Human subject research ethics refers to the moral principles that guide researchers when conducting studies involving human participants.

Some studies may offer direct benefits to participants, while others contribute to broader scientific knowledge that ultimately benefits society. Discoveries from such research support the development of more effective, personalized treatments and healthcare strategies.

Because research outcomes are never entirely predictable, it is essential that all studies are conducted with both scientific integrity and strong ethical oversight.

At the L.A. Orbeli Institute of Physiology, protecting the safety, rights, and well-being of research participants is a top priority. To ensure ethical review and oversight of all research involving human subjects, the Institutional Review Board (IRB) has been established. The IRB works in close collaboration with the Institutional Biosafety Committee (IBC) and Institutional Animal Care and Use Committee (IACUC) to uphold ethical and regulatory standards across all areas of research.

All employees and students involved in research with human participants are required to complete the online training module “Ethical principles in research involving human subjects”.

Autonomy – Every individual has the right to make a free, informed choice about joining a
study, with full understanding of its purpose, risks, and benefits, and the option to withdraw
without penalty.
Beneficence – Research should aim to produce meaningful benefits for participants or society,
and be carried out to the highest ethical and professional standards.
Non-Maleficence – Researchers must avoid causing harm, reduce risks to the lowest possible
level, and ensure that no harm is disproportionate to potential benefits.
Justice – The benefits and burdens of research must be shared fairly, with participant selection
based on scientific goals rather than convenience or vulnerability.

The IRB holds key responsibilities before, during, and after a biomedical research project is
approved, conducted, and its results are evaluated and reported. Its role covers the entire research
process, with the primary goal of ensuring that all biomedical research is conducted ethically.
The IRB operates in accordance with the procedural standards outlined in its Statute and Rules of
Procedure (insert links – one to Statute, another one to Rules of Procedures).
The Committee consists of five members, including Chair, with the option to increase this
number as necessary to meet evolving requirements. If a proposed study falls outside the

expertise of the current members, the IRB may invite external consultants to provide specialized
guidance during the review process.

IRB Chair: Margarita Danielyan, P.h.D.

Contact information: [email protected]

Statute of the Institutional Review Board (IRB)

L.A. Orbeli Institute of Physiology, National Academy of Sciences, Republic of Armenia

Legal Basis and Establishment

The Institutional Review Board (IRB) is established by L.A. Orbeli Institute of Physiology of
the National Academy of Sciences of the Republic of Armenia, in accordance with national
legislation and international principles regulating biomedical research and ethical review.
The IRB operates as an independent body to ensure the ethical conduct of research involving
human participants and/or identifiable personal data.

Purpose and Scope

The purpose of the IRB is to:

• Protect the rights, dignity, safety, and well-being of research participants;
• Promote ethical and responsible research practices in line with international and national standards.

The IRB is responsible for the ethical review of:

• Research involving human participants conducted under the auspices of the Institute;
• Collaborative research projects involving national or international partners;
• Studies involving identifiable personal or health data.

Researchers must incorporate the IRB's ethical recommendations prior to starting their
studies.

Composition and Membership

The Board consists of five members, including Chair, with the option to increase this number
as necessary to meet evolving requirements. If a proposed study falls outside the expertise of
the current members, the IRB may invite external consultants to provide specialized guidance
during the review process.

The IRB shall include members from varied disciplines to ensure balanced and competent
review. It must include:

• Members with expertise in relevant scientific fields, biomedical or clinical research, research ethics, law, and regulatory standards.
• One lay member, not affiliated with biomedical research, to represent the public perspective.
• One member, not affiliated with the Institute except for Board membership.

Appointment of Members

Members, including the Chair, are appointed by the Director of the Institute of Physiology,
following a transparent process based on:

• Professional qualifications and research ethics experience;
• Ability to make independent judgments;
• Contribution to balanced Board composition.

Appointments are for a three-year term, renewable once. Appointed members receive a
formal letter of appointment.

Responsibilities of IRB Members

All members are expected to:

• Review applications thoroughly and impartially;
• Attend meetings regularly;
• Declare and manage any conflicts of interest;
• Maintain confidentiality of documents and discussions;
• Participate in ongoing training.

Conflicts of Interest

At the time of appointment, and on an ongoing basis, IRB members must declare any actual
or potential conflicts of interest. These must be documented and updated regularly. Members
with a conflict must abstain from reviewing or voting on the related proposal.

Confidentiality

All IRB members, administrative staff, and external experts must treat all submitted
materials, meeting discussions, and decisions as confidential.
Confidentiality supports open discussion during meetings and protects sensitive information.

Reporting

The IRB shall provide annual reports to the Director of the Institute of Physiology and the
Ethics and Compliance Committee. These reports will summarize:

• Number and types of protocols reviewed;
• Decisions issued;
• Training activities conducted.

Record Keeping

All records shall be stored securely in accordance with data protection regulations and
institutional policies. Access to these records is limited to authorized IRB personnel and
institutional oversight bodies.

Revision and Amendment of the Statute

This Statute may be amended by the Director of the Institute of Physiology, in consultation
with the IRB, to reflect changes in national legislation, international guidelines, or
institutional priorities.

Institutional Review Board (IRB)

L.A. Orbeli Institute of Physiology, National Academy of Sciences, Republic of Armenia

Purpose

These Rules of Procedure are established to guide the operational and decision-making processes
of the Institutional Review Board (IRB), as defined by the Statute of the IRB. They ensure
consistency, transparency, and adherence to ethical standards in the review of research involving
human participants or identifiable personal data.

Scope

These rules apply to all activities, meetings, and decisions of the IRB and are binding on its
members, administrative staff, and external consultants involved in the IRB`s work.

Responsibilities
Chair:
– The Chair is responsible for overseeing the operation of the IRB, ensuring that meetings
are conducted in an orderly and efficient manner, and making final decisions on the IRB’s
activities. The Chair also has the casting vote in the event of a tie.
Vice-Chair:
– The IRB does not have a permanent Vice-Chair position. However, in the event of the
Chair’s absence or recusal due to a conflict of interest, the Chair will nominate a member
of the IRB to temporarily assume the Chair’s responsibilities for that meeting or decision-
making process. This ensures continuity and allows for smooth operations without the
need for a formal Vice-Chair role.

Members:
IRB members are responsible for reviewing applications impartially, attending meetings
regularly, declaring conflicts of interest, maintaining confidentiality, and contributing to
the development of ethical guidelines and standards.

Preparation for and Conduct of Meetings

• The IRB shall convene at least quarterly and additionally as needed, depending on the number of submissions.
• Extraordinary meetings may be called by the Chair or at the request of at least one-third of the members.
• Members shall receive written notification of each meeting, with the agenda and relevant materials, at least 7 days in advance.
• Regular attendance is expected. Members unable to attend must notify the IRB Secretariat in advance.
• Members who miss more than two consecutive meetings without a valid reason may be subject to review by the Chair. Participation in meetings via an online format may be permitted under certain conditions, subject to the Chair’s approval.
• A quorum requires the presence of more than half of the appointed members, including at least one lay member.
• If a quorum is not met, no decisions shall be made, and the meeting may proceed for discussion purposes only.

Submission and Review Procedures

Submission

Researchers must submit a complete application including:

• Research protocol
• Informed consent documents
• Data protection and confidentiality measures
• Tissue transfer agreement/MOU with the medical facility
• Other applicable materials (e.g., recruitment flyer, information booklet, etc.)

Applications must be submitted via the website https://era-chair.am/ and the IRB Administrative
staff will review the submissions for completeness before assigning them to the agenda.

Primary Reviewers

• The Chair may designate one or more members as primary reviewers for each protocol, based on expertise.
• Primary reviewers shall present a summary of the study and ethical concerns at the meeting.

Decision-Making
The IRB may issue the following decisions:

• Approval
• Conditional Approval (subject to revisions)
• Deferral (pending further information)
• Rejection

Decisions shall be made by consensus, or majority vote if consensus is not possible.

Voting

• Each member has one regular vote.
• Voting may be conducted by show of hands or secret ballot, as determined by the Chair.
• Decisions are made by majority vote of the members present, provided a quorum is met.
• In the event of a tie (equal number of votes for and against), the Chair shall have a casting vote, which is a second, tie-breaking vote, in addition to their regular vote as a member.

Procedure for Handling Differing Opinions

In cases where IRB members express differing ethical opinions during the review process, the
Chair shall facilitate open and respectful discussion to explore the basis of the disagreement.
If consensus cannot be reached, a decision may be postponed to a subsequent meeting in order to
seek additional information or expert advice, provided that a majority of the members present
and voting support this action. Alternatively, the decision shall be made by a majority vote.

The final decision, along with a summary of the differing viewpoints, should be documented in
the meeting minutes. Dissenting opinions may be formally recorded upon request of the
concerned member.

Expedited Review Procedures

The IRB will use expedited review procedures for research applications involving minimal risk
to participants, such as non-invasive procedures and studies using de-identified human residual
tissues.
Expedited review shall be carried out by two IRB members designated by the Chair. Both
members shall independently review the submission and provide their opinions and
recommendations to the Chair.

The Chair will consider the reviewers’ feedback and make the final decision regarding:

– Approval
– Requesting modification or additional information
– Referral of the application to the full IRB if concerns arise or if the risk is assessed as
more than minimal

The opinions of the two reviewers and the Chairperson’s decision shall be documented and
retained in the IRB records. The timeframe for completing expedited review by designated IRB
members shall not exceed 10 working days.

The Chair shall present a summary of expedited reviews conducted at the next full IRB meeting.

Exemption from IRB Review
The Chair or a designated member shall review the research application to determine whether it qualifies for formal Exempt status.

Conflicts of Interest

Members must declare any actual or potential conflicts of interest at the start of each meeting or
upon receipt of materials.
A conflicted member shall not participate in the review, discussion, or voting on the affected
protocol and must leave the room during the decision.

Confidentiality

• All documents, discussions, and decisions are strictly confidential.
• Members must sign a confidentiality agreement upon appointment.

External Expertise

The IRB may seek external expertise when necessary to assist in the ethical review of research
protocols. External experts will be required to follow the same confidentiality and conflict of
interest rules as IRB members. They are also expected to maintain the same standards of
impartiality and ethical conduct during the review process.
External consultants do not have voting rights and will serve in an advisory capacity only. Their
input will be considered by the IRB when making decisions, but the final decision rests with the
IRB members.
Meeting Minutes

Detailed minutes of each meeting shall be recorded, including:

• Attendees and quorum confirmation
• Summary of discussions
• Decisions and voting outcomes
• Any dissenting opinions (if requested)

The minutes shall be sent to IRB members for review and approved prior to the next meeting.
Minutes shall be archived securely.

Communication of Decisions

Researchers shall be informed of the IRB’s decision within 10 working days following the full
committee meeting. For protocols reviewed under the expedited procedure, the decision shall be
communicated within 4 weeks from the date of application submission
The decision letter must include:

• The decision category
• Required modifications or conditions
• Rationale for rejection or deferral, if applicable

Appeals and Resubmissions

Researchers may submit a written appeal within 30 days of receiving a decision. Appeals shall be
reviewed at a subsequent meeting, with the researcher given the opportunity to present their case.

Communication with Researchers

The IRB will maintain effective communication with research applicants throughout the review
process. This includes the possibility of meetings or discussions with the applicant before the
formal IRB assessment. These communications aim to clarify any ethical concerns and ensure
that the research proposal is properly understood by both parties prior to the formal submission
and evaluation.

Training and Capacity Building

IRB members are required to complete initial training before participating in reviews.
Ongoing training is organized by the Chair or designated personnel to ensure members are kept
up to date with research ethics, regulations, and best practices.

Record Keeping and Archiving

The IRB is required to maintain comprehensive and accurate records of its operations, including:

• Submitted research protocols and supporting documents
• Meeting minutes with IRB decisions
• Conflict of interest declarations
• Copies of correspondence with researchers and relevant institutional bodies

All IRB records shall be stored securely for a minimum of 5 years. Access is restricted to
authorized personnel and relevant oversight bodies.

Amendments

These Rules may be amended by majority vote of the IRB, subject to approval by the Director of
the Institute. Amendments must be documented and circulated to all members.

Before beginning any research involving human participants, all investigators must
submit study protocol for IRB review and approval. The protocol should outline the
study’s purpose, methodology, participant protections, and ethical considerations to
ensure compliance with institutional regulations and policies. Investigators should also
submit any other relevant documents alongside the protocol. A protocol template is
available for download.
IRB full committee meetings are held quarterly. If a study qualifies for expedited review,
the protocol will be evaluated by two IRB members, who will provide feedback to the
Chair. Investigators will be notified of review outcomes within 10 working days after the
review is completed. Please note that researchers must still submit an application to the
IRB and obtain formal approval even for studies qualifying for Exempt status.

Forms and templates needed to complete an IRB application are available here. Please use these documents and adjust them as appropriate for your specific study.

All members of the Human Research Ethics Committee are required to undergo training on the protection of human research participants and the responsibilities of the Committee. By completing this training, members will become familiar with the regulations for reviewing research applications, ethical principles, and institutional policies. To successfully complete the course, participants must correctly answer at least 80% of the questions. In case of failure, it is possible to review the materials again and retake the test.

All IRB members are required to complete training in human subjects research protections and IRB responsibilities. This training ensures members are familiar with the regulations, ethical principles, and institutional policies that guide the review of research applications. Successful completion of the course requires a score of at least 80% on the quiz. Training materials may be reviewed, and the quiz may be retaken if needed.

Go to Course

• Oviedo Convention – Council of Europe
• International Ethical Guidelines for Biomedical Research Involving Human Subjects – CIOMS
• Armenian Legislation – Act 98338
• Armenian Legislation – Act 152295
• Ethics and Data Protection – EU Horizon Guidance
• Ethics in Social Science and Humanities – EU Horizon Guidance