Cultural traditions, norms and beliefs
A significant amount of time in each focus group was devoted to topics having to do with belief systems and cultural norms that were perceived to influence how the collection of biospecimens would be viewed by individuals and communities in Botswana. All four groups referenced Botswana’s current national safe male-circumcision (SMC) campaign to illustrate how cultural meanings can affect local understanding of a medical procedure. Until the mid-20th century when medical missionaries actively discouraged the practice in Botswana, circumcision was part of a month-long rite-of-passage for adolescent boys that taught traditions, values, and ways in which men should relate to women . Meanings that were once attached to circumcision remain, reinforced by the campaign’s use of the Setswana term for the traditional initiation, go rupa or bogwera, as the term for the medical procedure itself.
“When [the campaign] started, [health workers] took their foreskins and just threw them away. Local people were concerned because this is not a tissue. This has meaning. There was a rumor that the foreskins were being sold to traditional doctors. They started thinking that maybe this circumcision is not what they thought it would be.”
Study participants also observed many Batswana are concerned that foreskins removed as part of this campaign are being sold for other people’s use. Many people, particularly those with less education and those from remote areas of the country, still believe in witchcraft and fear that body parts, including blood and samples that are collected by health workers, will be stolen or sold to make powerful magic (muti) that can harm or bring benefit to others.
Discussions of religious beliefs were common to all four groups. Belief that “God has his own way of healing” was seen as discouraging patient utilization of medical services in general, and by extension, of experimental efforts to treat and cure disease. As one discussant characterized a common local sentiment:
“Why should I allow a medical person to collect a sample from me? If I am sick, for example, if I have cancer; God has his way of healing cancer. Why would I just allow a person who gets his wisdom from God to go and test it? Nature will take its course; it will heal in time if one believes in God.”
The cultural significance of bodily integrity was seen to stem from the belief that one must return to one’s Maker ‘whole’ and from the importance placed on being able to account for one’s ‘parts’ at the moment of death. One IRB member, describing the case of a young Motswana woman who had had a mastectomy while living outside of Botswana, characterized local fears about loss of bodily integrity in this manner:
“If these [stored] specimens are out there somewhere in the developed world – far out there- just as I am about to die, can these specimens come back because I want to go to my grave whole? Not to leave part of it over there, overseas? How do these specimens come back? I will not have a peaceful death because I am worried that I am facing death without all my specimens. A breast is somewhere.”
Lack of trust
At odds with what IRB members described as Batswana’s ‘tendency to trust’ was the consensus across groups that there was a general lack of trust in research and, by extension, in researchers themselves. Foreign researchers were viewed with greater distrust than local researchers:
“If you are a foreign team coming from outside and going to the rural areas, there may be suspicion. Even if you are from Botswana and you come with a team – let’s say you are coming from Gaborone to a rural area- they will always suspect that you are going to take something and that you are doing it for something. But if you were from a foreign country, I think it will be even worse.”
One group discussed at length what it perceived to be the general erosion of trust in clinicians as a direct result of medical research activity in Botswana. What was once trust in the medical doctor to care for the people’s needs has now been replaced by skepticism as to the underlying motives of the health care team. Referring to the current SMC campaign as an illustration of the problem, one IRB member who was a physician offered:
“I think that [early on] they saw the [actual] process of circumcision as a medical component – as separate from the rest of the circumcision initiation. They never asked what we were going to do. I think they were confident that we were doing exactly what we said we were going to do… Since research arrived in the country, most people are wary of research, suddenly these issues take on a different complexion. These tests are often not used for the person’s own care. So they don’t know who will see the results or how [specimens] will be used.”
Misunderstanding of the role of biospecimens in clinical and research settings
Considerable discussion took place in all sessions about the general lack of knowledge in the population about biomedicine, both in clinical and research settings. Participants observed that Batswana on the whole associate the giving of a specimen with clinical care and perceive that in doing so they are contributing to their own well-being. Sick patients come for treatment; physicians draw blood or take a urine sample which goes to the ‘lab’ either for the doctor to use in diagnosing the cause of illness or as an ingredient for a treatment that the nurse or doctor prepares for them in the form of a pill, an injection, or a salve. The patient returns home and in due course feels better. The scenario suggests that often patients associate specimens with treatment, that they believe that their specimens are “used up” in the preparation of that treatment (effectively returning one’s specimen in another form), and that the giving of specimens results in personal benefit. To date, most biomedical research and specimen collection in Botswana has taken place in hospital settings or in association with patient care. Research subjects give specimens because they expect a cure.
“You know, most Batswana, they expect to get results after you’ve collected a specimen, But now with research, if you take a specimen, you are not going to give any results. Is that right? [Researchers] go to families and collect blood specimens. And the results are not revealed to the people. They were advised to go to the hospital to get tested to know their HIV status. So you know from their perspective, they feel cheated. They sometimes feel cheated when it is put that way.”
Some patients believe that the collection of certain types of specimens, especially spinal fluid, actually worsens health and may hasten death in sick patients. Spinal taps, invariably performed in very sick patients, were reported to be broadly perceived as deadly. In instances of amputation or extraction, it was not uncommon for patients to ask that the limb or tooth be returned to them for ritual disposal.
Several IRB members observed that most Batswana were unaware that samples collected as part of clinical care were generally kept by the medical facility. As one IRB member who was medical staff commented:
“I think mostly they don’t know that they are being kept. If they knew…they will think that persons are using their specimens to do something else which they didn’t agree to. Mostly they don’t know. They think that their specimen was taken and was used.”
Reuse of biospecimens
Questions regarding reuse elicited broadly diverse responses from participants on issues relating to consent, privacy and confidentiality, criteria for reuse, competing research interests, and benefits. A number of IRB members offered that Batswana are likely to be very concerned over specimens being re-used for purposes for which they have not given explicit consent. Several participants felt that a blanket consent for reuse obtained at the time of collection might be acceptable, although they were concerned that research subjects would not fully appreciate the risks and potential benefits associated with such a choice. There was particular concern voiced about the legitimacy of consents obtained from Botswana’s most vulnerable populations, such as the San people of the Kalahari, who may not have fully understood the information on which they were asked to base their decisions.
“If they are going to take research samples and store them for a long time and then use them for studies that are not disclosed to the individuals, then those persons do not have autonomy over what is going to be don. The researcher needs to at least say something like ‘I am going to use this in the future for HIV research’, and then if the researcher were to [want to] use it for some other purposes, it would not be permitted without permission… I do not think there should be blanket consent, particularly for research that relates specifically to them [the participants].”
Consent for each new use was the predominant preference among discussants, although there were mixed opinions about the source and nature of such consent. A number of IRB members felt that even when research subjects could give meaningful consent to reuse at the time of collection, requests for reuse should still be reviewed and approved by an IRB or another ‘local group’. Some participants felt that donors should be contacted and new consents obtained for each use, while others were comfortable with review and approvals for future uses by an individual assigned responsibility for the management and supervision of the specimen storage facility. One group agreed that an IRB could approve future uses but emphasized that the reviewing IRB should be a national body, such as the HRDC, and not a local IRB like itself. Those that felt that authority for approval of future use could be delegated to an IRB or other body also felt it was imperative that a strong national regulatory framework be in place so that ‘rules were established and clear’.
IRB members who felt that all reuse was contingent on re-consent by individuals and families from whom the specimens had been obtained stated that specimens needed to be kept in identifiable form for this purpose. Somewhat at odds with this point of view, they were also part of a majority of participants who expressed the view that it was important that specimens be stored in de-identified form for all reuse as a way to ensure privacy. At the same time, most felt that it was important to be able to link data back in the event of discoveries that might be relevant to their health.
There was a fairly lengthy discussion in all groups about the criteria for reuse. Several participants voiced the opinion that many Batswana would be opposed to reuse if the intended uses were not specified. It was felt that researchers would be seen to be “conniving” if they request permission to re-use specimens for unspecified purposes. Those who thought reuse might be acceptable to research subjects shared a number of different viewpoints about the conditions that would apply, including reuse only within the context of the original study, reuse for future studies within the same disease category, reuse during a fixed period of time, and reuse contingent on approval of donors and/or an IRB.
Several groups raised the topic of priority-setting in the context of reuse; they expressed concerns that international researchers might have aims in mind for future use that did not address local needs in Botswana.
“It should not just be a blanket, open reuse…I shouldn’t [get] to reuse specimens just because today I feel like doing research on something that doesn’t return to the nation or to the community. You shouldn’t just be doing research because you just want to learn whatever is happening. There are national and community interests.”
Ownership and storage
Discussions regarding ownership elicited strong opinions from all the IRB members. Some members felt that specimens belong to the person who gave them, and that individual donors should retain control and access to them, even in storage, and should be able to retrieve them if they so choose.
“If I donate a sample for research as a participant, that sample is mine. That belongs to me…My DNA and everything is there. That belongs to me… I need some control or comfort level with my sample.”
Several IRB member participants expressed the minority opinion that biospecimens should be the property of the researcher or the research institution to whom they were originally given. Even though several participants suggested that there might be gradual transference of ownership between researcher and the nation, and that specimens may for a time have to be located outside the country, the majority of participants agreed that ultimately the specimens should belong to Botswana. The government, they felt, should be the ultimate gatekeeper.
“I think that if I get specimens for my research, there should be a point at which they don’t belong to me anymore, when they ought to belong to the community of researchers or to the human community. [But] there should also be regulations at different levels. You know, if the specimens are here at some stage, they have to be transferred from me either to the university or to the country and the country will take custody of those specimens for future generations and everybody else.”
The common belief that specimens are “used up” in an individual’s care was seen by most IRB members as a major obstacle to acceptance by Batswana of HBS reuse and storage. One discussant observed “the keeping is the problem,” conveying in one phrase local concerns that specimens would not be wholly used for a person’s own care, that specimens would be “out there somewhere” at the time of death, and that someone else without the same obligations to self, community, and country would control them.
One group voiced distinctly different views about duration and benefits of storage. This group included the more ‘seasoned’ IRB members from the HRDC and the University of Botswana. These participants introduced some pragmatic considerations not voiced by others.
“My concern is the fact that once specimens have been collected, at some point, people [will be] required to destroy them. It’s such a waste, you know…. To say after three years, ‘okay, destroy them’ doesn’t seem to me to be a good solution. It presumes that we are going to do harm with that specimen [and that] we [the IRB] are not watching. We just throw away specimens. One hundred years from now, researchers would benefit from specimens if they can keep them that long. But unfortunately we throw them away.”
IRB-member attitudes towards storage were linked to concerns about access. Many felt that storage of specimens could be of benefit if priority access was given to local researchers wishing to conduct research of direct benefit to Botswana. There was general agreement that a regulatory framework was needed to ensure safeguarding of specimens regardless of duration of storage.
There was widespread consensus among participants that, ultimately, specimens should be kept in Botswana.
“I have a problem with the specimens going out. Why? Because you never know what they are going to be used for. You have no control over them once they have left the country. I’d rather prefer whoever wants to do that research should have a budget that is enough to bring whatever equipment or facility here and do whatever he wants to do in the country so we can benefit.”
Participants acknowledged the need to build capacity in-country for storage, safekeeping, and research, with most voicing the view that the international research community should help in this effort.
Potential benefits and benefit-sharing
Concerns about reuse and storage were generally linked to considerations about how individuals, communities, and the nation could benefit. Complicating such discussions was the conflation of ‘payment’ to research subjects for their time and inconvenience at point of specimen collection with ‘benefit’. Because many IRB members viewed this practice as payment to subjects for the use of their sample or information, it followed that subjects should continue to be paid (in their words ‘benefit’) each time their samples were re-used.
IRB members felt it was important that any benefits derived from the use of stored specimens, including monetary gains, intellectual property rights, or new treatments, should be shared with the individuals who provided the specimen, their communities, and/or the nation as a whole. Most participants recognized that this is already a concern with current single-study use that would become more pronounced when specimens were stored and reused, particularly if storage was located outside of Botswana.
Several participants felt that concerns over benefits were exacerbated by a general lack of feedback to research subjects about study results, particularly in light of widespread confusion about ‘research’ versus ‘clinical care’, from which patients routinely received some benefit, often in the form of a medication, treatment, or a return to health.
“If they [research subjects] are not given results, it affects the future and the chances that others will give specimens. How come you always come to us and never give us feedback?”
Others remarked on the woeful lack of recognition of the contribution that research subjects make. Seeing such recognition as a form of benefit, it was their opinion that a lack of such acknowledgement had a negative impact on people’s willingness to participate in research.
“We see nowadays people who have contributed to the good work, contributed to the research in many ways….how do we recognize [and] reward the person, from whose specimens we learned something important?....Reward does not need to be monetary… If the people contributed to an achievement in research, they should be recognized and acknowledged. If our grandfathers built a school, we continue to be proud of this school because it wears our grandfathers’ names.”
Educational needs and regulatory guidance
Study participants were unanimous in their recognition of the need for more education and training opportunities for IRB members, particularly on issues relating to genetic and genome-based research. They agreed that all committee members must be knowledgeable about issues relating to biomedical research, research ethics and, in particular, the use of biospecimens. A number of participants, particularly those from the newer IRBs, voiced frustration at the lack of information they had on which to base their deliberations and the limited recognition that was given to the amount of time required for review.
“The official training would help. It would be better than what we are now. We don’t want to be biased. If we tell someone that they have to comply, we need to know… For some [IRB members] its core business, but the rest of us are dragged in. If you knew this was ‘certified’ business, you would work more at it.”
“We came here to do other things; we are [co-] opted to be in the IRB. I don’t even have time to think or read on my own, or to learn what the expectations are. And I have to read so many papers.”
When asked if they were familiar with any regulatory guidance for research and if so, if they felt it was adequate, most study participants agreed that such guidance existed, but were generally not familiar with it or felt that it was ‘easy to bypass’. All but one IRB member believed that there were existing regulations about biospecimens. Most participants were familiar with the existence of a forthcoming Health Research Law and expressed general anticipation that this law would address existing inconsistencies and concerns with respect to access, ownership, and storage of biospecimens and benefit-sharing.
It was generally felt that regulations would increase the consistency of IRB reviews and would reduce the perception of inconsistent, discretionary decision-making by IRB members.
“[A national policy] would be very important. See, right now, either we don’t know things well, or we can bypass them. If there were clear regulations, we would be able to prevent people from operating differently. Tomorrow I am going to be able to say, ‘This is the law’. A proper legislation, along with penalties and everything. It will apply to everybody. That would be better.”