The Right to Informed Consent in a Clinical Trial

A patient participating in a clinical trial has the right to know all the information regarding the trial, including its potential benefits and risks, so that he can make an informed decision

Clinical trials are scientific research experiments, conducted on human volunteers in order to find new ways to prevent, detect and cure diseases. Medical science has grown leaps and bounds on the back of such biomedical research. When done properly, such studies are very useful in improving our medical knowledge base.

However, not all clinical trials are conducted ethically. This is especially true in India, which is fast becoming an attractive destination for carrying out clinical trials, primarily because we have a huge and diverse pool of patients on whom these trials can be conducted fairly inexpensively. Many of the patients chosen are uneducated, who can easily be exploited by doctors, researchers and pharmaceutical companies, alike. Unethical researchers (who get paid huge sums for signing up as many participants as possible) may exaggerate the benefits of a treatment, offer financial sweeteners, or attempt to play down the risks of the trial.

In 1997, the oncology division of the Indian Council of Medical Research (ICMR) carried out an observational study on cervical cancer in Indian women. The study did not have any ethical clearance from the All India Institute of Medical Sciences (AIIMS) from where the subjects were drawn ; nor did the researchers get informed consent from the subjects themselves. Under the ICMR study, 1100 uneducated urban women from Delhi with pre-cancerous lesions were studied between 1976 and 1988. The objective was to study the natural progression of cervical dysplasia to cervical cancer (the most prevalent cancer amongst Indian women) without any medical intervention. So despite the fact that a simple surgery would have removed the cervical lesions, before they could turn cancerous, the women were wantonly left untreated. The outcome was that 62 of these women needlessly developed cancer; and in nine the disease had already spread to other parts of their body.

In another equally scandalous incident, an Indian scientist attempted to inject the bovine HIV strain into a human subject. This research was also not approved by any ethical body. Likewise there have been reports of a pig’s heart transplant into humans; and controversial trials with mepacrine, an anti-malarial drug that is injected into a woman’s uterus for contraceptive purposes, although some doctors suspect it causes cancer. Although every hospital unit is supposed to have its own ethical committee, in our country most are defunct bodies. The National Human Rights Commission (NHRC) guidelines propose that a research group must provide human subjects with printed literature, explaining in simple, non-technical language, the purpose of the study; details of the procedure; the risks involved; the financial or other interests of the researcher; and a commitment to treat, completely and free-of-cost, any complication that may arise during the course of the trial.

Audio-Video Recording of Consent Process Will Soon Be Made Mandatory While it is important that clinical trials need to be allowed in India, these have to be fair and transparent. With a view to curb the practice of procuring illiterate subjects and making them sign consent forms which they do not understand, the Union health ministry is planning to amend the Schedule Y of the Drugs & Cosmetics Rules to make audio/video recording of informed consent process in clinical trials mandatory. The amendment seeks to ensure that the trial subjects are adequately informed about the failure of investigational products. The purpose is to make participation in clinical trials voluntary. (Source:http://pharmabiz.com/ArticleDetails. aspx?aid=71218&sid=3)

The subject too has to certify in writing that she has understood the document and is volunteering to participate in the research, without the promise of any monetary inducement that is not permitted under the Indian law. There are a few other government bodies that monitor clinical trials such as the Drug Controller of India and the Clinical Trial Registry in India (CTRI). Nonetheless, the Supreme Court recently expressed reservations about the unethical way in which most clinical trials are being conducted in the country, and has directed the Ministry of Health to formulate proper guidelines on this, to protect patients’ interests. According to existing rules, an ethically sound clinical trial:

                Will aim for the enhancement of medical knowledge

                Will have strong scientific validity

                Will recruit participants fairly

                Will have a favourable risk-benefit ratio

Will have people who independently review, approve, amend or terminate it

9Will obtain informed consent from its participants

9Will respect the participants privacy and will strive hard to protect their wellness and rights

Role of patient advocates in clinical trials

Patient-advocates can play an extremely important role in clinical trials. Among other things they are required to:

                Make sure whether the information about the trial is presented in a format which is easily understandable to the patient

                Assist the research team in developing relevant educational materials about the trial in lay-friendly terms that is simple and easy to understand

                Identify and address potential ethical issues in the trial

                Promote patient safety and confidentiality

                Assist the research team in obtaining valid informed consent from the patients, recruited in the trial

QUIZ TIME: Informed Consent Quality Assessment Questionnaire

Use this form to gauge patient’s understanding of their participation in clinical trials

·                     Do you feel that you have been informed how long your participation in this clinical trial will last?

·                     Do you think that all the treatments and procedures that the investigator proposed for you are the best for your disease?

·                     Do you understand what “randomisation” means?

·                     Do you know that no direct medical benefit will derive to you from your participation in this clinical trial?

·                     Are you sure that your participation in this trial will not involve any additional risk or discomforts?

·                     Do you know that because you are participating in a clinical trial, it is possible that the study sponsor, various government agencies, or others not directly involved in your health care could have access to your medical records?

·         Do you know that the consent form you signed lists the names of the contact persons, who must answer any of your questions or concerns about the clinical trial?

·         Do you know that the consent form you signed describes how you will be covered by insurance if you are injured or become ill as a result of participation in the clinical trial?

·         Do you understand that if you do not want to participate in the clinical trial you are free to refuse to sign the consent form? This will not affect the quality of medical care you receive, so you do not need to be scared that your doctor will get angry or upset if you refuse to participate.

·         Do you understand that you are not obliged to remain in the clinical trial if you decide to withdraw at any point of time?

·         Explain in your words the purpose of the clinical trial to which you have consented to be a subject.

A patient-advocate who uses such questionnaires with patients who have been recruited to participate in a clinical trial will help to protect the patients; and will also ensure that the research team is never caught on the wrong side of the fence.