Ethical Issues inInternational

ResearchResearch

Daniel R. Vasgird, PhD, CIPOffi f R h I i & C liOffice of Research Integrity & ComplianceWest Virginia UniversityEmail: drvasgird@mail.wvu.eduEmail: drvasgird@mail.wvu.eduWebsite: http://oric.research.wvu.edu

October 18, 2010,

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R b K MRobert K. Merton

Stated that the disinterested pursuit of truth is the norm of science expressed as:science, expressed as:

UniversalismlCommunalism

DisinterestednessOrganized skepticismOrganized skepticism

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Mil F i dMilton Friedman

Stated that the limits of the social responsibility of industrial

ti “t k h corporations are “to make as much money for their stockholders as possible”.p

What does this mean for science id i th l f i t considering the scale of private

research funding these days?

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C f A bi iConsequences of Ambition

Perseverance and success,

but increased:but increased:

1. Risk for unintentional bias2. Willingness to cut corners3. Willingness to commit serious

dmisconduct

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EmpathyEmpathy

“The first step in the evolution of ethics is a sense of solidarity with other human beings.”

Albert Schweitzer

“Ethics primarily concerns the effects of our actions on others.”

Randy Cohen

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“Managing ExternallyF d d R h P Funded Research Programs:

…Effective Management Practices”COGR-COGR

Research integrity is now listed as a b i i i l f lit basic principle of quality management, emphasizing that it is no longer enough for administrators no longer enough for administrators to presume that it is beingattended to informallyattended to informally.

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RCR Core AreasRCR Core Areas

• Human Research Protections • Human Research Protections • Research Protections for Animals• Research MisconductResearch Misconduct• Conflict of Interest and

Commitment • Mentor/trainee Relationships• Responsible Authorship

Peer Review• Peer Review• Data Management, Sharing and

Ownership Ownership • Collaborative Science

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Jesse GelsingerJesse Gelsinger

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National Academy of S iSciences

To maintain (public) confidence and trust in this (the scientific) and trust in this (the scientific) enterprise, researchers must protect the empirical objectivity of protect the empirical objectivity of research, the unbiased reportingof results and the open sharing of of results and the open sharing of that information for the good of societysociety.

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I t ti l R h EthiInternational Research Ethics

The term “international research” The term international research generally refers to research conducted in developing countries by conducted in developing countries by researchers and sponsors from industrialized countries.

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International Research Ethics

Only recently has international Only recently has international research ethics begun to receive the benefit of widespread public benefit of widespread public discourse and debate

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International Research

Traditionally, industrialized countries set the research agenda and carry set the research agenda and carry out research in developing countries.

Research conducted in developing countries is increasingly becoming a

ll b ti ff t b t collaborative effort between industrialized and developing countries.

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countries.

International Research Ethics

Fundamental ethical questions arise due in large part to the global due, in large part, to the global imbalance of power and huge disparities in wealth and access to health care between developing host health care between developing host countries and industrialized countries that either conduct or sponsor researchresearch.

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International Research Ethics

In addition to economic-related conditions historical cultural conditions, historical, cultural, political, or legal factors that exist in a particular community or country

t ib t t th diffi lti f can contribute to the difficulties of conducting research in developing countries.

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Fundamental Premises of Conducting u da e ta e ses o Co duct gResearch in Developing Countries

#1- Research conducted by researchers and sponsors from researchers and sponsors from industrialized countries in developing countries should be responsive to the health needs and priorities of the health needs and priorities of the population on which it is conducted. But what does it mean to be “responsive?”

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Fundamental Premises of Conducting Research in Developing Countries

#2 - It is unethical to exploit vulnerable populations or individual vulnerable populations or individual participants in the conduct of research. But what constitutes research. But what constitutes exploitation?

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Fundamental Premises of Conducting Research in Developing Countries

#3 It is unacceptable to lower the #3 - It is unacceptable to lower the ethical standards adopted in the industrialized world when carrying out y gresearch in developing countries. But is a different standard necessarily a lower standard?standard?

It certainly can be in some cases such It certainly can be in some cases such as the use of prisoners in research in some developing countries. Could

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never be done in this country.

Awareness of the Context in which the Research will be Conducted

Certain beliefs and values that exist in developing countries may conflict p g ywith fundamental ethical principles.

There are 2 areas that should give one pause in that regard: informed consent and prior ethical review.

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Informed Consent

Research conducted in developing countries presents unique challenges during the informed consent process.

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Informed Consent

Literacy rates

Language barriers unrelated to literacyliteracy

Belief systemsBelief systems

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Informed Consent

Withholding key informationWithholding key information

Same problem where there is Same problem where there is absolute trust in the physician to make decisions for patientsmake decisions for patients

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Informed Consent

Significance given to “signing” a consent formconsent form

Need for translators, not just , jstraightforward interpreters

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Informed Consent

Ethical concerns may arise in Ethical concerns may arise in developing countries where family or community members traditionally are y yinvolved in the consent process.

Cultural accommodations should be made. In no case, however, should the permission of a family member or the permission of a family member or tribal or community leader serve as a substitute for individual voluntary i f d t

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informed consent.

Informed Consent

Requirement of voluntariness is Requirement of voluntariness is particularly troublesome in research conducted in developing countries. p g

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Informed Consent

A related concern about voluntariness arises when research voluntariness arises when research subjects are recruited from developing country populations that are considered to be especially are considered to be especially vulnerable.

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Ethnographic Research

In a nutshell researchers must make their In a nutshell, researchers must make their research goals clear to the members of the community where they undertake their research and gain the informed consent of research and gain the informed consent of their consultants to the research beforehand. It is also important to learn whether the group would prefer to be named in the written report would prefer to be named in the written report of the research or given a pseudonym and to offer the results of the research if informants would like to read it Most of all researchers would like to read it. Most of all, researchers must be sure that the research does not harm or exploit those among whom the research is done

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done.

http://www.aaanet.org/committees/ethics/ethics.htm

Prior Ethics Committee Review

In international research, prior In international research, prior review of research can occur:- In the sponsor’s home country;- In the host country (local review); or

I i b th t i- In many cases, in both countries.

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Prior Ethics Committee Review

It is generally agreed that there is a need to help build the capacity of developing countries to conduct thi l i f hethical review of research.

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New and Important Issues in International Research Ethics

o Three new and important issues in international research ethics:- Post-trial benefits- Capacity building- Community consultation

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Post-Trial Benefits

Until recently, little attention has been paid to the provision of benefits to research subjects and host

iti d t i ft communities and countries after a study is completed.

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Post-Trial Benefits

When research is conducted in developing countries, the huge p g , gdisparity in power between rich and poor nations manifests itself in two waysways.

(1) In most cases the industrialized (1) In most cases, the industrialized world sets the research agenda and carries out the research. A gradual h i id t h

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change is evident however.

Post-Trial Benefits

(2) Typically, the industrialized world receives the great majority of research benefits, but assumes very research benefits, but assumes very few of its burdens.

Th bli i id i l The obligation to provide post-trial benefits is based upon distributive justice.j

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Post-Trial Benefits: Biomedical Research

Post-trial benefits for subjects are most Post-trial benefits for subjects are most typically an experimental intervention proven effective by the study but may also take the following forms:also take the following forms:- Effective interventions; - Technology transfer (e.g., license to Technology transfer (e.g., license to

manufacture a drug); - Health services (e.g., maintenance of

a primary care clinic); a primary care clinic); - Capacity building (applicable to most

types of research); and

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yp );- Researcher commitments.

Post-Trial Benefits

S t f t t i l bli ti i f d Support for post-trial obligations is found in a number of international and national research ethics documents (biomedical). research ethics documents (biomedical).

Even among those who agree that such g gan obligation exists, there is sharp disagreement about its nature and scope.

New issue in international research called a “Prior Agreement ”

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a Prior Agreement.

Capacity Building

There is a need for researchers and sponsors from developed countries to sponsors from developed countries to help build the capacity of developing host countries for (1) designing and conducting research; (2) scientific conducting research; (2) scientific and ethical review of research; and (3) implementing the results of research after the study is research after the study is completed.

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Capacity Building

Capacity building objectives should be consistent with the expectations pof subjects and communities.Examples: transfer of scientific knowledge and skills; provision of research facilities and equipment; d l t f thi i development of ethics review capacity.

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Community Consultation

Consultation means that in some fashion the community role in fashion the community role in research goes beyond simple participation such that community participation such that community interests are discussed within the framework of the research project.

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Community Consultation

Designed to respect the culture and dignity of the community and achieve its full understanding and acceptance its full understanding and acceptance of the research.

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Community Consultation

h b d ff l d f hThere may be difficulty in defining the community for purposes of research.P i i ll i t t i Process is especially important in research, such as genetic research, that may present risks to villages may present risks to villages, communities, or racially or ethnically defined groups, particularly with regard g p , p y gto the publication of research results or the identification of the group or place in

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which research was conducted.

“Progress depends on extending our imaginative extending our imaginative

range, identifying with th h those who are

unnecessarily suffering.”

George Scialabba

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“One is apt to think of mo al fail e as d e to moral failure as due to weakness of character:

more often it is due to an inadequate ideal.”q

Richard Livingstone

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