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RESEARCH ETHICS AND RESEARCH PRIORITIES:
PART 1: ROLE OF ADVOCACY GROUPS

Jim Till, Ph.D.

Joint Centre for Bioethics, University of Toronto
c/o The Ontario Cancer Institute
610 University Avenue, Room 9-416
Toronto, Ontario, Canada  M5G 2M9


ABSTRACT

In these notes, I consider a particular issue from a research-ethics
perspective:  the representation of non-researchers (and, especially, the
representation of advocacy groups) within councils responsible for the
setting of research priorities.  A major role in the setting of research
priorities at the level of individual research projects has been performed
by 'peer-review' groups (the term 'grants panels', or 'scientific review
panels' will be used to describe such groups in these notes).  In the
past, such grants panels have been composed entirely of researchers.  Is
there a justification for the inclusion of non-researchers (and,
especially, members of advocacy groups) on grants panels?  A conceptual
approach to a justification will be outlined here.  It includes the
application of a 'macro-level' perspective about group representation to
the 'micro-level' context of research priority-setting.  Two appendices
dealing with some empirical and pragmatic perspectives are attached. 


INTRODUCTION

There is increasing pressure, especially from advocacy groups, for
representation in processes used for evaluation of the scientific merit of
individual research proposals.  For example, the National Cancer Institute
of Canada (NCIC),[1] the main non-governmental source of funds for the
support of cancer research in Canada, has recently decided to include two
non-researchers on each of its grants panels (they will not necessarily be
members of any advocacy groups).  The NCIC relies upon these panels for
assessments ('peer review') of the scientific merit of research
applications submitted to it.  At least initially, these non-researchers
will be non-voting members of the grants panels. 

BASIC RESEARCH AND THE PEER-REVIEW PROCESS

A very significant proportion of the research proposals submitted to the
NCIC are for the support of discovery-oriented 'fundamental' (or 'basic')
research.  Such proposals are regarded as a crucial source of the new
ideas upon which novel approaches to the control of cancer are likely to
be based in the future.  John Polanyi (a winner of the Nobel Prize in
Chemistry) has recently emphasized that the main guiding principle for
assessing the merit of basic research, now as in the past, has been
excellence as perceived by the scientific community.[2]

One very important guiding principle in the selection of research is 
that individual research proposals should be initiated by individual
scientists.  Polanyi has suggested that these individuals should, perhaps, 
be regarded as scientific risk-taking entrepreneurs, who may be gambling 
their whole careers on a choice of the right research topic to pursue.  
Others (including governments) should not be trusted to select winners 
in the subtle marketplace for ideas.[2]

There are concerns, especially among scientists, that the inclusion of
non-researchers on grants panels will subvert the process of peer review. 
Polanyi has argued that only other scientists have the ability to pick out
what matters most from the vast landscape of science, and to be able to 
do so before it is evident to anyone else.[2]

On the other hand, I'll argue that, if science is indeed an investment in
the future (and that means that it's everybody's business), then
scientists are not really representative of 'everybody'.  They may have a
particular kind of expertise that permits them to identify research
proposals that are novel, feasible, and well-justified from a scientific
perspective, but their values may not be typical of those of 'everybody'. 

In particular, they may have some conflicts of interest (and thus may
favor the research proposals of some investigators over those of others),
in those very areas of scientific research in which they have special
expertise.  The addition of well-informed 'generalists' to scientific
review panels might be expected not only to permit such potential
conflicts of interest to be revealed and discussed openly, but also to
bring more public accountability to the scientific review process. 
Indeed, the novel perspectives of such 'generalists' might even foster
creativity. 

But, where to find well-informed non-researchers who could fulfil the role
expected of 'generalists'?  An obvious starting point is organized
advocacy groups.  An obvious disadvantage is that members of such groups
are not necessarily well-informed 'generalists'.  They may not even accept
the political maxim (intended to be humorous): "Get the facts first. 
Distort them later"!). 

SOME EXAMPLES OF ISSUES ABOUT ADVOCACY

Below are some illustrative examples of relevant advocacy issues, from the
perspective of priorities for cancer research (and, especially, priorities
for breast-cancer research):

1) An excerpt from a review by Gina Kolata in The New York Times, Oct. 1,
1997: 

     "The women [in the documentary film Rachel's Daughters] are far
     removed from the universe of scientists and others who make
     distinctions between hypotheses and evidence, who believe that
     speculation is not proof, and that when evidence fails to support a
     hypothesis, the hypothesis should be abandoned".[3]

Should a lack of familiarity of with some key aspects of the scientific
method mean that non-researchers should be ineligible to participate in
the evaluation of research projects? 

2) An excerpt from an article by Molly Ivins in The Fort Worth
Star-Telegram, Oct. 12, 1997: 

     "Even the medical establishment admits that no more than 50 percent
     of breast cancer cases (cancer groups say no more than one-third of the
     cases) can be attributed to diet, family history and hormones.
     There's something else out there killing a million women every year
     ... Now here is the interesting part: Why does the cancer
     establishment refuse to look at the obvious? ... Because the cancer
     establishment is beholden to the chemical establishment, and they are
     often one and the same ...".[4]

Do many researchers have conflicts of interest, to such an extent that the
conventional peer-review system for assessing the scientific merit of
research projects should be regarded as in need of a major reform (and,
does the inclusion in the process of 'non-establishment' non-researchers
recruited from advocacy groups provide an example of an appropriate
reform)? 

3) An excerpt from a commentary by Jon Church, an attendee at the First 
World Conference on Breast Cancer (Kingston, Ontario, July 13-17, 1997): 

     "... After 30 years and billions and billions of dollars, where are
     we in the 'War on Cancer'? Is it not still 'slash, poison and burn'?
     ... Thus the message from this conference to academia, to world
     leaders, to policy makers: You've had your shot, and it has failed. 
     It is time to move breast cancer from a purely medical/health model
     to a new paradigm involving politics, sociology and the environment. 
     Let's redirect research efforts and dollars to prevention. Let's 
     look to good data from wildlife studies and from work in laboratory 
     animals, and put the billions of dollars we now spend on basic 
     research in cell biology into an expanded attack on environmental 
     contamination.  Let's learn from our errors and not wait 30 years to 
     act like we did with tobacco".[5]

In cancer research, have research priorities become somewhat unbalanced? 
For example, has there been too much emphasis on basic laboratory research
in biology? 

4) The example of tobacco use as a risk factor for some cancers raises
another controversial issue (the priority that should be given to research
oriented toward genetic determinants of disease versus research oriented
toward environmental determinants of disease): 

    "We ought to be deeply worried about the prospect of elegant and
    simple genetic explanations diverting our attention and resources from
    the messy and complex business of managing environmental triggers".[6]

In the same article, the author (Erik Parens) points out that cigarette
companies' attempts to attribute lung cancer to genetic susceptibility is
one very good example of the use of genetic explanations, instead of an
environmental one (carcinogens in cigarette smoke), as a way to let "genes
become the scapegoat".[6]

Have cancer researchers devoted to much attention to genetic factors, and
not enough to environmental ones? 

These examples illustrate ways in which value-laden advocacy-related
issues could influence research priorities, and the processes used for
setting research priorities. 

HOW CAN RESEARCH ETHICS HELP?

Ethicists deal with value-laden issues, and might be able to provide some
guiding principles or concepts that may be useful when there is a need for
consideration (and clarification) of values. 

A definition of research ethics has been provided by Weijer, Dickens and
Meslin:[7]

    "Research involving human subjects can raise difficult and important
    ethical and legal questions. The field of research ethics is devoted
    to the systematic analysis of such questions to ensure that study
    participants are protected and, ultimately, that clinical research is
    conducted in a way that serves the needs of such participants and of
    society as a whole".

This definition appears in an article that was intended for a clinical
audience, and was published in the Canadian Medical Association
Journal.[7] Hence, there is an emphasis on the needs of human subjects
asked to participate in clinical research.  However, if 'clinical
research' is replaced by 'research involving humans', then the same
definition is somewhat more widely applicable. 

From the perspective being emphasized in these notes, the words 'research
... that serves the needs ... of society as a whole' merit particular
emphasis.  From this perspective, research ethics includes the systematic
analysis of ways in which research serves the needs of society as a whole. 
One starting point for such an analysis might be an examination of ways in
which research priorities are developed and implemented. 

SOME BASIC PRINCIPLES OF RESEARCH ETHICS

Research ethicists very often refer to three basic principles of research
ethics set out in the Belmont Report, published in 1979.[8] Excerpts from
the descriptions of these three principles are as follows: 

    Principle #1: Respect for persons: "... To respect autonomy is to give
    weight to autonomous persons' considered opinions and choices while
    refraining from obstructing their actions unless they are clearly
    detrimental to others ...".

This principle was intended to be applied to the personal considered
opinion and choices of individuals.  It could also be applied to the
considered opinions and choices of individual members of advocacy groups,
'unless they are clearly detrimental to others'. 

    Principle #2: Beneficence: "Two general rules have been formulated as
    complementary expressions of beneficent actions in this sense: (1) do
    not harm and (2) maximize possible benefits and minimize possible
    harms ... In the case of scientific research in general, members of
    the larger society are obliged to recognize the longer term benefits
    and risks that may result from the improvement of knowledge and from
    the development of novel medical, psychotherapeutic, and social
    procedures". 

Here, 'members of the larger society', including members of advocacy
groups, are obliged to recognize longer term benefits and risks that may
results from the kinds of research and development for which they are
advocates. 

    Principle #3: Justice: "Who ought to receive the benefits of research
    and bear its burdens?  ..... There are several widely accepted
    formulations of just ways to distribute burdens and benefits. Each
    formulation mentions some relevant property on the basis of which
    burdens and benefits should be distributed. These formulations are (1)
    to each person an equal share, (2) to each person according to
    individual need, (3) to each person according to individual effort,
    (4) to each person according to societal contribution, and (5) to each
    person according to merit". 

The key question here, for all those concerned about research priorities
(including members of the larger society ), is:  Who ought to receive the
benefits of research and bear its burdens? 

This question becomes especially important when (as may often be the
case?) those who receive the greatest benefits from research are not the
same as those who find themselves bearing the greatest risks. 

The various formulations of the Justice Principle permit it to be
interpreted in various ways.  Interpretations seem likely to differ, as a
result of different political or philosophical perspectives. 

If so, one source of further help with interpretations of these principles
of research ethics might be found in the works of political philosophers. 
For example, the role of members of advocacy groups in research
priority-setting could be regarded as an issue of 'group representation
rights'. 

THE ISSUE OF GROUP REPRESENTATION RIGHTS

The Canadian political philosopher Will Kymlicka has considered group
representation rights within the context of liberal political theory.  To
illustrate the perspective of this particular political philosopher, some
excerpts from Kymlicka's book: Multicultural Citizenship: A Liberal
Theory of Minority Rights [9] are quoted below: 

    Page 141:  "Group representation rights are often defended as a
    response to some systematic disadvantage or barrier in the political
    process which makes it impossible for the group's views and interests
    to be effectively represented" .... "In so far as these rights are
    seen as a response to oppression or systematic disadvantage, they are
    most plausibly seen as a temporary measure on the way to a society
    where the need for special representation no longer exists - a form of
    'affirmative action' ...". 

This is the 'equality-based argument' for group representation rights.

    Page 140:  "... most proponents of group representation do not favour
    'the kind of politics in which people were elected only to speak for
    their own group identity or interests'..." 

    Page 140:  "... the argument that the members of one group cannot
    understand the interests of other groups, if accepted, seems to
    undermine the possibility of group representation as well.  For it
    surely applies within groups as well as between them.  Each group has
    subgroups, with their own distinctive experience and characteristics". 

    Page 145:  "Once we are clear that group representation applies
    only to oppressed social groups, then the fear of an unworkable
    proliferation of group representation should dissipate ...". 

Concerns about an 'unworkable proliferation of group representation', lead
to an emphasis on the extent to which the group seeking the right to be
represented is currently subjected to 'oppression or systematic
disadvantage'. 

    Page 149:  "... Accountability is always the other side of
    representation, and, in the absence of procedures for establishing
    what any group wants or thinks, we cannot usefully talk of their
    political representation ...". 

Perhaps 'accountability' should be regarded as a duty, that should go
hand-in-hand with political representation, in those situations where the
latter can be justified as a right? 

From Kymlicka's perspective, group representation is not inherently
illiberal or undemocratic, provided that there is not an unworkable
proliferation of group representation, and that mechanisms are in place to
ensure accountability of the representatives to the groups that they claim
to represent. 

If this 'macro-level' perspective on group representation can be applied
to the 'micro-level' context of research priority-setting, then perhaps
those who are expected to bear the burdens of research (for example, as
participants in therapeutic or preventive research studies or trials) may 
have a particularly strong claim that they ought to be appropriately
represented in research priority-setting processes? 

Examples of issues that then come to the fore include:  Which groups merit
group representation (only those who can justify a claim that they are
currently subjected to 'systematic disadvantage'?).  What kind of
accountability mechanisms are appropriate?  What role should such group
representatives play in evaluations of the scientific merit of research
proposals? 

SOME CONCLUDING OPINIONS

1.  The views and interests of those already coping with cancer, or who
are at high risk of having to cope with cancer in the future (and
especially those who might be eligible for participation in therapeutic or
preventive research studies or trials) have usually not been effectively
represented among those responsible for the setting of research
priorities. 

2.  If exclusion of those coping with cancer (or at high risk of having to
cope with it) from research priority-setting is accepted as a form of
'systematic disadvantage', then group representation in such
priority-setting processes can be justified by an equality-based
argument. 

3.  Advocacy groups that seek group representation on the grounds that
they are a systematically disadvantaged social group can avoid an
unworkable proliferation of additional requests for group representation
by involving members with diverse perspectives, and by developing
processes for accountability as well as representation. 

4.  The Belmont principles of respect for persons, beneficence and justice
can be usefully applied not just to individuals, but also to advocacy
groups.  For example: 

* Advocacy positions should involve considered opinions and choices (e.g.
in that they take into account both scientific evidence and ethical
principles). 

* Advocacy groups have a duty to recognize the longer term benefits and
risks that may be inherent in their proposed policies. 

* Advocacy groups also have a duty to recognize that those who benefit the
most from a particular policy may not be those who are exposed to the
greatest risks. 

5.  The issue of appropriate evaluation of scientific merit needs
empirical study (see Appendix A).  (For example, might group representation
within councils responsible for setting research priorities lead to an
inappropriate emphasis on political considerations, versus considerations
of scientific merit?).

6.  The perspective presented above is based on bioethical and political
theory, rather than on practical experience.  For a more pragmatic
perspective, see Appendix B, below. 


APPENDIX A:  Some criteria for the evaluation of scientific merit:

Question:  How should the scientific merit of a research proposal be
evaluated? 

The usual answer:  By a process of scientific peer review. 

Question:  What criteria of scientific merit are usually used by peer
reviewers ? 

Answer (obtained from an empirical qualitative research study by
Sutherland, Meslin, Da Cunha and Till; in this article, an emphasis 
was placed on non-methodological criteria of scientific merit):[10]

*  potential impact (relevance, usefulness)
*  justification (logical, has specific goals)
*  feasibility (has a good chance of success)
*  track record (experience, reputation)
*  innovation (novel, original, visionary)
*  intuitive response (positive 'gut feeling')
*  aesthetics (elegance, clarity, simplicity)
*  politics (timely, big topical problem)

Most, if not all, of these criteria involve value judgments.  Scientific
peers seem likely to be much better qualified than non-researchers to make
value judgments based on methodological criteria (including methodological
feasibility).  They may also be better qualified to make judgments about
how innovative the proposed research project is, and about the track
records of the investigators.  

Researchers seem less likely to be uniquely qualified to make judgments
about the potential impact of the research (especially on those likely to
bear its burdens), about its justification, or about such very value-laden
criteria as 'intuitive response', 'aesthetics', or 'politics'.


APPENDIX B:  Comments from a non-researcher's pragmatic perspective:

Karen Gray, a graduate of Project LEAD and a 3-year "consumer reader" on
basic science panels of the U.S. Department of Defence's Breast Cancer 
Research Project, posted some comments about the participation of 
"consumer readers" on scientific review panels to the Internet-based 
Breast-Cancer Discussion Group.  She has given me permission to include 
a link to her message [11].  A reference to my response is also 
attached [12].

Karen Gray raised four issues:

1)  On a typical basic science panel, only a (sometimes very small) 
minority of the panel members are experts in the precise science of 
many of the proposals.

My own experience with scientific review panels supports this view.
External experts are often asked to provide additional written reviews, 
but their written reports may not be as influential as those of the 
panel members, who are present, and able to argue in favor of their 
own evaluations.

2)  Scientists are themselves biased and subjective evaluators.

I agree, and suggest that, at least in part, this happens because the 
criteria used for the evaluation of research proposals are, to varying 
degrees, mostly quite subjective (see Appendix A).

3)  No single agency (or group, or perspective) should have monopoly 
control of the research environment.

I agree that a diversity of agencies and groups, with a diversity of 
perspectives about research priorities, seems likely to have a positive 
impact on the research environment ... provided that more than one agency 
or group has resources sufficient to permit it to support large-scale, 
expensive research programs (such as large prospective randomized 
controlled trials of preventive or therapeutic interventions involving 
human populations).

4)  The inclusion of "consumer readers" or "patient advocates" on 
scientific review panels provide a way to enhance understanding in the 
lay population of science, scientists and scientific methods.

Again, I strongly agree. Also, in my opinion, such inclusion provides 
a way for the scientific review process to achieve greater public 
accountability.


REFERENCES

1.  National Cancer Institute of Canada (NCIC) website [see:
http://www.ncic.cancer.ca/]

2.  Polanyi, John. The power of ideas: If science is an investment in the
future, that means it is everybody's business.  University of Toronto
Bulletin, No. 7, November 10, 1997, page 16. 

3.  Kolata, Gina.  Review of the documentary film "Rachel's Daughters" in
the New York Times, October 1, 1997.

4.  Ivins, Molly. A month to be aware of chemicals and breast cancer. The
Fort Worth Star-Telegram, October 12, 1997.

5.  Church, Jon. Let's redirect breast cancer research. Network News, 
Canadian Breast Cancer Network, Fall 1997. [See also bclist archives]

6.  Parens, Erik.  Glad and terrified: on the ethics of BRCA1 and 2
testing.  Cancer Investigation 14(4): 405-411, 1996. [Medline]

7.  Weijer, Charles, Bernard Dickens, Eric M. Meslin.  Bioethics for
clinicians: 10. Research ethics.  Canadian Medical Association Journal
156(8): 1153-1157, 1997 [see: CMAJ 1997; 156(8): 1153-1157]

8.  Belmont Report. [see:
http://helix.nih.gov:8001/ohsr/mpa/belmont.phtml#xbasic]

9.  Kymlicka, Will. Multicultural Citizenship. A Liberal Theory of
Minority Rights. (Clarendon Press, Oxford, 1995). 

10.  Sutherland, Heather J., Eric M. Meslin, Raquel Da Cunha and James E.
Till. Judging clinical research questions: What criteria are used?  Soc.
Sci. Med. 37: 1427- 1430, 1993. [Medline]

11.  Gray, Karen. Re: Role of Advocacy Groups. [see:
Message from Karen Gray, December 1997]

12.  Till, Jim.  Re: Role of Advocacy Groups. [see:
Response from Jim Till, December 1997]


Copyright 1997, 1998 by Jim Till
Format last modified: May 23, 1999
Links in references updated: August 4, 2002

-----------------------------------------------------------


To see the second part of this set of notes on Research Ethics and
Research Priorities, please go to: PART 2: ENVIRONMENTAL RESEARCH

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