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The Uganda National Council for Science and Technology (UNCST) has released strict guidelines for scientific researchers for undertaking research on human beings.  

Human materials such as blood, urine, stool, saliva, hair, skin, nail clippings and other samples are usually collected by scientists for research purposes.

Under the new guidelines, researchers are required to obtain informed consent before obtaining human materials, avoid fabrication of data, avoid claiming false authorship, engage communities involved in research, sign agreements for data sharing and partnerships, ensure privacy and confidentiality of the data of participants.

The guidelines are intended to assist individuals and organisations plan, conduct and/or participate in research following sound scientific and ethical principles and protect human rights, justice and welfare. The guidelines target scientists engaged in clinical trials, medical research and student researchers undertaking scientific research work.

Penalties have been included in cases of plagiarism, falsification and fabrication where data from the researcher shall be withdrawn. The culprit will be referred to the National Information and Technology Authority as provided for under the Data Protection and Privacy Act in case of breach of privacy and confidentiality. The guidelines are titled: National Guidelines for Research Involving Humans as Research Participants, June 2023.

UNCST executive secretary Dr Martin Ongol said the revised guidelines from the 2014 edition take into consideration the changing national and international research landscape.

It handles issues such as e-informed consent, research in emergencies, genetics and genome research and research integrity. UNCST on February 15, 2024, presented the guidelines for validation to the scientific community in Uganda at the Kampala Serena Hotel.

Ongol said in the past two decades, the number of research protocols registered at UNCST has grown fourfold. A research protocol is written to detail a clinical study's plan to meet specified ethical norms for participating subjects.

“The growth has been observed not only in the number of research protocols but also in their complexity, which often requires review by a multi-disciplinary approach. These reviews are sequential and may produce different or even contradicting results or decisions from the respective regulatory bodies thus the importance of having a joint review mechanism," Ongol said.

He explained that the guidelines are intended to enhance the quality of the review, optimise review timelines, serve as a platform to allow regulators and institutional ethics committees to exchange and validate findings about the application and also act as a capacity-strengthening platform.

He rallied stakeholders to validate the guidelines so that they could be used as an assurance measure for the protection of research participants and to preserve the integrity of science.

(Photo by John Odyek)

What the regulation says

Makerere University Walter Reed Project executive director Dr Hannah Kibuuka, who is the chairperson of the national taskforce, presented the guidelines.

The guidelines emphasize the oversight role of Uganda National Health Research Organisation. The National Health Research Ethics Advisory Board is set up not for approvals of research but to provide guidelines on issues like political safety issues and help in arbitration where scientists have appealed.

Alongside the Data and Safety Monitoring Board there is a set up of the Safety Monitoring Committee which will work depending on risk categorisation of the study. Where the risk is high the board may be recommended.

For the Community Advisory Board (CAB) the term of office is four years and renewed once. CAB is a group of individuals selected from the community to facilitate dialogue between the community and a research team. The CAB member can serve one institution at a time and handle a maximum of three related studies within the same institution they are responsible for. CAB is required to give an annual report to PI for submission to UNCST.

National Biosafety Committee to be accredited by the National Biosafety Committee and the operating procedures of biosafety committees have to be followed. On the accreditation of Research Ethics Committees, the guidelines provide that at least 60% of the members shall not be affiliated to institutions.

In 2018 UNSCT inaugurated a task force to revise the guidelines to take into account the changing landscape. The force was chaired by Prof. Nelson Sewankambo with a team of 14 experts including state attorney Susan Nakabuye.

Brenda Nakazibwe team leader of the Pathogen Economy Science Technology Innovation secretariat in the Office of the President, said under the pathogen economy they undertake research where humans are involved.

She added that there was a need to get products to the market out of research from Uganda.

Nakazibwe said they are asking scientists to return from abroad but they have queried the availability of facilities and support systems which we are working on.

“We need Internet Protocols, we need to ensure the scientists are well taken care of and get a high percentage of return for their work, data is gold and we need to set up our own data banks,” Nakazibwe said. UNCST has also produced the ‘National Guidelines for Joint Scientific and Ethical Review of Research in Uganda, November 2023’.