From schools and colleges to medical studies, groups can be given research projects to work on. Specific research studies will need consent if any human participants are involved. This is to protect the faculty of the school and the students running the test from liability should there be any incidents. Consent is recorded using a Research Informed Consent Form.
What is Informed Consent in Research?
When doing research using human beings, informed consent means going over the details of the research being done, any medications, risks potential, benefits, and they must be aware that they are volunteers that can withdraw from the study at any time they wish. The participant must give this consent before they enter any research facility.
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What is a Research Informed Consent Form?
This is the document that participants of research will sign once all of the details of the study have been gone over and are clearly understood by the participants. It frees those researching liability and makes the participants aware of their responsibilities as well. Any risks must be fully documented on the form.
The standard consent process has two separate stages:
- Stage 1: In this stage, information is given, and the participant is given time to reflect upon that information. They are under no obligation to respond or agree to anything.
- Stage 2: This is the stage where consent is obtained. The terms of the research project are gone over individually, and the participant agrees to each of these terms before they can participate in the research. Once the Research Informed Consent Form has been signed, consent has been given.
All researchers must ensure that they comply with the General Data Protection Regulation both during the research and after. If the research you are doing will involve photos or filming, you need to gain consent for that as well.
This type of form is used to protect the people, and the organization is researching liability issues should something happen to a participant. Without it, if the participant should become injured or ill during the research, they can sue the organization and researchers because there is no proof that they were legally made aware of any risks.
Also, if a threat is not mentioned in the consent form, it can make the researchers liable. This is why it’s essential to be very thorough and disclose all of the facts and information regarding the research being done.
When Should a Research Informed Consent Form be Used?
Written consent forms should be used in situations where:
- The research project has several stages or is complex
- Initial access to participants requires that written information is provided.
- You need to have extra proof that the participants understood the consent terms, especially where consent is necessary for data copyrighting and future use.
What It Should Include?
Your form should have the title of the research study being done, along with the contact information of the leading researcher overseeing the project. Next, there should be detailed information on the study’s purpose, what procedures will be used, any risks to the participants, and any benefits. The participant should initial each of these sections once they have been gone over, and the participant understands the information.
You should have a compensation section if compensation were provided to the participant. You should also have alternative contact details should a participant not wish to contact the primary researcher directly. Lastly, signatures of both the participant and the researcher need to be on the form, along with the date the form is being signed.
Frequently Asked Questions
It is required when doing any type of clinical research. The informed consent procedure is where a competent participant is given all of the details needed to make an informed decision to participate. It needs to show that the participant voluntarily agreed to take part in the research knowing all of the risks and procedures involved.
In general, informed consent forms remain valid for a period fo 30-day or the duration of the study.
Yes. Research is voluntary, and participants have the right to stop at any point during the study.
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