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 lasts 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 reasons (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 healthcare 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% non-AIDS-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 found to be HIV positive, the mother of each child will be informed and counseled appropriately.  No patient is discharged prematurely if he/she (s/he) is HIV+.  On this ward, a physician/clinical investigator feels that there is a difference in the clinical presentation and simply laboratory tests (e.g. 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 settings where 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.   He suggests that the benefit would be two-fold: (1) to determine the effectiveness of this simple inexpensive dietary treatment in 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 treated in the hospital with 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 its potential use have any bearing on how you would arrive at your decision?  If so how?
• For the treatment to be considered effective, (a) what percent of HIV+ children would need to benefit from the treatment and (b) to what degree?
• 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).

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 of India, 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 (PHCs) 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 PHCs, was also observed.   An ethical review board (ERB), convened to advise the project and consisting of leading researchers in the country, recommend against gathering any information that could lead to the identification of specific PHCs by those in authority.  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 PHCs 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 jeopardizing the patients 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 insufficient 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 PHCs were doing an excellent job and that the quality of services in the PHCs 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 PHCs be identified.  They contended that it was not possible that such adverse conditions really existed and that such possible study findings must have been fabricated (made up, falsified).  They also suggested that, if the names of the PHC and their staff were identified, the matter could be verified. They also argued that positive identification was necessary to rectify the situation, if it truly existed.

Comment on the following questions:

• Should the names of the PHCs 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 PHCs must be identified?  Conversely, is there any effective way to correct erroneous protocols in some settings without identifying the settings or staff members specifically?
• Could the requested 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?