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© 2005 American Public Health Association
DOI: 10.2105/AJPH.2004.037788
RESEARCH AND PRACTICE |
Catherine Mathews, Yolisa Y. Mtshizana, and Andiswa Hani are with the Health Systems Research Unit, South African Medical Research Council and the School of Public Health and Primary Health Care, University of Cape Town, Cape Town, South Africa. Sally J. Guttmacher is with the Department of Health Studies, New York University, New York, NY. Alan J. Flisher is with the Department of Psychiatry and Mental Health, University of Cape Town. Merrick Zwarenstein is with the Knowledge Translation Programme and Department of Health Policy Management and Evaluation, Faculty of Medicine, University of Toronto, Toronto, Canada.
Correspondence: Requests for reprints should be sent to Catherine Mathews, Health Systems Research Unit, Medical Research Council, PO Box 19070, Tygerberg 7505, South Africa (e-mail: cm{at}cormack.uct.ac.za).
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ABSTRACT |
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Objectives. We examined the process of obtaining "active," written parental consent for a school-based HIV/AIDS prevention project in a South African high school by investigating (1) parental consent form return rates, (2) parents’ recall and knowledge of the research, and (3) the extent to which this consent procedure represented parents’ wishes about their child’s involvement in the research.
Methods. This cross-sectional descriptive study comprised interviews with parents of children in grades eight and nine in a poor, periurban settlement in Cape Town.
Results. Within 2 weeks, 94% of 258 parents responded to a letter requesting written consent and of those, 93% consented, but subsequent interviews showed that 65% remembered seeing the consent form. At the end of the interview, 99% consented to their child’s participation.
Conclusions. These findings challenge many of the assumptions underlying active written parental consent. However, they should not be used to deny adolescents at high risk of HIV infection the opportunity to participate in prevention trials. Rather, researchers together with the communities in which the research is undertaken need to decide on appropriate informed consent strategies.
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INTRODUCTION |
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More than 60% of the 39.4 million people living with HIV/AIDS live in sub-Saharan Africa.1 In South Africa, 1500 new HIV infections occur daily, 60% of these in persons aged 15 to 25 years.2 Adolescence, when sexual activity generally commences but behavior patterns are still malleable, is a critical time for HIV prevention.3,4 Schools are particularly important for adolescent sexual behavior interventions, especially where health services are inaccessible.4 Yet in sub-Saharan Africa, few school-based AIDS prevention programs exist, and even fewer have been evaluated using randomized, controlled designs.4
Because adolescents may not legally consent to participate in research in South Africa, parental consent is needed. South African research ethics committees accept "passive" parental consent procedures. Parents/guardians are informed (usually by letter) about the nature of the research, their permission for their child’s participation is sought, they are alerted to their right to refuse this, and they are given directions for whom to contact if they should wish to do so. In the absence of such notification, it is assumed that consent has been given.
In the United States, by contrast, "active" written parental consent for adolescents’ participation in research is required by the US Department of Health and Human Services, the US National Institutes of Health, and most ethics review boards.5 The parents/guardians must be informed and must positively notify the school or researcher in writing that they permit their child to participate in the research, or else it is assumed that consent has been denied.
In the United States and Canada, many parents fail to return consent forms, and so even though research shows that the overwhelming majority of "nonresponding" parents approved of their child’s participation, it is presumed that consent was denied.6–8 Active consent procedures in school-based research on youths’ risk behaviors produce less representative samples and underrepresent minority and high-risk youths in the sample, in comparison with passive procedures.9,10
The National Institutes of Health funds South African school-based HIV prevention research but requires active consent, so we have examined the process of obtaining active, written parental consent in the South African context. This research was undertaken in 2003 in a high school participating in a school-based HIV prevention controlled trial. We investigated (1) parental consent form return rates, (2) parents’ knowledge and recall of the research, and (3) the extent to which active, written parental consent represented parents’ wishes about their child’s involvement in the research.
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METHODS |
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Study Population and Setting
This research was undertaken in a school participating in a school-based HIV prevention controlled trial during 2003. The aim of the trial was to assess the efficacy of a storytelling and drama-based intervention for students in grades eight and nine. The intervention took place in 1 school while a second school served as a control school. The parental consent investigation took place at the intervention school.
The intervention school was the only high school in a poor, periurban settlement of approximately 1200 plots and 10 000 people in the Southern Cape Peninsula, South Africa. The settlement area is well demarcated and geographically isolated from other high-density areas. Apart from its relative geographic isolation, the area is typical of poor periurban settlements in South Africa, characterized by high unemployment rates, shack dwellings, and a high risk of HIV infection. The prevalence of HIV infection among the 330 pregnant women attending antenatal clinics in the settlement during 2003 was 21% (oral communication, Keren Middelkoop, 2004).
The parental consent investigation was conducted with the parents/guardians of all the 258 children in grades eight and nine at the high school (median age, 15 years).
Obtaining Informed Parental Consent
After obtaining permission from the Western Cape Education Department and the school principal, we addressed a meeting of the school governing body (consisting of parent and teacher representatives). After obtaining consent from this group, we sent a notice to all the parents of the students in grades eight and nine, inviting them to learn about the research at an evening meeting at the school. Approximately 60 of the 258 invited parents attended. Table 1
describes the information conveyed to them during the meeting. Parents were also informed that they would be asked for an interview to discuss their involvement in decisions about school-based research.
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A parental consent letter was composed to include clear information about the research (Table 1
). It was translated in Xhosa (the home language of the majority of the students), and both the English and Xhosa versions were pretested to ensure that they were understandable and conveyed the appropriate messages. A consent form (in English and Xhosa) was attached to the letter. A member of the research team visited each class in grades eight and nine and described the research to the students, in their home language. She explained that parents/guardians would have to indicate in writing whether or not they wished their child to participate in the research before students could be invited to participate. The researcher gave each student in the class a copy of the consent letter and the attached consent form to take home to their parent or guardian.
The researcher revisited each class 3 days later and collected returned consent forms. The students who had not returned consent forms were given a second copy of the consent letter and form and a reminder of the importance of returning the form. Remaining forms were collected in class 1 week and 2 weeks after the initial letter was sent home. The research team then compiled a list of students in each class, noting those whose parents had given written consent (consenters), those whose parents had denied consent in writing (refusers), and those whose parents had not returned the consent form (nonresponders).
In the control school, a passive parental consent procedure was used.
Investigating Parents’ Responses to the Research
Two weeks after the initial consent letter was given to the students, the research team sent letters to all parents/guardians in the intervention school informing them that a fieldworker would telephone or visit them to request an interview about their opinions about the research and their child’s participation in it. It explained that no disadvantages would accrue to them or their child if they chose to refuse to be interviewed by completing and returning a form, attached to the letter.
The fieldworkers then telephoned each parent/guardian to request consent for participation and make an appointment for an in-person interview. If there was no biological parent in the child’s home, we invited the guardian who assumed primary responsibility for the child’s care and schooling to participate. If the parents/guardians did not have a telephone, the fieldworkers visited them to request consent for their participation and make an appointment for the interview. The fieldworkers were blinded as to whether the parents/guardians had been classified as a consenter, refuser, or nonresponder. Interviews were conducted either at the school or at the home, depending on the preference of the parents/guardians.
During the interview, the fieldworkers showed the parents/guardians a copy of the consent letter and form (which was easy to remember because, unlike other letters from the school, it had been printed on brightly colored paper) and asked whether the parents/guardians had seen it, read it, signed it, and returned it, and what they remembered about the research. Then the fieldworkers carefully informed the parents/guardians about the research, making sure to correct any misunderstandings they had about the research. Once the parents/guardians clearly understood the research, the fieldworkers asked them whether or not they wished their child to participate. The fieldworkers had been explicitly trained to conduct the interview so that the parents/guardians did not feel any sense of coercion to consent, or any need to please the fieldworkers by consenting.
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RESULTS |
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Parental Consent Form Return Rates
All 258 students in grades eight and nine were included in the study and given consent letters for their parents. Within 2 weeks, the students returned 243 (94%) of the 258 parental consent forms, of which 225 (93%) indicated parental consent and 18 (7%) parental refusal (Figure 1
).
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Demographic Details of Parents/Guardians Who Were Interviewed
Many students (73; 30%) did not live with a biological parent, in which case their guardian was interviewed. We interviewed 246 (95%) of the 258 parents/guardians. Only 76 (31%) parents/guardians had completed grade 10 or higher. Most parents/guardians (177; 72%) were employed, predominantly in domestic work. Few parents/guardians (91; 37%) had ever spoken with their child about HIV. Many parents (151; 61%) had attended a meeting at the school during the last academic year, but only 57 (23%) knew the name of the principal. Only 65 (26%) parents/guardians stated that they had attended the meeting called by the school to explain the nature of our research.
Parents’/Guardians’ Knowledge and Recall of the Research
Only 159 of the 246 parents (65%) stated that they had received the consent letter and form. Of those who received the letter, many were unaware about what was in it (Table 2).
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Did the Consent Form Reflect Parental Wishes?
When the fieldworker asked parents/guardians whether they wished their child to participate in the research, 243 (99%) of the 246 parents/guardians interviewed stated that they did (Figure 1
). All 243 wished their child to participate so that they would be better prepared to protect themselves from HIV. Of these, 18 (7%) wanted their child to share the new knowledge about HIV prevention with other family members; 11 (5%) wished their child to participate because, as parents, they found it difficult to talk about HIV at home; and 16 (7%) specifically stated that they felt it was important for their child to participate because it was a program sanctioned by the school. Only 2 of the 18 (11%) parents/guardians classified as refusers based on the consent forms preferred that their child not participate. We interviewed 12 of the 15 nonresponding parents/guardians, and all 12 (100%) said they wished for their child to participate.
The fieldworker identified 87 parents/guardians who reported that they had not seen the consent letter and form. However, the students had returned a signed form for 81 (93%) of these 87 parents/guardians (Figure 2). Most (71; 88%) of these forms indicated consent, and only 10 (12%) indicated refusal.
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DISCUSSION |
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This study has several limitations. At the time of seeking parental consent, the students in our study knew that their school had been allocated to the intervention arm (as opposed to the comparison arm) of the trial. We suspect that some students signed "on behalf" of their parents, mostly in their enthusiasm to participate in the intervention. Ideally, parental consent needs to be obtained before allocating schools to the intervention or comparison arm of a trial. Our finding of a high prevalence of parental consent may not be generalizable to other studies (especially if they are descriptive as opposed to intervention studies) nor to other communities. Another potential limitation is that it might have been difficult for parents/guardians to refuse consent during the interviews conducted by fieldworkers, resulting in a social desirability bias. However, our careful selection and training of the fieldworkers, and the frank appreciation expressed by parents for the opportunities afforded their children by the research, suggests that this was not the case.
Three assumptions are implicit in the approach of obtaining active informed consent from parents of adolescents participating in school-based research. These assumptions are that (1) having a signed form in which active informed consent is indicated provides sufficient evidence for the actual existence of such consent, (2) the person providing informed consent understands the study, and (3) a written refusal of informed consent reflects the actual wishes of the parent/guardian. However, in the present study none of these assumptions were supported.
These research findings should not be used to deny adolescents at high risk of HIV infection the opportunity to participate in prevention trials. Rather, the ethical conundrum that is raised by this research (weighing the benefits of developing effective widespread HIV prevention programs at schools against the harms resulting from imperfect parental informed consent procedures) needs to be acknowledged. Researchers need to explore the values and preferences of the communities in which the research is conducted and to work together with these communities to decide on appropriate strategies to gain the kind of informed consent that is appropriate for studies of this nature.
The current implicit gold standard of consent is active written consent by parents. We believe that in South African school settings, this standard of consent, if widely applied, would artificially lower the proportion of parents who wish to have their child included in low-risk studies of educational and informational interventions. This applies to both non-responding and refusing parents: for both groups the vast majority of parents gave consent once fully informed. Active consent restricts access to interventions, places children at odds with their parents, and skews the resulting studies in ways that are likely to overestimate the effect of interventions because of volunteer bias. We support a return to the use of passive consent procedures for low-risk studies of educational and informational interventions (many of which are consistent with the objectives of the new South African school curriculum), and we suggest that a carefully worded, pretested parent/guardian consent form be developed for each such study. Further, we suggest the use of methods other than asking students to solicit their parents’ consent. These could involve sending letters home in the post, or giving letters to parents when they register their child at the school at the beginning of the academic year, and providing information to parents at meetings held to discuss school fees (which are well attended).
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Acknowledgments |
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Thanks to Linda-Gail Bekker, Fiona Mendelson, the participating school, and the Western Cape Education Department, who made this research possible. The South African Medical Research Council and the New York University Challenge Fund funded this research.
Human Participant Protection
This research was approved by the New York University institutional review board and the University of Cape Town ethics research committee.
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Footnotes |
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Peer Reviewed
Contributors
M. Zwarenstein, C. Mathews, S. Guttmacher, and A. Flisher originated the idea and wrote the protocol. C. Mathews, Y. Mtshizana, and A. Hani supervised the data collection and analysis. All authors contributed to the final article.
Accepted for publication March 27, 2004.
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References |
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TOPABSTRACTINTRODUCTIONMETHODSRESULTSDISCUSSIONReferences |
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1. Global summary of the AIDS epidemic, December 2004. UNAIDS Web page. Available at: http://www.unaids.org/wad2004/report_pdf.html. Accessed January 10, 2005.
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5. Protection of Human Subjects. 45 CFR 
46 (2001).
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7. Esbensen FA, Deschenes EP, Vogel RE, Arboit K, Harris L. Active parental consent in school-based research. Eval Rev.1996;20:737–753.
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10. Anderman C, Cheadle A, Curry S, Diehr P, Shultz L, Wagner E. Selection bias related to parental consent in school-based survey research. Eval Rev.1995;19: 663–674.
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