title: Ethical and legal constraints to children's participation in research in Zimbabwe: experiences from the multicenter pediatric HIV ARROW trial.
abstract: BACKGROUND
  Clinical trials involving children previously considered unethical are now considered essential because of the inherent physiological differences between children and adults. An integral part of research ethics is the informed consent, which for children is obtained by proxy from a consenting parent or guardian. The informed consent process is governed by international ethical codes that are interpreted in accordance with local laws and procedures raising the importance of contextualizing their implementation.
  
  
  RESULTS
  In Zimbabwe the parental informed consent document for children participating in clinical research is modeled after Western laws of ethics and requires that the parent or legally authorized representative provide consent on behalf of a minor. This article highlights the experiences and lessons learnt by Zimbabwean researchers in obtaining informed consent from guardians of orphaned children participating in a collaborative HIV clinical trial involving the Medical Research Council, United Kingdom and four centers, three of which are in Uganda. Researchers were faced with a situation where caregivers of orphaned children were not permitted to provide informed consent for trial participation. The situation contrasted with general clinical practice where consent for procedures on orphans is obtained from their caregivers who are not legal guardians.
  
  
  CONCLUSIONS
  The challenges faced in obtaining informed consent for orphans in this clinical trial underscores the need for the Zimbabwe ethics committee to develop an ethical and legal framework for pediatric research that is based on international guidelines while taking into account the cultural context. The Medical Research Council of Zimbabwe has since started the process that is expected to involve critical stakeholders namely the community including children, ethicists, the legal fraternity and researchers.
authors: Department of Pediatrics and Child Health, University of Zimbabwe College of Health Sciences, Box A178, Avondale, Harare, Zimbabwe. dangas@zol.co.zw
authors: Mutsa
authors: M
authors: Bwakura-Dangarembizi
authors: Rosemary
authors: R
authors: Musesengwa
authors: Kusum J
authors: KJ
authors: Nathoo
authors: Patrick
authors: P
authors: Takaidza
authors: Tawanda
authors: T
authors: Mhute
authors: Tichaona
authors: T
authors: Vhembo
mesh_terms: D000328:Adult; D019380:Anti-HIV Agents / Q000627:therapeutic use; D017028:Caregivers; D002648:Child; D054540:Child, Orphaned; D002986:Clinical Trials as Topic / Q000941:ethics* / Q000331:legislation & jurisprudence*; D005260:Female; D015658:HIV Infections / Q000188:drug therapy*; D006801:Humans; D007872:Legal Guardians; D008297:Male; D015337:Multicenter Studies as Topic / Q000941:ethics / Q000331:legislation & jurisprudence; D033282:Parental Consent / Q000941:ethics* / Q000331:legislation & jurisprudence*; D035842:Research Subjects; D014454:Uganda; D015030:Zimbabwe
chemical_list: D019380:Anti-HIV Agents