Institutional Review Board & Ethical Committee

Institutional Review Board & Ethical Committee (IRB & EC)

IRB & Ethical Committee is a formally designated body constituted to approve, monitor and review biomedical research involving human subjects and animals by conducting the risk-benefit analysis.

Ethics Committees Functioning at NUMS

·      NUMS Institutional Review Board and Ethical Committee (NUMS IRB & EC)

NUMS-Institutional Review Board & Ethical Committee (IRB & EC) has been constituted and is functional at NUMS for protecting the right and welfare of human volunteers & patients participating in a research study/clinical trial.

·   NUMS Institutional Animal Care & Use Committee (NUMS IACUC)

NUMS Institutional Animal Care & Use Committee (NUMS IACUC) has been constituted and is functional at NUMS for safeguarding the rights and welfare of animals utilized in research studies and clinical trials. This committee is dedicated to ensuring ethical and responsible animal research practices within the institution.

·   NUMS Institutional Review Board and Ethical Sub-Committee (NUMS IRB & EC)

A subcommittee of NUMS IRB & Ethical Committee has been constituted and is functional at NUMS to review and approve research studies/projects of M.Phil/MS and PhD students at the National University of Medical Sciences (NUMS)

·   PEMH Institutional Review Board and Ethical Committee for Clinical Trials (PEMH IRB & EC)

An IRB & Ethical Committee has been constituted and is functional to review, monitor and approve Clinical Trials in PEMH, AFIRI, AFIMH and AFIO.

AIM

To facilitate effective independent functioning of the IRB & Ethical Committee in NUMS and its constituent institutes/hospitals to ensure uniform ethical review process and sound scientific procedure for all research (biomedical and social science) projects involving human subjects and animal care, individuals or communities, including drug/device trial, surveys and any other research funded internationally or nationally.

Composition of NUMS Institutional Review Board and Ethical Committee (NUMS IRB & EC)
  • Members of NUMS IRB & Ethical Committee shall be appointed by the Vice Chancellor NUMS.
  • NUMS IRB Ethical Committee’s Board shall be constituted with a Chairperson and at least seven members along with 1 x external member from a non-scientific background for a minimum period of three years.
  • IRB & Ethical Committee shall work autonomously, and all protocols approved by IRB & Ethical Committee Chair shall bear the signatory seal/approval of the office of the Research
  • ORIC will facilitate ongoing professional development of IRB & EC members.
Role of NUMS Institutional Review Board and Ethical Committee (NUMS IRB & EC)
  • To ensure that appropriate steps are taken to protect the rights and welfare of human volunteers & patients participating in a research study/clinical trial.
  • To review all research projects involving human subjects to be conducted by medical faculty, social scientists, staff or students on scientific basis irrespective of the sponsor/funding agency.
  • To monitor the research study/project through appropriate well-documented procedures for example periodical reports, site visits and publications etc.
  • The board will also examine compliance with confidentiality of research data and regulatory requirements as per NUMS policy/ Pakistani laws/ICH –GCP principles.
  • To constitute a data safety and monitoring board for protocols involving more than reasonable risks and involving any safety concerns.
  • To safeguard rights of vulnerable subjects inclusive of autonomy and distributive justice in cases of soldiers, pregnant females, children and prisoners.
  • To identify and address potential conflicts of interest within IRB & Ethical Committee members, investigators, sponsors and monitors.
NUMS Institutional Review Board Process