Resources
Transforming Informed Consent: New Approaches to Making it Better (Website)
Lilly will begin piloting Tiered eConsent on US clinical trials in 2016 to see if this new approach to consent is really improving the experience for Lilly clinical trial participants.
Australian Institute for Aboriginal and Torres Strait Islander Studies (AIATSIS) Guidelines for Ethical Research in Australian Indigenous Studies
Indigenous peoples have inherent rights, including the right to self-determination. The principles in these Guidelines for Ethical Research in Australian Indigenous Studies are founded on respect for these rights, including rights to full and fair participation in any processes, projects and activities that impact on them, and the right to control and maintain their culture and heritage
National Statement on Health Literacy: Taking action to improve safety and quality
This statement can be used by organisations and individuals to drive and support their work on health literacy and to inform decision-making about what they can do to address health literacy.
‘Right to try’ laws are compassionate, but misguided (Website)
This resource is to complement your learning, and introduce you to other perspectives on the topics under discussion.
This article talks about situations where right to try laws miss the target. It concludes that there is need for more focus on the duty of physician-researchers to help patients and their surrogates distinguish realistic from unrealistic hope while maintaining reasonable expectations.
Disclosure of Financial Relationships to Participants in Clinical Research (Website)
This resource is to complement your learning, and introduce you to other perspectives on the topics under discussion.
Policymakers and officials charged with oversight of human subjects may consider several different goals when deciding whether to require that financial relationships be disclosed to potential research participants. The article discusses six possible goals of such disclosures
Informed consent for phase I studies: evaluation of quantity and quality of information provided to patients (Website)
This resource is to complement your learning, and introduce you to other perspectives on the topics under discussion.
The process by which patients are informed and their consent is obtained in phase I trials has thus far been only marginally studied. Meerwein's model, which defines three main dimensions of the informing process (the information itself, the emotional and interactive aspects), has been studied to ascertain whether it can be applied to evaluate the quality of the information proffered. Thirty-two conversations were taped, transcribed and evaluated by one psychiatrist and one psychologist. Meerweins's model proved to be applicable and useful for identifying pitfalls in communication. Greater attention should be paid to the indirect messages and implied criticisms of the patients to improve their participation in decision making. Physicians should become more skillful in providing adequate information and improve their methods of communication.
Elderly patients’ participation in clinical trials (Website)
This resource is to complement your learning, and introduce you to other perspectives on the topics under discussion.
The elderly population is a large and the fastest-growing portion of the population worldwide. Typically, clinical trials conducted in adult population include patients between the ages of 18 and 64 years. However, drugs should be studied in all age groups and trial participants should be representative of the patient population receiving the therapy in daily medical practice. This article describes the need for including elderly patients in the clinical trials in order to garner data from geriatric patients who form major medication users in most of the chronic diseases.
Should dying patients have the right to access experimental treatments? (Website)
This resource is to complement your learning, and introduce you to other perspectives on the topics under discussion.
Right to try laws are designed to ensure that terminally ill patients taking part in clinical trials are true volunteers and have no incentive to cheat the clinical trials system as has happened in the past. Recently, these laws have been critiqued as misguided, and the ethics of allowing patients to use experimental drugs are still up for debate.
Patient motivation and informed consent in a phase I study of an anticancer agent (Website)
This resource is to complement your learning, and introduce you to other perspectives on the topics under discussion.
In order to evaluate the quality of an informed consent procedure (I.C.P.) 48 patients with advanced cancer were offered participation in a phase I clinical trial and entered an I.C.P. consisting of three separate conversations. Forty-one patients gave their consent motivated by hope for improvement of their conditions, pressure exerted by relatives and friends, the desire to contribute to the progress of medicine or simply because they felt they had 'no choice'. Encouragement by relatives or friends seems to be a powerful incentive to participate.
Clinical Trial Accrual: Obstacles and Opportunities (Website)
This resource is to complement your learning, and introduce you to other perspectives on the topics under discussion.
It discusses how lack of accrual to clinical trials can lead to early closure of studies and a waste of critical resources as well as extended periods of enrollment, which can hinder the ability to interpret the results.

