Ministry of Health Research Division

The section of Human subject protection operates with the fundamental ethical recognition that human subjects are partners and participants in health research and as such, the highest quality of ethical standards is warranted in research conducted in Malawi. This section is spearheaded by Mr Billy Nyambalo.

The backbone of any HSP program, including the Ministry of health Research department, is the fulfilment of nine functions that are delineated in the federal regulations (Department of Health and Human Services, 2009):

  1. The risks of the research are minimized;
  2. The risks to subjects are reasonable in relation to anticipated benefits;
  3. The selection of subjects is fair;
  4. Each participant gives a voluntary and informed consent;
  5. When appropriate, the research plan makes adequate provisions for monitoring the data collected to ensure the safety of subjects;
  6. There are adequate provisions to protect the privacy of subjects and to maintain the confidentiality of data;
  7. Conflicts of interest are transparent and appropriately managed;
  8. Consideration is given to what additional protections, if any, are needed for vulnerable populations; and
  9. Proper training in human subjects’ protections is provided for research personnel.

Additionally, the section facilitates the following functions:

  • Advise the government including the MOH on all scientific and ethical aspects
  • Review for clearance all research proposals with a health science content from researchers, whatever their discipline.
  • Offer guidance in relation to each research proposal, on the balance between the use of laboratories and expertise outside of the country, and import of techniques and equipment into the country
  • Review and clear for publication all materials originated from studies approved by NHSRC
  • Encourage and make recommendations to government on contacts among research scientists of varying capabilities and/ or attachments to advanced research centers, within and outside Malawi, for the purpose of upgrading research manpower and skills.
  • Enhance capacity building and promote health research especially among local professionals
  • Ensure proper collection, acquisition, dissemination, use, storage and management of research information