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Ethical issues in Community Trials

Ethical issues in Community Trials. Dr Smita Joshi HCJMRI and JCDC Jehangir Hospital and Medical Centre, Pune. Community trial. It is an epidemiological study in which the unit of allocation of intervention is the entire community

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Ethical issues in Community Trials

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  1. Ethical issues in Community Trials Dr Smita Joshi HCJMRI and JCDC Jehangir Hospital and Medical Centre, Pune

  2. Community trial • It is an epidemiological study in which the unit of allocation of intervention is the entire community • ‘Community’ usually refers to geographical boundaries such as cities, villages, etc. Sometimes it could be schools, workplaces, etc. • Community trials are very useful in public health and epidemiological research

  3. Community trials • Community trials are done to address preventable public health interventions • Studies for infectious disease control (leprosy vaccine trial), neonatal mortality, vaccination uptake, unhealthy behaviours (smoking), cervical cancer prevention studies, etc • Interventions are offered to the entire community or to individuals within that group in certain geographic area and then the effectiveness of these interventions is evaluated

  4. There are methodical differences in cluster randomized trials and individual randomized trials • Community trials are done when individual randomization is difficult or when the intervention is designed to be implemented at the group level

  5. 131 746 Women aged 30-59 yrs in52 clusters Control13 clusters(N = 31 488) VIA13 clusters(N = 34 074) HPV13 clusters(N = 34 126) Cytology13 clusters(N = 32 058) Health education, routine existing care Diagnosis and treatment of screen positive women Diagnosis and treatment of screen positive women Diagnosis and treatment of screen positive women Follow up for cervical cancer incidence and mortality(passive and active) Follow up for cervical cancer incidence and mortality (passive and active) Follow up for cervical cancer incidence and mortality(passive and active) Follow up for cervical cancer incidence and mortality(passive and active) Comparative efficacy of visual inspection with acetic acid, HPV testing and conventional cytology in cervical cancer screening: a randomized intervention trial in Osmanabad District, Maharashtra State, India Study design Sankaranarayanan et al., N Engl J Med 2009;360:1385-1394

  6. Effect of home-based neonatal care and management of sepsis on neonatal mortality: field trial in rural India. Bang AT, Bang RA, et al. Lancet. 1999 Dec 4;354(9194):1955-61. • 39 intervention villages and 47 control villages in the Gadchiroli district in India • Village health workers were trained in diagnosis and treatment of birth asphyxia, premature birth or low birth weight, hypothermia, breast-feeding problems and neonatal sepsis

  7. Community Intervention Trial for Smoking Cessation (COMMIT) • Twenty-two cities in the USA and Canada were randomized to either a community-level antismoking intervention delivered through mass media, health care professionals and worksites, or to a no-intervention control. • Baseline data were collected from a random sample of citizens using a telephone survey, and a sample of smokers identified and followed with annual telephone surveys to ascertain smoking cessation status.

  8. The investigators interacted with the community by forming a board of community representatives. • Individual respondents were not aware that they were involved in a trial, although they provided verbal consent to complete the telephone surveys.

  9. Large community trials in Rakai (Uganda) and Mwanza (Tanzania) to evaluate effect STI treatment on incident HIV infections Rakai (Uganda) Mwanza (Tanzania) 40% reduction on HIV incidence Emerging HIV epidemic Treatment of symptomatic STIs Continuously available services • No effect on HIV incidence • Established HIV epidemic • Symptomless STIs • Intermittent mass treatment to control rapid STD re-infection • Differences in prevalence of curable STIs

  10. International Ethical Guidelines for Epidemiological Studies • Prepared by the Council for International Organizations of Medical Sciences (CIOMS) in collaboration with the WHO, 2009 • 2008 version is available at http://www.ufrgs.br/bioetica/cioms2008.pdf

  11. Ethical Guidelines for Biomedical Research on Human Participants • Indian Council of Medical Research 2006

  12. CIOMS guidelines • Guideline 1: Ethical justification and scientific validity of epidemiological research involving human beings • Guideline 2: Ethical review committees • Guideline 3: Ethical review of externally sponsored research • Guideline 4: Individual informed consent- long term studies, comprehension, community members, waiver

  13. Waiver of consent requirements in epidemiologic studies • the use of personally non-identifiable materials-individuals are unknown to the researcher b. the use of personally identifiable materials with special justification • studies performed within the scope of regulatory authority- data collected as adverse reaction monitoring d. studies using health-related registries that are authorized under national regulations – cancer registries, anomalies of new born, etc e. cluster-randomized trials- fluoridation of water

  14. Guideline 5: Obtaining informed consent: Essential information for prospective research subjects -26 points included in 2009 guidelines • Guideline 6: Obtaining informed consent: Obligations of investigators and sponsors – no undue influence, revision of the ICF if new information/ changes in study design/ objectives of research, PIs responsibility-delegated staff are complying with the guidelines • Guideline 7: Compensation for participation • Guideline 8: Benefits, harms and risks of study participation

  15. Guideline 9: Special limitations on risk when research involves individuals who are not capable of giving informed consent-eg studies in pediatric population • Guideline 10: Research in populations and communities with limited resources-responsive to the health needs • Guideline 11: Choice of control group in clinical trials-placebo, no treatment arm • Guideline 12: Equitable distribution of burdens and benefits in the selection of groups of subjects in research- no group should be deprived of the benefits • Guideline 13: Research involving vulnerable persons

  16. Guideline 14: Research involving children • Guideline 15: Research involving individuals who by reason of mental or behavioral disorders are not capable of giving adequately informed consent • Guideline 16: Women as research participants • Guideline 17: Pregnant women as research participants • Guideline 18: Safeguarding confidentiality • Guideline 19: Rights of injured subjects to treatment and compensation • Guideline 20: Strengthening capacity for ethical and scientific review and epidemiological research • Guideline 21: Ethical obligation of external sponsors

  17. Guideline 22: Disclosure and review of potential conflicts of interest • Guideline 23: Use of the Internet in epidemiological research • Guideline 24: Use of stored biological samples and related data

  18. Community support is an important element

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