Institutional Review Committee (IRC)

An independent body constituted of medical and non-medical members, whose responsibility is to verify that the safety, integrity and human rights of the subjects participating in a particular research projects are protected and to consider the general health research ethics, thereby providing public reassurance. It should be constituted and operated so that their tasks can be executed free from bias and from any influence of those who are conducting the health research in the respective institutions.

IRC Approval

It means the decision of the IRC that the proposal has been reviewed and may be conducted at an institution within the conditions set forth by the IRC.

Principal Investigator

Main person responsible for overall aspects of the particular research Project.


A document which states the background, rationale and objectives of the research project and describes its design, methodology including statistical considerations, and the conditions under which it is to be performed and managed. The protocol should be dated and signed by the investigator.


A systematic investigation., including research development, testing and evaluation designed to develop or contribute to generalizable knowledge.

Research Participant

An individual who is or becomes a participant in research, either as a recipient of the test article or as a control. A participant may be either a healthy individual or a patient.

Raw Data

All records or certified copies of original observations, clinical findings or other activities in a research project. Such material includes laboratory notes, memoranda, calculations and documents, as well as all records of data from automated instruments or exact verified copies in the form of photocopies, microfiches etc. Raw data can also include photographic negatives, microfilm or digital media (e.g. computer diskettes).




The objective of this Guideline for Institutional Review Committees (IRCs) for Health Research in Nepal is to establish a consistency in three major areas:

  1. In the formation of IRC's in the Health Institutions,
  2. In the ethical review procedures that will be undertaken by the Health & Research Institutions, and
  3. In the supervision & monitoring procedures

Role of an IRC

  1. The role of an IRC in a Health Institution is to safeguard the dignity, right, safety & wel1 being of al1 the research participants. It should always take into considerations the basic principles of ethics as dignity/respect of the person, the value of beneficences, justice etc. without compromising the scientific merit and quality of research.
  1. The IRC should be aware of and fol1ow the Ethical Guidelines for the Care and Use of Animals in Health Research in Nepal when the research is applicable to animals.
  2. The IRC should provide independent, competent, and timely review of the research proposal. The IRC's should be independent from political, institutional, professional and market influences.
  3. The IRC's are responsible for carrying out the review of proposed research before the commencement of the research. The IRC should also ensure that there is proper supervision and a regular evaluation of the proposal project work once it has been approved.

Establishing a System of Institutional Review Process

Every Health Institution which undertakes the health & biomedical research should develop an IRC to ensure the broadest possible coverage and protection for potential research participants. It should work within the framework of highest possible ethical and the scientific standards in biomedical research.

  1. It is mandatory that IRC must be independent, multidisciplinary, multi sectoral and pluralistic in nature.
  2. A mechanism for co-operation and communication needs to be developed between the IRCs and National Ethical Review Board must exist.
  3. Procedures need to be established for review of biomedical research protocols carried out in the institution.
  4. The IRC should also develop and establish a mechanism to educate & train members of its IRC in order to maintain a high ethical and scientific standard.
  5. IRC requires administrative and financial support.

IRC's Role in Supervising and Monitoring Health Research

An institution and the IRC have the responsibility to ensure that t/"le conduct of all research approved by the IRC is monitored by procedures and/or by using existing mechanisms within the institution. The IRC should establish a follow-up procedure for following the progress of all research studies for which a positive decision has been reached, from the time the decision was taken until the termination of the research. The ongoing lines of communication between the IRC and the researcher should be clearly specified. The frequency and type of monitoring determined by the IRC should reflect the degree of risk to participants in the research project.

  1. Provide guidelines to the researcher and help the researcher to follow those guidelines.
  2. Ensure relevance of the research to national and scientific needs.
  3. Monitor the progress of the research to see whether it has remained true to the proposal accepted by IRC's through periodic review process.
  4. Review the proposed revision in the original research proposal (if necessary) and approve or disapprove it. An IRC shall require that researchers immediately report anything which might warrant additional review of ethical approval of the protocol including:
  5. Serious or unexpected adverse effects on participants.
  6. Proposed changes in the protocol; and
  7. Unforeseen events that might affected the continual ethical acceptability of the project
  8. Review the problems (if any) in the implementation of the research proposal and guide the researcher to solve them.
  9. Provide feedback to the researcher in the research process particularly on problem identification, methodology, data analysis, lacunae identified in the ethical and scientific aspects of research (if any) and advice on corrective steps to be taken.
  10. The IRC shall require researchers to inform the IRC and give reasons if the research project is discontinued before the expected date of completion
  11. Advice regarding the soundness of the conclusions reached on the basis of results of the study and their relevance to the scientific body of knowledge as wel1 as to the health services.
  12. Advice on the dissemination process and use of research findings in further research.
  13. Advice on the application of research findings into practice.


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