Assent in clinical trials

Another example of a very informative and beneficial exchange on Global Health Trials. Thank you all for these responses. We know this is a difficult area for researchers and so we suggest we turn this exchange into a guidance article because this will be such a useful topic for trialists. We shall therefore be in touch with each of you and invite you to be authors. The templates that anyone has will also be a great help - so please send them in. Please also know that 1,000's of trialists will be reading this and that it is helping them in the design and conduct of their trials. Well done indeed. Please keep these examples coming.

Hello,

The common practice for documenting assent is for the minor (12-17 in most settings) to sign or thumbprint the assent form, as well as that of the parent or guardian. But this is often based on an understanding that the minor has 'adequate decision-making capacity' and understands important aspects of the research.

In other cases, verbal consent (without the signature of the minor) is acceptable if the investigator and/or parents believe that it is not in the best interest of the child to obtain written consent. The form is signed by a witness and the parent/guardian.

As Dkamuya has highlighted this will also depend on the context in which assent is being obtained and the definition of who a minor is. The local ethics committee may also be able to give some guidance on what counts as an acceptable approach to documenting assent in the local context.

I am happy to forward a couple of assent templates to you if that will be helpful.

Good-luck!!

This is what we do
1. if the child is over 12 years we get his signature after giving the Participant information leaflet and consent form.
2. as school attendance is 100% in Sri Lanka we get the permission from relevant educational authorities, school principals, teachers etc
3. we also get consent from parents in all kids who are under 18 years
4. when the child is under 12 if the child expresses verbal displeasure and reluctance to participate we will not recruit him
Bit of a detailed process but i feel ethically sound

Hi,
The question you raise resonates with dilemmas many researchers face especially where ethical review mechanisms are not strong. I am assuming that the question is not about children. There are some points to think about:
a)guidelines provide that it is imperative for proxy consent from parent/guardian for a minor to be involved in research; additional protection measures as would be advised by ethical review mechanisms would include ensuring that the consent/assent form and other materials used in assent are age-appropriate and in a language minors can understand/relate with.
c) It is important to contextual definition of a minor, in some countries, a minor is from 7/8 years, in others from 12/13 years.
d) In some countries, "emancipated minors", those under 18 years but are themselves parents are treated as adults and consented rather than assented, but again this may vary across context. For example, based on some of the work we are doing, we have found that if such emancipated minors live within extended households, the household head will also need to be consented.
e) importantly is whether the minor understands what they assent for and what signing of the assent form
f) another important consideration is what to do when the parent consents, but the minor refuses assent; guidelines provide that should be treated as a refusal. As one of the paper indicates, there are many factors that influence a minor’s decision to assent or otherwise, including for example previous experiences, important relations..
g) On whether to sign for assent, as you will probably have noticed in the above points, the main issue is about whether the minor understands what they are being asked to participate in. A few articles to look at:

Gill, D., F. P. Crawley, et al. (2003). "Guidelines for informed consent in biomedical research involving paediatric populations as research participants." Eur J Pediatr 162(7-8): 455-458.
Koelch, M., H. Singer, et al. (2009). ""...because I am something special" or "I think I will be something like a guinea pig": information and assent of legal minors in clinical trials--assessment of understanding, appreciation and reasoning." Child Adolesc Psychiatry Ment Health 3(1): 2.
Mystakidou, K., I. Panagiotou, et al. (2009). "Ethical and practical challenges in implementing informed consent in HIV/AIDS clinical trials in developing or resource-limited countries." SAHARA J 6(2): 46-57.
Spriggs, M. and P. H. Caldwell (2011). "The ethics of paediatric research." J Paediatr Child Health 47(9): 664-667.
van Wyk, C. (2003). "The participation of minors in preventive HIV research trials in South Africa: legal and human rights considerations." Med Law 22(4): 589-598.