The research activities have continued to grow in number and complexity in Kenya. Due to this, it became necessary to institutionalize and mainstream research ethics issues in the country. As a start, only Kenyatta National Hospital had a committee, KEMRI then established a committee which called itself National Ethics Committees. Other Committees came up in Moi University, Nyanza region, and at the Coast. They were under the Medical Directorate in the Ministry of Health.

In 2009, UNESCO was engaged and it was decided that guidelines for accrediting these Committees should be developed. The National Bioethics Committee (NBC) was thus formed under Health Science Schedule and members appointed in 2010. NBC is anchored under the Science, Technology, and Innovation (ST&I) Act, No 28 of 2013.

As part of Quality Assurance of Research, NACOSTI established the National Bioethics Committee (NBC) as per section 9 of the ST&I Act to provide an advisory role in accreditation of Institutional Ethics and Review Committees (IERCs).

The mandate of the Committee

  1. To ensure that the highest ethical (professional, moral, social, cultural, and legal) standards are maintained in research;
  2. Consider and review accreditation applications for Institutional Ethics And Review Committees (IERCs) in Kenya;
  3. Advise government on the scientific and technological requirements for the conservation of the natural and social environment in Kenya; and
  4. Maintain relationships with corresponding scientific organizations in other countries.

This status report focuses on the programmes and activities for the period 1st July 2020 to 30th June 2021 of NBC. The major activities undertaken by NBC are as below.

Quality Assurance

One of the key functions of NACOSTI is to consider applications for the grant of research licenses. The Commission receives and reviews all submitted research proposals before issuance of research licenses. However, there are proposals that require ethical review before consideration of application for a research license. NACOSTI has assigned the task of reviewing research proposals for ethical clearance to accredited Institutional Ethics Review Committees (IERCs). This is to ensure that research conducted in the country observes high standards research ethics.

These Committees are accredited by NACOSTI on the recommendation of the National Bioethics Committee (NBC) and are established in research institutions, universities and hospitals, As of 30th June 2021, there were thirty-two (32) accredited IERCs which can accessed using the following link:

Monitoring and Evaluation of IERCs

NACOSTI conducts Monitoring and Evaluation (M&E) of Institutional Ethics Review Committee. During M&E, data is collected on the composition, training, secretariat, infrastructure and equipment, review of protocols and all associated undertakings of IERC. The objectives of M&E visit are to assess IERCs preparedness; Assess compliance to the set standards; and assess suitability of expansion of the scope of accreditation. In 2020/2021 FY, NACOSTI in collaboration with NBC conducted M&E of the following five (5) Institutional Ethic Review Committees as per the table below.

Table 1: Monitoring and Evaluation of IERCs

No Institutional Ethics Committee Scope of accreditation Date of M&E Visit
1 Great Lake University of Kisumu (GLUK) IERC Public Health 2nd October 2020
2 Daystar University IERC Social and environmental sciences 22nd October 2020
3 University of Eastern Africa, Baraton Health science 26th May 2021
4 United States International University – Africa Social and environmental sciences 17th May 2021
5 Alupe University College Yet to be accredited 25th May 2021

Institutions set to be monitored in this FY is as shown in the table below:

Table 2: IERC to be visited.

NO. Institution Purpose of the visit
1 Jomo Kenyatta University of Agriculture and Technology Assess the capacity and personnel to expand the mandate
2 Jaramogi Oginga Odinga University of Science and Technology Assess the capacity and personnel to expand the mandate
3 Adventist University of Africa Assess preparedness for accreditation
4 St. Paul’s University Assess preparedness for accreditation
5 Tangaza University College Assess preparedness for accreditation
6 Kisii Teaching and Referral Hospital Assess preparedness for accreditation
7 Meru University of Science and Technology Assess preparedness for accreditation
8 Dedan Kimathi University of Technology Assess preparedness for accreditation
9 Pan Africa Christian University Assess preparedness for accreditation

Accreditation of Institutional Ethics Review Committees

In 2020/21 FY, thirteen (13) IERCs were accredited/reaccredited as per the table below.

Table 3: Institutional Ethics Review Committees and Area of Accreditation

NO. Institutional Ethics Committee Area accredited
1 Laikipia University IERC Social, Biomedical and Environmental Sciences
2 Kenya Medical Research Institute Scientific and Ethic Review Committee Health and Biomedical Research
3 AIC Kijabe Hospital IERC Health, Biomedical, Biological, Social and Environmental sciences
4 The Nairobi Hospital Research Protocols involving human participants
5 Strathmore University Social sciences
6 Mt. Kenya University Health sciences
7 JOOUST Biomedical sciences
8 Kabarak University Social, Biomedical and Environmental Sciences
9 Aga Khan University Hospital Research protocols involving human participants
10 Moi -MTRH Biomedical and human participants
11 AMREF Research protocols involving human participants
12 Africa International University Research protocols involving human participants
13 Masinde Muliro University of Science and Technology Health sciences

The following IERCs applied for accreditation, and they are currently under review

Table 4: New IERC applications

NO. Institutional Ethics Committee Area requested for accreditation
1 Great Lakes University of Kisumu Public health
2 Pwani University Biomedical, Physical, social and Environment sciences
3 University of Eastern Africa Baraton Health science

Meetings of National Bioethics Committee (NBC)

During the period under review NBC held three meetings. The meetings were held virtually as planned.

S/No. Meetings Date
1 1St Quarter – The 35th NBC meeting 27th August 2020
2 2nd Quarter - The 36th NBC meeting 10th December 2020
3 3rd Quarter – The 37th NBC meeting 18th February 2021

Capacity Building of Institutional Ethics Review Committees

NACOSTI recognized the need to provide standardized basic training for IERC members to improve on the discharge of the delegated mandate of reviewing research proposals for ethical clearance to IERCs. The Commission developed a curriculum in Research Ethics to be used to train the IERC members.

NACOSTI in collaboration with the University of Nairobi’s Strengthening Research Ethics Review and Oversight in Kenya (STReK) project organized for two (2) online training workshop for members of IERCs. The training took place on 18th – 22nd January 2021 and 24th – 27th May 2021. They both attracted seventy three (73) participants.

Furthermore, NACOSTI collaborated with Kenya National Commision for UNESCO (KNATCOM) organized a four-day training workshop for members of IERCs from 7th – 10th June 2021 in Nakuru. The training attracted fifty (50) participants.

The participants were drawn from various institutions including Public universities, private universities, public Hospitals, private hospitals and research institutions.

Develop Ethical Guidelines For Health Research In Response To Covid – 19 Pandemic In Kenya

The responses to pandemics such as COVID-19 pandemic create extraordinary circumstances such as isolation, quarantining, limited freedom, compassionate use of drugs and clinical trials among many other containment measures some of which raise ethical issues and dilemmas. In view of NACOSTI’s mandate and functions, and in response to the current COVID-19 pandemic, the Commission found it prudent to develop guidelines for health emergencies in response to COVID-19 pandemic in Kenya.

NACOSTI through National Bioethics Committee (NBC) constituted adhoc committee to spearhead the development of Ethical Guidelines for Health Research in response to COVID-19 pandemic in Kenya.

The draft prepared by the adhoc committee was presented to NBC members for input. This was then subjected to other stakeholders through a workshop which was held virtually.

The adhoc committee incorporated all comments received from stakeholders and presented to the 36th NBC meeting on 10th December 2020 which was in turn adopted for publishing and dissemination.