The Tropical Diseases Research Centre Ethics Review Committee (TDRC ERC) is a legally constituted independent committee that reviews diverse biomedical research proposals in Zambia. It was established in the early 1980s.
The Committee is made up of 9 (nine) members, eight of whom are appointed by the board in consultation with Management.
The Committee is multidisciplinary and multisectoral in composition, including relevant scientific expertise, balanced age, gender distribution, and laypersons representing the interests and concerns of the community. All its eight members are drawn from diverse fields and are unaffiliated with the Institution, except for the Secretary of the Committee, who is an employee of the Institution.
Further, it reviews proposals whose scientific content has been reviewed by the Scientific and Technical Committee (STC). Members of the Committee then pay particular attention to the observance of key elements of Good Clinical Practice (GCP), especially the informed consent process, documentation of study information, confidentiality, suitability and feasibility of the proposed research objectives.
The Committee has scheduled quarterly meetings for proposal reviews and it is at such meetings that ratifications of previous decisions made on expedited reviews are also done.
The Committee, just like all the other Ethics review committees in the country, is affiliated to the National Health Research Ethics Committee in the Ministry of Health
The office for Committee is located on the 6th Floor of Ndola Central Hospital at the TDRC offices .
LIST OF TDRC ETHICS COMMITTEE MEMBERS
| S/N | NAME | TITLE | POSITION |
| 1 | Mr. Joe Kasama | Communication Consultant | Chairman |
| 2. | Dr. Mubiana Inambao | Senior Registrar Obstetrics & Gynecologists Ndola Teaching Hospital | V/Chairman |
| 3. | Mrs. Lynette M Hampande | Retired Nurse Ndola Polytechnic Nursing School | Member |
| 4 | Fr. Raphael Chanda | Parish Priest | Member |
| 5. | Ms. Fanny Nyirenda | Lawyer | Member |
| 6. | Mr. Alick Mwambungu | Biomedical Scientist College of Biomedical Sciences | Member |
| 7. | Mr. David Mwakazanga | Statistician | Member |
| 8 | Dr. Nickson Kachusha Ms. Ruth Mwanza | Traditional Health Practitioners of Zambia(THAPAZ) Veterinary Officer | ADHOC Members |
| 9. | Dr. Sam Miti | Pediatrician | Member |
| 10. | Mesta N. Shamakamba | Social Worker | Member |
| 11. | Mrs. Edna Mwale Simbayi | TDRC – PRO | Ethics Review Committee Secretary |
| 12 | Sydney Mwanza | TDRC – Scientific Officer | Member of the Secretariat |
| 13 | Alice M Kasongo | TDRC – Personal Assistant | Administrative Secretary |
SUBMISSION REQUIREMENTS
The following are the submission requirement for protocols to be reviewed b y the Committee:
1, The Investigator’s C V, including those of Co-investigators
2. 4 copies of the complete protocol
3. A two-paged summary of the protocol (18 copies)
4. Questionnaires
5. Informed consent forms including patients information sheets. These have to be be translated and back translated if need be.
6. For clinical trials, investigators must submit the investigator brochure insurance documents,
any adverts for the study
7. For multi-center studies you need to submit the decisions of the other ethics committees in
the other countries.
8. Proposed Budget
9.A payment of Ethics Submission fees of K500 and K3,500 for expedited review
10. For students (Bachelor’s and Masters programmes) a recommendation letter from the supervisor is a requirement
Mrs Edna Mwale Simbayi
Secretary
TDRC Ethics Review Committee
Box 71769
Ndola
Zambia
Tel/fax :+260 212620737
Emai|: simbayiE@tdrc.org.zm