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 in 52 clusters
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
Women aged yrs in 52 clusters
Cytology 13 clusters (N = )
HPV 13 clusters (N = )
VIA 13 clusters (N = )
Control 13 clusters (N = )
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)
Health education, routine existing care
Sankaranarayanan et al., N Engl J Med 2009;360:

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 Dec 4;354(9194):
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)
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
40% reduction on HIV incidence
Emerging HIV epidemic
Treatment of symptomatic STIs
Continuously available services

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

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