Standard Operating Procedures (SOP) for Research at the Institute of Stomatology SIA

Version 0.1                Date 2025-Jan-23        Responsible and contact: sergio.uribe@rsu.lv

Overview

This SOP outlines the standardized process for conducting research within the Institute of Stomatology. It ensures that all research activities are systematic, transparent, and aligned with institutional priorities.

Research Workflow

1. Research Idea Generation

• Meeting: Lead Researcher SI and Head of Programs

• Residents: Become familiar with basic research principles
• Purpose: Identify priority research lines based on institutional goals, current trends, and societal needs.
• Output: Documented research priorities and assigned research lines.

2. Research Protocol Development

• Assigned Resident Responsibility:

• Write the first draft of the Research Protocol
• Write the Research Data Management and Sharing Plan
• Submit the protocol for review to the Senior Researcher.
• If required, the protocol must be submitted to the Ethics Committee for approval before proceeding.

3. Initial Researcher Meeting

• Meeting: Senior Researcher with Resident(s)

• Purpose: Discuss the assigned research line, objectives, and methodology. Address any questions or challenges.
• Output: Finalized protocol ready for implementation.

4. Research Implementation

• Conduct research activities as per the approved protocol.

• Data collection, analysis, and documentation must follow the protocol and adhere to ethical guidelines.

5. Mid-Term Progress Meeting

• Meeting: Senior Researcher with Resident(s)

• Purpose: Track progress, troubleshoot issues, and ensure adherence to timelines and quality standards.
• Output: Documented progress report and action plan for remaining tasks.

6. Final Data Collection Meeting

• Meeting: Senior Researcher with Resident(s)

• Purpose: Confirm that all data collection is complete and of sufficient quality.
• Output: Dataset finalized for cleaning, analysis and dissemination.

7. Dissemination

• Prepare and share the following outputs with a DOI (Digital Object Identifier):

• Protocol published (OSF or ISRCTN)
• Dataset for RSU Dataverse
• Preprint (optional)
• Manuscript for peer-reviewed publication (submitted)

Key Milestones and Deliverables

1. Research Protocol: Detailed methodology with objectives, timeline, and resources.
2. Ethics Approval (if applicable): Approval letter from the Ethics Committee.
3. Progress Reports: Submitted during the mid-term meeting.
4. Finalized Dataset: Prepared for analysis and sharing.
5. Publication Outputs: Draft preprint and/or manuscript ready for submission to a peer-reviewed journal.

Meeting Requirements

1. Senior Researcher with Head of Programs

• Frequency: Bi-annual or as needed
• Agenda: Identify and update research priorities.

2. Senior Researcher with Assigned Researchers

• Initial Meeting:

• Timeline: Within two weeks of assigning the research line.
• Agenda: Discuss objectives, methodology, and challenges.

• Mid-Term Meeting:

• Timeline: Midway through the research timeline.
• Agenda: Review progress, resolve issues, and adjust plans as necessary.

• Final Data Collection Meeting:

• Timeline: Upon completion of data collection.
• Agenda: Ensure data completeness and readiness for analysis.

Responsibilities

• Head of Programs:

• Identify Key Research lines of interest
• Provide strategic direction for institutional research.
• Oversight of residents' research
• Approve research protocols and progress reports.

• SI Lead Researcher:

• Lead and oversee all research activities.
• Facilitate meetings and provide guidance.
• Provide research support (methodology design, data management, data analysis, publication)
• Approve research protocols

• Resident Researchers:

• Develop and implement research protocols.
• Attend required meetings and submit deliverables on time.
• Ensure ethical compliance and data quality.

Publication Guidelines

Research dissemination efforts should focus on established journals with strong reputations to ensure impact. Avoid predatory journals, non-indexed journals, and publishers with questionable peer review processes, such as MDPI and Frontiers.

Compliance and Documentation

• All research activities must comply with institutional policies and ethical guidelines.
• Deliverables and meeting minutes must be documented and archived.

Additional documents:

1. RSU Research Ethics Guidelines 
2. RSU Research Data Management Guidelines
3. Guidelines for Clinical Research - BBCE

• Complementary website: clinical.sergiouri.be
• Basic readings

1. Hulley, 2013. Hulley Chapters 1 & 2. In: Hulley S: Cummings S: Browner W: Grady D: Newman T (Ed.), Designing Clinical Research. pp. V–vi.
2. Grimes, D.A., Schulz, K.F., 2002. 01 An overview of clinical research: the lay of the land. Lancet 359, 57–61.
3. Grimes, D.A., Schulz, K.F., 2002a. 02 Descriptive studies: what they can and cannot do. Lancet 359, 145–149.
4. Grimes, D.A., Schulz, K.F., 2002b. 03 Bias and causal associations in observational research. Lancet 359, 248–252.
5. Importance of Transparent Reporting of Health Research
6. Selecting the appropriate reporting guideline

• Suggested reference books

1. Browner, W.S., Newman, T.B., Cummings, S.R., Grady, D.G., 2022. Designing Clinical Research. Lippincott Williams & Wilkins.
2. Schulz, K., Grimes, D.A., 2018. Essential concepts in clinical research: Randomised controlled trials and observational epidemiology, 2nd ed. Elsevier Health Sciences, London, England.
3. Evans I, Thornton H, Chalmers I and Glasziou P (2011). Testing Treatments, 2nd Edition; London: Pinter and Martin. (online version)
4. WHO - Research