With the Nuffield Council of Bioethics inviting comments from LMIC researchers on the ethical implications of involving children in clinical research, this month Global Health Trials is keen to hear your thoughts and experiences.
Have you worked on paediatric studies, and what ethical issues did you face? what factors did you consider in your recruitment and retention plans? What are the ages of assent and consent in your country, and what are your personal feelings on when children's own opinions should be taken into account relating to their participation in research? What about child-headed households, or children married when still at the age of assent: who should consent in these instances?
Read more about the Nuffield Council of Bioethics here: https://globalhealthreviewers.tghn.org/community/blogs/post/383/2014/05/children-and-clinical-research-consultation-on/ and please comment on your own experiences below.
Hi , Very interesting post there. I have one question which I feel is coming up in discussions frequently in global health research these days. Should there be consent for vaccinating children? if so who should give the consent? Should parents consent for their children to get vaccines?
that's an interesting question. Do you mean, for vaccinations which are part of a trial (but are already proven - such as when a trial blinds participants to receiveing a trial malaria vaccine versus a routine rabies vaccine)? Or do you mean, when giving vaccinations in general practice?
The Editorial Team
I am Pediatric Infectious Diseases consultant and researcher who currently focuses on pediatric HIV and PMTCT in Nigeria. I am currently working on a large PMTCT study that has both mother (15+ years) and infant as participants, as well as two pediatric/adolescent HIV studies. My biggest challenges are lack of clear guidelines for consenting children under 18 years, and the clear definitions of emancipated minors. There are management guidelines that more strongly (but not fully) state what emancipated minors are, and how young a patient can be before testing or providing care without parental consent. However it is the law under which a researcher or clinician can get into trouble, However, the law is woefully inadequate in setting or explicitly discussing clear guidelines. 1. Pregnant teens under 18 years old, children living with HIV under 18 years, and the general population of children under 18 years who may want/need HIV testing become a huge problem if we are to test them or conduct research with them without parental consent. This has led to severely reduced access to HIV testing for young adolescents because they get turned away during outreach and clinic-based HIV testing. The only clear statement on age of consent is 16 years--for a child who has to undergo testing for establishment of paternity in a parental dispute. There is no clear legal statement on assent or emancipation, and part of that comes from the very authoritarian attitude towards children, even those who may have their own children. I think emancipated children (married-male or female; sexually active or seeking SRH care, head of household or independently self-supporting should be able to provide full consent. The issue is to establish that they fall into those categories. For HIV testing, a clear minimum age for consent for testing, regardless of whether they are emancipated or not, should be provided. However we should also consider if we ask the age of a child if they are independently coming in for a Haemoglobin vs HIV test.
I wish to congratulate you on this research project and wish you a very successful completion in the midst of the challenges.
Its usually difficult to provide access to quality care and treatment when laws are clearly not reflecting and addressing the true situation as it relates to minors and access to health care. Sad but true minors are sometimes the ones who suffer as a result of unclear legislation. However as health care providers we must protect and function in accordance with the laws ,rules and regulations of the country in which we work and function. We however must continue to provide guidance in order to direct policy makers in the area of policy and legislation.
Vaccination is very important in the fight against vaccine preventable diseases. I think the government should provide legislation to protect populations against vaccine preventable diseases of which parent would have to comply, with exclusion for health and other reasons'.Also the reason for the government being responsible they will also be responsible for financing of the immunization thus freeing parents for that added burden of access because of inability to pay.
On the other hand if it is for the purpose of vaccine trials a research ethics committee should examine the pros and cons and direct government of options in such case parents / communities should also be involved.