Changes to the law on consent in South Africa: implications for school-based adolescent sexual and reproductive health research.

BACKGROUND: The National Health Act, No 61, 2003 in South Africa is the first effort made by the government to protect health-related research participants under law. Implemented on March 1, 2012, the law mandates active consent from a parent or legal guardian for all research conducted with research participants under the age of 18 years. This paper focuses on the Act's implications for school-based adolescent sexual and reproductive health research. DISCUSSION: Although well intentioned, the added legal protections in the National Health Act may have the unintended consequence of reducing participation rates in school-based adolescent sexual and reproductive health research, thereby excluding the most at-risk students. The Act may also compromise adolescents' right to dignity and privacy, especially considering the personal nature of research on sex and sexuality. Devolved, discretionary decision-making, which empowers local human research ethics committees to permit a wider range of protective measures, including passive consent, independent adolescent consent or community consultation ought to be considered. The continued and direct involvement of young people in their sexual and reproductive health and well-being is an important principle to uphold. SUMMARY: This paper calls for a re-examination of section 71's ethical guidelines relating to informed consent in the National Health Act, No 61, 2003 in South Africa in order to better serve the interests of South African adolescents in sexual and reproductive health research.

Does the requirement of getting active consent from parents in school-based research result in a biased sample? An empirical study.

Active parental consent is a requirement that may threaten the validity of including minors in research. This study investigated possible sources of bias between the responses of children whose parents actively consented to their participation in a school-based survey and those of children whose parents were nonresponders. Due to a serious administrative error in a study to examine health-related quality of life (HRQoL), all 514 eligible schoolchildren were tested, although only 177 parents signed consent. After deliberation, the relevant human research ethics committee gave permission to include all results in the analysis. The HRQoL was not different between the groups. Male children returned significantly fewer consent forms (p=.026). More of the nonresponding group reported that their parents "Never had enough time for them" (p=.023). The high nonresponse rate and associations between response and parental interest and gender indicate that some bias may be introduced through the need for active consent, but overall there were no differences in responses to the quality of life questionnaire.

Reporting ethical protections in physical therapy research.

BACKGROUND AND PURPOSE: Efforts to make physical therapy more evidence based have increased demand for human participants, raising concerns for their safety and welfare. This study examined how often research articles in physical therapy journals report basic ethical protections. METHODS: We carried out a retrospective audit of research articles in 6 physical therapy journals between 1996 and 2001. RESULTS: Of 806 articles reviewed, 48% documented both research ethics committee approval and informed consent. Articles reporting clinical interventions had the highest reported rate (64%) of both protections. Articles reporting qualitative methods, chart reviews, and case reports had the lowest rates of documentation of both requirements: 30%, 17%, and 11%, respectively. Reported rates of both requirements in vulnerable populations were 55% for children, 48% for students, and 33% for employees. Twenty-six percent of articles included confidentiality assurances. Case reports were most likely and chart reviews were least likely to mention confidentiality: 88% and 8%, respectively. DISCUSSION AND CONCLUSION: There is no uniform editorial policy among physical therapy journals for reporting basic ethical requirements. Physical therapy journals should standardize ethical protections and make documentation of compliance a prerequisite of publication.

End of life care in HIV-infected children who died in hospital.

The aim of this study was to evaluate terminal care among hospitalized children who died of HIV/AIDS. The design was a retrospective chart review of the terminal hospitalization. The setting was a public, secondary and tertiary children's hospital in Cape Town, South Africa (SA). The patients included a consecutive series of in-patient deaths from HIV-related causes. The main outcome measures included: documentation of do not resuscitate (DNR) orders and comfort care plans, intensity of diagnostic and therapeutic interventions in the last 24 hours of life, and presence of pain and distress in last 48 hours of life. The results are based on the review of 165 out of 167 in-patient deaths. Of those, 79% of patients died in general wards. Median age and length of stay were 4 months and 6 days respectively. A total of 84% of patients had a DNR order. DNR orders appeared simultaneously in only 41% of medical and nursing notes. Only 44% of patients had a comfort care plan. Pain and distress in the last 48 hours was documented in 55% of patients who died in the general wards. Respiratory symptomatology and painful skin conditions accounted for most discomfort. Half (36/72) the patients with pain and distress, including 16 with a comfort care plan, received no analgesia. Conclusions drawn found that, despite clinical uncertainty, doctors made tough end of life decisions that included DNR orders and comfort care plans. The lower rate of comfort care plans suggests doctors had difficulty making the transition from curative to palliative care. Many comfort care plans were incoherent and included interventions unlikely to promote patients' comfort. In light of the HIV/AIDS pandemic in SA, reforms are needed to integrate palliative care within mainstream hospital medicine. However, without adequate human resources including trained interpreters, doctors and nurses will struggle to deliver optimal terminal care in acute hospitals.