ethics in biomedical research a study must employ a scientifically valid design to answer the...

ETHICS IN BIOMEDICAL RESEARCH

A study must employ a scientifically valid design to answer the research question.


A study must address a question of sufficient value to justify the risk posed to participants. Exposing subjects even to low risk to answer a trivial question is unacceptable.


A study must be conducted honestly. It should be carried out as stated in the approved protocol, and research ethics boards have an obligation to ensure that this is case.


Study findings must be reported accurately and promptly. Methods, results and conclusions must be reported completely and without exaggerating to allow practising clinicians to draw reasonable conclusions.


It is the researcher’s duty to have informed from research subjects.


Patients who are invited to enter a study must be informed of, among other things, the nature and extent of the known risks of participation, the possibility that participation may present unknown risks, and the intended benefit of the study to participants and others.


The study to ensure confidentiality is founded in the physician patient contract, physicians disclose information about a patient only in the patient’s best interests and they avoid any conflict of interest in the disclosure of patient information.

ETHICS IN BIO MEDICAL RESEARCH

A number of international policies guide the conduct of research. Although the Nuremberg Code and the International Covenant on Civil and Political Rights remain important early statements, [ 18,19 ] the World Medical Association’s Declaration of Helsinki, as amended most recently in October 1996, is probably the most influential document governing research world wide.


Ethical issues in research must not be addressed by researchers as an afterthought. Ethical issues permeate research and must guide research design.


Medical and related research using human beings as subjects must necessarily ensure that:

The PURPOSE of such research is that it should be directed towards the increase of knowledge about the human condition in relation to its social and natural environment.


Research is CONDUCTED under conditions that no person or persons become a mere means for the betterment of others and that human beings who are subject to any medical research or scientific experimentation are dealt with in a manner conducive to and consistent with their dignity and well being under conditions of professional competence, fair treatment and transparency.


Such research must be subjected to a regime of EVALUATION at all stages of the proposal I.e. , research design and experimentation, declaration of results and use of the results thereof; and, that each such evaluation shall bear in mind the objects to be achieved, the means by which they are sought to be achieved, the anticipated benefits and dangers, the potential uses and abuses of the experiment and its results.


Any research using the human beings as subjects of medical or scientific research or experimentation shall bear in mind the following principles:


Principles of essentiality whereby, the research entailing the use of human subjects is considered to be absolutely after a due consideration of all alternatives; in the light of the existing knowledge in the proposed area of research and after the proposed research has been duly vetted and considered by an appropriate and responsible body of persons who are external to the research and who, after careful consideration, come to the conclusion that the said research is necessary for the advancement of knowledge and for the benefit of all members of the human species and for the ecological and environmental well being of the planet.


Principles of voluntariness, informed consent and community agreement whereby, research subjects are fully apprised of the research and the impact and risk of such research on the research subject retain the right to abstain from further participation in the research irrespective of any legal or other obligation that may have been entered into by such human subjects or someone on their behalf.


Principle of non-exploration whereby, as a general rule, research subjects are renumerated for their involvement in the research or experiment; and, irrespective of the social and economic condition or status, of literacy or educational levels attained by the research subjects kept fully apprised of all the dangers arising in and out of the research.


Principles of privacy and confidentiality whereby, the identity and records of the human subjects of the research or experiment are as far as possible kept confidential; and, that no details about identity of said human subjects, which would result in the disclosure of their identity, are disclosed, without sound scientific reasons.


Principles of precaution and risk minimisation whereby, due care and caution is taken at all stages of the research and experiment to ensure that the research subject and those affected by it are put to the minimum risk.


Principles of professional competence whereby, the research is conducted at all times by competent and qualified persons who act with total integrity and impartiality and who have been made aware of, and are mindful of, the ethical considerations.


Principles of accountability and transparency whereby, the research or experiment will be conducted in a fair , honest impartial and transparent manner after a full disclosure is made by those associated with the research or experiment of each aspect of their interest in the research, and any conflict of interest that may exist:


Principle of the maximisation of the public interest and of distributive justice

whereby, the research or experiment and its subsequent applicative use are conducted and used to benefit all human kind.


Principle of Institutional Arrangements

whereby, there shall be a duty on all persons conducted with the research to ensure that all the proceedures required to be complied with and all institutional arrangements required to be made in respect of the research and its subsequent use or application are duly made in a bonafide and transparent manner.


THE WORLD MEDICAL ASSOCIATION

Declaration of Helsinki

World Medical Association Declaration of Helsinki: Recommendations Guiding Medical Doctors in Biomedical Research Involving Human Subjects


The Purpose of biomedical research involving human subjects must be to have the effect to improve diagnostic, therapeutic and prophylactic procedures and the understanding of the aetiology and pathogenesis of disease.


In the field of biomedical research a fundamental distinction must be recognized between medical research in which the aim is essentially diagnostic or therapeutic for a patient, and medical research, the essential object of which is purely scientific and without implying direct diagnostic or therapeutic value to the person subjected to the research.


What is the Research Ethics Process About?

All sound scientific research is predicated on three fundamental ethical principles:

Doing good Avoiding causing harm ( biomedical ethicists identify

at least three kinds of harm in this context: physical harm, psychosocial harm ( eg invasion of privacy, threats to self-esteem, threat of anxiety, fear, etc), and a risk of harm of any kind)

Respect for the person ( ie a person must not be used as a means to attain another’s ends)


What are the main ethical issues in human subjects research?

There are several ethical issues that must be considered when designing research that will utilize participants who are human beings:


The primary concern of the investigator should be the safety of the research participant. This is accomplished by carefully considering the risk / benefit ratio.


The scientific investigator must obtain informed consent from each research participant. This should be obtained in writing (although oral consents are sometimes acceptable ) after the participant has had the opportunity to carefully consider the risks and benefits and to ask any pertinent questions. Informed consent should be seen as an ongoing process, not a singular event or a mere formality.


The investigator must enumerate how privacy and confidentiality concerns will be approached.


The investigator must consider how adverse events will be handled; who will provide care for a participant injured in a study and who will pay for that care are important considerations.


A true null hypothesis \should exist at the onset regarding the outcome of the trial.


What are the main ethical principles that govern research with human subjects?

There are three primary principles that are traditionally cited when discussing ethical concerns in human subjects research:

1. Autonomy 2. Beneficence 3. Justice


What are the components of an ethically valid informed consent for research?

Disclosure : The potential participant must be informed as fully as possible of the nature and purpose of the research, the procedures to be used, the expected benefits risks, stresses, and discomforts.


Understanding: The participant must understand what has been explained and must be given the opportunity to ask questions and have them answered by one of the investigators.


Voluntariness: The participant’s consent to participate in the research must be voluntary, free of any coercion or promises of benefits unlikely to result from participation.


Competence: The participant must be competent to give consent. A designated surrogate may provide consent if it is in the participant’s best interest to participate.


Consent: The potential human subject must authorize his/her participation in the research study, preferably in writing, although at times an oral consent or assent may be more appropriate.


What is research ethics?

Research involving human subjects can raise difficult and important ethical and legal questions. The field of research ethics is devoted to the systematic analysis of such questions to ensure that study participants are protected and, ultimately, that clinical research is conducted in a way that serves the needs of such participants and of society as a whole.


The predominant ethical framework for human experimentation was set out by the US National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research in the Belmont Report.


The principles set out in the Belmont Report do not, however, exhaust the ethical requirements for clinical research. Conditions such as the following must also be met:


BY

Prof. Adnan Albar


Biomedical Research is the area of science devoted to the study of the processes of life, the prevention and treatment of disease and the genetic and environmental factors related to disease and health.


The public is generally not aware of the fundamental practices, process, and benefits derived from biomedical research.

Medical research with animals must ensure the humane and responsible care and treatment of laboratory animals.


Research animals must be well cared for, under the supervision of veterinarians specializing in laboratory animal medicine. These professionals provide the care and treatment of animals.


The scientific community supports the highest quality of care and treatment for research animals because their use in research remains a necessity. These animals help to unlock the mysteries of disease and deserve our respect and the best possible care.

ethics in biomedical research a study must employ a scientifically valid design to answer the...

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