Mulusew Andualem Ethics in Health Research
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Transcript of Mulusew Andualem Ethics in Health Research
Ethics in Health Research
By
Mulusew Andualem (BSc, MPH):
A research consultant and Research advisor
February 2015
1 Mulusew Andualem: College of Medicine & Health Sciences,
Bahir Dar University, Ethiopia
Overview of lecture
1. Introduction
2. Principles of Ethics in Health Research
3. Ethics Codes, guidelines and regulations
2 Mulusew Andualem: College of Medicine & Health Sciences,
Bahir Dar University, Ethiopia
References1. Richard A. Cash and Tracy L. Rabin. Overview of Ethical Issues in Collecting Data in
Developing countries, with Special Reference to Longitudinal Designs. Leveraging Longitudinal Data in Developing Countries: Report of a Workshop 2002.
2. Bonnie Steinbock, Alex John London, John D.Arras. Ethical issues in Modern Medicine,2008.ISBN:0073407356/9780073407357
3. Hirotsugu Aiga. Bombarding people with questions: a reconsideration of survey ethics. Bull World Health Organ 2007; 85:823.
4. Zulfiqar Ahamed Bhutta. Ethics in international health Research: a perspective from the developing world. Bull World Health Organ 2002; 80:114-120.
5. Ethiopian Science and Technology Commission in Collaboration with the Ethiopian Public Health Association and Regional State Health Bureaus. Health Research Ethics Training Module 4, Addis Ababa Ethiopia2005.
6. Ethiopian Science and Technology Commission. National Health Sciences and Technology council. Health Department. National Health Research Ethics Review Guideline.4 th Edition Revised, Addis Ababa Ethiopia 2005
7. Ethical Principles and Guidelines for the protection of human subjects of research. The Belmont Report. The National Commission for the Protection of Hunan Subjects of Biomedical and Behavioral Research 1979
3Mulusew Andualem; College of Medicine & Health Sciences,
Bahir Dar University, Ethiopia
1.Introduction
There are wide inequalities in burden of disease and health outcomes between the developed and developing countries
Health research plays a pivotal role in addressing these inequities in health and human development, but to achieve these objectives the research must be based on sound scientific and ethical principles
4 Mulusew Andualem; College of Medicine & Health Sciences,
Bahir Dar University, Ethiopia
What is Research?
A systematic collection, analysis and interpretation of
data to solve a problem
Systematic investigation designed to produce
generalizable knowledge
Can be applied to other populations
Published and disseminated
5 Mulusew Andualem: College of Medicine & Health
Sciences, Bahir Dar University, Ethiopia
What is Research?
Research has contributed immensely to human progress and to the development of modern society
Scientific knowledge generated through research is powerful tool for solving challenges humanity
Food security to diseases such as AIDS, pollution to the proliferation of weapons
Recent advances in information technology, genetics and biotechnology hold extraordinary prospects for individual well-being and humankind as a whole
6 Mulusew Andualem: College of Medicine & Health Sciences,
Bahir Dar University, Ethiopia
What is Research? In developed countries research :
Search for new knowledgeAdvancement of theoretical formulations Development of new inventions and innovation
In developing countries research perceived Luxury done only when a country becomes more developed and
has extra resources Many of the world’s most serious problems have a impact on
developing countries, such as in sub-Saharan Africa
7 Mulusew Andualem: College of Medicine & Health Sciences,
Bahir Dar University, Ethiopia
Ethics and Science The paradox: To be ethical, the investigator must treat his/her
subjects as autonomous persons, possessed of free will and an impressive set of moral rights
To be professional, the investigator must treat his/her subjects as scientific objects, subject to the laws of nature and the impersonal rules of cause and effect.
8 Mulusew Andualem: College of Medicine & Health Sciences,
Bahir Dar University, Ethiopia
Participants of Research
Living individuals from whom the researcher may obtain:
• Data through interaction or intervention.
• Identifiable private information
9 Mulusew Andualem: College of Medicine & Health Sciences,
Bahir Dar University, Ethiopia
What is Informed Consent? A formal approach of inviting a person to participate in a
research undertaking
Is consent given by a competent individual whoHas received necessary informationAdequately understood itConsidered itArrived at a decision without coercion, undue influence, inducement or intimidation
Who precisely is consenting to participation?The community , household, or individuals?
10 Mulusew Andualem: College of Medicine & Health Sciences,
Bahir Dar University, Ethiopia
Informed consent (cont.)
Informed consent of the second party: Is it ethical for a male head of household to consent for his
entire family to participate in research? Would choosing household over individual consent express
cultural sensitivity or “ethical double standards”?
Is it ethical for Consenting husband for a women? In no case a competent adult woman be enrolled in research
solely upon the consent of another person. But , IRB may accept a consent process:
If it is impossible to conduct the research without obtaining supplemental permission
If failure to conduct the research would deny benefits to women
11 Mulusew Andualem: College of Medicine & Health Sciences, Bahir Dar University, Ethiopia
Informed Consent - elements
Research description
Benefits
Alternative
Confidentiality Compensation
Voluntary participation
Withdrawal Contact
Documentation of informed consent
12 Mulusew Andualem: College of Medicine & Health Sciences, Bahir Dar University, Ethiopia
2.Fundamental Principles of Ethics in Health Research
Universally accepted principles to guide researchers in
their selection and treatment of human subjects are :
1. Respect for persons
2. Beneficence
3. Justice
Universal regardless of geographic, economic, legal and
political boundaries
13 Mulusew Andualem: College of Medicine & Health Sciences, Bahir Dar University, Ethiopia
Respect for Personsa) Respect for autonomy: respect for their capacity for self-
determination.
b) Protection of persons with impaired or diminished autonomy.
Autonomy ?= self determination
Diminished autonomy ?= Vulnerable groups So it is the researcher’s responsibility to
systematically assess capacity to consent prior to and during the research activity.
14 Mulusew Andualem: College of Medicine & Health Sciences,
Bahir Dar University, Ethiopia
Respect for Persons: considerations
Informed consent
• Comprehensive Information
• Appropriate Language
• Individual autonomy and locus of decisional authority
Individual vs Community
Selective disclosure
Inducement to participation
15 Mulusew Andualem: College of Medicine & Health Sciences,
Bahir Dar University, Ethiopia
Confidentiality
Personal identifiers
• ID variables
Communities identifiers
• Geocoding and GIS data
16 Mulusew Andualem: College of Medicine & Health Sciences, Bahir
Dar University, Ethiopia
Beneficence Persons are treated not only by respecting their decisions and
protecting them from harm, but also by making efforts to secure their well-being (physical, mental and social as related to the study)
Beneficence is an obligation and not just as acts of kindness
/charity Protection of the well-being of the participant is the primary
responsibility of the study team. Weigh risks Vs benefits
Physical, mental and social well-being Risk reduction to a minimum Protection of participants 17
Mulusew Andualem: College of Medicine & Health Sciences, Bahir Dar University, Ethiopia
Maximizing benefits
Communication of study results
Provision of health care
Training of local health staff
‘Fair Benefit’ framework
18 Mulusew Andualem: College of Medicine & Health Sciences,
Bahir Dar University, Ethiopia
Minimizing harm Careful use of local health resources and respect for
local priorities Avoid stigmatization, prejudice, economic loss …
Prepare local research staff for special situations Propose measures against eminent risks observed during the study Avoid harmful publicity
Respect local social and cultural norms Confidentiality Disclosure of conflict of interest
19 Mulusew Andualem: College of Medicine & Health Sciences, Bahir Dar University, Ethiopia
Justice Distribution of risk and benefits
Equitable recruitment of participants
Protection of vulnerable groups
The principle of justice forbids placing one group of
people at risk solely for the benefit of another
20 Mulusew Andualem: College of Medicine & Health Sciences,
Bahir Dar University, Ethiopia
Justice: considerations
Equity in selection of subjects
Exclusions must be justifiable: it is unjust to
deprive groups of persons the benefit of research
Ensure access to the benefits of the research to the
research community, particularly when no superior or
equivalent approaches to therapy are available.
Institutionalization: Sustainability21
Mulusew Andualem: College of Medicine & Health Sciences, Bahir Dar University, Ethiopia
Justice(cont.) Over crowding of research project
Overcrowded community: Community fatigue
“A survey, again? You are the third survey team who visited us during these couple of months. I am fed up with ...”
May result in duplication of efforts
Over accumulation of analyzed data
22 Mulusew Andualem: College of Medicine & Health Sciences,
Bahir Dar University, Ethiopia
Group work and Presentation
23 Mulusew Andualem: College of Medicine & Health Sciences,
Bahir Dar University, Ethiopia
3.Ethics Codes, guidelines and regulations
Nuremberg code
Declaration of Helsinki
Belmont report
Common rule
CIOMS
International conference on Harmonization
National Bioethics Advisory Committee
24 Mulusew Andualem: College of Medicine & Health Sciences,
Bahir Dar University, Ethiopia
Changing International Guidelines
1947, the Nuremberg Code
1964, The Declaration of Helsinki (World Medical Association) …revised in 1975, 1983, 1989, 1996, 2000, 2002
1991, International Guidelines for Ethical Review of Epidemiological Studies [Council for International
Organizations of Medical Sciences(CIOMS)]
1993, International Ethical Guidelines for Biomedical Research Involving Human Subjects (CIOMS) … revised in 2002
25 Mulusew Andualem: College of Medicine & Health Sciences,
Bahir Dar University, Ethiopia
Nuremberg Code
Emphasized on:
Informed consent
Qualified researchers
Appropriate design
Weigh risk against benefit
Free to stop at anytime
26 Mulusew Andualem: College of Medicine & Health
Sciences, Bahir Dar University, Ethiopia
Helsinki Declaration Emphasized on:
Wellbeing of subject takes precedence over interests of science
and society
Consent in writing
Limited use of placebo
Greater access to benefit
Use caution if participant is in dependent relationship to
researcher
27 Mulusew Andualem: College of Medicine & Health Sciences,
Bahir Dar University, Ethiopia
Common Rule Approved by Ethics committee
Written informed consent and documentation
Equitable recruitment of participants
Special protection of vulnerable groups
Continuing review of approved research
28 Mulusew Andualem: College of Medicine & Health Sciences,
Bahir Dar University, Ethiopia
CIOMS (Council for International Organization of medical Science) guidelines
Emphasis on:
Informed consent
Protection of vulnerable groups
Distributions of burdens and benefits
Role of Ethics committee
Research in developing countries
29 Mulusew Andualem: College of Medicine & Health Sciences,
Bahir Dar University, Ethiopia
Common to all
Fundamental principles : respect , Beneficence and justice.
Research is a privilege not a right
Well being of participant is paramount
30 Mulusew Andualem: College of Medicine & Health Sciences,
Bahir Dar University, Ethiopia
Some Reasons for Frequent Revisions HIV/AIDS pandemic; large-scale trials of vaccine and
treatment drugs
Rapid advances in medicine and biotechnology Changing research practices such as multinational field
trials.
Experimentation involving vulnerable population groups Involvement of populations in developing countries in
human experimentation
31 Mulusew Andualem: College of Medicine & Health Sciences,
Bahir Dar University, Ethiopia
Source: Addis continental institute of public health, Ethiopia.
32 Mulusew Andualem: College of Medicine & Health Sciences,
Bahir Dar University, Ethiopia
Researchers’ Responsibilities
Protection of human participants
Conduct research according to protocol
Compliance with Ethics Committee requirements
Post study : long term interest of participants
33 Mulusew Andualem: College of Medicine & Health Sciences,
Bahir Dar University, Ethiopia
Sponsors’ Responsibility
Ensure appropriate review, approval and supervision
Monitor research
Select qualified researchers
Provide policies and procedures
Comply with local ethical requirements
Ensure local relevance of research
Provide research integrity
34 Mulusew Andualem: College of Medicine & Health Sciences,
Bahir Dar University, Ethiopia
Respect for persons, Beneficence and Justice
35 Mulusew Andualem: College of Medicine & Health Sciences,
Bahir Dar University, Ethiopia
Thank you !
36 Mulusew Andualem: College of Medicine & Health Sciences,
Bahir Dar University, Ethiopia