IRB/REC

GSA Biomedical Research Ethics Committee (IRB/REC)

About Us

The Georgian Dental Association (GSA) Biomedical Research Ethics Committee is an independent body whose main mission is to guide the research process within an ethical framework and to protect the rights, safety, and well-being of research participants. Our activities are based on internationally recognized ethical standards, including the Declaration of Helsinki, CIOMS guidelines, and the principles of Good Clinical Practice (GCP). The committee ensures that all submitted research complies with both international regulations and the national legislation of Georgia.

Our Fundamental Principles

All decisions of the committee are based on three fundamental principles of bioethics:

  • Respect for Persons:
  • We recognize the right of every individual to make a free and informed decision about their participation in research (autonomy).
  • To obtain informed consent, the research participant must be provided with complete and understandable information about the research objectives, methods, possible risks, and benefits.
  • Special protection is afforded to vulnerable groups who may have a limited ability to make independent decisions (e.g., minors, persons with disabilities).
    • Beneficence and Non-Maleficence:
  • Research must be planned in such a way as to maximize the potential benefits for science while minimizing possible harm to participants.
  • The committee assesses whether the potential benefits of the research always outweigh its risks.
  • Strict monitoring is carried out during the research process to ensure the safety of participants.
    • Justice:
  • The selection of research participants must be based on fair and objective criteria, without any discrimination.
  • The burden of research should not be disproportionately placed on specific or vulnerable groups.
  • The benefits derived from the research should be distributed equally and fairly.

Committee Structure and Composition

The independence and impartiality of the committee are ensured by its multidisciplinary composition.

  • Composition:The committee consists of at least 5 members representing various professional fields, including bioethics specialists, lawyers, medical and dental professionals, and community representatives.
  • Independence:The committee members are independent of any interests that could influence the impartiality of their decisions. In any case of a potential conflict of interest, a member is obliged to declare it and abstain from the review and decision-making process.
  • Mandate:Committee members are appointed for a term of 3 years, with the possibility of reappointment.

Information for Researchers: The Review Process

The Ethics Committee reviews all biomedical research before it begins. The review process includes the following stages:

  1. Application Submission:The researcher must submit a detailed application, which includes:
  • A complete description of the research (objectives, methodology).
  • Informed consent forms.
  • Data protection policy.
  • Information about financial sources.
    1. Ethical Review:Depending on the risks and complexity of the research, the committee uses three review formats:
  • Full Review:For high-risk studies or studies involving vulnerable groups.
  • Expedited Review:For minimal-risk studies.
  • Exempt Review:For studies with practically no risks.
    1. Decision-Making:Based on the review, the committee makes one of the following decisions:
  • Approval without changes.
  • Approval with recommended changes.
  • Request for additional information.
    1. Research Monitoring:After granting approval, the committee conducts regular monitoring of the research progress to ensure continuous adherence to ethical standards.

Rights of Participants

The committee ensures the full protection of research participants’ rights, including:

  • Right to Information:The right to receive complete and understandable information about the research.
  • Voluntary Participation:Participation must be completely voluntary, without any coercion. You have the right to withdraw from the study at any time without any negative consequences.
  • Confidentiality:Your personal information and research data will be anonymized and strictly protected.
  • Safety and Well-being:Your health and safety will be protected during the research process.

Documentation and Transparency

The committee ensures the secure storage of all documentation (applications, review records, decisions) for a minimum of 5 years. To ensure transparency, the committee publishes an annual report on its activities.

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Important Notes:

  • Timeline Commencement:The specified timelines begin after a fully completed application has been submitted and the service fee has been paid.
  • What the Fee Includes:The fee covers one initial review and the subsequent verification of minor corrections requested by the committee.
  • Incomplete Documentation:In case of an incomplete submission, the timeline will be paused until the deficiencies are fully rectified.
  • Decision Format:The committee’s final decision (approval, request for modifications, or disapproval) is communicated to the researcher in writing via email.

Contact

For submitting research or for any other inquiries, please contact us:

info@gsa.ge