OBTAINING INFORMED CONSENT e.g. for Mental Health Research

 Such research includes, just as one example, investigating whether apps are useful for treating outpatients suffering from trauma. When requests are made on social media subjects for people with mental health issues to volunteer to participate, then we should be very wary as to whether the human subjects regulations are being followed. Convenors of Facebook mental health groups would be well advised to considering banning such requests that are posted to their pages

    OBTAINING INFORMED CONSENT FOR RESEARCH ON HUMAN SUBJECTS

                                                           ABSTRACT

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The process of obtaining informed consent for clinical trials is tightly regulated; complications arise in circumstances when consent may be waived, or when needed from vulnerable populations http://ow.ly/rEMe30j5MVq

Current biomedical research on human subjects requires clinical trial, which is defined as “any research study that prospectively assigns human participants or groups of humans to one or more health-related interventions [i.e. drugs, cells or other biological products, surgical procedures, devices] to evaluate the effects on health outcomes” [1]. In our modern ethical conception, all research conducted on humans must be pre-emptively accepted by the subjects themselves through the procedure known as informed consent, which is a process by which “a subject voluntarily confirms his or her willingness to participate in a particular trial, after having been informed of all aspects of the trial that are relevant to the subject’s decision to participate”, as stated in the International Council for Harmonisation Good Clinical Practice guidelines [2]. Informed consent is documented by means of a written, signed and dated informed consent form. This form is required in the following cases: 1) when the research involves patients, children, incompetent/incapacitated persons, healthy volunteers, immigrants or others (e.g. prisoners); 2) when the research uses/collects human genetic material, biological samples or personal data [3].

The informed consent form must be written in language easily understood by the subjects, it must minimise the possibility of coercion or undue influence, and the subject must be given sufficient time to consider participation. However, informed consent is not merely a form that is signed, but is a process in which the subject has an understanding of the research and its risks, and it is tightly described in ethical codes and regulations for human subject research [2].