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KAMPALA ISSUES NEW GUIDELINES FOR HUMAN-RELATED RESEARCH AS PROJECTS MUSHROOM

By Gloria Nakajubi

KAMPALA, jULY 15 — With more than 700 new research projects being initiated in Uganda, the government, through the Uganda National Council for Science and Technology (UNSCT), has issued new guidelines for research involving humans.

The event which 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 for the new guidelines, Maxwell Otim Onapa, the Deputy Executive Secretary of the UNSCT, noted that 80 per cent of all research projects in Uganda involved humans, meaning that tens of thousands of Ugandan children, women and men were being exposed to risks which might accrue from these initiatives.

“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 WAs no need to carry out research just for the sake of it, if it was not going to benefit the community.

“I 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 added.

Dr Christine Grady, the head of Department of Bioethics at the National Institute of Health, of the United States, highlighted in her keynote address the need for researchers to respect decisions of participants, especially as regards to 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, the National Drug Authority in regards to safety, quality, efficacy, handling and use of drug and drug related products or devices in research, the Uganda National Health Research Organization, and the Research Ethics Committee, 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.

SOURCE: NEW VISION

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