According to Sonya Audy (2005), six conditions must be met before obtaining the free and informed consent of clinical trail participants.

1. The potential participant must possess all information that is relevant to his decision-making process. In Canada, informed consent forms must at the very least contain the information listed in article 4.8.10 of the document Good Clinical Practice (GCP). When the research is conducted in a public institution, the concepts outlined in chapter two of the Tri-Council Policy Statement (TCPS) apply. The resulting list is very long, hence the growing complexity of today's consent forms, but does not offer much information about the potential participant's perspective or real needs. In the field of HIV/AIDS research, these needs vary according to whether the trial is designed for newly infected individuals, treatment-naive or treatment-experienced patients.

2. The potential participant must fully understand the information provided. With regard to informed consent, the Research Ethics Board’s (REB) involvement is too often limited to overseeing the content of the consent form. Despite adherence to highly commendable rules regarding its wording, the form invariably ends up being too long and complex for the average person to understand. Alternative methods of communication should be encouraged and properly structured to convey the information. These other methods often have a real impact on the potential participant's decision-making process. The REB must ensure that the information provided is not biased by any conflict of interest or perspective that the research team may face despite its best intentions to the contrary. The potential participant must have access to resources other than those provided by the research team in order to support his decision-making process.

3. Consent must be voluntary. As stated in the TCPS, consent must be voluntary and granted without manipulation, coercion or excessive influence. Examples of excessive influence include exaggerated monetary incentives or the exertion of power or authority over a potential participant. The physician's opinion weighs heavily in the balance, so attention must be paid to the level of confidence and dependence that characterize the doctor-patient relationship.

4. The potential participant must be capable of understanding and making decisions. The road traveled by any person living with HIV is inevitably punctuated with a series of shocks that jeopardize his stability, cause him distress and increase his vulnerability: the diagnosis; the realization that it's time to begin treatment or that treatment is failing; the detection of complex multiresistant virus; the death of a loved one from the same disease, etc. Each of these shocks can induce what Audy refers to as a « temporary inaptitude ». This must be taken into account when identifying additional measures to support the decision-making process in situations such as this.

5. The potential participant must be given sufficient time to consider his decision. It takes a long time to digest all the information that a potential participant must understand. The potential participant must receive a copy of the consent form so he can review it as thoroughly as he wishes before making the decision to sign. He must be given enough time to consult friends and family and to study the form with whomever he chooses. We must challenge the climate of urgency and the pressure to make a quick decision that too often prevail in the AIDS world.

6. The potential participant's ongoing freedom must be guaranteed. The TCPS defines informed consent as an ongoing process that begins at the initial contact with the potential participant and does not end until the project's conclusion. It must be made clear to the participant that he can withdraw his consent and leave the project at any time. He must also be guaranteed access to any new information that comes to light during the trial that might influence his decision.

References:

1. Sonya AUDY, 2005. Rédiger un formulaire de consentement respectueux de l’autonomie des sujets pressentis ; une mission impossible? Document du Comité de liaison en éthique de la recherche de l’Université de Montréal. http://www.recherche.umontreal.ca/PDF/FdCFINAL2005.pdf

2. Health Canada, 1997. Good Clinical Practice: Consolidated guideline- ICH topic E6.

http://www.hc-sc.gc.ca/dhp-mps/prodpharma/applic-demande/guide-ld/ich/efficac/e6_e.html

3. Canadian Institutes of Health Research, Natural Sciences and Engineering Research Council of Canada, Social Sciences and Humanities Research Council of Canada, 1998 (with 2000, 2002 and 2005 amendments). Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans. http://www.pre.ethics.gc.ca/english/policystatement/policystatement.cfm


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By Jean-Pierre Bélisle, CTAC Clinical Trials Working Group