Reference no: EM133289340

Assignment:

The Institute for Family and Youth has an agreement with a bilateral financing institution to implement programs for the prevention of HIV and sexually transmitted infections (STIs), as well as family planning in developing countries. The financing is conditional on the inclusion of an evaluation component. Through its "Healthy Ideas" program, the Institute has recently established three public health prevention projects in developing countries:

¦ An HIV testing and counseling program for adolescents, based in one country in each of three regions - Eastern Europe, Sub-Saharan Africa and South-East Asia - using adolescent-tested questionnaires, for three years, in order to investigate the frequency and types of drug use, sexual activity and preferences.

¦ The second project provided antenatal care in poor urban communities in a country where HIV infection remains highly stigmatized. The evaluation component will examine the frequency of notification to partners of married and unmarried women with a clinical diagnosis of HIV positive.

¦ The third is a condom education program to be held in a South American city with a rapidly increasing incidence of STIs and HIV. The model was built on the basis of a "100% condom use" program that has proven effective in Southeast Asia, whereby grading sanctions are imposed on brothel owners according to the STI rate detected among sex workers on those sites. Ultimately, the whorehouse is at risk of being shut down if the sex workers continually get infected with STIs. An evaluation is planned to determine the feasibility of implementing a condom use program.

According to the Institute for Family and Youth, these projects do not require the authorization of a CEI because the activities are low risk, they are not aimed at testing an intervention, and it is an "operational research" and not of biomedical research. The head of evaluations of the Institute cites the regulations on "research with human beings" of the E.U. which she believes ongoing evaluations of actual interventions are not subject to ethical review. It also emphasizes that the findings of the evaluations will be used to help design better public health programs in other places where the Institute carries out disease prevention programs.

Questions:

1. Are some of these projects research studies? Explain why or why not.

2. What distinguishes research from ongoing evaluations of public health interventions?

3. Do these activities require any ethical oversight?

4. According to the Family and Youth Institute, these projects are low risk. Discuss what "low risk" means in the context of an ethics review. Does the level of risk affect the need for a review?