Informed Consent - The Backbone of Ethical Clinical Research

chillibreeze writer — Dr. Sachin Dighe

When we talk about drug development or clinical research, the first thing comes to our mind is the safety and wellbeing of the patients (or subjects, as per clinical research terminology) involved in the clinical trial. Ethical clinical research is based on the declaration of Helsinki and the guidelines for ethical clinical research, called International Conference of Harmonization and Good Clinical Practice Guidelines (ICH GCP Guidelines). The main objective of ICH GCP guidelines is to protect the safety and wellbeing of the subjects participating in clinical trial. This objective has been ensured with the process called ‘Informed Consent’. The reliability and accuracy of clinical trial data are depend on the reliability of informed consent process. Informed consent is considered as a backbone of ethical clinical research.

The process in which the patient/subject shows his/her willingness to take up a medical treatment suggested by the physician, after being informed about all aspects (including risk and benefit) of the particular treatment, is called ‘Informed Consent’.

In general medical science the word 'informed consent' can be used in routine medical practice as well as in ethical clinical research. However, informed consent in routine medical practice differs from that in clinical research. In routine medical practice the primary goal of the physician is to treat the patient, where the patient rightly assumes that the physician's motives are well-intentional. In routine medical practice therefore, patient's consent is not the mandatory requirement, except for potentially hazardous treatments or surgical process. In clinical research the primary goal of the clinical researcher is to test a scientific hypothesis for safety and efficacy of the investigational new drug. Researcher faces a conflict of interest between what is good for the current patient, future patient, the sponsor, and the researcher himself. This conflict of interest may influence the safety of the subject. To protect and ensure the subject’s safety in the clinical trial, the documentation of effective and efficient consent process is the mandatory requirement for regulatory approval.

Written informed consent has to be obtained voluntarily from each and every subject participating in the trial. Investigator, the medically qualified person under whose supervision the trial has to be conducted, is responsible for obtaining efficient informed consent. Written informed consent need to be documented on informed consent form preapproved by ethics committee or other regulatory authority. If subject is unable to give consent, then it can be obtained by subject’s legally acceptable representative. Legally acceptable representative can be blood relative (father/ mother/ son/ daughter), spouse, or anybody who has a close association and is authorized legally. If the legal representative is also not able to read and understand the consent form, then impartial witness has to be present during the informed consent discussion and read the consent form/ any other written information provided to the subject. Impartial witness is the person independent of the trial, who could not be unfairly influenced by the investigator or other people involved in trial.

Investigator or his delegate has to discuss all pertinent aspects of the study with the subject (and legally acceptable representative or impartial witness, if applicable). The summary of the consent form should include (but not limited to) information that the trial involves research, the purpose of trial, treatment options, potential risk, reasonably expected benefits, alternatives available for subject’s health problem, expected duration of the study, and any other relevant information. It should also mention clearly that the participation of the subject in the trial is voluntary and subject may withdraw from the trial any time. All queries or doubts of the subject regarding investigational new drug or any other aspect of the conduct of the trial need to be resolved. Once all the queries get resolved and the subject shows his/her willingness to participate in the trial, informed consent has to be documented.

The consent form need to be signed and dated by subject (and legally acceptable representative or impartial witness, if applicable), and the person conducting the informed consent discussion. For non-English speaking subject the summary and consent form has to be in the local vernacular language. The written translated version of the consent form needs to be approved by ethics committee as per local regulatory requirement. Method of obtaining consent also needs to be documented. For pediatric clinical trials, consent from parents as well as an assent from the child to show the willingness to participate in the trial is required.

If any new safety information on the investigational product is available during the course of the study, or any change in the conduct of the trial has been implemented which may affect the subject’s decision to continue in the trial, the re-consent need to be obtained on updated version of informed consent form.

Efficient informed consent documentation is very crucial for regulatory audit purpose and further approval. Non-compliance to which may lead to condemnation of the entire clinical trial. Indeed, an importance of informed consent in ethical clinical trial resembles backbone of the entire drug development process!

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Chillibreeze's disclaimer: This is a contributed article and was published on Chillibreeze in October, 2010. The views and opinions expressed in this article are those of the author(s) and do not reflect the views of Chillibreeze as a company. Chillibreeze has a strict anti-plagiarism policy. Please contact us to report any copyright issues related to this article. The relevance of the facts and figures cited (if any) could change after a period of time.

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—About our writer:

A highly proficient and experienced medical writer having overall 14 years experience;9 years as general medical practitioner and 5 years as a clinical research professional . He has varied experience including writing, editing and QA of regulatory documents . Sachin has worked as a senior medical writer for MNC pharmaceuticals like Pfizer, GSK, and Johnson & Johnson.

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