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Sollers is a graduate school located in New Jersey, specializing in clinical research, drug safety and pharmacovigilance training.

Our graduate certificate and masters programs cover a wide range of subjects tailored to this fast growing industry, and our graduates go on to highly successful careers in the pharmaceuticals industry and healthcare industries.

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What is Informed Consent(IC)?

Posted by Doctor Dan on Aug 4, 2016 12:53:12 AM

Healthcare and medical ethical code requires the health care provider ask for consent to perform any medical procedure on the patient. It could be for a therapy, a surgery, or counseling.

The patient giving this consent must have reasoning ability and must be made aware of all the facts regarding the procedures conducted on them. It means that they have an understanding of the implications and consequences of the actions performed on them.

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What Prevents IC?

A patient who is emotionally immature, has mental illness, disability, sleep deprivation, or is intoxicated and not liable to give an informed consent. In this scenario, another person who is authorized and is fully functional to understand the implications can give the informed consent on behalf of the patient. In clinical trials, where issues are raised due to wrong diagnosis or procedures, the IC is used as a backing.

Decision to Go Ahead

Before you take up a medical procedure, the patient is given a roster of risks and benefits of that procedure. It is up to the patient to decide if they want to go ahead or not. You can ask questions and get your doubts resolved before signing an Informed Consent.

Verbal IC is never valid and must never be accepted before accepting any treatment. A form is signed by the patient and has all the clauses about the consent related to the treatment. In simple terms it means that you are informed. If the patient is not comfortable, alternatives are presented. In case of children, consent is given by parents.

Conclusion

In case of emergencies where there is no surrogate or the patient is not in conscious state, presumed consent is considered to go ahead with the treatment. The patient’s decisions matter when treating their mind and body, when they are in conscious state.  Get more details on Informed Consent and Clinical Trial Management

Topics: Informed Consent IC, Clinical Research