FACILITATOR’S NOTES
This case study explores the role of both community and family relationships in recruiting and retaining participants. Medical research institutions employ several strategies to recruit and retain trial participants, often making use of informal structures such as Community Advisory Boards, peer leaders, or
community liaison personnel to try to reach their target community. However, despite these efforts, smooth relationships with participants are not guaranteed, and recruiting and retaining people remains a challenge. This case study invites us to think critically about questions related to the recruitment and retention of trial participants. It provides an example of the requirement for female participants to use contraception in a trial, and the impossibility of ‘enforcing’ this. It invites you to think about the role of male partners in
decision-making about following study rules.
It also raises questions over the role of reimbursements in the recruitment process. Attempts to control the problems could infringe on participants’ basic rights. The study also points to the underlying suspicion and cynicism with which communities can view trials, and the difficulties Community Advisory Board members face in trying to overcome this mistrust.
None of these questions are straightforward, so you will need to take care in how you manage the ensuing discussions.
LEARNING
OBJECTIVE
To consider challenges in recruiting participants and ensuring they follow study rulesKEYWORDS
Informed consent Gender Money Recruitment Partner involvementCOMMUNITY AND FAMILY RELATIONSHIPS HANDOUT Chop your money!
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CHOP YOUR MONEY!:
CHALLENGES IN RECRUITMENT AND ENFORCING
STUDY RULES
‘DON’T WORRY, I’LL PRACTICE ABSTINENCE DURING THE TRIAL,' SAID MARY, REJECTING THE OFFER OF CONTRACEPTIVES. 'UM… OK…' SAID THE DOCTOR DOUBTFULLY
THE STORY
story in a major national newspaper quotes a group of scientists from the National AIDS Vaccine Institute, expressing their frustration with the high pregnancy rates among women participating in vaccine trials. All women are advised not to become pregnant during the trials, due to the unknown side effects of the vaccine, however in one study a number of women conceived children. They have apparently been coerced by their partners to have unprotected sex.
All the women in the trial have had the risks explained to them, and were offered a choice of contraception for free. Those who became pregnant were the ones who opted for
abstinence as their preferred method of contraception, so in the article the scientists
recommended that abstinence should no longer be an option given to trial participants. They state, ‘Every effort must be made to ensure that trial participants do not get pregnant during the specified periods, and that they are retained until the end of the vaccine trial.’
COMMUNITY AND FAMILY RELATIONSHIPS HANDOUT Chop your money!
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After reading the newspaper article, Community Advisory Board (CAB) members in the National Aids Vaccine institute start talking about some of the frustrations they experience in participant recruitment. Many of the members were trial participants themselves before joining the board. Researchers hoped this would help with recruitment, as they hoped that ex-
participants could allay fears among community members and use their experience to convince others to join the vaccine trials.
According to CAB members, however, this is never enough to convince suspicious community members. ‘Any time we tell them that we have participated in a previous study, they do not believe us. They say we are lying,’ says one board member. Another remarks: ‘I took part in a trial with other community members, but they were not convinced that I was injected with the same vaccine as they were. They thought I was injected with a different substance.’
When the researchers talked to the CAB members about the issue of women becoming pregnant during the trial, the CAB members said that perhaps these girls didn’t participate for the right reasons and therefore were not ‘good participants’. They pointed out that this was part of a bigger problem. They told the researchers that they thought many people they try to recruit take advantage of the process to obtain money, with no intention of ever
participating. Some of the participants who refuse to enrol only at the final stages of the recruitment process tell CAB members that this is due to fear of the vaccine, yet, the CAB members argue, they seem very keen to complete the initial counselling and screening sessions to obtain the transport reimbursements for these sessions.
One of the CAB members explains: ‘You know, in the recruitment we often recruit our friends. Some of them have been quite frank and told us: “We knew all along that we would not take part in the trials, but you guys pay lots of money for transport, and give us snacks any time we come. We just wanted to chop your money.” Perhaps those women who conceived were just thinking about chopping money and ignored the rules of the research.’ (This expression, ‘to chop money’, is coined from a popular African song and means ‘taking someone’s money without giving anything in return’.)
‘But on the other hand,’ one of the male CAB members says, ‘we all know that pregnancy is an issue between men and women, not between women and researchers! Perhaps these ladies did not tell their husbands about the trial.’
COMMUNITY AND FAMILY RELATIONSHIPS HANDOUT Chop your money!
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QUESTIONS
Do you think the female trial participants ‘intended’ to get pregnant despite enrolling? What are the problems with this concept of ‘intention’ in this sort of case? What does this tell us about informed consent?
What do you think about the scientists’ suggestion that trial participants must use contraception methods other than abstinence to ensure that they do not get pregnant? What about those whose relationship status changes during a trial or before a trial, and who therefore decide they want to have children? What about participants or potential participants whose health or personal circumstances make it difficult for them to use contraceptive methods consistently?
Do you think there was a need to involve participants’ male partners more in the trial? How could this be achieved?
Given the problems of recruitment, what ethical issues emerge from the use of financial inducements to recruit trial participants – for the trial, and for the potential participants? Can you think of any reasons why the friends of the CAB members, who were recruited to the trials, were very opportunistic about trying to ‘chop’ the money?
What do the quotes in this story tell us about the experiences of Community Advisory Board members? Do you think the researchers could do more to support them, and if so, how?
REFLECTION ON YOUR OWN EXPERIENCES
Have you observed similar opportunism when it comes to getting a share of research resources – maybe even before participants take part? If, yes, what happened, and how did you deal with this?
What is your view about the role of CAB members or similar representatives? Should they be actively involved in recruitment activities?
FURTHER READING
Geissler, W. (2011) ‘Transport to where?’: reflections on the problem of value and time à
propos an awkward practice in medical research.Journal of Cultural Economy4(1), 45–64.
Painter, M.T., Kassamba, K.L. et al. (2004) Women’s reasons for not participating in follow up visits before starting short course antiretroviral prophylaxis for prevention of mother to child transmission of HIV: qualitative interview study. British Medical Journal 329 (7465), 543.
COMMUNITY AND FAMILY RELATIONSHIPS FACILITATOR’S NOTES My husband doesn’t know
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