Clinical trials referenced in this document:
Documents that mention this clinical trial
Effect of nutrition education on iodine deficiency disorders and iodized salt intake in south west Ethiopian women: a cluster randomized controlled trial
Funding for this research was provided by:
Jimma University (Ref. No- RPGC/4052/2008)
Received: 5 May 2020
Accepted: 10 November 2020
First Online: 16 November 2020
Ethics approval and consent to participate
: Ethical clearance and approval was obtained from Jimma University, College of public health and medical sciences ethical clearance review committee (IRB). The IRB deeply examined this work at proposal level and approved with the letter issued on 10, Feb 2016 (Ref. No. RPGC/4052/08). Permission was obtained from government officials and community leaders before randomization. After establishment of consent at cluster levels, an eligible woman from household was consulted for voluntariness. For women who were under the age of 18 years old, we used assent in addition to their parental consent. Finally, the woman who agreed to participate was included in the trial. Written consent was not necessary at least for two reasons: first, the research protocol was about nutrition education, which was neither hostile nor invasive to the study participants. Secondly, according to the legislative of research ethics in Jimma University, having verbal consent suffices for non-invasive research procedures. Moreover, all the study participants were informed about the purpose and confidentiality of the information along with their right to refuse. When the participants agree, the interviewers sign on the verbal informed consent form and start the interview. Interviewer’s signature certifies that respondent has given informed consent verbally. Finally, the consent was checked and documented by the principal investigator. The study was also registered on pan African clinical trials registry with a Registration Number of PACTR 201809544276357 on 14 Sept 2018.
: Not applicable.
: The authors declare that they have no competing interests.