186788 Ethical challenges in studying psychosocial needs of children in a time of HIV

Wednesday, October 29, 2008

Shuaib Kauchali, FCPaed, MPhil , Epidemiology, Columbia University, Durban 4062, NY, South Africa
Leslie L. Davidson, MD, MSc , Department of Epidemiology, Columbia University Mailman School of Public Health, New York, NY
Background: Among many challenges faced in the conduct of an epidemiologic study on health and psychosocial needs of child in a rural developing country with a high HIV prevalence rate are the definition of a care giver and the issue of obtaining informed consent to involve children in research, particularly that which may bring assessment, referral and treatment for disabling conditions.

Purpose: to highlight ethical challenges faced in such settings and to present approaches to overcome these barriers.

Process: We developed procedures used to act in the best interests of the child while fulfilling ethical responsibilities to inform and empower communities particularly where there are a high proportion of orphans. This is particularly true where sensitive information around HIV, substance use and mental health are being investigated. Failure to involve children without parents in the study would deprive them of possibly their only chance of assessment and treatment. Therefore we needed to develop an approach to consent which would be both ethical and within the law. We will share approaches to obtaining informed consent in situations where the parent may frequently be absent, ill or dead. In addition, a substantive challenge has been the definition of primary caregiver in situations where the mother may be alive but because of work or illness may not be taking care of her child. The literature was reviewed, discussions held with key informants from legal field, the ethical board and the community were held to assess the approach in this situation.

Source of funding: NIH/NIDA

[Word Count: 247 words]

Learning Objectives:
To comprehend the ethical issues in including orphans in research To review possible approaches to ensure the possibility that children will not be excluded from research and possibly put at further risk simply because disease has killed their parents. to discuss the complexity of determining the identity of the primary caregiver.

Keywords: Bioethics, Vulnerable Populations

Presenting author's disclosure statement:

Qualified on the content I am responsible for because: I am one of the lead investigators, PI of the South African Sub contract, of the study for which the protocols to be discussed were developed by me and my colleagues
Any relevant financial relationships? No

I agree to comply with the American Public Health Association Conflict of Interest and Commercial Support Guidelines, and to disclose to the participants any off-label or experimental uses of a commercial product or service discussed in my presentation.