جامعة النجاح الوطنية
An-Najah National University

You are here

  1. Home
  2. Research
  3. Institutional Review Board

Institutional Review Board (IRB)

The Institutional Review Board (IRB) at An-Najah National University is a formally designated committee responsible for reviewing, approving, and monitoring research involving human subjects to ensure that ethical standards are implemented, and the rights, welfare, and safety of participants are protected. The IRB operates under both national regulations and international ethical guidelines, including the Belmont Report, Helsinki Declaration, and 45 CFR 46 of the Code of the American Federal Regulations. All projects that meet the definition of research with human subjects (45 CFR 46.102 ) must be reviewed and approved, or receive an exempt determination, by an IRB prior to beginning the research. The Board has the authority to approve, disapprove or make recommendations to proposed clinical research proposals to be conducted at An-Najah University or its affiliated institutions.

The An-Najah IRB consists of representatives from various university faculties and departments, each bringing expertise in fields such as Sharia, law, medicine, scientific research, and the humanities, in addition to public representatives with relevant backgrounds contribute an external perspective. The Dean of the Faculty of Medicine and Health Sciences serves as an Ex-Officio non-voting member, representing the administration. To ensure all members are familiar with ethical research practices and the principles behind the establishment of the IRB, they are required to complete the Human Participant Protections Education for Research Teams (or equivalent) online course. This ensures that the board remains informed and capable of addressing the complex ethical issues that arise in human subjects’ research.

  • Insurance that human subjects are not placed at undue risk

  • Insurance that human subjects are granted uncoerced consent to participate

  • Insurance the protection of research findings validity 

  • Compliance with the Palestinian legislations and internationally accepted standards

  • Research involving human subjects, as defined by 45 CFR 46 .

  • Research utilizing records or data collected from human subjects.

  • Research involving human biological specimens.

This includes any research falling into the following categories:

  • Research conducted by university faculty, staff, or students.

  • Research that is performed on university premises.

  • Research involving university faculty, staff, or students as participants.

  • Research that is undertaken as part of the completion of an award, degree, or course requirement.

  • Collaborative research involving multiple institutions in which the university is a participant.

The primary responsibilities of the IRB include:

  1. Ethical Review of Research: The IRB reviews all research protocols involving human subjects to ensure that the studies are ethically sound and minimize risks to participants. This includes evaluating the scientific merit of the study, the informed consent process, and the protection of vulnerable populations.

  2. Risk-Benefit Analysis: The IRB assesses whether the potential risks to research participants are justified by the anticipated benefits to the participants or society. The IRB ensures that risks are minimized, and participants' well-being is prioritized.

  3. Informed Consent: Ensuring that participants provide voluntary, informed consent is a key responsibility of the IRB. This includes reviewing consent forms and processes to guarantee that participants are fully aware of the nature, risks, and benefits of the research.

  4. Monitoring and Oversight: The IRB provides ongoing oversight of approved research projects. This includes reviewing any amendments to protocols, monitoring adverse events, and conducting periodic reviews for longer-term studies to ensure continued compliance with ethical standards.

  5. Ensuring Compliance with Laws and Regulations: The IRB ensures that all research complies with local, national, and international laws and ethical guidelines. This includes reviewing protocols for compliance with data protection laws, privacy regulations, and research standards for human subject protection.

  6. Protecting Vulnerable Populations: The IRB gives special consideration to research involving vulnerable populations, such as children, prisoners, and individuals with cognitive impairments. These populations require additional safeguards to ensure their rights and safety.

  7. Training and Education: The IRB ensures that all researchers and research staff involved in studies have completed the necessary ethical training. It may also conduct educational outreach to promote the importance of ethical research practices at the university.

The IRB at An-Najah National University has the authority to:

  1. Approve, Modify, or Reject Research Proposals: The IRB has the full authority to approve, require modifications, or reject research protocols. It ensures that research can only proceed once all ethical concerns are addressed and the necessary approvals are obtained.

  2. Suspend or Terminate Research: If a research project is found to be in violation of ethical standards, or if the risks to participants are found to be too high, the IRB has the authority to suspend or terminate the research. This includes stopping ongoing research that has already been approved if new concerns arise.

  3. Audit and Monitor Compliance: The IRB can conduct audits of research projects to ensure compliance with approved protocols and ethical standards. This includes reviewing data collection practices, informed consent procedures, and any reported adverse events.

  4. Review Amendments and Continuing Review: For studies that extend beyond the initial review period or undergo significant changes, the IRB has the authority to require continuing review and re-approval to ensure compliance with ethical guidelines.

© 2025 An-Najah National University

 

Nablus, Palestine

P.O. Box: 7

Phone: +970 (9) 2345113

Fax: +970 (9) 2345982

Email: [email protected]

Email: [email protected]

Contact Details