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Informed consent in a research setting 

Informed consent in a research setting
Chapter:
Informed consent in a research setting
DOI:
10.1093/med/9780199608478.003.0009
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date: 23 October 2020

Informed consent is a legal requirement for all clinical trials conducted on human subjects. This chapter summarises the process for obtaining consent for non-clinical trial research and goes on to describe the more highly regulated consent process for clinical trials in investigational medicinal products (CTIMPs). The chapter defines consent and discusses the requirements for consent in capable adults. The process for CTIMP studies is outlined together with the required elements of consent to be documented in the patient information sheet and the process to be followed with withdrawal of consent is also described. Consent, assent and the concept of legal representatives in vulnerable groups is discussed including children and incapacitated adults. How to assess capacity is described along with consent in emergency situations. Formally documenting the consent process and how the information is given to the patient is vital. The role of the research team in consent is outlined. The investigator is advised to describe the process of consent and should identify which registered health professionals will undertake the process. In some situations a medically qualified person will be required to determine eligibility prior to enrolment, to discuss the study and assess capacity if necessary. A participant's decision to consent for research may be influenced by 'the research culture' in the country or the health care setting. Transparency and providing information continuously to participants throughout the study will re-assure them and reaffirm their willingness to continue.

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