L. Duke
(1999)
PRINCIPLES OF ETHICS
PRINCIPLES OF ETHICS
Four major constraints of research
1. Scientific
2. Administrative
3. Ethical
4. Political
Webster defines ethics as conforming to the standards of
conduct of a given profession or group.
History
Before World War II, few guidelines existed to ensure protection of
human subjects while conducting research. During World War II, Nazi
physicians and scientists conducted experiments including mass sterilization,
genetic reeingineering, deliberate infection of wounds with gas gangrene
and malaria.
The Nuremberg Code was developed in 1947 to address problems in human experimentation, specifically revelations of Nazi atrocities conducted during WWII. Core of this is the protection of human subjects, especially informed consent. Includes also principles that research be based on prior animal experimentation, free of unnecessary physical and mental harm to subjects and conducted for good of society.
Additionally, in 1964, the Declaration of Helsinki was developed by the World Medical Association in a meeting held in Finland. It reiterates the Nuremberg Code and adds protection of subject’s rights. This declaration has been updated periodically with the use of 1) scientific principles, 2) adequate research design, 3) qualified researchers, and 4) minimal risk to subjects being stressed. Major contribution of this declaration is the distinction it draws between therapeutic and non therapeutic research. When there is indication of potential harm to subjects, the benefits of the research must outweigh the harm. The essence of this declaration was the need for subjects to be informed of the benefits or possible harm of the study before the subject consent was received.
*Today, additional concern evolves around the use of animal subjects for experimentation.
The Helsinki declaration has served as the basis for regulations for testing new drugs under United States law and also as the basis for guidelines for Internal Review Boards (IRB) for Medical Research Centers in the United States, Great Britain, and Canada, even in universities and hospitals.
The basic rights of human subjects include
1) right to freedom from injury,
2) right of privacy and dignity, and
3) right to anonymity and confidentiality.
The Belmont Report identified three basic ethical principles
of research; respect for persons, beneficence and justice.
These principles can be used to guide the researcher in designing procedures
for selecting subjects, developing written consents and assessing risk/benefit
ratios of proposed research studies.
The Patient Bill of Rights document addresses informed consent, privacy and confidentiality within institutional settings. Emphasis is placed on the right to choose to participate or to choose not to participate in human experimentation.
Many disciplines in the health care field have developed Codes of Ethics. Codes offer guidelines to assist researchers in exploring ethical concerns that arise in practice and research. Generally, the codes discuss issues that can be applied to research, i.e., respect for human dignity, patient confidentiality, and safeguarding against incompetent, unethical, or illegal practices.
Institutional Review Board
Federal regulations require institutions that receive significant federal funding or conduct drug or medical device research regulated by the Federal Drug Administration (FDA) to establish institutional review boards (IRB).
The major responsibility of IRB is to protect human subjects from risk or deprivation of personal rights or dignity. FGCU’s IRB provides consent forms for adults and children with wording which verifies free self determination for potential research subjects.
Decisions as to approval, modification or disapproval must be made by the majority of the board. There are not always clear cut answers about ethics. This is why “board” has broad representation. Lawyers, lay persons, and clergy often serve on IRB to deal with nonscientific issues. This, then provides a more holistic view of the ethics of the proposed study.
Code of Federal Regulations
There are certain regulations developed for institutions receiving
funding from the government. These are as follows:
Informed consents are common forms used in health care settings
to ensure the client has had explanation of the nature and purpose of the
treatment procedure they are about to undergo. Extra effort is needed
in developing informed consent for researchers.
Basic principles for ethical conduct of research
1. Veracity – obligation to tell the truth, not lie or deceive others.
2. Privacy – obligation to maintain the state or condition of limited access to a person including knowledge about the person’s body, relationships or secrets.
3. Confidentiality – obligation not to divulge information learned in treating or caring for a patient to a 3rd party without the permission to do so.
4. Fidelity – obligation to remain faithful to one’s commitments; keeping promises, maintaining confidentiality and demonstrating caring behaviors.
Principles for Human Research
1. Research must be justifiable for its scientific value
2. Even if the inquiry has scientific value, it must not be pursued
if benefit is outweighed by risk to the subject.
3. Research must be conducted by scientifically competent people.
4. Research must be conducted with a sound design or proposal and carried
out according to the design.
5. Care must be taken to see the subject will not be harassed and the
research must be terminated if risk of harm, physical or emotional, is
apparent.
6. Subjects are entitled to withdraw at any time
7. No subject should be used without free consent.
Principles of Behavior Research
1. Subject’s permission must be obtained.
2. Nature, purpose and results of research should be described
to all involved
3. No coercion of individuals should be done.
4. Misinformation should not be given out to subjects unless the problem
is significant and can be investigated in no other way.
5. If serious after effects are a possibility, subjects must be fully
informed
6. All harmful after effects are removed as soon as permitted by design
of the study.
from: Currier, D.P., Elements of research in physical therapy
CONSIDERATIONS
When students are asked to complete questionnaires which researcher
hopes to analyze and publish, students should be told this is completely
voluntary. Even though told there will be no effect on their status;
subjects may still believe there will be an effect if they do not participate.
Example – Prisoners, employees, students, etc. May feel
their participation will enhance their status with researcher.
When we speak of “no harm”; even if participants volunteer for the study, just about any research you may conduct runs the risk of some harm either physiological or psychological. Even in reporting the findings. If some feel what is reported not the norm this may have an affect on their self esteem. Be sensitive to this.
Funding agencies typically require independent evaluation of treatment of human subjects.
Protection of identity
Anonymity – example – mail survey with no identification numbers on questionnaires. Makes it difficult to conduct research as try to keep track of who has and has not returned questionnaires.Reporting and analyzing – Researcher is obliged to report known shortcomings of the study.Confidentiality – Train research assistants in ethical responsibilities. Remove names and addresses from questionnaires and replace with identification numbers (ID#s).
Deceiving people is unethical. This needs to be justified by compelling scientific or administrative concerns.
Laws have been written in an effort to protect the rights and welfare
of every human in society. Ethical considerations in research have
only risen because of previous uses to which research has been put, misdeeds
of individuals conducting research and appropriation of public funds to
support research. Consideration must be given to researchers who
fail to report findings accurately. This could result in morbidity
and even mortality in populations relying on the truthfulness of research
findings.