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Issues’ regarding consenting subjects into trials is not a GCP\ICH issue, but the law protecting the fundamental rights of any individual. GCP/ICH is a recommendation to ensure that we are on the right side of the law. The law is blind to the circumstances/situation we encounter in urban, rural, or remote villages. When something goes wrong during a clinical trial, the researcher is guilty until proven otherwise. The law would hold anyone guilty of abuse if it cannot verify a consent document in its details to prove that the subject gave an informed consent. Safety is still the best policy, which explains the extensive content of a consent sheet (1,2 or 100…. Pages). From my experience as a clinical trial subject, a field investigator and a clinical development manager in an international pharmaceutical company, a very detailed informed consent document seen in a company sponsored studies is actually the nearest to compliance. Therefore summarized versions either by investigators or by special groups or committees in my own opinion does not ideally meet the requirements of an ‘INFORMED’ consent. This is not to annul the benefits of these very important groups or committees. As much as I understand the stress of researchers on the field who are expected to obtain an informed consent, which seems rather exhausting, we must maintain our common objective of ‘safety and dignity of the human person’. Consenting can only be ideal if considered as a process. Therefore emphasis needs to be given to this step just like the enrolment process. This means that sponsors, investigators, IRB’s or stakeholders need to reconsider certain basics. (1) An ideal age for consenting language in our different sites should be defined (in the developed nation steps are being taken in that direction) (2) The ideal time suitable for consenting subjects needs to be defined according to age/education within different social and cultural context. That is the time it takes to obtain an informed consent from a subject (an adult, a child or a geriatric). (3) This defined time for consenting subjects into a clinical trial should be taken into consideration when protocols are being drafted in company or investigator driven studies and clearly expressed in protocol procedures. As time is allocated for enrolment of subjects into a trial (1, 2 years or months or days), time should also be allocated to consenting subjects (1, 2, 3..weeks or days or hours) (4) Our ethics and conscience expressed in the Nuremberg Code and Belmont report has to come into play; whereby Investigators have to be convinced in themselves that the subjects’ choice to participate or not is an informed one; that is the index would be himself as though the investigator was the subject whose consent is being solicited (5) Subjects need to make decision to participate or not in a trial based on what they understood and can communicate this knowledge in court if asked. Therefore Investigators responsible for obtaining informed consent would ideally need to bring potential subject to understand the information about the trial, like he/she (investigators) would require if he were to consent as a trial subject. It is understandable that these considerations above will warrant longer time for trial completion and huge amount of funds for an already expensive trial, which no company or sponsor would be willing to consider. However I believe it is our ethical responsibility to pursue this path of consideration for subject’s safety and dignity in any trial before the benefits either for subject, patient or company. The frustrations we express about the volume of consent documents (1, 2, 3 or 100….pages) or our attempts to summarize detailed consent document seems consistent with the spirit ‘the human guinea pig’. As medical scientists this should not be our pursuit. When I do consent a subject, I compel myself to follow these ideals I mention above even though no provision is given as such in the protocol (since most protocols I have seen are not designed as such). I give time and room for the consent process using myself and good conscience as my index to comply with a consent document no matter how long it is. I encourage my research colleagues to do the same and even be more patient.

  • Well done Sunny for this. What is even more difficult is when it comes to very young children less than 5 years. You are right, time needs to be given to patients before they sign the informed consent. I believe what compensates for the time they are not given is letting them know they can withdraw from the study anytime. This makes the patient be in control. Remember human beings are dynamic, we can take years to decide on something and change our minds in seconds. Remember informed consent is a process and not a one off thing.

  • mamulla Moses 12 Jan 2011

    Well done to you both for this topic. We need more research on this in our countries. Assent is used commonly in the US and Europe I understand. I think it is more difficult in many of our cultures. We need some behavioural science studies to really know

  • sunnyoyakhirome Sunny Oyakhirome 7 Jan 2011

    I kind of understand these sentiments your have expressed.
    and true for most cultures; decision making capacity is not in the hands of children, but 'Assent' is quite different from decision making.
    A child is a vulnerable person so deserves double protection : so we have (1)a consent from parents or LARS and(2)his/her own assent to the consent after being informed to his/her understanding.

    For example a society or culture where children or girls are not taken to school does not change the fact that it is their right to have an education and cultures/society have evolved in this right direction. Same for 'assent' of a child to be in a trial as a subject or consented by parents to be a GUINEA PIG.

  • jagarwal jagarwal 4 Jan 2011

    This is an engaging post and I congratulate you in encouraging researchers to think on this. I think this age issue is important. My concern is with the appropriateness of seeking formal assent from children. In my experience this is difficult and problematic. Many cultures do not give decision making capacity to children so doing so in a research context is not the right thing. What is your view on this and what do others say?