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2research Ethics
2research Ethics
DEFINITION
Definition
“Research ethics” refers to the moral principles that govern how
researchers should carry out their work.
Objectives of Research Ethics
• Paternalism
• ETHICAL PRINCIPLES ACORDING TO Belmont Report
• The Belmont Report identified three principles essential to the ethical
conduct of research with humans:
• Respect for persons
• Beneficence
• Justice
INFORMED CONSENT
• Informed consent requires that patients or subjects give permission
for treatment or testing, and that they be given adequate information
in order to make educated decisions about undergoing the treatment
or test.
• 4 components
• i- disclosure
• ii- comprehensions
• iii- voluntariness
• iv- competence
• Institute of Medicine’s Committee on assessing the system for
protecting Human Research Participants recommended in 2001
• “The informed consent process should be of an ongoing process……”
According to the APA, Informed Consent should include
Title of Study: Cross culture adaptation, reliability, and validity of Urdu version of Quebec Back Pain
Disability Scale.
Investigators:
Description of study: You are invited to participate in a research study being conducted by above mentioned
investigators. The purpose of this study is to translate and culturally adopt QBPDS to Urdu and to evaluate the
reliability and validity of Urdu version of QBPDS -Urdu. Your participation will involve of completing few
questionnaires. On the first day of study, maximum half an hour of your time will be required. During this
session, the researcher will answer any question you may have and if you are willing to take part, you will
then be asked to complete 3-4 questionnaires. After that you will be provided with the required treatment. On
the following visits maximum, 30 - 40 minutes of your time will be required for the treatment purposes only.
After three to four weeks, on the day of last treatment session you will be asked to complete few
questionnaires again.
Potential benefits: QBPDS was originally developed in English language. As the native language of the
people of Pakistan is Urdu, QBPDS-Urdu will help to provide better understanding of the questionnaire to
Urdu speaking people.
Risks and discomforts
There are no known risks associated with this research.
Protection of confidentiality
We will do everything we can to protect your privacy. All information that is collected about you during the course of
the research will be kept strictly confidential. Your personal information which might identify you will be removed in
data entry and analysis. Your identity will not be revealed in any publication resulting from this study.
Voluntary participation
Your participation in this research study is voluntary. You may choose not to participate, and you may withdraw your
consent to participate at any time. You will not be penalized in any way should you decide not to participate or to
withdraw from this study.
Contact information
If you have any question or concern about this study or if any problem arises, please contact;______________,
Islamabad College of Physiotherapy, Margalla Institute of Health Sciences, Quaid-e-Azam Avenue, Gulrez III,
Rawalpindi (Tel: 051-5509817 at, Ext: 827). If you have any question or concern about your rights as a research
participant, please contact the Ethical Review committee of the College.
Consent
I have read this consent form and have been given the opportunity to ask questions. I give my consent to
participate in this study.
Participants signature: _______________________________ Date: __________________
RESEARCH CODE OF ETHICS
• Numberg code developed in 1949 as a reaction to Nazi atrocities.
• World Medical Association’s Declaration of Helsinki developed in
1964.
• U.S. Department of Health & human services
RESEARCH RISK
• Physical Risk
• Psychological risk
• Social risk
• Economic risk
ultimate determinant rests
with researcher’s value
system and moral code