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ETHICAL ISSUES IN
PHYSIOTHERAPY RESEARCH
• ETHICS is derived from a greek word “ETHICOS” which
means custom.
• Ethics is the code written or unwritten that guides the
behaviour of human beings, in the context of different
cultures and situations, as moral code may vary from
society to society.
• The World Confederation of Physical Therapy in the year
2007 laid down the revised guidelines governing
physiotherapy practice as a whole which stated that –
1. A physical therapist must respect the rights and dignity
of all individuals.
2. A physical therapist must be commited to providing
quality service.
3. Physical therapist must accept responsibility for the
exercise of sound judgement.
4. Physical therapist must provide an honest, competent
and accountable professional service.
5. Physical therapist must comply with the laws and
regulations governing the practice of physical therapy in
the country in which they work.
6. Physical therapists must contribute to planning and
development of services which address the health needs
of the community.
7. Physical therapists must provide accurate information to
patients/ clients, other agencies and community about
physical therapy and about the services that physical
therapist provides.
8. Physical therapists are entitled to a just and fair
remuneration for their services.
ETHICS IN BIOMEDICAL RESEARCH INVOLVING
HUMANS
Ethical issues in research include the conduct of the
researcher in planning and execution of research and valuing
and protecting the subjects.
1. AUTONOMY –
• Autonomy refers to each person’s right to make an informed
decision about participation in the study.
• It ensures that informed consent is taken from the
participant by the investigator prior to the study.
• The investigator must ensure that the participant has
received full disclosure of nature of the study, the risks,
benefits and alternatives with an extended oppurtunity to ask
questions.
2. BENEFIENCE –
• It refers to the obligation on the researcher to ensure that the
participants gains maximum benefits of the study and to
reduce possible risk of harm to them.
3. JUSTICE –
• It ensures a fair selection of participants
For eg. – avoiding prisoners and institutionalized children,
mentally ill, aged, children, critically ill, dying, poor, with learning
disabilities, sedated, unconscious coerced into participation of
research.
• The investigator must ensure equal distribution of benefits and
burden on all participation population groups.
4. NON MALEFIENCE –
• The health provider must ensure that no harm is done to the best of
her knowledge to prevent any assault on integrity of the patient &
protect personal liberty.
• Discomfort and harm can be physiological, emotional, social and
economic in nature.
5. The researcher should maintain high levels of privacy and
confidentiality towards participant’s data,
6. No treatment should be withheld from any participant group,
7. The sample size must be decided according to the rationale of the
study, the area of research and with the use of statistical methods.
8. The researcher must take utmost care to avoid errors in
measurements and should use measures of high
reliability and validity.
9. Appropriate statistical procedure should be used and all
observed and measured data should be analyzed and
only true results should be reported.
10. PLAGIARISM –
• It ranges from unreferenced use of others’ published and
unpublished ideas, including research grant applications
to submission under “new” authorship of a complete
paper, sometimes in a different language.
• A researcher must disclose all sources of information,
and if large amount of other peoples’s written or
illustrative materials is to be used, permission must be
sought.
11. OVERLAPPING PUBLICATIONS -
• Refers to publication of paper that substantially overlaps with
one already published, without reference to previous
publications.
• Slicing of data from a single research process into different
pieces to artificially increase the publication volume.
• Transparent disclosure is important when submitting papers
to journals.
12. CONFLICTS OF INTEREST –
• This happens when researchers have interests that are not
fully apparent and that may influence their judgements on
what is published.
• These conflicts include personal, commercial, political,
academic or financial interests.
13. AUTHORSHIP –
Authorships is entitled based on the following criteria’s –
• Substantial contributions to conceptions of design of work,
acquisition, analysis or interpretation of data .
• Drafting the data or revising it critically.
• Final approval of version to be published.
• Agreement to be accountable for all aspects of work .
INFORMED CONSENT
• It is an indication of individual giving consent to voluntarily
participate in research after getting true information on
research, benefits/risks involved in the study.
• The information should be provided in the language and
method that potential subjects can understand.
• Components of informed consent are –
a) Disclosure of true information about the nature of the study, its
purpose as well as an explanation about the selection of research
subjects.
b) Strategy of management, adverse events, benefits, compensation.
c) Information regarding confidentiality
d) Compliance of researcher to answer queries of participant at any
time.
e) Non coersive disclaimer – which states that participation is
voluntary and no penalties are involved in refusal to participate,
freedom to withdraw must be explained.
f) Information regarding research publication.
INSTITUTIONAL ETHICS COMMITEE
• The need for institutional committee to review research
was appraised and regulations were made by World
medical Association at Helinski 1975.
• Institutional ethics committee (IEC) / Instituional review
board (IRB) should ensure to safeguard the welfare and
rights of human participants in biomedical research.
• The IEC should be multidisciplinary and multi dectorial
team which ensures the independency and competency of
the committee.
• The IEC should compromise of minimum 5
members –
a) Chairman
b) Medical scientist/expert
c) Other professions/clinicians
d) Legal expert
e) Ethicist/theologian
f) Lay person from community
REFERENCES
• Legal and ethical issues in research; Camille Yip
et al; Indian journal of anaesthesia; 2016.
• World confederation for Physical Therapy; 2007.
THANK YOU

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Ethics in Physiotherapy Research

  • 2. • ETHICS is derived from a greek word “ETHICOS” which means custom. • Ethics is the code written or unwritten that guides the behaviour of human beings, in the context of different cultures and situations, as moral code may vary from society to society. • The World Confederation of Physical Therapy in the year 2007 laid down the revised guidelines governing physiotherapy practice as a whole which stated that – 1. A physical therapist must respect the rights and dignity of all individuals. 2. A physical therapist must be commited to providing quality service. 3. Physical therapist must accept responsibility for the exercise of sound judgement.
  • 3. 4. Physical therapist must provide an honest, competent and accountable professional service. 5. Physical therapist must comply with the laws and regulations governing the practice of physical therapy in the country in which they work. 6. Physical therapists must contribute to planning and development of services which address the health needs of the community. 7. Physical therapists must provide accurate information to patients/ clients, other agencies and community about physical therapy and about the services that physical therapist provides. 8. Physical therapists are entitled to a just and fair remuneration for their services.
  • 4. ETHICS IN BIOMEDICAL RESEARCH INVOLVING HUMANS Ethical issues in research include the conduct of the researcher in planning and execution of research and valuing and protecting the subjects. 1. AUTONOMY – • Autonomy refers to each person’s right to make an informed decision about participation in the study. • It ensures that informed consent is taken from the participant by the investigator prior to the study. • The investigator must ensure that the participant has received full disclosure of nature of the study, the risks, benefits and alternatives with an extended oppurtunity to ask questions. 2. BENEFIENCE – • It refers to the obligation on the researcher to ensure that the participants gains maximum benefits of the study and to reduce possible risk of harm to them.
  • 5. 3. JUSTICE – • It ensures a fair selection of participants For eg. – avoiding prisoners and institutionalized children, mentally ill, aged, children, critically ill, dying, poor, with learning disabilities, sedated, unconscious coerced into participation of research. • The investigator must ensure equal distribution of benefits and burden on all participation population groups. 4. NON MALEFIENCE – • The health provider must ensure that no harm is done to the best of her knowledge to prevent any assault on integrity of the patient & protect personal liberty. • Discomfort and harm can be physiological, emotional, social and economic in nature. 5. The researcher should maintain high levels of privacy and confidentiality towards participant’s data, 6. No treatment should be withheld from any participant group, 7. The sample size must be decided according to the rationale of the study, the area of research and with the use of statistical methods.
  • 6. 8. The researcher must take utmost care to avoid errors in measurements and should use measures of high reliability and validity. 9. Appropriate statistical procedure should be used and all observed and measured data should be analyzed and only true results should be reported. 10. PLAGIARISM – • It ranges from unreferenced use of others’ published and unpublished ideas, including research grant applications to submission under “new” authorship of a complete paper, sometimes in a different language. • A researcher must disclose all sources of information, and if large amount of other peoples’s written or illustrative materials is to be used, permission must be sought.
  • 7. 11. OVERLAPPING PUBLICATIONS - • Refers to publication of paper that substantially overlaps with one already published, without reference to previous publications. • Slicing of data from a single research process into different pieces to artificially increase the publication volume. • Transparent disclosure is important when submitting papers to journals. 12. CONFLICTS OF INTEREST – • This happens when researchers have interests that are not fully apparent and that may influence their judgements on what is published. • These conflicts include personal, commercial, political, academic or financial interests. 13. AUTHORSHIP – Authorships is entitled based on the following criteria’s – • Substantial contributions to conceptions of design of work, acquisition, analysis or interpretation of data . • Drafting the data or revising it critically. • Final approval of version to be published. • Agreement to be accountable for all aspects of work .
  • 8. INFORMED CONSENT • It is an indication of individual giving consent to voluntarily participate in research after getting true information on research, benefits/risks involved in the study. • The information should be provided in the language and method that potential subjects can understand. • Components of informed consent are – a) Disclosure of true information about the nature of the study, its purpose as well as an explanation about the selection of research subjects. b) Strategy of management, adverse events, benefits, compensation. c) Information regarding confidentiality d) Compliance of researcher to answer queries of participant at any time. e) Non coersive disclaimer – which states that participation is voluntary and no penalties are involved in refusal to participate, freedom to withdraw must be explained. f) Information regarding research publication.
  • 9. INSTITUTIONAL ETHICS COMMITEE • The need for institutional committee to review research was appraised and regulations were made by World medical Association at Helinski 1975. • Institutional ethics committee (IEC) / Instituional review board (IRB) should ensure to safeguard the welfare and rights of human participants in biomedical research. • The IEC should be multidisciplinary and multi dectorial team which ensures the independency and competency of the committee.
  • 10. • The IEC should compromise of minimum 5 members – a) Chairman b) Medical scientist/expert c) Other professions/clinicians d) Legal expert e) Ethicist/theologian f) Lay person from community
  • 11. REFERENCES • Legal and ethical issues in research; Camille Yip et al; Indian journal of anaesthesia; 2016. • World confederation for Physical Therapy; 2007.