Safety of patients participating in medical research is an aspect of vital significance from moral, ethical as well as legal point of view.
Being highly technical aspects, about which even the researchers would not have full comprehension, the patient would be completely ignorant and can hardly be able to protect himself from the hazards that may visit him, during or after the trial.
The doctor in-charge of the research program and the Institutional Ethics Committee, therefore, have all the responsibility of ensuring safety of patients participating in research, in all aspects.
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To address the ethical/legal issues and regulate clinical research on the human subjects the World Medical Association laid down certain guidelines in 1964 known as World Medical Association Declaration of Helsinki, accepted world wide as the basic document for regulating all research on human subjects.
It has framed 32 principles governing various essential aspects such as an informed consent from the research subjects, protection of their privacy and dignity and confidentiality of information.
It further states that medical research involving human subjects should be conducted only, if the importance of the objectives outweighs the risks to the subjects and it is the duty of the investigators to minimize the impact of the study on physical and mental integrity, and personality of the research subjects.
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In India, the ICMR had brought out comprehensive guidelines called ‘Policy statement on Ethical Considerations involved in Research on Human Subjects’ in 1980 which were reviewed in September 2000 and the salient aspects of the revised “Ethical Guidelines for Biomedical Research on Human Subjects” are discussed below.
1. General Principles for Biomedical Research:
Any research using the human beings as subjects of medical or scientific research or experimentation, shall bear in mind the following principles:
I. Principles of essentiality
II. Principles of voluntariness, informed consent and community agreement
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III. Principles of non-exploitation
IV. Principles of privacy and confidentiality
V. Principles of precaution and risk minimization
VI. Principles of professional competence
VII. Principles of accountability and transparency
VIII. Principles of maximization of the public interest and of distributive justice IX. Principles of institutional arrangements
X. Principles of public domain
XI. Principles of totality of responsibility
XII. Principles of compliance.
All the research involving human subjects should be conducted in accordance with the four basic ethical principles, namely Autonomy (respect for person/subject), Beneficence, Non- malfeasance (do no harm) and Justice.
The Principal Investigator is responsible for not only undertaking research but also for observance of the rights, health and welfare of the subjects recruited for the study.
She/he should be well qualified and competent in biomedical research methodology and should be aware of and comply with the scientific, legal and ethical requirements of the study protocol as described in detail in the ICMR guidelines. In addition to the above, the guidelines include detailed provisions covering the:
i. Informed Consent Process:
Consent form, participants information sheet, obligations of investigators regarding informed consent, essential information for prospective research participants (the aims and methods of research, expected duration, benefits, alternative courses of treatment, any foreseeable risk/discomfort to the participant, right to withdraw from research, confidentiality of records with limitations).
ii. Compensation to be paid to the research subjects.
iii. Conflict of Interest:
May happen in case of academic institutions conducting research in alliance with industries/commercial companies the conflict of interest should not be allowed to damage the scientific integrity of a project or cause harm to research subjects.
iv. Selection of Special Groups as Research Participants:
Such as pregnant or nursing women, children, other vulnerable groups such as aged, mentally challenged, economically/ socially disadvantaged.
v. Confidentiality of all information about the research subjects and the research data, except:
i. In a court of law under the orders of the presiding judge
ii. If there is threat to a person’s life
iii. In cases of severe adverse reaction information may be required to be communicated to drug registration authority
iv. If there is risk to public health which takes precedence over personal right to privacy
The limitations should be communicated to appropriate individuals or authorities as the case may be.
vi. Compensation for Accidental Injury:
Obligation of the sponsors to pay.
vii. Post-trial Access by study participants to prophylactic, diagnostic and therapeutic procedures identified as beneficial in the study or access to other appropriate care to be specified in the protocol.
viii. International Collaboration/Assistance in Biomedical/Health Research.
ix. Researchers Relationship with the Media and Publication Practices: Guidelines for publication/disclosure of data/results in the media so as to avoid any misunderstandings or unnecessary panic or breach of confidentiality.
Specific principles related to different types of research (Clinical Evaluation of Drugs, Vaccines, Surgical procedures/Medical Devices, Diagnostic agents and Herbal remedies, Specific Principles for Epidemiological Studies, Human Genetic Research, Research in Transplantation Including Fetal Tissue Transplantation, and Assisted Reproductive Techniques) are beyond the scope of this book and the reader is advised to refer to ICMR guidelines on Bio Medical Research, if required.
2. Trial of New Drugs/Experimental Procedures in Clinical Practice:
There are often situations in clinical practice where the patient may be suffering from a disease /problem which does not have any established or satisfactory treatment and some new drug or procedure, though still in the experimental stage, may have a promise for better effects, such as stem cell therapy which has shown beneficial effects in some disease situations, but is not yet accepted as established modality of treatment because the side effects/ long term effects of the modality are not yet fully known.
In these situations, if the doctors feel that an experimental trial of some new surgical/other intervention or medication holds promise to provide a more effective cure for the ailment and enhance the well-being of the patient, the doctors may be tempted to conduct the trial.
However, in view of the lack of adequate knowledge about the effects of the procedure/drug/treatment modality, it is essential that the doctors follow the ethical guidelines before and during the experimental trial.
i. Principles of essentiality: Only if it is essential as a life saving procedure. If it is not a life threatening situation then the procedure/medication proposed to be tried should be such as has been tried before for other problems and the effects, in general, are mostly known.
ii. Informed consent of the patient, after full briefing about the side/after/toxic effects, their chances of occurrence and the chances of relief, to the patient, to full extent of knowledge of the doctor. The decision must be by the patient/his legal guardian.
iii. Privacy and confidentiality of all information as applicable in all cases.
iv. Risk minimization: The doctor in charge case must, before starting the trial, ensure that the chances of all risks have been minimized to the extent possible.
v. Professional competence: The doctor must ensure that the experimental procedure, treatment modality is such as within his professional competence.
vi. It should be ensured before starting the trial that all necessary arrangement is available to manage the side effects/toxic effects/complications that may occur during/after the trial.
vii. The conduct of proposed procedure/trial must have the approval of Institutional Ethics Committee who should be monitoring the progress of the trial throughout.
viii. The institutional Ethics Committee must ensure that the patient’s interests are fully safeguarded and the patient has the choice to discontinue the trial at any stage.