Gov’t issues new research regulations
Publish Date: Jul 14, 2014
Gov’t issues new research regulations
Director General, Uganda National health Research organization, Doctor Sam Okware (2nd right) interacts with the senior ENT consultant, Sam Zaramba (left) as Dr. Maxwell Otim, the deputy executive secretary UNCST looks on during the Conference at Kampala Serena hotel. Photo/Juliet Kasirye
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By Gloria Nakajubi

With over 700 new research projects initiated in the country, government through the Uganda National Council for Science and Technology (UNSCT) has issued new guidelines for research involving humans.

The event that took place during the 6th Annual National Research Ethics Conference at the Serena Hotel in Kampala recently attracted researchers and health experts from across the continent.

While explaining the rationale of the new guidelines, Maxwell Otim Onapa, the deputy Executive Secretary, UNSCT noted that 80% of all research projects in the country involve humans meaning that tens of thousands of Ugandan children, women and men are exposed to the risks that may accrue from these initiatives.

ENT senior consultant Sam Zaramba (right) interacts with the executive secretary NDA, Gordon Katende (left) as doctor Maxwell Otim, the deputy executive secretary Uganda National council for science and technology looks on. Photo/Juliet Kasirye

“The whole objective of these guidelines is to establish a coherent regulatory framework for conduct of research involving humans without compromising their rights and welfare,” he said.

According to the new guidelines, all research should be conducted for the benefit of communities without causing unnecessary harm or inconvenience let alone compromising the rights and welfare of research participants.

While launching the guidelines, the State Minister of Finance, Planning and Economic development, Matia Kasaija noted that there is no need to carry out research for the sake of it, if it’s not going to benefit the community.

“Am not saying don’t carry out research, but the reason for doing so should be of higher value to society such as improving lives and coming up with innovations,” Kasaija said.

Dr Christine Grady, head of Department of Bioethics at the National Insitute of Health, USA, in her key note address highlighted the need for researchers to respect decisions of participants especially as regards withdrawal from the project.

“Voluntary participation is research depends on not only the respondent’s ability to understand what it is about but the impact it might have on their lives,” Grady advised.

As highlighted in the guidelines research participants should be given the opportunity to make choices about what should be done on them and more so withdraw at any time without penalty.

“A community leader may not consent for participation of community members in research without the individual research participants’ informed consent,” the document states.

The document also highlights care and treatment for research participants where these are entitled to fair compensation for inconveniences, time spent and expenses incurred in taking part in the study such as travel costs, refreshments, and meals among others.

As regards vulnerable groups, the new guidelines stipulate among others that research can only be conducted in this group and individuals if the objective of the research can not be addressed using non-vulnerable groups and individuals.

The other key requirement of any research undertaking in the country is seeking approval from the relevant regulatory authorities such as UNSCT, the lead body, National Drug Authority in regards to safety, quality, efficacy, handling and use of drug and drug related products or devices in research, Uganda National Health Research Organisation, Research Ethics Committees among others.

Onapa cautioned that non compliance with these guidelines may lead to revocation of the study, withdrawing research registration permits, suspension and eventual termination of the studies among others.

For her contribution towards bioethics and mentorship in research spanning over 13 years, Dr Florence M Mirembe formerly working with Makerere University was honoured with the 2014 national bioethical award.




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