An informed consent form
An informed consent form is an essential document in conducting research that involves human subjects. For example, before a drug is released into the market, it has to prove its safety and efficacy in clinical trials. No institution or individual has been given the right to infringe on the fundamental rights of another person to fulfil their research interests.AN informed consent document becomes necessary. The informed consent document describes the ethical codes and regulations that guide research that involves human participants. The goal of the informed consent document is to equip the participant with enough information in a language that is easily understood so that they can make a voluntary decision to participate in the research study. The informed consent document outlines the potential risks that are involved in the research study and the mitigating factors. The benefits the participant will enjoy if they decide to participate in the research study.
Moreover, the participant will know to what extent some of the information that has been recorded will be kept confidential, and the persons who are allowed to access. The final statement of the informed consent document gives the participant the choice of discontinuing in the study without having to face any penalty or incur losses.
A critical aspect of the informed consent document is that the participant must personally sign the document in the presence of a legal representative without any form of coercion. Furthermore, there are circumstances in which an informed consent form is waived. They are outlined under 45 code of federal regulations(CFR)46. They entail the following: There is minimal risk to the subjects. The rights of the participants will not be infringed upon once the consent form is waived. The participant seeks to provide additional information after the research has been conducted. Challenges to the administration of consent forms include if the human subjects are minors, religious beliefs, misguided patients perceptions. This should be put into consideration to prevent any likelihood of malpractice actions.