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Ethics & Engagement across the Wellcome Trust Major Overseas Programmes

In November 2014, I presented a poster on valid consent for adolescents at the 63rd annual meeting of the American Society of Tropical Hygiene and Medicine meeting in New Orleans. The ASTMH annual conference is the biggest meeting for researchers working in tropical medicine attracting about 4000-5000 delegates each year. This year’s meeting was very special. Bill Gates gave the key note address. His speech was very moving and I thought that he was indeed very impressive. He talked about malaria elimination, child mortality and other neglected diseases. He did not come to see my poster though!  

My poster  argued that minors should be allowed to consent for medical research in their own right if the requirements for valid consent are met and the study meets the usual scientific and ethical criteria. International guidelines stipulate that for minors to participate in medical research, consent must be obtained from their parents or guardians. Significant numbers of minors particularly in low income settings are currently being ruled out of research participation because either their parents are unavailable or they refuse to provide consent. These minors may not live with their parents, are married and make important decisions in their daily lives.

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Comment by Dina Rippon on December 12, 2014 at 12:09

Congratulations on your poster presentation Phaik Yeong! Great photo too!

Comment by Francis Kombe on December 19, 2014 at 20:38

Hi Phaik Yeong,

I am interested in the argument that minors should be allowed to consent for medical research in their own right if the requirements for valid consent are met and the study meets the usual scientific and ethical criteria. Are you trying to advocate against assenting? Are the minors you are talking about still under the care of their parents? The guidelines allow minors who are under the direct care of their parents to consent-such as those who are married, living alone. My only concern is on the minors who are still under the care of their parents. We know that consenting process is a factor of information giving, understanding/comprehension and decision making. In this case, one could argue that, although minors are almost mature, their understanding and decision making ability is often considered to be limited hence can easily be exploited. Do you know of any trials that have looked at differences in comprehension and decision making between minors and adults?  Secondly, research always has unknown level of risk/ham. Where minors make independent decisions and if anything was to happen, would the parent have any role to play?

Much regards

Francis

Comment by Michael Parker on December 23, 2014 at 9:05

Congratulations on the poster!

Comment by Phaik Yeong Cheah on December 23, 2014 at 9:24

Dear Kombe, thanks for your comments. My poster is focusing on consent of a minor rather than assent. I think that a minor should be allowed to provide consent (rather than assent), if these requirements are met, regardless of age.

1. The minor must be competent that is he or she has the ability to understand and retain relevant information, to weigh or judge the relative merits of the options, and to make and communicate a decision to the consent seeker.

2. Their consent must be voluntary – that is, free from coercion. This means that participants must not come under undue pressure to participate while being informed about the potential value of the research. Careful assessment needs to be made because young people may be more afraid of doctors, researchers and others in authority.

3. They must have the maturity that is they have the life experience to make decisions that are significant in their consequences. Genuine maturity, which is undeniably a challenge to assess, is a prerequisite for making decisions that are more significant in their consequences, involving perhaps substantial changes to a person’s life prospects or where the decision may have irreversible effects. A great deal will depend on the nature of the study.

4. The minor must be relatively “independent”. This could mean having his own accommodation and job and the freedom to make decisions in daily life.

5. The context must be appropriate, for example the way doctors relate to minors in research should be consistent with how they related to them in clinical care.

6. The consent taker must be trained to obtain consent from minors, and to assess their maturity; and the study information must be presented in a way minors can understand illustrated with meaningful examples.

What do you think? Can you tell me about emancipated minors? 

Comment by Francis Kombe on December 23, 2014 at 10:15

Hi Phaik,

This is very nice and interesting. I clearly get what you mean. I think like the video we saw in Malawi, minors from different settings have different levels of competence-as this is very much attributable to environmental and social factors. To assess competence may require more than a single interaction as may be true for assessing maturity. I assume the consenter should also be trained to make these complex assessments to grantee a true informed process.

Having said that, i agree with you, the independence of the minor is fundamental in making the decision whether or not a minor should give consent; which was my concern. In essence, ethical guidelines already give the necessary conditions for seeking consent from independent minors which i support. Emancipated minors fall under this broad category of "independent minors" who in my view, without granting them the permission to consent, would be unfairly excluded in otherwise potentially beneficial trials.

However, in a context such as ours- seeking consent from minors might have to be considered within the wider context of social/community relations where the minor belongs. Just like what you might be aware about women decision making, independence is not necessarily being autonomous!

Wishing you a merry xmas and a very happy new 2015

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