Case Study 2a: Persistent Diarrhea in HIV + Children Case Study 2b: Confidentiality vs. Credibility in Health Services Evaluation Defining the Ethics of Clinical Study: Persistent Diarrhea in HIV+ Children An early Clinical Sign of HIV infection in children is persistent diarrhea that is diarrhea that last for more then 14 days. In some eastern and southern African countries where HIV infection rates are very high in children (from 5-10 of newborns), a child with persistent diarrhea is often presumed to be HIV+. For a variety of reason (cost, limited ability to intervene and to provide counseling to HIV_ individuals) testing for HIV infection is not often done in urban hospitals and rarely if ever done outside the major city. As hospitals are overcrowded and very short on resources the health care workers will often send patients home with minimal care if the workers suspect that the patient will not recover; children presumed to have AIDS fall into this category. Not all children who have persistent diarrhea have AIDS. Recent studies have demonstrated that over 85% nonAIDS related persistent diarrhea in children can be effectively treated with a diet based on locally available, inexpensive food. It is presumed that a certain small percent of HIV+ children with persistent diarrhea will also respond to these diets; however, no study has yet been done to measure the effectiveness in these children. What is clear is that a number of children with non-AIDS related persistent diarrhea are being sent home without therapy and may die or become increasingly undernourished because of this premature discharge from the hospital. In a diarrhea ward in a large South African medical center, children are routinely tested for HIV and if they are positive the mother are informed and counseled. No patient is discharged prematurely if he/she is HIV+. A physician/clinical investigator on this ward feels that there is a difference in the clinical presentation and simply laboratory tests (eg stool microscopy) between children with persistent diarrhea who are HIV+ or are not infected with the virus. He wishes to conduct a two part study; the first part of the study will help to differentiate on clinical signs alone ( in those setting when testing for HIV infection is not conducted) whether a child under five years of age with persistent diarrhea is HIV+; the second part of the study will examine the effectiveness of the dietary treatment of persistent diarrhea in the HIV+ children. The benefit, he suggests, would be two-fold: (1) to determine the effectiveness of this simple inexpensive dietary treatment HIV+ children with persistent diarrhea; and (2) if the treatment proves to be ineffective in HIV+ children, to assist health workers in identifying those children with persistent diarrhea who are not infected with HIV so they can be kept in the hospital and treated for a possible cure. An algorithm would then be developed to triage patients by their likely response to available treatment. Comment on the ethics of this study. Some of the questions might include: Does it potential use have any bearing on how you would arrive at your decision? If so how? What percent of HIV+ children would have to benefit from the treatment ( and to what degree) for it to be considered effective? Comment on the ethics of the study regarding the dietary treatment of persistent diarrhea in HIV+ children I (especially whether or not a placebo can be given to the control group). Name: Email: Response: Please type or paste your response over this text. Confidentiality vs. Credibility in Health Services Evaluation A study to evaluate the quality of care in the Family Welfare Program was undertaken by a group of university-based Indian investigators in one of the States with funding for the project provided by a grant from a European university to the Indian university. As part of the evaluation process, doctors, supervisors, multi-purpose health workers, and family planning clients working in or visiting selected Primary Health Centers (PHC's) in the state were interviewed. The client-provider interactions were also observed for a period of one week. During this period of observation a sterilization camp, organized by one of the selected PHC's, was also observed. An ethical review board, convened to advise the project, and consisting and leading researchers in the country, recommend that all information that could lead to the identification of specific PHC's by those in authority should be specifically avoided. Even mentioning the Taluk (a political division of about 20,000) in which the study was undertaken could result in repercussions to the PHC or its employees by the National or State government health programs. The proposal, with a section insuring confidentiality for the PHC and health workers, was then submitted to the Government of India (GOI) Ministry of Health and Family Welfare (MHFW) through the state bureaucracy in order to obtain the permission to undertake the study. Following review by the National and State governments the, project, was approved. The permission from the state government was necessary since the staff at the PHC are employees of the State and it is not possible to interview them or obtain any data from the PHC's without the express permission of the State government authorities. The study began on time and without incident. During to fourth week of the study, a field worker reported back the following incident to the principal investigator and asked for some guidance, 'While observing procedures at a local PHO, I noticed that a health worker was reusing one of the syringes. When I told the workers supervisor about this practice (I did not identify the worker), I was thanked for my observation and assured that this situation would be rectified, I returned to the clinic one week later to deliver some papers and out of curiosity returned to the outpatient area of the clinic, Once again I observed the practice of reusing syringes, I am unsure how to react to this situation, The practice may be putting the patient's at risk for other diseases but I have guaranteed confidentiality to the clinic and its workers Comment on the following questions. What advice should the principal investigator give to the field investigator? Should the principal investigator undertake any actions and if so what should they be? Should the principle of confidentiality be strictly held to especially as the health of the patients may be put at risk? PART II The study was completed on time and the findings revealed that the State's services with respect to the family planning were demand driven and no specific efforts had been made to maintains quality. Further national level protocols for service delivery were noticeable by their absence. Camps for sterilization had been organized with minimal efforts made to accommodate the clients; there was not sufficient water and/or sanitation facilities to meet requirements; and the large number of clients sterilized in a short period of time was in violation of medical protocols, Results also indicated that some PHC's were doing an excellent job and that the quality of services in the PHC's was widely distributed in a bell-shaped curve distribution. A dissemination workshop to discuss the findings of the study in the state capital was attended by health activists, bureaucrats belonging to the Health Ministry at the National and State level, and medical services personnel, When the findings of the study were reported, the medical services officials and the government representatives requested that the specific PHC's be identified. They contended that it was possible that the findings of the study were fabricated since it was not possible that such adverse conditions really existed, They suggested that if the names of the PHC and their staff were identified the matter could be verified. They also argued that to rectify the situation, if it truly existed, identification was necessary. Comment on the following questions: Should the names of the PHC's be given to the State (or National) governments and/or the medical service officials? How valid is the argument that if something is to be done then the offending PHC's must be identified? Could the information be given to the interested party without loss of confidentiality? Are there situations within this case (or in other situations) when confidentiality could/should be ignored? What, if any, are those particular circumstances? Name: Email: Response: Please type or paste your response over this text. Note: Cases are fictional, but based on real events. All organization and individual names have been changed. For more information on the Program on Ethical Issues in International Health Research, click here!