|Year : 2012 | Volume
| Issue : 3 | Page : 204-207
The ethical aspects of health research
Roopa Sidde Gowda, MS Rani
Department of Orthodontics, V. S. Dental College and Hospital, Bangalore, Karnataka, India
|Date of Web Publication||19-Feb-2013|
Roopa Sidde Gowda
Department of Orthodontics, V. S. Dental College and Hospital, Bangalore, Karnataka
Source of Support: None, Conflict of Interest: None
Ethics is a system of moral principles that not only applies values and judgments to medical practice, but also to any research that deals with human participants. Before pursuing any research, it is mandatory for a researcher to have some basic information about the ethics and ethical guidelines. Hence, the purpose of this review article is to give a brief insight into the ethics and ethical guidelines to Biomedical Research.
Keywords: Ethics, health research, consent, ethical principles
|How to cite this article:|
Gowda RS, Rani M S. The ethical aspects of health research
. SRM J Res Dent Sci 2012;3:204-7
| Ethics: A Science that Deals with Morals|| |
An experiment is an attempt to discover something unknown or to test a supposition or a principle. However, we cannot be sure of its outcome, because an experiment invariably involves an element of chance or probability. It is this chance or the element of the unknown that makes ethics a paramount issue in experiments that involve human participation. 
The need for caution for any kind of research or experimenting cannot be overemphasized, especially if it involves human subjects. Therefore, several important codes have been laid down by the Nuremberg Code of 1947 and Declaration of Helsinki, to protect human rights. 
The underlying principles of ethics
The principles of ethics are as follows: 
- Beneficence: The benefits of any experiment should justify its expected risk or harm. In other words, the end result of any research should be good or beneficial to humanity.
- Autonomy: Respect the rights of the subjects and their protection.
- Justice: Equal distribution of burden and benefit to the participants.
| Background|| |
After the Second World War trial (1939-1945), German medical practitioners were accused of conducting experiments on human participants without their consent. They were also accused of exposing their subjects to great risk of death or permanent impairment. Hence, the first International statement on the ethics of medical research using human subjects was the Nuremberg Code of 1947, which highlighted the essentiality of the voluntariness of this consent. 
In 1966, the International Covenant on Civil and Political Rights specifically stated that, no one shall be subjected to torture or to cruel, inhuman, or degrading treatment or punishment. In particular, no one shall be subjected without his consent to medical or scientific treatment.
The World Medical Association, assisted by the World Health Organization, developed an expanded and revised code of ethics.  It was called the Declaration of Helsinki. The objective of this declaration was to guide doctors in their research involving human subjects. In 1975, a revised declaration, Helsinki II, came into force. The declaration saw a shift of focus from Clinical Research to Biomedical Research involving human subjects, and was adopted in 1975 at the Twenty-ninth World Medical Assembly in Tokyo.
Guidelines of the helsinki code
- Biomedical Research should follow scientific principles and should be based on adequately performed laboratory and animal experimentation. It should be based on a thorough knowledge of literature.
- The design of the experimental procedure that involves human subjects should be clearly formulated in the experimental protocol. It must be reviewed by an independent committee.
- The experiment must be conducted only by a scientifically qualified person. Also it must be conducted only under the supervision of clinically competent medical experts.
- Any Biomedical Research involving human subjects cannot be legitimately carried out unless the importance of the objectives of the experiment justifies its inherent risk to the subject.
- Every Biomedical Research project that involves human subjects should be preceded by careful assessment of the predictable risks over foreseeable benefits to the subject or to others.
- The right of the research subject to safeguard his or her integrity must always be respected. Precaution has to be taken to respect the privacy of the subject.
- The accuracy of the research results must be preserved and maintained at all times.
- Whenever a research involves human subjects, every potential subject must be adequately informed about the aims, methods, anticipated benefits, and potential hazards of the study, and the discomfort/s that the research may entail.
- No pressure or threat should be exercised by the doctor on his/her subject while obtaining informed consent for a research project.
- In case of any legal competence, in accordance with national legislation, informed consent should be obtained from the legal guardian.
- The subject/s must be informed that he/they is/are free to ascertain or to withdraw from participation at any given point of time.
| Consent of Subjects|| |
- Children: A research program that involves children as human participants can be approved only after a thorough and detailed briefing of the objectives of the experiment and of the possible hazards, discomforts, or inconveniences to the child's parent/other legal guardian.
- Pregnant and nursing women: A research program that involves pregnant and nursing women has to be dealt with precaution. Under no circumstances should any pregnant and/or nursing woman be a subject of non-therapeutic research that would carry the possibility of risk to the fetus or to the neonate. Therapeutic research is permissible only with a view to improve the health of the mother, without prejudice to that of the fetus; and to enhance its viability or to aid the nursling's healthy development.
- Mentally ill and mentally challenged individuals: Such individuals should never be subjects, unless the research addresses the origin and treatment of that mental disease or disability.
- Other vulnerable social groups: Subjects who are junior/subordinate members of a hierarchically structured group require careful consideration, as willingness to volunteer may be unduly influenced by expectation of adventitious benefits; like, medical or nursing students, hospital personnel, employees of a pharmaceutical industry, members of armed forces, and so on.
- Community-based research: For a research program that involves human participation at a macro level, for instance of a community, an individual's consent may not be feasible. For example, for subjects that involve experimental treatment of water supplies, health system research, large-scale trials of new insecticide, nutritional fortification or substitutes, and the like, it would be highly complex to get an individual's consent.
Nevertheless, all possible means should be taken to inform the community concerned about the aims of the research, advantages expected from it, and the possible hazards or inconveniences, if any.
In highly centralized administrations, from both scientific and ethical standpoints, a national review committee may be constituted to review the research protocols. The basic responsibilities of the locally operative ethical review committees may be two-fold: 
To verify that a competent body with expertise has assessed all proposed interventions and certified that the research is acceptably safe for human subjects.
To ensure that all other ethical considerations, arising from a protocol, are satisfactorily resolved.
The Indian Council of Medical Research [ICMR] has outlined a few ethical guidelines to be followed while undertaking any research. 
Principles of essentiality.
Principles of voluntariness, informed consent, and community agreement.
Principles of non-exploitation.
Principles of privacy and confidentiality.
Principles of precaution and risk management.
Principles of professional competence.
Principles of accountability and transparency.
Principles of maximization of public interest and of distributive justice.
Principles of institutional arrangements.
Principles of public domain.
Principles of totality of responsibility.
Principles of compliance.
These twelve principles laid down by the ICMR are common to all Biomedical Research.
Principle of essentiality
The principle of essentiality defines research involving human participants to be essential for the advancement of knowledge and for the benefit and well-being of human species and the environment as well.
Principles of voluntariness, informed consent, and community agreement
The principles of informed consent and voluntariness are cardinal principles to be observed throughout the research program. The participants are to be kept informed continually of any development/s on how the research will affect them and others. On the basis of the degree of risk involved, an ethical committee will decide on the form of consent to be taken. Any research that involves a community or a group of individuals as a research participant, must apply these principles to the community as a whole and to each individual member who is a participant of that research program. Where a human participant is incompetent to give consent, and it is considered essential that research be conducted on such a person, this consent and voluntariness shall be obtained and exercised on behalf of such research participants by someone who is empowered and under a duty to act on their behalf.
Principle of non-exploitation
The principle of non-exploitation emphasizes that participants involved in the research, irrespective of their social and economic condition, literacy, or educational levels, must be kept aware of all the dangers arising from the research. Every research must include an in-built mechanism for the compensation of human participants, either through insurance cover or any other appropriate means, to cover all foreseeable risks of the experiment by providing remedial action and comprehensive aftercare, including treatment during and after the research.
Principles of privacy and confidentiality
The principles of privacy and confidentiality lay stress on the fact that the identity and records of the human participants involved in the research must be, as far as possible, kept confidential. Without the specific consent of the human participants concerned, in writing, no details of the identity of the said human participants must be revealed. Again, there must be no disclosure without any valid scientific or legal reasons, which may be essential for the purpose of therapeutics or other interventions.
Principles of precaution and risk minimization
The principles of precaution and risk minimization recommend that proper care and caution must be ensured by the research toward its human subjects. Requisite steps must be taken to ensure that both professional and ethical reviews of the research are undertaken at the appropriate stages so that further specific guidelines are laid down, and necessary directions given with respect to the conduct of the research.
Principles of professional competence
The principles of professional competence stress that the research must be, at all times, conducted only by competent and qualified persons, who act with total integrity and impartially and only by those who have been made aware of the research, preferably through training.
Principles of accountability and transparency
The principles of accountability and transparency state that the research has to be conducted in a fair, honest, impartial, and transparent manner, after full disclosure is made by those associated with the research, of each aspect of their interest in the research. Full and complete records of the research, inclusive of data and notes, must be retained for a certain reasonable period, as may be prescribed or considered necessary. It may be mandatory for the purposes of post-research monitoring, evaluation of the research, conducting further research, and/or in order to make such records available for scrutiny by the appropriate legal and administrative authority, if necessary.
The principles of the maximization of public interest and of distributive justice
The principles of the maximization of public interest and of distributive justice lays down that the research and its subsequent applications are conducted and used to benefit all human kind; not just for those who are socially better off, but also for the least advantaged individual in society; in particular, for the research participants themselves and/or for the community from which they are drawn.
Principles of institutional arrangements
The principles of institutional arrangements mention that it shall be the duty of all persons connected with the research to ensure that all the procedures required to be complied with and all institutional arrangements required to be made in respect to the research and its subsequent use are duly made in a bona fide and transparent manner. All appropriate steps must be followed to ensure that research reports, materials, and data connected with the research are duly preserved and archived.
Principles of public domain
Any further research in response to or from such research is brought into the public domain so that its results are generally made known through scientific and other publications, subject to such rights as are available to the researcher and those associated with the research, under the law in force at that time.
Principles of totality of responsibility
It is a professional and moral responsibility to observe all the principles, guidelines, and prescriptions laid down in respect to the research question by those responsible for funding or the institutions where the research is conducted, and by the various persons, groups or undertakings who sponsor, derive benefit from the research, market the product, or prescribe its use, so that the effect of the research is monitored, constantly subjected to review, and remedial action taken at all stages of the research, for its future use.
Principles of compliance
It is the general duty of all persons conducting, associated with, or connected with any research using human participants, to ensure the spirit of these guidelines, as well as any other norms and guidelines These guidelines are to be observed and should be applied to that particular research.
Adequate information about the research is given in a simple and easily understandable language in a document known as the Informed Consent Form. In simple terms it is the amount of information given to the participants and their willingness to participate in the research. ,
Components of an informed consent.
Title of the research.
Brief introduction of the study.
Information to the participant.
Declaration by the participant.
Declaration about the Principal investigator and Co-investigators.
Title of the research
The title of the proposed research has to be mentioned in the beginning of the document.
A brief introduction of the study
The purpose of the study: Why the research is to be conducted has to be highlighted.
Target population: The population involved in the research has to be mentioned.
Rationale behind the study: The underlying purpose of the study.
Information to the participant
Study procedure: The research procedure has to be informed briefly.
Modifications, if done: The participants have to be informed of any modifications done, then and there.
Outcome of the study: The expected results of the study have to be mentioned.
Adverse effects of the study: If any ill effects of the study are envisioned, they should be informed to the participants beforehand.
Participant autonomy: All participants have the right to clarify any doubt at any time of the research. It should be brought to the notice of the participant that he/she can quit the research at any time and this will not affect the research in any manner.
Declaration by the participant
The participant states that she/he has understood the objectivity of the proposed research and will clarify any doubts, if any.
participant gives her/his consent to participate in the research program.
Declaration about the Principal investigator and Co-investigators
Details about the primary investigator and the co-investigator have to be mentioned.
| Conclusion|| |
The research involving human subjects must not violate any universally applicable ethical standards. The human rights of research subjects as well as of health professionals as researchers have to be maintained. A sincere effort has been made by the authors to bring about this review article and to give some valuable and in-depth information about Ethics and Biomedical Research involving Human Participants to upcoming researchers.
| References|| |
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|3.||Council for International Organizations of Medical Sciences (CIOMS). International Guidelines for Biomedical Research involving Human Participants. Geneva: CIOMS 1992. |
|4.||Indian Council of Medical Research. Ethical Guidelines for Biomedical Research on Human Participants. New Delhi: ICMR 2006. |
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