In this study of consent to genetic epidemiological research on breast cancer in the urban center of Ibadan, Nigeria, the majority of all participants (70%) reported that the study purpose was to learn about genetics and breast cancer. However, breast cancer patients (83%) were more likely than women in the control group (58%) to report that the purpose of the study concerned the genetic inheritance of breast cancer. The overall high level of comprehension among all participants about the genetic purpose of the study could reflect the skill of research staff in explaining study goals during the consent discussion for the genetic research. It could also reflect the relatively high level of education among the participants. The higher level of comprehension among the women with breast cancer about the study purpose, compared to women in the control group, could be attributed to their greater interaction with the health system because of their cancer. Women being treated for breast cancer are asked to complete a number of forms during clinical interactions, including consent forms for treatment interventions. This could have increased their attentiveness to the consent process for research participation in the genetic study. In addition, the diagnosis of cancer may sharply focus the mind of the breast cancer cases on every aspect of their interaction with the health care team, including the research staff, to a higher degree than individuals who are enrolled as controls in the community. This higher level of attention by breast cancer cases may be associated with greater attention to detail and improved comprehension. The breast cancer patients may also ask for more clarifications and ask more questions but we did not examine these issues in this study.
In contrast to findings in this study, results from analysis of data in our study of consent to genetic epidemiological studies of hypertension conducted in metropolitan Chicago in the U.S. and in the rural town of Igbo-Ora, Nigeria, show that only about half of respondents at both sites reported the study purpose was to learn more about the genetic inheritance of hypertension . Differences in comprehension of study purpose between participants in the breast cancer study and the hypertension study may reflect the symbolic power attributed to a disease such as cancer, especially among the women with breast cancer in our study. Breast cancer generally evokes greater concern among women everywhere than illnesses perceived as less threatening such as hypertension, and this could impact comprehension of the study purpose during the consent discussion. Hypertension is more common than breast cancer and thus, more people have personal experience with hypertension or perhaps know others with hypertension. Finally, hypertension is a chronic condition that is treatable with medicines or changes in diet or exercise habits while breast cancer requires more invasive interventions such as surgery, chemotherapy or radiation and the outcomes of treatment may not be favorable in the long-term.
Nearly all of the women in this study recalled being told participation was voluntary and that they did not feel pressured to participate. In-depth interviews reveal two important dimensions of participants’ understanding of “voluntariness”. First, women addressed the need for self-determination—in order for participation to be voluntary, a person must be able to make their own decision about joining a study. Second, women emphasized that a decision could not be coerced or forced by someone else. From this perspective, the act of voluntary participation requires both individual choice and the absence of coercion.
The concepts of individual autonomy and self-determination are foundational in the western ethical practice of informed consent. Yet, individuals everywhere may discuss medical issues, including participation in scientific research, with husbands, family members or others who are important to them. Our survey results indicate that only one-fifth of the married participants sought permission from their husbands to join the genetic study. In contrast, findings from our study on consent to the genetics of hypertension research in the town of Igbo-Ora show that nearly half of the married women reported they sought permission from their husbands . In both of these studies, the survey format asked participants to respond “yes” or “no” to the question, “Did you seek permission to participate in the study from your husband?” Because the survey was not designed to evoke explanations about the meaning of seeking permission to join the study, we are cautious about over-interpreting participants’ reports of “seeking permission” from husbands.
Acquiescence to the husband’s authority in decisions about research participation does not represent normative behavior either in the urban city of Ibadan or the rural setting of Igbo-Ora where we conducted our research. Indicative of the lack of a single normative expectation about husbands’ permission for research participation is the variability of the responses at both sites. In other words, not all rural married women reported seeking their husband’s permission and not all urban women reported they did not need to seek their husband’s permission to join the study. Nevertheless, findings from our breast cancer study, compared to the hypertension study, suggest an urban-rural trend. Moreover, if this study has been conducted with Hausa women who were practicing Muslims living in rural northern Nigeria, they may be more likely to seek husbands’ approval to participate in a study because of the possibility for more conservative views about the hierarchy of decisional authority and its implications for the relationship between wives and husbands.
In-depth interviews with participants in the breast cancer study call attention to the nuanced and complex negotiations in the process of decision making between a wife and her husband. We believe that “seeking permission from a husband” to participate in research represents a more dynamic and fluid process of discussing information about a research project, not a simple request to be “allowed” to participate.
Our findings suggest that in the urban setting of Ibadan, Nigeria, decisions concerning participation in genetic epidemiological research on breast cancer did not involve input from community elders. It is important to note that in the community where the study took place there is a well-established council of elders; regularly scheduled public meetings are held with community members to discuss activities, events, and issues of concern. Our survey asked participants to reply “yes” or “no” to the question, “Did you ask permission of a community elder to join the study?” It could be that women did not seek permission from local elders for practical reasons associated with study recruitment. Women may also have reported not seeking permission for study participation from a community elder because they did not believe that the study represented an investigation that might call for consultation with elders.
Although the approval of elders for research participation was not a concern for participants in our study, international guidelines for biomedical research recognize that, in some areas, investigators may need to consult with community leaders or elders before implementing research projects [30, 32]. The views of community leaders may be communicated to local populations through accepted social venues such as council meetings or public events; it is in this public arena where their opinions are likely to influence someone’s decision to join a study.
Findings from our study suggest that participants in the genetic epidemiological study of breast cancer in Ibadan reported a high level of comprehension of study goals and voluntary participation. However, these findings need to be treated cautiously; as Hollowell and her colleagues and others have demonstrated, even highly educated individuals may have difficulty understanding information communicated during the process of consent, and specifically, the differences between research and clinical practice [61–63]. This has particular relevance for the breast cancer patients who participated in our study.
There are several limitations of this study. First, findings may not be generalizable to other African sites. The cultural and social context of the site where genetic research is conducted will vary depending upon local traditions, geographic location, and the goals and procedures of the genetic study itself. For example, our study focused on informed consent to genetic epidemiological research on breast cancer in the urban center of Ibadan, Nigeria. By comparison, a study on informed consent for biobanking of DNA samples conducted in a Xhosa community in rural South Africa may result in different findings. Second, the translation of the instruments from English to Yoruba for Nigeria represents another possible limitation. However, a process of back-translation was implemented and all field staff were fluent in English and Yoruba and trained to conduct the survey and in-depth interviews. Third, in our descriptive study, we did not attempt to assess participants’ knowledge of the difference between research and clinical care. Thus, we do not know the extent to which the patients with breast cancer who participated in the study differentiated between consent for clinical care or research.
Our study contributes to the literature on voluntary participation and comprehension of informed consent to genetic research conducted in African settings. The importance of both quantitative and qualitative empirical research on applications of requirements for informed consent to genetic studies will increase as genetic and genomic investigations continue to expand in Africa [64, 65]. Currently, for example, genomic research on a range of topics is being implemented through the H3Africa (Human Heredity and Health in Africa) initiative; the goal of H3Africa, supported with funds from the Wellcome Trust and the National Institutes of Health, is to build capacity for genome science on the continent of Africa .
The fundamental goal of consent to research-informed and voluntary participation—applies to all medical and behavioral studies, including genetic investigations. Nevertheless, the nature and purpose of particular scientific studies and their associated risks and benefits vary in complexity and this can influence the process of communicating information during the consent conversation. In some genetic and genomic research, for example, the creation of cell lines, ownership of donated DNA samples and data sharing are key features in the design and implementation of the study. The role of the individual in research, whether as someone with disease who has been recruited as a case participant, or someone proven not to have the disease of interest and therefore enrolled as a control, may also affect engagement with the processes of research in a way that may affect comprehension of consent. A breast cancer patient pays more attention to information being provided about breast cancer than a control does. The level of investment in the information is markedly different.
Future empirical investigations on the process of informed consent will further our knowledge of comprehension and voluntary participation in the context of genetic and genomic research involving complicated issues that have implications for individuals and their communities.