A career in clinical research puts you at the heart of a dynamic industry and provides you with an opportunity to make direct contributions to the field of healthcare. If you become a clinical researcher, you might be employed by government departments or agencies, universities, medical institutions, and other organizations. You could be responsible for coordinating research projects, analyzing statistical data, and implementing new policies or programs at different levels of the public and private sectors.
As a clinical researcher, you will also need to understand informed consent. This is an important concept in clinical research and ensures the rights of research participants are respected. Keep reading to find out what informed consent is and how it applies to your career.
What Exactly is Informed Consent and How Does it Work?
Informed consent, as defined by Health Canada, is “an ongoing process that starts with the researcher's first contact with the individual and continues until the study is complete or the participant withdraws.” The objective of informed consent is to guarantee that people who participate in clinical research receive all the necessary information to make informed decisions about their participation.
Informed consent ensures study participants can make informed decisions
Before a clinical research project begins, all participants should receive the following information, although specific informed consent documents might vary depending on the nature of the project:
- A statement explaining the purpose of the research
- An explanation as to why the candidate was selected
- The identity of the researcher(s)
- Description of the procedures and requirements
- Any foreseeable risks or inconveniences of the research
- Confidentiality details (Will the research results be public?)
Working with Underaged Participants During your Clinic Researcher Career
For clinical research that involves minors, different regulations apply in different provinces. In Ontario, persons under the age of 16 must present an assent form which provides parental permission for participation in clinical research. At the age of 16, an individual is considered to have the maturity required to make their own decisions and therefore is authorized to sign a consent form. It is important to note that in the province of Quebec, persons under the age of 18 must provide an assent form, and that an individual must be at least 18 to give their own consent to participate in clinical research.
A clinical research coordinator career means having an understanding of different consent technicalities and making sure that professional standards and best practices are applied during every phase of a clinical research project, including consent rules that apply to minors.
Appropriate Language Must be Used in an Informed Consent Document
During your clinical researcher career, you might be involved in developing an informed consent document. There are some things to keep in mind for these documents. First, the level of language should be appropriate to the age and comprehension level of the participant population. Generally, the language used is at a grade 6-8 level. You should also avoid using complicated jargon and technical phrases that cannot be easily understood by an individual who is not an expert.
Informed consent documents must be written so that they are comprehensible to participants
You Can Make a Difference After Your Clinical Research Course
Clinical research is essential to healthcare development and clinical research professionals are there to make sure that everything is done appropriately. Informed consent is one aspect of a clinical researcher’s job that must be taken seriously so that the work can be completed with mutual respect between the researchers and the participants.
Are you interested in a clinical research course?
Contact Oxford College to find out more about our Clinical Research program.