Research Ethical Clearance of Nutrition specific and sensitive research
a) Rationale
Kenya Nutritionists and Dieticians Institute draws its mandate from Section 6 to engage in priority area researches either actively or through training institutions and such bodies that deal on matters related to nutrition and dietetics in Kenya. KNDI conducts researches within the institute and/or in partnership with accredited departments training in nutrition and dietetics. As KNDI continues to implement this mandate a gap has been realized on ethical areas related to research. Currently Nutrition and Dietetics researches in the country are cleared by ERC recognized by NACOSTI.
This can be done by training institutions in collaboration with teaching and referral hospitals. In most cases representation of nutrition and dietetics is missing and issues that concern nutrition methodological approaches are not considered in-depth as would be done by the professionals themselves.
KNDI ERC will therefore take on their role to review and approve research protocols and proposals touching on nutrition and dietetics specific or sensitive matters in Kenya and beyond. This will ensure that before any research activity in this subject is permitted by NACOSTI, KNDI or ERC will have to give ethical clearance based on subject expertise of soundness and ethical procedures in research involving human and animal subjects with nutrition and dietetics component. This would also increase efficiency in ethical reviews for nutrition specific and sensitive research proposals/protocols.
b) Scope of the Ethical Review Committee
The guideline provides a framework for assessing ethics conformity of research proposals in nutrition and dietetics sensitive and specific matters in Kenya. It lays the foundation for enhancing the quality of research through the best possible ethics review by ensuring that highest standards in the composition of the committee that review proposals and the operational procedures. It emphasizes the duty of ethics review committee to safeguard the dignity, rights, safety and wellbeing of all actual or potential research participants and ensure that animals, if used for research, are treated humanely.
c) The Role of Ethics Review Committees
The Ethics Review Committee (ERC) is a committee established to review the ethics of nutrition and dietetics research involving human participants, tissue and data; and animals used in research in both community, food industry and clinical setting. The purpose of the ERC is to safeguard the dignity, rights, safety and well-being of all actual or potential research participants and ensure that animals, if used for research, are treated humanely. The ERC will ensure the full review and evaluation of all ethical aspects of the research proposals it receives before they are carried out to make sure they follow ethical guidelines as per the good practices in nutrition and dietetics in Kenya. The tasks of the ERC will be executed free of bias and influence.
The KNDI ERC has the authority to demand research protocol modifications, enforce and monitor all informed consent or client/patients’ rights issues and to suspend or stop any research that present problems within the scope of the subject prescribed by the Nutritionists and Dietetics Act., no. 18, 2007, the KNDI regulations and Code of Ethics for Nutrition and Dietetics. The ERC serves as the conscience of the scientific research community and the protector of the human (or animal) participants.
The KNDI ERC provides independent, competent and timely review of the ethics of the proposed studies. The ERC should also be involved in the on-going monitoring of the conduct of research projects that are approved by it.
The KNDI ERC will be responsible for acting in the interests of potential research participants and the concerned communities, taking into account the interests and needs of the researchers, and having due regard for the requirements of relevant laws including the Constitution of Kenya.