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Informed Consent In Clinical Trials In Inida

Informed consent is considered as one of the most crucial element in medical practice. It is the duty of the medical practitioner to explain the pros, cons, procedure of the treatment to the patient irrespective of the treatment, whether it is simple or critical before going to treat patient. In the same, the patient has the right to refuse the treatment except in the case of emergencies. The medical practitioner cannot treat a patient without his consent. The consent must be a valid consent. Treatment without valid consent leads to tort or criminal liability.

The concept of consent arose after the Nuremberg Trails during World War II and the Nuremberg Code 1947 was adopted. This code mandates voluntarily informed consent of human subjects. Consent has to be taken not only during treatment; it is must to take the informed consent of a human being when such person is being used for research purpose which is also known as clinical trials. Clinical trials can be simply defined as testing the effectiveness of a research study. The research study may be related to medical or surgical or behavioral study.

The world Medical Organization adopted the Declaration of Helsinki in the year 1964 which emphasizes the importance of obtaining consent for medical research by informing them about the aim, methods, benefits and hazards in detail. Clinical trials which is nothing but experimenting new drugs on human being has became one of the most crucial human rights issue faced by the third world countries due to their unethical ways.

Legislation Of Clinical Trials

In India, the clinical trials are governed through the New Drugs and Clinical Trials Rules, 2019 (NDCT Rules) along with Drugs and Cosmetics Act, 1940; Medical Council of India Act,1956; Central Council for Indian Medicine Act,1970 under the Ministry of Health and Family Welfare.

In order to bring regulation in the process of clinical trials and to bring transparency, laws related to this are being amended for many years. After many amendments, the NDCT Rules came into picture.

Clinical trials were previously conducted in accordance with Schedule Y of the Drugs and Cosmetics Rules, 1945 (D&C Rules). However, there were concerns about patient safety and compensation provided to patients in cases of adverse effects caused by clinical trial participation.

A patient-centric NGO filed a Public Interest Litigation (PIL) before the Hon'ble Supreme Court of India in 2012, alleging malpractices in the conduct of clinical trials by government and non-governmental organizations, as well as independent investigators. The Court discussed regulatory aspects of clinical trials while hearing this case. In an order dated October 21, 2013, the Hon'ble Supreme Court stated that clinical trial approvals should be based on all relevant aspects of safety and efficacy, particularly risk versus benefit to patients, innovation in comparison to existing therapeutic options, and unmet medical need in the country.

Certain amendments to the D&C Rules were made in 2013 to regulate clinical trials conducted in India. The Drugs and Cosmetics (First Amendment) Rules, 2013 inserted Rule-122DAB into the D&C Rules. This Rule, among other things, provided compensation to a clinical trial subject who was injured or killed during a clinical trial. The clinical trial participant was made eligible for financial compensation in addition to free medical care. The Licensing Authority was to determine the amount of compensation.

The Drugs and Cosmetics (Second Amendment) Rules, 2013 inserted Rule-122DAC into the D&C Rules, which lists the conditions for the conduct of clinical trials. These conditions include, among other things, adhering to Schedule Y of the D&C Rules, obtaining the approval of an Ethics Committee, registering the trial with the Clinical Trials Registry of India, reporting serious adverse events, and so on. Furthermore, the Drugs and Cosmetics (Third Amendment) Rules, 2013 notified the guidelines for the composition and registration of ethics committees.

Deficiencies in clinical trial regulation were identified in the 59th Report of the Parliamentary Standing Committee on Health and Family Welfare on the functioning of the Central Drugs Standard Control Organization (CDSCO, as well as in the report of an expert committee established by the MoHFW and chaired by Prof. Ranjit Roy Chaudhury. Following that, on February 1, 2018, the MoHFW published a draft of the NDCT Rules for public comment. The deadline for submitting comments on these rules was set at 45 days. However, it took the MoHFW a long time to consider and finalize the Rules.

The Supreme Court took note of the delay and noted the Government's submission that the rules would be finalized within two months in an order dated December 4, 2018. When the Court expressed concern that two months might be too long, the Government assured the Court that, if possible, the NDCT Rules could be finalized sooner. On March 19, 2019, they were finally notified.

The NDCT Rules, 2019 has made significant changes in field of clinical trails and tried to cover many loop holes in this field. It had made key changes by introducing the regulations on biomedical and health research, academic clinical trials, orphan drug registration, revised the definition of new drug, post marketing studies, post trial process, ethics committee, rules related to imports and manufacture of unapproved new drug. The new rules aimed to retrieve the clinical industry in India and to improve the ethical standards of clinical trials in India.

Phases Of Clinical Trials

Clinical trials are conducted in four stages. Clinical trials of drugs developed in India must go through all four stages of testing in India.

Phase-I: clinical pharmacology trials:
This phase is also known as first in man study where the new drug is administered for the first time to a small number of volunteers under the close supervision of the doctor for the determination of the new compound reaction in patient's body.

Phase-II: Exploratory Trials:
This is the second phase of clinical trials and during this phase the new drug will be administered to group of 10-12 volunteers to determine effect and also to check the side effects of the drug.

Phase -III: Confirmatory trials:
This is the major and important phase of the entire process where the drug is given to a large number of people ranging between 1000-3000 volunteers and the data is compared with the standard drug to obtain the sufficient evidence about the safety and effectiveness of new drug. If the results are positive, the data is presented to the licensing authorities in order to obtain a commercial license to market the drug to the patients for the specified and approved indication.

Phase-IV: Post-marketing Phase- After the medicine is made available to doctors, who begin prescribing it, the phase of surveillance begins. Thousands of patients are being monitored to help identify any unexpected side effects.

Consent To Clinical Trials

Even before the Nuremberg Trials, human experiments were governed by the doctrine of consent. The Neisser Case was one of these, in which Albert Neisser, a dermatology professor, performed Serum trials for syphilis patients against their will or knowledge. Despite Neisser's medical authority in therapeutic care, the court insisted on patient consent and was fined. According to the lawyers' advice to the ministry, they advised that such trials would amount to criminal liability if done against the patient's will in non-therapeutic trials. The doctrine of informed consent had its implications even before the Nuremberg Code.

The law has made it mandatory to obtain the consent of the volunteer of clinical trial but the process is not easy. During the process of consent from volunteer, the main question arises is that upto what extent of the information has to be made available to the patient regarding the trial, impact of the trial and it is very difficult in case of non therapeutic trials.

The word informed will not always have the same impact in the case of a clinical trial as it does in the case of treatment. Generally, in the case of randomized trials, the majority of the information will be inadequately provided. It is also important to note that the law does not emphasize the importance of conveying all necessary information. There are some substantial variations between the processes of seeking informed consent and obtaining informed consent.

Seeking informed consent is only an ethical obligation, but obtaining the informed consent is based on the research involved in the process. In most cases, obtaining informed consent is viewed as a bureaucratic form-filling exercise, which it should not be. The questions and explanations that must be communicated to the trial subject must be designed by the researcher. Communication and its precision form the foundation for the nicety to the objective of informed consent. In the case of therapeutic care, the legal principle of adequate or reasonable information cannot apply to experiments. The researcher must communicate all relevant information and persuade the trial subject of the trials' shortcomings.

The viability of the informed consent doctrine is also dependent on factors such as the investigator's mindset, the priority given to the trial subject's autonomy, and the method used for the conversation.

The rule of informed consent requires the following disclosures in order for there to be true consent:
  • That the subjects are not only patients, and that their therapeutic interests, even if incidental, will be subordinated to scientific interests
  • That it is uncertain whether their welfare will be better served by putting their medical fate in the hands of a physician instead of the investigator
  • That by choosing medical care, they may be better or worse off
  • That clinical research will enable doctors to dig the mysteries of medicine's uncertainties about which treatments are best, risky, or ineffective;
  • That research is governed by a research protocol and a research question, and thus his or her interests and needs will give way to scientific claims
  • That any decision made by the subject will be respected by physician investigators

The preceding observations have numerous drawbacks in terms of human rights. The notion that the patient's therapeutic interests will be subordinated to scientific interests is presented with great ambiguity. The impact will differ depending on the stage of clinical trials. The subject in a phase I trial will have no therapeutic interest, only scientific or monetary interest. The extent of therapeutic interest in the coming stages is relative. There, trial subjects must look for alternative therapeutic cures for their disease or be properly convinced of the trial's risks. Analyzing the fourth point, it appears that it will never be a concern for any research subject, whether he is a patient or not, to reveal the safety and efficacy of any drug. All of these points highlight the doctrine of informed consent's inability to protect the human rights of trial subjects.

Consent-Ethics Committees

The law requires clinical trials to be monitored and reviewed on a regular basis in order to ensure the safety and dignity of trial subjects. Informed consent from the subject is not a complete doctrine for protecting the subjects' human rights. From the start of a trial, there should be an exact plan for the trial, which is modeled by a research protocol. The international documents envisage the protocal preparation and review of the same by an impartial and independent ethics committee of the research institution.

The World Medical Organization's Helsinki Declaration upholds the role of the ethics committee. Because this is a document created by the medical community, it may be biased. The operation of ethics committees is not dependent on international documents, but rather on national legislation. The Drugs and Cosmetics Rules 1945 in India maintain the establishment of ethics committees.

The scheme for the formation of ethics committees is detailed in Schedule Y of the said rules in its appendix. It specifies that only the chairman of the committee should be independent of the research institution. Apart from that, only two or three members are unaffiliated with the medical fraternity. The entire clinical trial process always helps members of the medical community earn more money and they will always favor trials and be poor defenders of subjects' rights. The committee should have at least seven members, with some representing the community of social scientists, NGOs, the community, and so on. These are the members of the ethics committee who have the potential to save the human rights of trial subjects.

NGOs fight for human rights not only in India, but in many other countries as well. NGOs can also play a role in the protection of trial subjects' rights in clinical trials. This is also legally permissible through the formation of ethics committees with NGO participation. The mere presence of an NGO member will not render the protocol review process impartial and fair. The very nature of protocol review and trial monitoring will create numerous technical barriers. The medical terminology used, drug side effects, and even the nature of the components included in a trial drug cannot be easily identified by the NGO representative.

This is only possible with the inclusion of a trained and knowledgeable NGO representative. Law either failed to anticipate or steadfastly avoided this aspect. The Indian law does not specify the procedure for electing the ethics committee. In most cases, the institution will appoint someone to represent their interests as an NGO representative. A few changes to the existing law can solve this challenge. The state shall keep a list of qualified nongovernmental organizations (NGOs) or social scientists with adequate qualifications and knowledge of human rights, medicine, and the side effects of various chemical compounds. This standard should be implemented on a global scale.

The United Nations, World Medical Association, and Red Cross Society can organize awareness campaigns or short-term courses to teach these values. NGO members' votes should be made crucial in determining the fate of the trials, and national authorities such as the Drugs Control General of India should maintain constant contact with these NGO members of various ethics committees. Recent Indian experiences demonstrate the importance of NGO intervention in clinical trials. Certain non-governmental organizations (NGOs) have brought the impact of unethical trials to the attention of the Indian Supreme Court.

Aside from reviewing the protocol, trained non-governmental organizations and their representatives can make the consent-taking procedure more consistent and reasonable. Thus, the role of non-governmental organizations (NGOs) should be positively designed in order to improve the human rights of clinical trial subjects. NGOs can act as a check on the medical community's excessive economic and professional interests.

The drug development process is a long-term commitment, and obtaining marketing approval is not the end point of such development, but rather a milestone that extends beyond such a milestone. As a result, a good clinical trial regulation must aim to consider the pre-study, implementation, and post-study aspects. The Clinical Trial Rules 2019 are a comprehensive enactment that resulted from many years of deliberation by regulatory authorities, industry, and Indian courts.

Prior to the Clinical Trial Rules 2019, the clinical trial law had been widely criticized for discouraging medical research in India. The Clinical Trial Rules 2019 have significantly clarified the regulatory position and implemented a robust mechanism that details minute aspects of the process and regulatory compliances. While the Clinical Trial Rules 2019 do not significantly alter the requirements detailed in Schedule Y of the DCR (Drugs and Cosmetics Rules, 1945), they do unify the principles outlined in the ICMR Guidelines and the DCR (Drugs and Cosmetics Rules, 1945) requirements for clarity and ease of compliance. Furthermore, the Clinical Trial Rules 2019 are aligned with international best practices, making it approachable and familiar.

The Clinical Trial Rules 2019 have significantly streamlined the approvals process in implementation and are reflective of a pro-participant approach. Provisions such as local clinical trial waivers, expedited approvals, specific timelines, and a compensation mechanism have strengthened clinical trial regulation in India in order to attract sponsors and increase patient participation. Compensation for biomedical and health research, the quantum of compensation for non-study related injuries, and post-study obligation timelines are some areas that require clarification.

The Clinical Trial Rules 2019, in our opinion, are best described as two steps forward and one step back. While it has enormous potential and promise for the future, its rigidity and lack of clarity on certain issues flattens it. Nonetheless, the Clinical Trial Rules 2019 reflect industry and regulatory consensus, and anticipate a bright future for clinical trials in India.

  • Christ University Law Journal, 3, 1 (2014), 1-16 ISSN 2278-4322|

Award Winning Article Is Written By: Ms.V.L.V.Chaitra
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