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CHAPTER 3
ETHICS IN NURSING RESEARCH
LEARNING OBJECTIVES
Describe the
concept of ethics
and bioethics
Enumerate the
historical
evolution of
ethical practices
in research
Discuss the code
of ethics in
research
Describe the
principals of
ethics in research
Discuss the
ethical dilemmas
in nursing
research.
LEARNING OBJECTIVES
Enlist the
various
elements of
informed
consent
Discuss the
role and
functions of
institutional
ethics
committee
Narrate the
ICMR ethical
guidelines for
biomedical
and health
research
CHAPTER OUTLINE
Concept of
ethics and
bioethics in
research Historical
evolution of
ethical
practices in
research
Code/principle
s of ethics
Informed
consent
Electronic
consent
Community
consent
Assent
CHAPTER OUTLINE
Consent of
institutionalize
people
Vulnerable
person
Ethical
dilemmas
Deception
Debriefing
Ethics
committee
ICMR ethical
guidelines for
biomedical and
health research.
MEANING OF ETHICS
Ethics is derived from the Greek word “ethos” meaning custom or character.
Rules that govern “right” conduct, what “ought to be”/right thing to do, the
“should” of human behavior.
ETHICS
It refers to the study of philosophical ideals of right and wrong behavior.
Ethics judges good, bad, right or wrong in human behavior.
BIOETHICS
It is ethics as applied to life (i.e. to life and death decision making). It is
concerned with human behavior in health care.
PROFESSIONAL CODE OF ETHICS
It is a set of collective statement about group’s expectations and standard of
behavior, and serves as guidelines to assist nurse and other health professional
groups when conflict or disagreement arises about correct practice or
behavior.
HISTORICAL EVOLUTION OF ETHICAL PRACTICES
IN RESEARCH
During 1942 and 1943, prisoners’ wounds were deliberately injected with
bacteria. Infection was aggravated due to forcing of wood shavings and ground
glass into the wounds. Sulfanilamide was then given to these prisoners to
determine effectiveness of this drug. Some subjects died and others suffered
serious injury.
Between June and September 1944, photographs and body measurements were
taken on 112 Jewish prisoners. Then, they were killed and their skeletons were de-
fleshed. One purpose of this study was to determine if photographs from live
human beings could be used to predict skeletal size. Widespread knowledge about
unethical research conducted in Germany was obtained immediately after World
War II. Shearer (1982) revealed some of the horrible experiments.
1.Infecting women prisoners with syphilis having them impregnated by male
prisoners, then dissecting the live babies and mothers.
2.Draining the blood from prisoners’ veins and substituting horse blood.
3.Exploding gas gangrene bombs next to prisoners tied to stakes.
During the 1960’s and 1970’s, a group of mentally retarded children
in Willowbrook, New York were deliberately exposed to infectious
hepatitis. In July 1963, doctors of New York injected live cancer cells
into 22 elderly patients. The study was designed to measure patients’
ability to reject foreign cells. The patients were told that they were
being given skin tests.
The present ethical standards used in nursing research, and in research
conducted by other disciplines are based on the guidelines that were
developed after world war-II. In 1947, Nuremberg code resulted from
the revelations of inhuman ethical behavior that occurred during the
war.
NUREMBERG CODE
Voluntary informed consent
Likelihood of some good result
Based on prior research (animal models)
Avoidance of physical or psychological injury
or harm
Benefits should outweigh risks
Proper experience of researcher
Right to withdraw consent
Research must stop if its results in harm
REQUIREMENT FOR HUMAN RESEARCH ETHICS
CLEARANCE
CODE OF ETHICS
Who needs to apply for human research ethics clearance?
Human research is “research which is conducted with or about people, or their data
or tissue”
Anybody wishing to conduct any research involving:
 Human participants
 Human tissue
 Personal records, or unpublished human research; must obtain ethics approval
before the research commences
TYPES OF HUMAN PARTICIPATION IN RESEARCH
As persons whose body organs or tissues are obtained and/or retained
for research.
As research participants from whom information is obtained.
As people who might be identified in official documents.
As people whose information (identified or de-identified) is part of an
existing, unpublished source.
ETHICAL PRINCIPLES (BELMONT REPORT)
I. RESPECT FOR HUMAN DIGNITY
It is the concept that all people deserve the right to fully exercise
their autonomy and assume that every individual is able to make a choice. It
comprises of two essential moral requirements:
a. Right for Autonomy (Self Determination)
An autonomous person is defined as an individual who is capable to make
judgments and actions based on his/her particular set of values, preferences,
and beliefs.
It also requires that subjects be treated in a non-degrading manner or out of
respect for their dignity. Respect for persons is practiced by doing followings
Obtaining informed consent
 Protecting the autonomy of all people
Treating them with courtesy and respect
b. The Right to Full Disclosure
Researchers must have fully disclosed information about the study and
explained the voluntary nature of participation (including the right to
refuse without repercussion) and possible benefits and risks related to
study participation. Without complete information, a potential
participant cannot make a truly informed decision. People have a right
to make informed, voluntary decisions about study participation which
requires full disclosure. Full disclosure can be troublesome for some
researchers based on their study designs and research questions
II. BENEFICENCE (ABOVE ALL, DOES NO HARM)
The philosophy of "Do no harm" while maximizing benefits for the research project and
minimizing risks to the research subjects. There are four aspects of beneficence i.e.
a. Freedom From Harm
Researchers may strive to minimize all types of physical, psychological, social and
economic harm and discomfort and achieve balance between potential benefits and risks
of being a participant.
b. Freedom From Exploitation
Involvement in a research study should not place participants at a disadvantage or expose
them to a situation for which they have not been prepared for. Assure participants that the
information provided by them will not be used against them in any way.
c. Benefits From Research
People agree to participate in research investigations for a number of reasons such as
direct personal benefits, benefits to society and other individuals or participate in desire to
be helpful. Researcher may communicate potential benefits to participants.
d. The Risk/Benefit Ratio
In designing a research study, carefully assess the risks and benefits that would be
incurred. In evaluating risk/benefit ratio researcher should consider how
comfortable he would feel if his family participated in the study.
III. PRINCIPLE OF JUSTICE
In research ethics, justice is the fair selection of research participants.
Justice is the ideal distribution of risks and benefits when scientists
conducting clinical research are recruiting volunteer research
participants to participate in study. In this, non-exploitative and well-
considered procedures are administered fairly — the fair distribution of
costs and benefits to potential research participants. There are two
aspects of justice i.e.
a. The Right to Fair Treatment
 Study participants have the right to fair and equitable treatment
before and during their participation in the study. Fair treatment
includes:
The fair and non-discriminatory selection of participants.
Respect for culture and other form of human diversity.
The non-prejudicial treatment of those who decline to participate or
who withdraw from the study after agreeing to participate.
b. The Right to Privacy
Researchers must keep any shared information in their strictest
confidence. Upholding the right to privacy often involves procedures for
anonymity or confidentiality. For participants’ data to be completely
anonymous means that the researcher cannot connect participant to their
data.
NATIONAL ETHICAL GUIDELINES (ICMR 2017)
 PRINCIPLE OF ESSENTIALITY
 PRINCIPLE OF VOLUNTARINESS
 PRINCIPLE OF NON-EXPLOITATION
 PRINCIPLE OF SOCIAL RESPONSIBILITY
 PRINCIPLE OF ENSURING PRIVACY AND CONFIDENTIALITY
 PRINCIPLE OF RISK MINIMIZATION
 PRINCIPLE OF PROFESSIONAL COMPETENCE
 PRINCIPLE OF MAXIMIZATION OF BENEFIT
 PRINCIPLE OF INSTITUTIONALARRANGEMENTS
 PRINCIPLE OF TRANSPARENCY AND ACCOUNTABILITY
 PRINCIPLE OF TOTALITY OF RESPONSIBILITY
 PRINCIPLE OF ENVIRONMENTAL PROTECTION
INFORMED CONSENT
It is a voluntary agreement to participate in research. It is not merely a form
that is signed but is a process, in which the subject has an understanding of
the research and its risks. Informed consent is essential before enrolling a
participant and ongoing once enrolled. The ethics code of the American
psychological association describes that the researcher should inform
participants about followings
1. The purpose of the research, expected duration and procedures.
2. Their right to decline to participate and to withdraw from the research
once participation has begun.
3. The expected consequences of declining or withdrawing.
4. Reasonably expected factors that may influence their willingness to
participate such as potential risks, discomfort or adverse effects.
5. Any prospective research benefits.
6. Limits of confidentiality.
7. Incentives for participation
ELEMENTS OF INFORMED CONSENT
RESEARCHERS CREDENTIALS
SUBJECT SELECTION PROCESS
PURPOSE OF THE STUDY
STUDY PROCEDURES
POTENTIAL RISKS
POTENTIAL BENEFITS
COMPENSATION IF ANY
ALTERNATIVE PROCEDURES
ANONYMITY OR CONFIDENTIALITY
OFFER TO ANSWER ALL QUESTIONS
MEANS OF OBTAINING STUDY RESULTS
DEVELOPING A CONSENT FORM
• Organize the consent form coherently.
• Use large font so that form is easily read, use spacing that
avoids making document too dense.
• Make form attractive.
• Use clear, consistent terminology and avoid technical terms.
• If possible, use a readability formula to estimate the form’s
reading level and make revisions to ensure an appropriate
reading level for the group under study.
• Test the form with people similar to those who will be
recruited and ask for feedback.
ELECTRONIC CONSENT
Electronic media can be used to provide information as in the written
informed consent document, which can be administered and documented
using electronic informed consent systems.
GATEKEEPERS CONSENT
Permission of the gatekeepers, that is, the head/leader of the group or
culturally appropriate authorities, may be obtained in writing or audio/video
recorded on behalf of the group and should be witnessed.
COMMUNITY CONSENT
In certain populations, the community plays an important role in the consent
process. Some participants may not participate in the research unless the
community’s consent is available. There may be situations when individual
consent cannot be obtained as it will change the behaviour of the individual.
In such situations community consent is required.
WAIVER OF CONSENT
The researcher can apply to the EC for a waiver of consent if the
research involves less than minimal risk to participants and the waiver
will not adversely affect the rights and welfare of the participants.
ASSENT
A child’s agreement to participate in research is called assent. In
addition to consent from parents or legal guardian, verbal/oral or written
assent, as approved by the ethical committee, should be obtained from
children of 7–18 years of age.
ETHICAL DILEMMAS IN CONDUCTING RESEARCH
An ethical dilemma is a problem in the decision-making
process between two possible ethical principles, neither of which is
absolutely acceptable from an ethical perspective. Ethical dilemmas are
extremely complicated challenges that cannot be easily solved.
Therefore, the ability to find the optimal solution for ethical dilemmas is
critical to researcher.
Ethical Dilemmas’ in Research
ETHICAL
DILEMMAS
Informed
consent
Beneficence
Aanonymity
and confidentia
lity
Respect for
privacy
Deception
Covert data
collection
HOW TO SOLVE AN ETHICAL DILEMMA
Following approaches can help to some extent to solve ethical dilemma.
Primary Consideration: decision on the basis of welfare of the
prospective study participants.
Value theory approach: Choose the alternative that offers the greater
good and the lesser harm.
Find alternative solutions: In some cases, the problem can be
reconsidered, and the new alternative solutions may arise.
Seek advice from institutional ethics committee:- Health care
institutions use an ethics committee to process dilemma. These
committees generally are multidisciplinary and include representatives
who are nurses as well as representatives from other disciplines.
DECEPTION
This is a process where participants are misled or wrongly informed about the aims of the
research. There are two possible types of deception include
1. Deliberate misleading, for example informing participants that the present study will
assess their health practices but the actual purpose of study is to assess the prevalence of
substance abuse..
2. Deception by omission, e.g., failure to disclose full information about the study, or
creating ambiguity.
The researcher should avoid deceiving participants about the nature of the research unless
there is no alternative and even then this would need to be judged acceptable by an
independent expert. However, there are some types of research that cannot be carried out
without at least some element of deception. Some researchers argue that deception can
never be justified and object to this practice as it
Violates an individual’s right to choose to participate.
It is a questionable basis on which to build a discipline.
 Leads to distrust of researcher in the community.
THE AMERICAN PSYCHOLOGICAL ASSOCIATION
PROVIDED STANDARDS GUIDELINE FOR USE OF
DECEPTION IS AS FOLLOW
Non-deceptive alternative procedures are not feasible:-
Researchers do not conduct a study involving deception unless they
have determined that the use of deceptive techniques is justified by the
study's significant prospective scientific, educational or applied value
and that effective non-deceptive alternative procedures are not
feasible.
No physical pain or severe emotional distress:- Researchers do not
deceive prospective participants about research that is reasonably
expected to cause physical pain or severe emotional distress.
Earliest disclosure of deception:- Researchers must disclose
deception to participants as early as is feasible, preferably at the
conclusion of their participation.
DEBRIEFING
Debriefing is a process that can be undertaken at the conclusion of any research
activities, regardless of whether deception is part of the research design. It is
appropriate to provide participants with a simple, clear, and informative
explanation of the research purpose and the methods that were used.
The APA outlines three basic requirements for debriefing:
 Researchers provide prompt and appropriate information about the nature, results,
and conclusions of the research, and correct misconceptions of participants.
 If scientific or humane values justify delaying or withholding this information,
researchers take reasonable measures to reduce the risk of harm.
 When research procedures have harmed a participant, researcher must take
reasonable steps to minimize the harm.
DEHOAXING
It is the process of convincing subjects who have been
deceived as part of a research study that they have in
fact been deceived. The purpose of dehoaxing is to
prevent possible future harm to the subject. For
example, subjects may be given false pretest scores in
order to test the effect of these scores on subsequent
tests of motivation levels. If subjects believe that the
false scores represent their true abilities, their level of
self-esteem would be high and put the person at risk.
ETHICS COMMITTEE
Research ethics committees have an important role to play in ensuring the
ethical standards and scientific merit of research involving human subjects.
There are three important obligations placed on the ethics committee.
1. Firstly and most importantly, the ethics committee must ensure that the
rights of research participants are protected. This is achieved by ensuring
that individuals receive sufficient information which can be easily
understood and ensuring that appropriate strategies are in place to protect
participants from potential adverse consequences of the research.
2. Secondly, the research ethics committee has an obligation to society which
provides the resources for research and will ultimately be affected by the
results.
Thirdly, the research ethics committee has an obligation to the
researcher. The research proposal should be treated with respect and
consideration. The research ethics committee should strive to meet each
of these obligations
COMPOSITION OF ETHICAL COMMITTEE
CHAIRPERSON/ VICE
CHAIRPERSON
NON-AFFILIATED A WELL-RESPECTED
PERSON FROM ANY
BACKGROUND WITH PRIOR
EXPERIENCE OF HAVING
SERVED/ SERVING IN AN EC
CONDUCT EC MEETINGS
Member Secretary Affiliated (Should be a staff
member of the institution)
Should have knowledge and
experience in clinical research and
ethics.
Schedule EC meetings, prepare the
agenda and minutes
Basic Medical Scientist(s) Affiliated/ non-affiliated Non-medical or medical person
with qualifications in basic medical
sciences
Scientific and ethical review with
special emphasis on the
intervention.
Clinician(s) Affiliated/ non-affiliated Individual/s with recognized
medical qualification, expertise
and training
Thorough review of protocol/
intervention.
Legal expert/s Affiliated/ non-affiliated Basic degree in Law from a
recognized university.
Interpret and inform EC members
about legal regulations.
SOCIAL
SCIENTIST/
PHILOSOPHER/
ETHICIST
AFFILIATED/
NON-
AFFILIATED
INDIVIDUAL
WITH SOCIAL/
BEHAVIOURAL
SCIENCE/
PHILOSOPHY/
RELIGIOUS
QUALIFICATION
ASSESS IMPACT
OF RESEARCH
PROPOSAL ON
COMMUNITY
INVOLVEMENT.
Lay person(s) Non-affiliated Literate person and
representative of the
community from
which the
participants are to be
drawn
Evaluate benefits and
risks from the
participant’s
perspective.
TYPE OF DECISION BY ETHICAL COMMITTEE
Approved with or
without
suggestions or
comments
Revision with
minor
modifications/
amendments
Revision with
major
modifications for
resubmission
Not approved
CHAPTER FOCUS POINTS
Ethics refers to the study of philosophical ideals of right and wrong
behavior. Ethics judges good, bad, right or wrong in human
behavior.The Belmont Report is one of the leading works concerning
ethics and health care research. Its primary purpose is to protect subjects
and participants in clinical trials or research studies. This report consists
of three principles: beneficence, justice, and respect for persons.
Minimal risk-as risk anticipated to be no greater than those ordinarily
encountered in daily life or during routine physical or psychological
tests. Principle of justice means the fair distribution of costs and benefits
to potential research participant and keep shared information in their
strictly confidential. ICMR in the year 2017 propose the National
Ethical Guidelines for Biomedical and Health Research Involving
Human Participants. Debriefing is a process that can be undertaken at
the conclusion of any research activities, regardless of the whether
deception is part of the research design.
CHAPTER-3-ETHICS-IN-NURSING-RESEARCH-Recovered (1).pptx

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CHAPTER-3-ETHICS-IN-NURSING-RESEARCH-Recovered (1).pptx

  • 1. CHAPTER 3 ETHICS IN NURSING RESEARCH
  • 2. LEARNING OBJECTIVES Describe the concept of ethics and bioethics Enumerate the historical evolution of ethical practices in research Discuss the code of ethics in research Describe the principals of ethics in research Discuss the ethical dilemmas in nursing research.
  • 3. LEARNING OBJECTIVES Enlist the various elements of informed consent Discuss the role and functions of institutional ethics committee Narrate the ICMR ethical guidelines for biomedical and health research
  • 4. CHAPTER OUTLINE Concept of ethics and bioethics in research Historical evolution of ethical practices in research Code/principle s of ethics Informed consent Electronic consent Community consent Assent
  • 6. MEANING OF ETHICS Ethics is derived from the Greek word “ethos” meaning custom or character. Rules that govern “right” conduct, what “ought to be”/right thing to do, the “should” of human behavior. ETHICS It refers to the study of philosophical ideals of right and wrong behavior. Ethics judges good, bad, right or wrong in human behavior. BIOETHICS It is ethics as applied to life (i.e. to life and death decision making). It is concerned with human behavior in health care. PROFESSIONAL CODE OF ETHICS It is a set of collective statement about group’s expectations and standard of behavior, and serves as guidelines to assist nurse and other health professional groups when conflict or disagreement arises about correct practice or behavior.
  • 7. HISTORICAL EVOLUTION OF ETHICAL PRACTICES IN RESEARCH During 1942 and 1943, prisoners’ wounds were deliberately injected with bacteria. Infection was aggravated due to forcing of wood shavings and ground glass into the wounds. Sulfanilamide was then given to these prisoners to determine effectiveness of this drug. Some subjects died and others suffered serious injury. Between June and September 1944, photographs and body measurements were taken on 112 Jewish prisoners. Then, they were killed and their skeletons were de- fleshed. One purpose of this study was to determine if photographs from live human beings could be used to predict skeletal size. Widespread knowledge about unethical research conducted in Germany was obtained immediately after World War II. Shearer (1982) revealed some of the horrible experiments. 1.Infecting women prisoners with syphilis having them impregnated by male prisoners, then dissecting the live babies and mothers. 2.Draining the blood from prisoners’ veins and substituting horse blood. 3.Exploding gas gangrene bombs next to prisoners tied to stakes.
  • 8. During the 1960’s and 1970’s, a group of mentally retarded children in Willowbrook, New York were deliberately exposed to infectious hepatitis. In July 1963, doctors of New York injected live cancer cells into 22 elderly patients. The study was designed to measure patients’ ability to reject foreign cells. The patients were told that they were being given skin tests. The present ethical standards used in nursing research, and in research conducted by other disciplines are based on the guidelines that were developed after world war-II. In 1947, Nuremberg code resulted from the revelations of inhuman ethical behavior that occurred during the war.
  • 9. NUREMBERG CODE Voluntary informed consent Likelihood of some good result Based on prior research (animal models) Avoidance of physical or psychological injury or harm Benefits should outweigh risks Proper experience of researcher Right to withdraw consent Research must stop if its results in harm
  • 10. REQUIREMENT FOR HUMAN RESEARCH ETHICS CLEARANCE CODE OF ETHICS Who needs to apply for human research ethics clearance? Human research is “research which is conducted with or about people, or their data or tissue” Anybody wishing to conduct any research involving:  Human participants  Human tissue  Personal records, or unpublished human research; must obtain ethics approval before the research commences
  • 11. TYPES OF HUMAN PARTICIPATION IN RESEARCH As persons whose body organs or tissues are obtained and/or retained for research. As research participants from whom information is obtained. As people who might be identified in official documents. As people whose information (identified or de-identified) is part of an existing, unpublished source.
  • 12. ETHICAL PRINCIPLES (BELMONT REPORT) I. RESPECT FOR HUMAN DIGNITY It is the concept that all people deserve the right to fully exercise their autonomy and assume that every individual is able to make a choice. It comprises of two essential moral requirements: a. Right for Autonomy (Self Determination) An autonomous person is defined as an individual who is capable to make judgments and actions based on his/her particular set of values, preferences, and beliefs. It also requires that subjects be treated in a non-degrading manner or out of respect for their dignity. Respect for persons is practiced by doing followings Obtaining informed consent  Protecting the autonomy of all people Treating them with courtesy and respect
  • 13. b. The Right to Full Disclosure Researchers must have fully disclosed information about the study and explained the voluntary nature of participation (including the right to refuse without repercussion) and possible benefits and risks related to study participation. Without complete information, a potential participant cannot make a truly informed decision. People have a right to make informed, voluntary decisions about study participation which requires full disclosure. Full disclosure can be troublesome for some researchers based on their study designs and research questions
  • 14. II. BENEFICENCE (ABOVE ALL, DOES NO HARM) The philosophy of "Do no harm" while maximizing benefits for the research project and minimizing risks to the research subjects. There are four aspects of beneficence i.e. a. Freedom From Harm Researchers may strive to minimize all types of physical, psychological, social and economic harm and discomfort and achieve balance between potential benefits and risks of being a participant. b. Freedom From Exploitation Involvement in a research study should not place participants at a disadvantage or expose them to a situation for which they have not been prepared for. Assure participants that the information provided by them will not be used against them in any way. c. Benefits From Research People agree to participate in research investigations for a number of reasons such as direct personal benefits, benefits to society and other individuals or participate in desire to be helpful. Researcher may communicate potential benefits to participants.
  • 15. d. The Risk/Benefit Ratio In designing a research study, carefully assess the risks and benefits that would be incurred. In evaluating risk/benefit ratio researcher should consider how comfortable he would feel if his family participated in the study.
  • 16. III. PRINCIPLE OF JUSTICE In research ethics, justice is the fair selection of research participants. Justice is the ideal distribution of risks and benefits when scientists conducting clinical research are recruiting volunteer research participants to participate in study. In this, non-exploitative and well- considered procedures are administered fairly — the fair distribution of costs and benefits to potential research participants. There are two aspects of justice i.e. a. The Right to Fair Treatment  Study participants have the right to fair and equitable treatment before and during their participation in the study. Fair treatment includes: The fair and non-discriminatory selection of participants. Respect for culture and other form of human diversity. The non-prejudicial treatment of those who decline to participate or who withdraw from the study after agreeing to participate.
  • 17. b. The Right to Privacy Researchers must keep any shared information in their strictest confidence. Upholding the right to privacy often involves procedures for anonymity or confidentiality. For participants’ data to be completely anonymous means that the researcher cannot connect participant to their data.
  • 18. NATIONAL ETHICAL GUIDELINES (ICMR 2017)  PRINCIPLE OF ESSENTIALITY  PRINCIPLE OF VOLUNTARINESS  PRINCIPLE OF NON-EXPLOITATION  PRINCIPLE OF SOCIAL RESPONSIBILITY  PRINCIPLE OF ENSURING PRIVACY AND CONFIDENTIALITY  PRINCIPLE OF RISK MINIMIZATION  PRINCIPLE OF PROFESSIONAL COMPETENCE  PRINCIPLE OF MAXIMIZATION OF BENEFIT  PRINCIPLE OF INSTITUTIONALARRANGEMENTS  PRINCIPLE OF TRANSPARENCY AND ACCOUNTABILITY  PRINCIPLE OF TOTALITY OF RESPONSIBILITY  PRINCIPLE OF ENVIRONMENTAL PROTECTION
  • 19. INFORMED CONSENT It is a voluntary agreement to participate in research. It is not merely a form that is signed but is a process, in which the subject has an understanding of the research and its risks. Informed consent is essential before enrolling a participant and ongoing once enrolled. The ethics code of the American psychological association describes that the researcher should inform participants about followings 1. The purpose of the research, expected duration and procedures. 2. Their right to decline to participate and to withdraw from the research once participation has begun. 3. The expected consequences of declining or withdrawing. 4. Reasonably expected factors that may influence their willingness to participate such as potential risks, discomfort or adverse effects. 5. Any prospective research benefits. 6. Limits of confidentiality. 7. Incentives for participation
  • 20. ELEMENTS OF INFORMED CONSENT RESEARCHERS CREDENTIALS SUBJECT SELECTION PROCESS PURPOSE OF THE STUDY STUDY PROCEDURES POTENTIAL RISKS POTENTIAL BENEFITS COMPENSATION IF ANY ALTERNATIVE PROCEDURES ANONYMITY OR CONFIDENTIALITY OFFER TO ANSWER ALL QUESTIONS MEANS OF OBTAINING STUDY RESULTS
  • 21. DEVELOPING A CONSENT FORM • Organize the consent form coherently. • Use large font so that form is easily read, use spacing that avoids making document too dense. • Make form attractive. • Use clear, consistent terminology and avoid technical terms. • If possible, use a readability formula to estimate the form’s reading level and make revisions to ensure an appropriate reading level for the group under study. • Test the form with people similar to those who will be recruited and ask for feedback.
  • 22. ELECTRONIC CONSENT Electronic media can be used to provide information as in the written informed consent document, which can be administered and documented using electronic informed consent systems. GATEKEEPERS CONSENT Permission of the gatekeepers, that is, the head/leader of the group or culturally appropriate authorities, may be obtained in writing or audio/video recorded on behalf of the group and should be witnessed. COMMUNITY CONSENT In certain populations, the community plays an important role in the consent process. Some participants may not participate in the research unless the community’s consent is available. There may be situations when individual consent cannot be obtained as it will change the behaviour of the individual. In such situations community consent is required.
  • 23. WAIVER OF CONSENT The researcher can apply to the EC for a waiver of consent if the research involves less than minimal risk to participants and the waiver will not adversely affect the rights and welfare of the participants. ASSENT A child’s agreement to participate in research is called assent. In addition to consent from parents or legal guardian, verbal/oral or written assent, as approved by the ethical committee, should be obtained from children of 7–18 years of age.
  • 24. ETHICAL DILEMMAS IN CONDUCTING RESEARCH An ethical dilemma is a problem in the decision-making process between two possible ethical principles, neither of which is absolutely acceptable from an ethical perspective. Ethical dilemmas are extremely complicated challenges that cannot be easily solved. Therefore, the ability to find the optimal solution for ethical dilemmas is critical to researcher.
  • 25. Ethical Dilemmas’ in Research ETHICAL DILEMMAS Informed consent Beneficence Aanonymity and confidentia lity Respect for privacy Deception Covert data collection
  • 26. HOW TO SOLVE AN ETHICAL DILEMMA Following approaches can help to some extent to solve ethical dilemma. Primary Consideration: decision on the basis of welfare of the prospective study participants. Value theory approach: Choose the alternative that offers the greater good and the lesser harm. Find alternative solutions: In some cases, the problem can be reconsidered, and the new alternative solutions may arise. Seek advice from institutional ethics committee:- Health care institutions use an ethics committee to process dilemma. These committees generally are multidisciplinary and include representatives who are nurses as well as representatives from other disciplines.
  • 27. DECEPTION This is a process where participants are misled or wrongly informed about the aims of the research. There are two possible types of deception include 1. Deliberate misleading, for example informing participants that the present study will assess their health practices but the actual purpose of study is to assess the prevalence of substance abuse.. 2. Deception by omission, e.g., failure to disclose full information about the study, or creating ambiguity. The researcher should avoid deceiving participants about the nature of the research unless there is no alternative and even then this would need to be judged acceptable by an independent expert. However, there are some types of research that cannot be carried out without at least some element of deception. Some researchers argue that deception can never be justified and object to this practice as it Violates an individual’s right to choose to participate. It is a questionable basis on which to build a discipline.  Leads to distrust of researcher in the community.
  • 28. THE AMERICAN PSYCHOLOGICAL ASSOCIATION PROVIDED STANDARDS GUIDELINE FOR USE OF DECEPTION IS AS FOLLOW Non-deceptive alternative procedures are not feasible:- Researchers do not conduct a study involving deception unless they have determined that the use of deceptive techniques is justified by the study's significant prospective scientific, educational or applied value and that effective non-deceptive alternative procedures are not feasible. No physical pain or severe emotional distress:- Researchers do not deceive prospective participants about research that is reasonably expected to cause physical pain or severe emotional distress. Earliest disclosure of deception:- Researchers must disclose deception to participants as early as is feasible, preferably at the conclusion of their participation.
  • 29. DEBRIEFING Debriefing is a process that can be undertaken at the conclusion of any research activities, regardless of whether deception is part of the research design. It is appropriate to provide participants with a simple, clear, and informative explanation of the research purpose and the methods that were used. The APA outlines three basic requirements for debriefing:  Researchers provide prompt and appropriate information about the nature, results, and conclusions of the research, and correct misconceptions of participants.  If scientific or humane values justify delaying or withholding this information, researchers take reasonable measures to reduce the risk of harm.  When research procedures have harmed a participant, researcher must take reasonable steps to minimize the harm.
  • 30. DEHOAXING It is the process of convincing subjects who have been deceived as part of a research study that they have in fact been deceived. The purpose of dehoaxing is to prevent possible future harm to the subject. For example, subjects may be given false pretest scores in order to test the effect of these scores on subsequent tests of motivation levels. If subjects believe that the false scores represent their true abilities, their level of self-esteem would be high and put the person at risk.
  • 31. ETHICS COMMITTEE Research ethics committees have an important role to play in ensuring the ethical standards and scientific merit of research involving human subjects. There are three important obligations placed on the ethics committee. 1. Firstly and most importantly, the ethics committee must ensure that the rights of research participants are protected. This is achieved by ensuring that individuals receive sufficient information which can be easily understood and ensuring that appropriate strategies are in place to protect participants from potential adverse consequences of the research. 2. Secondly, the research ethics committee has an obligation to society which provides the resources for research and will ultimately be affected by the results.
  • 32. Thirdly, the research ethics committee has an obligation to the researcher. The research proposal should be treated with respect and consideration. The research ethics committee should strive to meet each of these obligations
  • 33. COMPOSITION OF ETHICAL COMMITTEE CHAIRPERSON/ VICE CHAIRPERSON NON-AFFILIATED A WELL-RESPECTED PERSON FROM ANY BACKGROUND WITH PRIOR EXPERIENCE OF HAVING SERVED/ SERVING IN AN EC CONDUCT EC MEETINGS Member Secretary Affiliated (Should be a staff member of the institution) Should have knowledge and experience in clinical research and ethics. Schedule EC meetings, prepare the agenda and minutes Basic Medical Scientist(s) Affiliated/ non-affiliated Non-medical or medical person with qualifications in basic medical sciences Scientific and ethical review with special emphasis on the intervention. Clinician(s) Affiliated/ non-affiliated Individual/s with recognized medical qualification, expertise and training Thorough review of protocol/ intervention. Legal expert/s Affiliated/ non-affiliated Basic degree in Law from a recognized university. Interpret and inform EC members about legal regulations.
  • 34. SOCIAL SCIENTIST/ PHILOSOPHER/ ETHICIST AFFILIATED/ NON- AFFILIATED INDIVIDUAL WITH SOCIAL/ BEHAVIOURAL SCIENCE/ PHILOSOPHY/ RELIGIOUS QUALIFICATION ASSESS IMPACT OF RESEARCH PROPOSAL ON COMMUNITY INVOLVEMENT. Lay person(s) Non-affiliated Literate person and representative of the community from which the participants are to be drawn Evaluate benefits and risks from the participant’s perspective.
  • 35. TYPE OF DECISION BY ETHICAL COMMITTEE Approved with or without suggestions or comments Revision with minor modifications/ amendments Revision with major modifications for resubmission Not approved
  • 36. CHAPTER FOCUS POINTS Ethics refers to the study of philosophical ideals of right and wrong behavior. Ethics judges good, bad, right or wrong in human behavior.The Belmont Report is one of the leading works concerning ethics and health care research. Its primary purpose is to protect subjects and participants in clinical trials or research studies. This report consists of three principles: beneficence, justice, and respect for persons. Minimal risk-as risk anticipated to be no greater than those ordinarily encountered in daily life or during routine physical or psychological tests. Principle of justice means the fair distribution of costs and benefits to potential research participant and keep shared information in their strictly confidential. ICMR in the year 2017 propose the National Ethical Guidelines for Biomedical and Health Research Involving Human Participants. Debriefing is a process that can be undertaken at the conclusion of any research activities, regardless of the whether deception is part of the research design.