Informed consent is a practice that is widespread throughout just about every industry in the world, including academic research. Understanding the role of informed consent in your research practices is crucial to ensuring you meet this ethical and legal requirement any time you involve humans as participants in your research.
The process of informed consent includes making sure that every participant is informed about what is going on in the trial you are performing so that they can make a decision to willingly participate or not. They must understand what the clinical trial is for and the potential significance of the results as far as how they could impact medical knowledge or social changes, depending on the project. Neglecting to thoroughly inform participants in every aspect of the project can result in negative consequences to your research.
The Origins of Informed Consent
History gives us a lot to learn from, including the disastrous consequences of using humans for research without their consent. The origins of the need for informed consent come from historical events such as the Nuremberg Code, the Declaration of Helsinki, and the Belmont Report.
The Nuremberg Code was developed in 1947 as a result of the practices of Nazi doctors who performed research on humans immorally and unethically. This research was the basis of a code being written that required all human participants to voluntarily agree to be in the study. It also clarified what “voluntary” meant: that participants were able to consent mentally and physically, that they were not coerced into consenting, and that they fully understood the risks involved in participating in the study. This code laid the foundation for informed consent as we know it today.
The Declaration of Helsinki in 1964 added to this by developing twelve principles to guide researchers in the ethics of biomedical research as technology evolved and made this field more prolific. These principles focused on emphasizing that the research was performed to directly benefit the participant rather than future knowledge.
A final important part of informed consent as it is today was The Belmont Report of 1979. This report took the voluntary aspect of participation a step further and focused on respecting those humans in the study, including those who had reduced autonomy, such as children and the elderly.
Between these three important documents, today’s version of informed consent was born.
What is Involved in Obtaining Informed Consent?
Obtaining informed consent is a natural practice today for most researchers. But it must be well thought out before it is attempted.
Consent must include informing the potential participant about the rights they have should they choose to participate, the reason behind the study, the procedures that will be involved that include them, any potential risks or benefits that come with participating, how long the study is expected to take, and how much confidentiality that would come along with their participation. Only then can the participant decide to volunteer in the study or not.
The rights and welfare of any humans participating in a research study must be fully considered and addressed. There are some instances in which informed consent can be waived, provided no human rights or welfare are violated. These instances typically include research that has minimal risk to the participant or that couldn’t be done practically while waiting on the informed consent to be gathered. Other instances occur when the subject is a minor and has parental consent.
As a rule, however, it’s crucial that the researcher gathers thorough documentation that evidences their version of informing the participant as to what is involved in their research participation. This information can be written, recorded through audio, or videotaped, but it must be clear that the participant was given everything necessary to make an informed voluntary decision and that they did so willingly, which should also be recorded.
Impactio Can Help Your Research Grow
Part of ensuring your informed consent is in line with your research is including it in your work professionally. Impactio’s all-in-one platform allows you to use templates to put together your research into professional PDF documents and web pages.
When you’re ready to publish your findings, Impactio makes it simple to transfer your work to the publisher for submission and then track your impact through citation indicators. With so much to help the academic scholar, it’s no wonder Impactio is the go-to platform for experts all over the world.