Knowing the proper guidelines for writing patient information sheets is extremely important. Patients deciding whether to participate in a research study or clinical drug trials need pertinent information written in an easy to understand manner. For both legal and ethical reasons, it is necessary to follow strict guidelines in crafting this important document.
Write in Lay Terms
Perhaps most importantly, a patient information sheet should be written in lay terms. According to the Greater Manchester NHS University Teaching Hospital, "The tone should be invitational, and not persuasive." Use of medical terms should be explained in a way anyone can understand. Medical abbreviations and technical terms should not be included in the patient information sheet. If such terms are required, they should include a detailed explanation to facilitate patient understanding. Begin by explaining what the study is for, how long it will take, what will happen during and after the study is completed, the fact that participation is voluntary and other basic information.
Explain Risks
A section on potential risks should explain to the patient considering joining the clinical trial any potential risks associated with participation. Disadvantages and potential side effects from any medications or procedures included in the study should be detailed here. You can also use this section to inform the patient of benefits from participation.
Practical Considerations
Include a section for practicalities to give potential participants information regarding how often they will need to be available to the researchers, including when and where they will need to meet researchers, and details on reporting symptoms and side effects. Make sure the participant has easy to find contact information on who to contact in case of questions or an emergency. Also include information on contact information for the patient and her emergency contacts. The patient needs a section on compensation that explains what happens and what protections are in place if something goes wrong.
Detail Exclusion Factors
The section on exclusion factors is particularly important. This is the place to inform potential participants of reasons why they should not participate in the study or trial. For example, if the trial could be dangerous to pregnant women, or individuals taking MAO inhibitors, this would be the area to inform them. Also find out if the patient will be informing his general practitioner about his participation. If he does not intend to inform his GP, find out why. Communication with the patient's general practitioner is a good safety net for learning about chronic health problems and possible drug interactions.
Explain Confidentiality Matters
The section of the patient information sheet on confidentiality should explain in lay terms the terms of the confidentiality agreement the researchers are to follow to protect participant information. The participant needs easy to follow information on who will have access to the information gathered during the study.
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