Table 1 Examples of participant-cited risks of youth research participation
Direct Research Risks | Blood Draw Complications | “I think one of the risks that I even think about myself is when your blood is being sampled and taken for a blood test then all of a sudden the needle breaks inside your arm.” –adolescent above 18 in R01, male “Yes, infection from, let’s say, the blood sample, maybe the tools that they used for blood sampling can lead to infection. Maybe they were not sterilized well, yes…in which they can lead into infection.” –adolescent below 18, research-naïve, female |
Ineffective or Dangerous Experimental Drugs | “The only risk that can be there is if it is a research study that aims to research at a particular drug that hasn’t been proved, there will be an effect because they will stop using the initial drug and switch to the one being researched on, and during this certain period the viral load will go high because the drug has not been approved and it is not working, so by the time they realize this, the viral load will have shoot high…” –caregiver, male | |
Harassment or Intimidation in Research | “…maybe when they get to the clinic where they are going, and then they are harassed then the child might refuse to come another day… as in being harassed…someone who maybe does not know how to talk in low tones like for example like for my daughter whom I have brought, then someone shouts at her ‘Why are you not talking?’ So you know my child will develop some [fear] so she cannot agree again to come to that clinic.” – caregiver, female | |
Accidental HIV Disclosure to Child through Research | “As I had said before, some young people do not know why they take drugs, and they may learn why they take drugs in research. You don’t know how it could affect the child. It can lead to something bad like being in denial and in the process, they may stop taking the drugs which will increase the viral load.” –adolescent below 18, involved in R01, female | |
Accidental HIV Disclosure to Others | “Disclosing the child’s status by accident isn’t a good thing because when a negative person finds out he will go to tell others and when the child passes by they will be gossiping that he has HIV and they should keep away from him. The child will be stigmatized. It will be risky if the information leaks. We don’t know how we can keep the secret but we should just try so that we don’t ruin their lives.” –caregiver, female | |
Mental Health Risks | “Emotional injury. In the case where the researcher asks intense question to the participant, that may later lead to the participant wanting to maybe commit suicide and can also lead to depression sometimes.” –adolescent above 18, research-naïve, male | |
Coercion with Financial Compensation | “Again, they may just want to participate in as many research [projects] as possible especially when they know there's compensation, whether or not it affects them. Because they're vulnerable and you know that some of these adolescents are even orphaned, especially for those who were born with HIV, some of their parents have died. And we know some circumstances are very difficult, and so they can view research as a way of getting some money even when their own wellbeing is compromised…” –clinical researcher, female | |
Associated Behavioral/Social Risks | Stigma | “One of them is the most dangerous one, is stigma. You know when they come here, then when they go back home, maybe their peers will ask them ‘where were you, what happened to you?’ Then they might expose whatever they come to say. That stigma will be there. In a community, there are so many creations of stories, creation of rumors or words. It might even lead one to hang himself or herself.” –chief, male |
Discrimination | “They will discriminate you because they don’t have any more knowledge about HIV so they just see anyone with HIV even they cannot share cups with you because they just see you can transmit with them. But that’s not true… they may have negative thoughts about you when you don’t have any intentions.” –adolescent above 18, research-naïve, female | |
Youth Demoralizing Each Other | “The only bad thing that may happen is when they are together participating in the research and they start saying negative things about the research study, that will tend to demoralize them. When they are together without the research team. You may never find out because they will meet in other places and share research experiences. This can demoralize them from participating in the research.” –caregiver, female | |
Self-Stigma | “Self-stigma, am talking about a situation where the individual feels, feels less confident, feels less worthy, feels less important, you know? Negatively treats themselves, negatively discriminates against themselves on the basis of their status.” –community leader, female | |
Irresponsible Use of Monetary Compensation | “If you give them something we won’t know because they are adults so the risk that I can see is according to today’s world, there are a lot of things like bhang and the child can buy because he has money.” –caregiver, female | |
Loss of Confidentiality | “I don’t think that there is anything bad that can happen to you because they are informed; unless if the results are exposed or used for someone’s benefit or gain instead of being kept private.” –caregiver, female | |
Risk of Being Left Out of Benefits | “There is the risk of being left out of the benefits that come out of that research because benefits come much, much, much later and so…and there adolescents may not…you know adolescents especially the girls maybe married away and so they get left out of some of these as the benefits come to the community where the research was taking place and once you marry away now you lose the benefit, some of the things that I see.” –clinical researcher, male | |
Caregivers Taking Financial Compensation | “…young people shouldn’t be involved in a research… in this research, maybe there is some sort of appreciation [compensation… Because maybe this caregiver is the one who takes the appreciation [compensation] and not the child. But after the child notices that, when the research dates reach, maybe this child will no longer wish to participate in the research because the caregiver will be given the incentive. The child won’t benefit.” –adolescent above 18, involved in R01, male | |
No Risks | “It is good if they participate, I don’t see anything bad happening.” –caregiver, female “I don't think there are any risks.” –adolescent below 18, involved in R01, male | |