When conducting any kind of research involving human subjects, it’s important to get what is known as ‘informed consent’ from them before they participate in the study. But what exactly does ‘informed’ really translate to? Essentially, you need to ensure that all of the important details about participation and what will be done with the data collected are explained to the patient before they start the study. This can be as simple as providing them with a verbal explanation and a signature form, but normally a more detailed form is preferred. The primary items you need to explain to any participants include:
- Purpose of the study
Make sure that the participant knows the reason the study is being conducted, or in cases where they may need to be blinded from the true purpose (for example, in some psychological studies), that they understand the role they play in the research and that you may additionally evaluate behavioral responses that are not explicitly stated.
Explain all procedures that will involve the patient and any discomfort or sensations they may experience as a result of them.
Any physical, mental or emotional risks or benefits that the participant may experience must be stated to help them determine whether participation is right for them.
- Any influencing factors
Any other factors that a participant may need to consider to make an informed decision about their comfort in participating (for example, will their participation be known to others, how much time it will take) should also be shared with potential participants.
- Confidentiality procedure
Privacy is an important concern for many people so it is essential that you explain exactly how the data collected will be used, shared, and accessed, and whether any identifying characteristics of the participants will be required.
Any monetary compensation or other incentives given to entice people to participate, and what is expected in return, should be clearly stated on the consent form.
You can include more details than this if needed, but you can consider these as the base minimum required.
For a good example of an informed consent form, Michigan State University has an excellent template that you can use as a base for future studies. However, always be sure to check with your institution before using your form in case they have any specific requirements that you will need to include.