Consent for the use of personal medical data in research

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Abstract
Types of consent and choice We use “choice” in its simplest sense, free from the context of the current “patient choice” initiative. Consent is a person's expression of agreement with a proposed action. The recording of consent is distinct from the fundamental decision that the person has made, though how we approach candidates and the options we provide will influence their choice. Consent may be a positive action such as signing a form saying “yes” or just nodding. This is usually called “express consent” or “assent.” It may be hard to determine the expression of consent because of speech or language difficulties, though this may be eased by a member of the family or an interpreter. Box 2: Information for consent The following details should be sent with the invitation to participate in a study, so that people have the necessary information to decide whether to consent or not: A description of the aims of the work in lay terms, with an outline of the intended benefits of the research for health in general Summaries of the types of information needed from the participant (for example, questions on housing, occupation, and diet) and measures to be used (for example, measures of blood pressure, x rays of knees); for unusual measures (such as whole body scans) the procedures should be described, so that participants know what to expect in terms of invasiveness, discomfort or pain, and undressing A statement that any aspect of the data collection can be declined at the time of fieldwork. It should be mentioned that this may not be possible for specific future uses of stored biological specimens (including DNA) Information on who is expected to be involved in the analysis and in any data sharing; this can be descriptions of the types of workers (for example, NHS healthcare professionals and publicly funded health research scientists) Assurance about the confidentiality of information collected. The steps being taken to ensure confidentiality should be explained to potential participants A request for consent to access to medical records and other information sources, if applicable Details of the period for which each aspect of consent is sought—for example, specify that medical records will be followed up more than once Information on all foreseeable uses of the data, as any later changes in use require new consent In long running studies, it should be stated at the outset that refusal to continue to participate will not be taken to indicate the need to withdraw data already collected, unless specifically requested, and where data will have been anonymised, then it cannot subsequently be removed. More simply, a patient might hold out his arm for an injection without indicating consent as such. This is called “implicit consent” or “implied consent,” though it might simply show compliance rather than consent—a lack of objection rather than a positive choice. In the past, compliance has sometimes been presumed by researchers (such as in the retention of tissues), so no information is provided, no question is posed, and no question of assent or dissent arises. This is not consent as no choice has been offered. “Informed consent” is sometimes used to emphasise the need for adequate information on which to make a decision and give consent. If the information provided is inadequate, any assent given is qualified by the missing information. “Fully informed consent” describes the ideal of providing full information before seeking consent but is perhaps meaningless in practice. How can we determine how much information is full? What if the potential participant does not want to know all the options available and the range of consequences of each choice? Education has a cost, both to the provider and the trainee. The term “free choice” reflects that participants should not be coerced or cajoled into making a choice preferred by the questioner. However, people are usually constrained by their circumstances and personal experience, so no choice is wholly free, but we should try to make the choice as free as possible. We think that too much emphasis can be given to the precise definition of consent rather than dealing with the fundamental need to provide options for people and helping them to make the optimum choice in light of their circumstances, needs, and values, including their perceptions of the benefits from medical research. The NHS confidentiality code of practice model puts emphasis on choice.5