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Abstract of the full paper

Over the past 5 years, several epidemiology organizations have

published draft ethics guidelines for epidemiologists in general,

without regard to sub-specialty. In this paper, we have reviewed

these various guidelines. We have extracted the most salient of the

principles from these guidelines and consolidated them into a unified

set of ethics guidelines for environmental epidemiologists. Those

guidelines found most relevant to environmental epidemiology are

those from the Industrial Epidemiology Forum and those from the 1994

Ethics Workshop jointly organized by the International Society for

Environmental Epidemiology (ISEE) and the World Health Organization

(WHO). From these, core values for those specializing in the field of

environmental epidemiology are presented. It is to these core values

that the guidelines relate. Additional areas of concern to

environmental epidemiologists are noted that guidelines have yet to

address. It is emphasized that guidelines require ongoing input from

members of the profession and hence are expected to be revised

periodically. A discussion of the role and importance of ethics

guidelines to environmental epidemiologists within their individual

practices, as they relate to one another as colleagues, and as they

relate to society at large is included as a preface to the guidelines

themselves.

4.2.5. *Community involvement

Discussions should be initiated at international, national and

regional levels to facilitate community involvement and resolution of

issues in environmental epidemiology practice. Such issues include,

for example, genetic monitoring, markers of exposure, physiological

changes of uncertain biological significance, potential for

conflicting interests in the framing of research questions through

dissemination of results, and the use of biological banks and

historical datasets, issues so fundamental to much of environmental

epidemiology. A project steering committee made up of representatives

of all stakeholder groups is suggested as one mechanism for

addressing these kinds of issues.

Research involving a community ought to include from the inception,

or certainly prior to the formal design stage, through to completion

of the study, community representatives (a) knowledgeable about the

science (e.g. union and health representatives) and ( affected by

the problem being investigated (e.g. community stakeholders and also

the unempowered). The Institutional Review Board, or its equivalent

in different countries (e.g. in the European Union: Research Ethics

Committee; in Canada: Research Ethics Board) likely will include lay

community representatives. However, the researcher's task is to

ensure that community input through the entire research process, from

conception of the question to hypothesis formulation, methods

selection, analysis, interpretation and dissemination is included in

a partnership capacity with the principal investigator.

Ethics Guidelines for Environmental Epidemiologists

Introduction

" Towards Ethics Guidelines for Environmental Epidemiologists " by

Colin L. Soskolne and Light was published in The Science of

the Total Environment, Vol. 184(1996):137-147. This paper includes

the ethics guidelines adopted by the ISEE in 1999 as the Society's

official statement on ethical conduct for environmental

epidemiologists.

Elsevier has kindly granted permission to post the ethics guidelines

portion (Section 4) of this paper to the ISEE web site (see below).

The abstract to the full paper is posted below the guidelines. An

introduction, the preamble to the guidelines, and the concluding

remarks can be found only in the print version of the full paper.

Reprints in hard copy may be requested from Colin Soskolne at

colin.soskolne@.... Click here to visit the home page of The

Science of the Total Environment

(http://www.sciencedirect.com/science/journal/00489697).

Substantial portions of the ethics guidelines were drawn heavily

from " Ethics Guidelines for Epidemiologists, " which appears as

reference [3]. Wherever an asterisk (*) appears in the guidelines,

this refers to material not included in reference [3], but more to

material derived from the Proceedings of a World Health Organization

(WHO)/International Society for Environmental Epidemiology (ISEE)

International Workshop, " Ethical and Philosophical Issues in

Environmental Epidemiology, " 16-18 September 1994, Research Triangle

Park, North Carolina, USA. All papers from this workshop are

contained in the Special Issue of The Science of the Total

Environment, Vol. 184 (Nos. 1,2) 17 May 1996 (148 pages).

The ethics guidelines are structured into four subsections:

1. Obligations to subjects of research (for 'subjects,' please read

also/instead: 'participants/people');

2. Obligations to society;

3. Obligations to funders/sponsors and employers; and

4. Obligations to colleagues.

Through these guidelines the ISEE seeks to ensure the highest

possible standard of transparent and accountable ethical practice.

Please send any comments on the guidelines to Colin Soskolne for

consideration in possible updates.

4.1.7. Reviewing research protocols

All research involving human subjects should be reviewed by a proper

review process, for both scientific design and for ethical adequacy.

This review should operate pursuant to authoritative regulations that

establish the composition of and principles for such review. Moral

requirements in these regulations should always be considered in the

review process. In circumstances in which informed consent is not

required (see sub-section 4.1.4. 'Loosening requirements of informed

consent' above), special scrutiny of the research and alternatives to

the protocol should be considered. If a subject does or could be

expected to object to involvement as a subject, the research should

not be performed using that subject.

Review committees and (if appropriate) administrative review should

be structured so that officials (e.g. Institutional Review Board

members or members of its secretariat) work closely with

investigators in improving the ethical quality of the research.

However, investigators have a personal responsibility to evaluate the

ethics of a study and to ensure its ethical adequacy throughout its

term. Responsibility for ethical evaluation cannot be justifiably

transferred to the review committee or to administrative review.

4.2. Obligations to Society

4.2.1. Avoiding conflicting interests

A conflict of interests occurs whenever a personal interest or a role

obligation of an investigator conflicts with an obligation to uphold

another party's interest, thereby compromising normal expectations of

reasonable objectivity and impartiality in regard to the other party.

Such circumstances are almost always to be scrupulously avoided in

conducting environmental epidemiologic investigations (*because the

health consequences of deliberate or inadvertent bias in

environmental epidemiologic research can be great).

Every environmental epidemiologist has the potential for such a

conflict. An epidemiologist on the payroll of a corporation, a

university, or a government does not encounter a conflict of interest

merely by the condition of employment, but a conflict exists whenever

the epidemiologist's role obligation or personal interest in

accommodating the institution, in job security, or in personal goals

compromises obligations to others who have a right to expect

objectivity and fairness.

4.2.6. *Obligations to environmental health

Environmental epidemiologists, through the performance of their

professional duties, should work to advance the interests of the

discipline, ensuring that the broader public interest is maintained.

To assist in this process, interaction with environmental disciplines

that go beyond human health is encouraged because discussion of

ecological integrity has a direct bearing on human health.

4.2.9. Pursuing responsibilities with due diligence

The environmental epidemiologist has a general obligation to enhance,

protect, and restore public health. On this basis, there must be

sound reasons for commencing an epidemiologic investigation. It must

employ a scientific method appropriate for the research, and adequate

analysis must be performed to justify interpretations.

The more an individual or institution is involved in sponsoring or

conducting the research, the more responsibility and care are due to

ensure that the venture does not involve a compromise of the rights

of others. Monitoring and watchfulness are therefore requisite for

responsible investigations. The degree of diligence required depends

on the position of responsibility occupied by the environmental

epidemiologist and on the degree of the epidemiologist's involvement

in the research.

4.2.10. *Research area bias

Environmental epidemiologists must strive to redress the imbalance of

research attention to understudied populations. Disenfranchised

groups have traditionally not had a voice loud enough to be heard by

health research policy makers. Because of this, special attention

should be directed at such groups. (This concern has become known

as 'environmental justice' in the United States.)