Participant Information Sheets Flashcards
(13 cards)
What are the key policies and codes for consent in clinical research?
Key policies and codes for consent in clinical research include the Nuremberg Code, the Declaration of Helsinki, the International Conference on Harmonisation (ICH) from Good Clinical Practice (GCP), and the UK government policies like the Medicines for Human Use (Clinical Trials) Regulations 2004 and the UK Policy Framework for Health and Social Care Research.
What are the criteria for consent to be considered both legal and ethical?
For consent to be considered both legal and ethical, it must meet the following criteria:
Given by a person with capacity.
Voluntarily given.
Given with no undue influence.
Given by someone who has been adequately informed.
Involves a fair choice.
What steps should be taken in practice to ensure proper consent?
In practice, the following steps should be taken:
Provide written information through a participant information sheet.
Give sufficient time to consider the decision and the opportunity to address concerns or questions.
Confirm the participant’s capacity to understand and retain information, weigh risks and benefits, and make an informed decision.
Ensure the consent process is iterative, with new information available, and the participant is free to withdraw at any time.
How is information typically provided to potential participants in clinical research?
Information is typically provided through:
A consultation with the research team or independent personnel.
A Participant Information Sheet (PIS), which supports the consultation or verbal discussion around consenting for the study.
What is the role of a Participant Information Sheet (PIS)?
The Participant Information Sheet (PIS) is used to provide detailed information to potential research participants about the study. It serves to inform them of the nature of the research, any risks involved, and the procedures they can expect, supporting both written and verbal consent processes.
What is risk perception in clinical research, and what factors influence it?
Risk perception is the subjective judgment about the characteristics and severity of risk. It can be influenced by several factors, including:
The level of knowledge and certainty about the nature and effects of the risk.
The trustworthiness of the authorities providing information about benefits and risks.
The degree to which risk is perceived as manageable or controllable.
The individual’s mindset towards taking or avoiding risks, such as risk propensity (willingness to take risks) or risk aversion (preference to avoid risks).
What are the key principles of biomedical ethics?
The key principles of biomedical ethics are:
Non-maleficence: Do no harm.
Beneficence: Do good.
Autonomy: Allow individuals to make their own decisions.
Justice: Ensure fairness.
How can the communication of risk affect patient decisions in clinical trials?
he way risk is communicated can significantly affect how patients perceive the risk and may influence their decision to participate in clinical trials. Ethical requirements dictate that the information provided should be accurate and complete, balancing between being overly frightening or overly optimistic. The aim is to enable participants to make an informed decision without causing undue anxiety (non-maleficence) or misleading them about the trial’s benefits (autonomy).
What are the methods of communicating risk to participants?
Risk can be communicated to participants through:
Verbal communication.
Numerical data.
Pictorial representations.
What is the process for writing a Participant Information Sheet?
The process for writing a Participant Information Sheet involves:
Starting with the study protocol, which outlines the study in technical language.
Drafting the content in non-technical language, translating technical terms.
Getting input from patients and the public to ensure readability and clarity.
Writing a second draft and having a final review before submitting it to the ethics committee for approval, ensuring that all required information, including PICOT, is included.
What are some tips for clearer writing when preparing a Participant Information Sheet?
Some tips for clearer writing include:
Consider the audience and imagine speaking directly to them.
Use short sentences (15-20 words) and no more than three items of information to avoid overwhelming the reader.
Be cautious with technical language and explain terms when first introduced, avoiding unnecessary abbreviations.
Use active verbs, such as “we will send a report to your doctor,” rather than passive verbs like “a report will be sent to your doctor.”
What ethical principle is violated if risk communication is exaggerated and scares participants?
If risk communication is exaggerated and scares participants, it violates the ethical principle of Non-maleficence. This principle emphasizes doing no harm, and excessively frightening participants may prevent them from taking part in the trial or cause psychological harm, such as the nocebo effect.
What is the difference between risk propensity and risk aversion in the context of clinical trials?
Risk Propensity refers to an individual’s willingness or tendency to take risks.
Risk Aversion refers to an individual’s tendency to avoid risks and prefer safety.
These mindsets can influence how a participant perceives the risks of joining a clinical trial and whether they decide to participate.
