JARAMOGI OGINGA ODINGA UNIVERSITY OF SCIENCE AND TECHNOLOGY 
UNIVERSITY EXAMINATIONS 2012/2013 FIRST YEAR FIRST SEMESTER EXAMINATIONS FOR THE DEGREE OF MASTER OF EPIDEMIOLOGY AND BIOSTATISTICS
KISUMU LEARNING CENTRE
COURSE CODE: HES 5111 TITLE: BIOETHICS
DATE: 21/12/2016 TIME: 8.00-11.00AM
DURATION: 3 HOURS   
INSTRUCTIONS  
1. This paper contains TWO sections 2. Answer  ALL questions in section A (Compulsory) and ANY other Two questions form section B 3. Write all answers in the booklet provided
SECTION A. COMPULSORY QUESTION (40 marks) 1. Infant mortality rate is an important yard stick for determining how well a country is doing socio-economically. The higher the rate, the worse the country is doing. Childhood vaccination is an important public health intervention for reducing the morbidity and mortality associated with childhood illnesses. However, as any pharmaceutical product all vaccines carry some risk. Implementation of a vaccination programme is the responsibility of a Government’s Ministry of Health. In one country, the Ministry of Health has made a decision to make all the six childhood vaccines (BCG, oral polio, DPT, and measles) free of charge and compulsory. The main aim of the programme is to vaccinate a high proportion of children under 5 years of age in order to increase the vaccination coverage up to the point that herd immunity is achieved. The Ministry has also decided that no child will be admitted to school without having completed the immunization schedule and any parent who refuses to have their child vaccinated for any non-medical reason (religious belief) could be fined or imprisoned. (a) Discuss the points for and against the implementation of a compulsory childhood immunization programme (15marks) (b) Using each of the three ethical principles, discuss the implications of this policy decision (20marks). (c) In your opinion, do you agree or disagree with this decision? Give reasons for your opinion (5marks).
SECTION B. CHOOSE ANY TWO QUESTIONS FROM THIS SECTION (30 marks)
2. In a case-control study of sudden infant death syndrome in western Kenya, parents of deceased infants were interviewed within 72 hours of the infants death. The parents were interviewed about social factors; family history; maternal medical history; details of the pregnancy and perinatal period; and the infant’s medical history, including recent signs of illness, feeding, precise details of the infant’s last sleep, the position in which he or she had been found, the precise quantity and nature of clothing and bedding, whether the baby had been swaddled and whether the bedclothes had been over the baby’s head when found. (a) Was this the best study design to answer the research question? Why? (5marks) (b) What risks would you anticipate to occur in this study? (5marks) (c) What benefits would accrue from a study of this nature? (5marks) (d) Would you consider bereaved families to be vulnerable? (5marks)
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(e) What measures should be in place to ensure that epidemiological data such as this is collected in a manner that is not intrusive? (10marks)
3. A group of French and Zairean scientists published a short report in The Lancet on May 2000, stating that one of the French investigators had immunized himself with an investigational AIDS vaccine. The researchers had also immunized “a small group of Zaireans” all of whom were HIV-negative and immunologically normal. The trial had been approved by the Zairean Ethics Committee. (a) What safeguards are needed to protect the rights and well being of research participants in less developed countries? (10marks) (b) Whose ethical standards should be applied to an international vaccine trial such as the one described: Those of the researchers home country (France) or those of the host country? (5marks) (c) What does the term “exploitation” mean to you? Would you consider this study an exploitation? Why (10marks) (d) How can such a study be prevented from occurring in another developing country in future? (5marks)
4. Researchers are interested in testing frozen sera obtained in 1991 survey of 500 Ugandan children between the ages of 2 and 12 for antibodies to HIV. The banked sera were obtained as part of an earlier epidemiological study of Plasmodium falciparum conducted in mainland and island communities of Uganda, which are inhabited by the Acholi. Testing for HIV was not envisioned at the time the sera were originally collected. The epidemiology of HIV remains poorly understood although endemic foci of this infection have been described among Nilotic populations in Kenya, Sudan and Egypt. A high sero- prevalence (a) What information should be contained in an informed consent document to ensure that the participants are truly informed? (7.5marks) (b) If the sera collected and stored in 1991 (as part of an unrelated study) are tested for HIV, should the researchers recontact the participants or their legal guardians to provide informed consent? (2.5marks) (c) If it were not feasible to contact the participants to obtain some additional form of informed consent, would the seroprevalence study of banked frozen sera be ethical?why? (5marks)
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(d) Should representatives of the Acholi community be notified that the study is being undertaken? What obligations would the investigators have to notify the participants (or their parents) of their test results? (5marks) (e) What precautions should the investigators take to protect the individual participants or the Acholi community as a whole from possible discrimination or other adverse effects arising from the results of this study? (10marks)
5. A randomized controlled trial of artesunate as a chemopreventive agent is planned for children at risk of schistosomiasis (bilharzia) in Uyoma, western Kenya. This study will enroll about 5000 healthy school children who reside close to the lake. The participants will be randomly allocated to receive either artesunate or placebo for 12 months.  The efficacy of artesunate as a chemopreventive agent is unknown in humans but the potential benefits to the individual research participants and to society are substantial. Schistosomiasis is the second most prevalent parasitic disease in Kenya after malaria. It is a chronic debilitating disease that affects young children but manifests in adults with portal hypertension and other chronic liver pathology. The treatment of schistosomiasis using praziquantel is unsatisfactory as the parasite has developed resistance or tolerance to the drug. Artesunate is likely to reduce the risk of infection by 50%. Artesunate is currently used in combination with other drugs for the treatment of malaria but has been shown in laboratory studies to have anti-schistosomal activities. In the short-term it is relatively safe and well tolerated but the long-term effects are unknown. (a) Is it ethical to expose participants to a chemopreventive agent that may have unexpected side effects or be ineffective? Discuss (5 marks) (b) How do the investigators balance risks and potential benefits of this study by choosing children as study participants? (5 marks) (c) Is it ethical for the investigators to deny the children allocated to placebo group the potential benefits of the study? What purpose is placebo playing in this study? (10 marks) (d) What measures have the investigators taken to ensure that the potential benefits and burdens of the study will be distributed equitably among the participants? (10marks)