Hello Researchers and research students. We all know that writing and coming up with an excellent informed consent form can be cumbersome, especially if you have never participated in research. this is true for;
- University students
- Clinical Medicine Students
- Nursing Students
- First time researchers
Informed consent means the knowing consent of an individual or their legally authorized representative is not violated. This happens when there is no undue inducement or any element of force, fraud, duress or any other form of constraint or coercion. Sufficient information that a reasonable person would want to have in order to make an informed decision about whether to participate must be presented in understandable language. This because the potential subject can make an informed judgment about participation.
Research involving human subjects can pose complex ethical issues which require careful thought and consideration on the part of both researchers and research participants. Prospective participants must be given key information to allow them to make informed decisions about whether or not to participate in the research.
Key Information Elements:
- A statement that the project is research and participation is voluntary.
- A summary of the purpose of the research, procedures, and duration of participation.
- Reasonable, forseeable risks of discomforts.
- Reasonable, expected benefits.
- Alternative procedures or course of treatment, if any
WHAT SHOULD AN INFORMED CONSENT CONTAIN
As a researcher, it is your responsibility to educate the participants about the study purpose, the procedures, the risks and benefits, and obtain their consent before involving them in your research, and keep them informed. While a consent document that gives this information, and more, is a vital part of the process, the opportunity to discuss any questions or concerns with a knowledgeable research team member is also necessary. This is the “informed consent process”.
It is essential that consent forms be written in plain language that research subjects can understand. The consent document should always be revised if there are changes in the study that might affect the participant or when additional information will improve the consent process.
In addition, the consent form should not contain any exculpatory language. That is, subjects should not be asked to waive (or appear to waive) any of their legal rights, nor should they be asked to release the investigator, sponsor, or institution (or its agents) from liability for negligence.
We wrote down a copy of an informed consent form to make the “informed consent process easier for you”. It is in PDF form and unlocked. Copy and paste into your word document and edit accordingly.