Mulusew andualem ethics in health research

Ethics in Health Research

By

Mulusew Andualem Asemahagn (BSc, MPH):

A research consultant and Research Advisor at the

College of Medicine and Health Sciences, Bahir Dar University,

Ethiopia

February 2015

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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,


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,


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



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



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.



Participants of Research

Living individuals from whom the researcher may obtain:

• Data through interaction or intervention.

• Identifiable private information



A formal approach of inviting a person to participate in a research undertaking

It is an agreement b/t researcher & study participants to use data only for the stated objectives by keeping confidentiality

Is consent given by a competent individual whoo Has received necessary informationo Adequately understood ito Considered ito Arrived at a decision without coercion, undueo Influence, inducement or intimidation

Who precisely is consenting to participation?o The community , household, or individuals?

10 Mulusew Andualem: College of Medicine & Health Sciences, BDU, Ethiopia

What is Informed Consent?

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 statment


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. Beneficence3. Justice

Universal regardless of geographic, economic, legal and

political boundaries


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.



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



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


Maximizing benefits Communication of study results

Provision of health care

Training of local health staff

‘Fair Benefit’ framework



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


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



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


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



Group work and Presentation



3.Ethics Codes, guidelines and regulations Nuremberg code

Declaration of Helsinki

Belmont report

Common rule

CIOMS

International conference on Harmonization

National Bioethics Advisory Committee



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



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



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



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



Common to all

Fundamental principles : respect , Beneficence and justice.

Research is a privilege not a right

Well being of participant is paramount



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



Source: Addis continental institute of public health, Ethiopia.



Researchers’ Responsibilities

Protection of human participants

Conduct research according to protocol

Compliance with Ethics Committee requirements

Post study : long term interest of participants



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



Respect for persons, Beneficence and Justice



Thank you !



Mulusew andualem ethics in health research

Health & Medicine