific research/experimental development/clinical trial or the dissertation research supervisor/consultant
2. Copy of the previous expert opinion
3. Detailed description of additional procedures not included in the previous expert opinion.
D. At the Stage of Preparing for Dissertation Defense for a PhD/Doctor of Sciences Degree
1. Application from the PhD/postdoctoral student and the scientific advisor/consultant for conducting a bioethical review of the dissertation research.
2. Abstract of the dissertation research program.
3. Extract from the protocol of the department/scientific council meeting confirming the approval/refinement of the dissertation research topic.
4. Copy of the previous Expert Opinion (if the research is conducted within an SR/ED/CT that has already received an expert opinion)
For research involving patients (healthy volunteers):
5. Informed consent form.
For research involving experimental animals:
5. Protocol of work with laboratory animals.
E. Upon Request for International Competition Requirements/Editorial Policies of Journals
1. Application from the project leader/article author for conducting a bioethical review.
2. Text of the article/competition work
3. Copy of the previous Expert Opinion (for articles/works based on materials obtained within an SR/ED/CT that has already received an expert opinion)
For research involving patients (healthy volunteers):
4. Informed consent form.
For research involving experimental animals:
4. Protocol of work with laboratory animals.