Institutional Research Ethics Committee (IREC) was established to review and consider for approval all ILRI research activities involving human subjects with a view to safeguard their dignity, rights, safety and well-being and the wider community.

IREC bases its justification on the fact that however important the research goals can be, the research should never be permitted to override the health and well-being of the research participants.

IREC ensures that the cardinal principles of research ethics (autonomy, beneficence, non-maleficence and justice) are followed in planning, conduct and reporting of ILRI research. For this purpose, it covers the aspects of informed consent; harms, risks and benefits; distribution of these; management of these and provisions for appropriate compensations wherever required. IREC reviews research activity proposals before the start of the study and develop procedures for monitoring the research throughout the study until, and after completion. The committee will also examine compliance with all regulatory and donor requirements, applicable guidelines and laws, including national (local) laws.

ILRI IREC is registered by NACOSTI in Kenya and is accredited to grant ethical approval to research projects involving human subjects. The approvals granted are therefore recognized by the government of Kenya.

Application and Approval Process

An application for ethics review of a research study is made by the Principal Investigator (PI) for that study. All applications must be in English and submitted through the research compliance online review platform. The IREC secretariat then checks all submitted applications for completeness and correctness. Only complete applications are sent to IREC Members for review.

All proposals should be submitted in the prescribed application form. The purpose of this form is to identify whether research activities require NO (no ethical issues), BRIEF (low sensitivity ethical issues only) or IN-DEPTH (high sensitivity ethical issues) Ethical Review. All relevant documents, as specified in the relevant application form(s), should be enclosed along with the application form.

The average turnaround time from date of the meeting to final approval of a new application is estimated at three (3) to six (6) weeks, and can be more or less, depending on the quality of the application, the nature of the proposed research and the PI’s response time to the IREC’s review.

Proposal review meetings of the IREC are conducted electronically. Members with a conflict of interest will withdraw from review of a proposal. Decisions are taken by consensus after discussions and, when needed, voting is carried out. A minimum of four members is required to make a decision on approval. Discussions and acceptability will be synthesized within one week of the meeting and conveyed to applicants by email. Decisions may be to; approve, reject or revise the proposals. Specific suggestions for modifications and reasons for rejection are given. Applicants may also be invited to a face-to-face meeting to provide further information and/or clarifications. Independent consultants/experts may be invited to offer their opinion on specific applications if considered needed but they are not involved in decision-making. IREC decisions are communicated to the applicants (PIs) through duly signed letters of approval. The approval letters were signed by the IREC Chair and sent to the applicants by the Secretariat.

Training

IREC acknowledges that the foundation for effective implementation of all facets of ILRI human research ethics and for efforts to promote compliance lies in a comprehensive and mandatory education program for all its members. It is therefore the policy of IREC that all its members complete initial and ongoing trainings as necessary.

All IREC members are required to complete relevant modules being offered by Collaborative Institutional Training Initiative (CITI). This is an internet - based course in human research protection and bioethics, and is designed specifically for all personnel that have a significant involvement in planning, conduct and analysis of any scientific activity that employs human research participants. Research personnel are also encouraged to undertake the same modules.

Policies and Manuals

The objective of the IREC Guideline Manual is to provide guidance to ILRI IREC in ensuring quality and consistency in the ethical review of research conducted by or at ILRI.
Please refer to the manual for further information.

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