WHAT ARE THE BASIC PRINCIPLES OF ETHICAL RESEARCH IN HUMAN SUBJECTS ? 7 MARKS
B ) OUTLINE THE ISSUES SPECIFIC TO PSYCHIATRY ? 3 MARKS
A 7 INTRODUCTION
1 Is according to Belmont Report a report created by the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research.
2 The report was issued on 30 September 1978 and published in the Federal Register on 18 April 1979
3 The Belmont Report was first written by the National Commission for the Protection of Human Services of Biomedical and Behavioral Research - Prompted in part by problems arising from the Tuskegee Syphilis Study (1932–1972) and based on the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research (1974–1978), the Department of Health, Education and Welfare (HEW) revised and expanded its regulations for the protection of human subjects 45 CFR part 46 in the late 1970s and early 1980s.
4 In 1978, the Commission’s report Ethical Principles and Guidelines for the Protection of Human Subjects of Research was released, and it was published in 1979 in the Federal Register.
5 It was named the Belmont Report, for the Belmont Conference Center, where the National Commission met when first drafting the report.
6 The Belmont Report is one of the leading works concerning ethics and health care research - It allows for the protection of participants in clinical trials and research studies.
7 The Belmont Report explains the unifying ethical principles that form the basis for the National Commission’s topic-specific reports and the regulations that incorporate its recommendations.
BASIC PRINCIPLES OF ETHICAL PRACTICE
IT INCLUDES -
A ) The three fundamental ethical principles for using any human subjects for research are -
1 Respect for persons -
A ) protecting the autonomy of all people and treating them with courtesy and respect and allowing for informed consent
B ) Researchers must be truthful and conduct no deception
2 Beneficence -
A ) The philosophy of “Do no harm” while maximizing benefits for the research project and minimizing risks to the research subjects
B ) beneficence refers to actions that promote the well being of others.
C ) In the medical context, this means taking actions that serve the best interests of patients.
D ) However, uncertainty surrounds the precise definition of which practices do in fact help patients.
3 Justice - ensuring reasonable, non-exploitative, and well-considered procedures are administered fairly — the fair distribution of costs and benefits to potential research participants — and equally.
B ) Applications of these principles to conduct research requires careful consideration of -
i) informed consent -
Has following components ( vv imp ) - ** ( imp for PMR fellows as well ) for research
1 - Disclosure -
A ) The informed consent document must make clear that the study is a research study, and not clinical therapy.
B ) 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 to the participant and/or society, the potential of reasonably foreseeable risks, stresses, and discomforts, and alternatives to participating in the research.
C ) There should also be a statement that describes procedures in place to ensure the confidentiality of data and anonymity of the participant.
D ) The informed consent document must also disclose what compensation and medical treatment are available in the case of a research-related injury.
E ) The document should make it clear whom to contact with questions about the research study, research subjects’ rights, and in case of injury.
2 - Understanding -
A ) The participant must understand what has been explained and must be given the opportunity to ask questions and have them answered by someone fully conversant in the study particulars.
B ) The informed consent document must be written in lay language, avoiding any technical jargon.
C ) The potential participant must be able to read and/or understand the language in which the consent form is written.
D ) Consent forms for multinational research must be translated into the respective language for each participating country and back-translated to verify accuracy.
3 - Voluntariness -
A ) The participant’s consent to participate in the research must be voluntary, free of any coercion or inflated promise of benefits from participation.
B ) Care should be taken that the consent form is administered by someone who does not hold authority over the participant.
C ) Ideally, the potential participant is given the opportunity to discuss their participation in the study with family, trusted friends, or their physician before reaching a decision.
4 - Competence -
A ) The participant must be competent to give consent.
B ) If the participant is not competent due to mental status, disease, or emergency, a designated surrogate may provide consent if it is in the participant’s best interest to participate.
C ) In certain emergency cases, consent may be waived due to the lack of competence of the participant and absence of an appropriate surrogate.
D ) In the event that there is a question about competence, mental status exams may be administered
5 - Consent -
A ) The potential human subject must authorize his/her participation in the research study, preferably in writing.
B ) If there is no need to collect personally identifiable information, and a signature on the consent form would be the only thing linking the subject to the study, an oral or implicit consent may be more appropriate.
C ) Children who cannot read or write should still signal their willingness to participate by an affirmative act (for example, nodding their head). Consent by minors is referred to as assent.
6 - Exculpatory language -
A ) No informed consent may contain any exculpatory language by which the participant waives any legal rights or releases the investigator or sponsor from liability for negligence.
ii) risks benefit assessment and
iii)selection of subjects of research
C ) ROLE OF PRIMARY CARE GIVER OR NURSES
1 Ensure the study is approved by an IRB
2 Get informed consent from the patient
3 Ensure that the patient understands the full extent of the experiment, and if not, will contact the study coordinator
4 Ensure the patient wasn’t coerced into doing the experiment by means of threatening or bullying
5 Be careful of other effects of the clinical trial that were not mentioned, and report it to the proper study coordinator
6 Support the privacy of the patients identity, their motivation to join or refuse the experiment.
7 Ensure that all patients at least get the minimal care needed for their condition
D ) ADD ONNS TO BASIC PRINCIPLES
Respect confidentiality and privacy - RIGHT TO PRIVACY
B ) ISSUES SPECIFIC TO PSYCHIATRY IN ETHICS
INTRODUCTION
A ) line of demarcation between normal and abnormal is hazy and easily questioned while giving treatment for psychiatry as -
1 Treatment made can be utilised for a certain need or interest
2 exploitation of the patient due to close relationship
3 Psychiatric patients being unaware of the reality and can give a blank cheque to the psychiatrist
GOALS OF PSYCHIATRIC ETHICS
1 deliver competent , compassionate and respectful care
2 deal honestly with patients
3 act within boundaries of law
4 respect the rights and autonomy of the patient
5 be responsible to the society
INCLUSIONS OR ISSUES OF PSYCHIATRIC RESEARCH
1 - PROFESSIONAL ETHICS
1 Like other purveyors of professional ethics, the World Psychiatric Association issues an ethical code to govern the conduct of psychiatrists.
2 The psychiatric code of ethics, first set forth through the Declaration of Hawaii in 1977, has been expanded through a 1983 Vienna update and, in 1996, the broader Madrid Declaration.
3 - The code was further revised during the organization’s general assembblies in 1999, 2002, 2005, and 2011.
4 - The World Psychiatric Association code covers such matters as -
A ) patient assessment
B ) up-to-date knowledge
C ) the human dignity of incapacitated patients
D ) confidentiality
E ) research ethics
F ) sex selection
G ) euthanasia
H ) organ transplantation
I ) torture
J ) the death penalty
K ) media relations
L ) genetics, and
M ) ethnic or cultural discrimination.
2 - ANTI PSYCHIATRY
A ) is a movement based on the view that psychiatric treatment is often more damaging than helpful to patients.
B ) It considers psychiatry a coercive instrument of oppression due to an unequal power relationship between doctor and patient and a highly subjective diagnostic process.
C ) Anti-psychiatry originates in an objection to what some view as dangerous treatments.
Examples include - electroconvulsive therapy, insulin shock therapy, and brain lobotomy.
D ) An immediate concern is the significant increase in prescribing psychiatric drugs for children.
E ) There were also concerns about mental health institutions.
F ) All modern societies permit involuntary treatment or involuntary commitment of mental patients.
3 - POLITICAL ABUSE OF PSYCHIATRY
A ) Psychiatrists around the world have been involved in the suppression of individual rights by states wherein the definitions of mental disease had been expanded to include political disobedience.
B ) Nowadays, in many countries, political prisoners are sometimes confined to mental institutions and abused therein
C ) Psychiatry possesses a built-in capacity for abuse which is greater than in other areas of medicine.
D ) The diagnosis of mental disease can serve as proxy for the designation of social dissidents, allowing the state to hold persons against their will and to insist upon therapies that work in favour of ideological conformity and in the broader interests of society
E ) In a monolithic state, psychiatry can be used to bypass standard legal procedures for establishing guilt or innocence and allow political incarceration without the ordinary odium attaching to such political trials.
for example -
A ) during the Nazi era and the Soviet rule when political dissenters were labeled as “mentally ill” and subjected to inhumane “treatments”.
B ) In the period from the 1960s up to 1986, abuse of psychiatry for political purposes was reported to be systematic in the Soviet Union, and occasional in other Eastern European countries such as Romania, Hungary, Czechoslovakia, and Yugoslavia.
C ) The practice of incarceration of political dissidents in psychiatric hospitals in Eastern Europe and the former USSR damaged the credibility of psychiatric practice in these states and entailed strong condemnation from the international community
D ) Political abuse of psychiatry also takes place in the People’s Republic of China.
E ) Psychiatric diagnoses such as the diagnosis of “sluggish schizophrenia” in political dissidents in the USSR were used for political purposes
4 - IMPLEMENTATION OF HUMAN RIGHTS
CODE FOR PSYCHIATRIC RESEARCH
Is based on NUREMBERG CODE
It is a set of research ethics principles for human experimental set
It includes -
A ) informed consent and absence of coerction
B ) properly formulated scientific experiments
C ) beneficience
PRINCIPLES OF PSYCHIATRIC ETHICS
1 Responsibility - a research should be well planned
2 Competency - a rearearcher should be highly competent , shouldnot violate the rule
3 Benevolence - a researcher first should think benefit of the society
4 Moral standards - to be responsible
5 Patient welfare
6 Confidentiality
A PATIENTS WELFARE SHOULD BE GIVEN SOLE IMPORTANCE WHILE DOING RESEARCH IN PSYCHIATRY