The Copperbelt University-Biomedical Sciences Research Ethics Committee (CBU-BREC) was established by the University management in 2020. It was registered as a Research Ethics Committee by the National Health Research Authority (NHRA) in 2021. The Committee comprises 11 scientists from various disciplines within the University. Its mission is to be an ethics committee that ensures all health research activities within and beyond the University are conducted according to recommended standards. The committee falls under the Directorate of Research, Innovation and Consultancy (DRIC) of the University and its Secretariat is based at the Michael Chilufya Sata School of Medicine campus in Ndola.

The following are the terms of reference of Committee:

  1. To review ethical aspects of submitted proposals
  2. To inspect, as far as practical, the conduct of projects to ensure continued compliance with approved ethical standards
  3. To receive and investigate complaints concerning research and make recommendations to the Investigator and Director, Research, Innovation and Consultancy (DRIC)
  4. To provide timely reports to Director of the Directorate of Research, Innovation and Consultancy
  5. To maintain a register of all submitted proposals by approved and not approved status.
  6. To consider and report on any matter referred to it by the Vice Chancellor
  7. To review the Terms of Reference at the first meeting of each calendar year.

REVIEW MEETINGS

The committee meets quarterly to review submitted research proposals. However, there may be ad hoc meetings for research proposals that will be submitted for expedited review.

CBU- BREC RESEARCH PROPOSAL REVIEW PROCESS

APPLICATION PROCEDURE

 Any investigator wishing to have their research protocol reviewed by the CBU-BREC shall submit it to the secretary of the Committee. Once the review is complete, any comments or questions arising shall be communicated to the Investigator.

REQUIREMENTS.

The following are the general requirements and required documents expected of any protocol to be submitted to the CBU-BREC for ethical review:

  1. An Application letter signed by the Investigator requesting ethical review clearly indicating the Title of project, name of sponsor, name of Principal Investigator and date of application;
  2. National Health Research Authority (NHRA) registration certificate of supervisor, if the applicant is an undergraduate student, but for Masters and PhD students, applicants have to submit their NHRA registration certificates.
  3. Three hard copies of the protocol and an electronic of the same to the secretary
  4. Evidence of payment of an appropriate fee as may be determined by the Committee from time to time.
  5. The protocols must be submitted in English
  6. Protocol amendments may be submitted at least a week before the next review meeting- but should not be implemented before ethical approval.
  7. Any other information relevant to the study may be submitted to the committee at any time.
  8. A statement of agreement to comply with ethical principles set out in relevant guidelines
  9. Include all significant decisions obtained previously from other RECs and or regulatory agencies concerning the proposed study, irrespective of  whether the protocol has been amended or not. The reasons for the previous decisions should be provided.
  10. Updated and signed Investigator(s)’s curriculum vitae
  11. Signed complete protocols with supporting documents and annexes, Case  report forms, diary cards, and other questionnaires intended for the  research participants;
  12. The protocol must include a summary with a maximum of a page,
  13. Written and other forms of subject information intended for research participants, which are clearly identified and dated; in English and translated (where necessary) in a language(s) understood by potential participants.
  14. Informed consent document, which is clearly identified and dated and its translation into language, potential participants would understand. The informed consent must also have a statement about compensation for study participants where indicated, expenses, and access to medical care for the participants, that it is completely  voluntary, that they will not suffer any penalty for refusing to take part in the study.
  15. Samples of materials to be used for the recruitment of participants, such as advertisements.
  16. A description of arrangements for indemnity, if applicable;
  17. A description of the arrangement for insurance of research participants, if applicable.

FEES FOR ETHICAL REVIEW.

The following are the current fees for ethical review:

CATEGORY OF PROPOSALPROPOSED FEE
Expedited reviewK3,500
Government FundedK2,000
Internationally FundedK3,000
Undergraduate studentK500
MastersK800
PhDK2,500
RenewalK500

Bank account details for CBU-BREC payments

Name of Account: Copperbelt University-School of Medicine

Account number: 0110949500177

Bank: Zambia National Commercial Bank (ZANACO)

Sort code: 010145

Swift code: ZNCOZMLU

Branch name: Kitwe Business Centre

OUTCOME OF REVEW OF SUBMITTED RESEARCH PROPOSALS.

Title of research proposalStatusYear
   

DATES FOR QUARTERLY CBU-BREC MEETINGS

DateQuarterYear
   

Contact persons.

Chairman: Professor Victor Mwanakasale (Mobile phone: +260977804740, email: vickapasa@gmail.com)

Secretary: Mr. Eric Mbindo Njunju (Mobile phone: +260955800892/+260965209930, email: enjunju@yahoo.com)