Evaluation of standards of informed consent formats in research proposals approved by Faculty of Medicine, Addis Ababa University.
BACKGROUND
Medical research involves the voluntary participation of human subjects. Potential participants need information upon which they can make their decision. This review aims to evaluate standard of informed consent and information to human participants in researches conducted at Faculty of Medicine (FoM), Addis Ababa University (AAU).


METHODS
A retrospective cross sectional analysis was conducted to evaluate the medical research protocols submitted and approved by the Faculty Research Review Committee between 2000 and 2007 at the Faculty of Medicine, Addis Ababa University. The data were analyzed using computer based statistical software SPSS version 11.0.


RESULTS
Of 105 research protocols submitted and approved by the Faculty Research Review Committee, 40 (38.1%) were epidemiological and 28 (26.7%) clinical types of studies by design. The remaining 21 (20%) and 16 (15.2%) belong to behavioral and biomedical categories respectively. Informed consent sheets (ICS), 56 (53.3%) were written, and 15 (14.3%) verbal. The proportion of written ICS sheet was significantly higher than verbal type (p<0.0001). ICS and Study Information Sheet (SIS) were included in the research protocols in 71 (74.7%) and 57 (60.0%) of the cases respectively. Inclusion of statements describing potential risks in 45 (63.4%) protocols was significantly lower (p<0.0001) compared to benefits to the subjects in 58 (81.7%). Statements describing extent of confidentiality and voluntary participation were stated in 55 (77.9%) and 63 (88.7%) of the protocols, respectively, whereas, disclosure of refusal to participate without penalty and consent was found in 42 (45.9%).


CONCLUSIONS
During the initial years, the proportion of written ICS as well as complete ICS and SIS were very low. Nevertheless, the research protocols evaluated in this study had shown encouraging improvement in the proportion of written ICS (p<0. 0001) and completeness of ICS as well as SIS over time.
Biluts
Hagos
H
Department of Surgery, Addis Ababa University, Medical Faculty, Addis Ababa.
Mariam
Damen Haile
DH
Teka
Tilahun
T
D035843:Biomedical Research; D005002:Ethiopia; D019983:Guideline Adherence; D006801:Humans; D007258:Informed Consent / Q000941:ethics / Q000592:standards*; D012107:Research Design / Q000592:standards*; D012577:Schools, Medical