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Journal of Policy and Practice in Intellectual Disabilities
Volume 1 Number 2 pp 57 – 70 June 2004
© 2004 International Association for the Scientific Study of Intellectual Disabilities and Blackwell Publishing, Inc.
Blackwell Science, LtdOxford, UKPPIPolicy and Practice in Intellectual Disabilities1741-11222004 International Association for the Scientific Study of Intellectual Disabilities and Blackwell Publishing LtdJune 2004125770Original ArticleEthics GuidelinesA. J. Dalton and K. R. McVilly
Received January 25, 2004; accepted June 23, 2004
Correspondence: Arthur J. Dalton, 1050 Forest Hill Road, Staten Island, New
York, NY 10314, USA. E-mail: daltonaj@aol.com
1These guidelines were adopted by the International Association of the Scien-
tific Study of Intellectual Disability (IASSID) Council at its meeting in Buenos
Aires, Argentina on August 2, 2003.
2The IASSID Ad Hoc Committee on International, Multicenter Research Eth-
ics was co-chaired by Arthur J. Dalton (Center for Aging Studies, New York
State Institute for Basic Research in Developmental Disabilities) and Keith R.
McVilly (Center for Developmental Disabilities Studies, University of Sydney,
Faculty of Medicine).
3This document incorporates contributions from members of the IASSID Ad
Hoc Committee on International, Multicenter Research Ethics and other
interested persons. The names of contributors are listed at the end of this
document. It should not be assumed that anyone of the contributors endorses
the document in total.
4Editor’s note: Citations were not included in the text of these guidelines but are
found in the References section at the end of the article.
Ethics Guidelines for International,
Multicenter Research Involving People with
Intellectual Disabilities1,2,3,4
Arthur J. Dalton* and Keith R. McVilly†
*New York State Institute for Basic Research in Developmental Disabilities, Staten Island, New York, NY, USA; and †University of
Sydney, New South Wales, Australia
Abstract This position statement endorsed by the International Association for the Scientific Study of Intellectual Disabilities is
designed to promote and facilitate research projects affecting and involving people with intellectual disabilities. The paucity of
dedicated research infrastructure and expert ethical review processes to oversee research in this field, especially in developing
countries, is asserted as a major issue to be addressed by both the scientific community and governments. International multicenter
collaboration has been proposed as a means of addressing these problems. The statement draws on internationally recognized
documents outlining the ethical considerations involved in human research activities. It interprets these documents in light of the
particular needs and interests of people with intellectual disabilities and incorporates international consultation involving researchers
from a variety of disciplines. It affirms the importance of ethical decision making in local communities. Specific recommendations
are made concerning ethical review processes, research design considerations, consent processes and the conduct of research
involving and affecting people with intellectual disabilities, their families and communities. Research proposals, especially those for
international, multicenter projects, need to take into account cultural diversity among participants and differing legal requirements
across jurisdictions, while at the same time maintaining the scientific rigor of the research protocol. Promoting partnerships between
researchers and people with intellectual disability, together with their families, advocates and local communities are important
considerations when developing research projects. Similarly, the development of strategies to both communicate findings to partic-
ipants and their communities, and to promote their community’s access to the benefits of these findings are all important ethical
considerations.
Keywords: Research, ethics, intellectual disabilities
PREAMBLE
The International Association for the Scientific Study of
Intellectual Disabilities (IASSID) identified the need for a posi-
tion statement on research and ethical review issues associated
with research projects affecting and involving people with intel-
lectual disabilities. The need for such a position statement was
foreshadowed by Dr. Harvey Stevens (1967) in his Presidential
Address to the Inaugural IASSID World Congress at Montpellier,
France:
If this field is to continue to reserve support for its research
activities, it must assure its supporters and the public that
adequate safeguards have been delineated and are being rig-
orously applied, particularly when using the mentally defi-
cient [sic] as a research subject (pp. xxxi–xli).
More recently, IASSID President Dr. Neil Ross called for the
establishment of an IASSID Ad Hoc Committee to investigate
contemporary issues affecting international, multicenter research
and to prepare a position statement.
This position statement is designed to assist with the protec-
tion of people with intellectual disabilities and their advocates
who participate in research. Furthermore, it is intended to pro-
mote and provide guidance for the development and execution
Journal of Policy and Practice in Intellectual Disabilities Volume 1 Number 2 June 2004
A. J. Dalton and K. R. McVilly • Ethics Guidelines
58
of research projects affecting and involving people with intellec-
tual disabilities, especially projects that cross national boundaries
and involve participants in developing countries. In particular,
the statement is intended to aid the establishment and operation
of “ethics committees”/“institutional review boards” to oversee
international multicenter research projects, especially in develop-
ing countries and jurisdictions where there are no well-
established mechanisms for this purpose. It is also designed for
use in the education of new researchers and practitioners in the
field of disability.
Furthermore, IASSID asserts that one of the major ethical
issues to be addressed by the scientific community and govern-
ments alike is the lack of both theoretical and applied research
in this field. This problem, in part, is linked to a lack of fund-
ing at both national and international levels. Thus, IASSID
calls upon the research community and government agencies,
at both national and international levels, to consider how
issues affecting people with intellectual disabilities and their
families can be included on research agendas and funded
appropriately.
For the purpose of this position statement,
• Research is understood to be any systematic investigation or
inquiry involving human participants intended to discover
clinical, social or theoretical knowledge and/or verify pre-
vious findings or assertions. It can vary in its form accord-
ing to the methods employed (e.g., a controlled
experimental study, a clinical trial, a quantitative survey, or
qualitative interviews), the degree of intrusion into the lives
of the participants, and the degree to which participants are
at risk of adverse events.
• Multicenter research is understood to be a research con-
ducted according to a single protocol, but at more than one
site and therefore supervised by more than one investigator.
Such research could be conducted at more than one site
within a particular country or in different countries. In the
latter case, it is commonly designated as “international,
multicentre research”.
IASSID asserts that when evaluating the ethical merit of pro-
posed research projects, and conducting research involving peo-
ple with intellectual disabilities as participants, or research that is
intended to affect the lives of these participants, the three funda-
mental ethical principles identified by the Council for Interna-
tional Organizations of Medical Sciences (CIOMS, 2002) should
apply:
1. respect for persons, including their autonomy and right to
self-determination;
2. beneficence for participants and the community, that is,
maximizing benefits and minimizing risks; and
3. justice, both legally and morally, in the treatment of those
involved in research and in the treatment of the commu-
nities to which the participants belong.
In preparing this statement, IASSID endorses the four ethical
duties in conducting multinational, multicenter research identi-
fied by the Nuffield Council on Bioethics (2002):
1. the duty to alleviate suffering, especially in developing
countries;
2. the duty to show respect for persons;
3. the duty to be sensitive to cultural differences; and
4. the duty not to exploit the vulnerable.
IASSID calls on those in both scientific and political spheres
to recognize the power imbalance that can exist between research-
ers and those who are either direct participants in research or who
are members of communities whose interests are the focus of
research. Such power imbalances can be particularly evident
where people with intellectual disabilities live or work in congre-
gate care or institutional facilities, where they can be particularly
vulnerable to coercion and exploitation. Furthermore, IASSID
calls upon those involved in the development of research proto-
cols and those responsible for the oversight of research (including
members of “ethics committees”/“institutional review boards”)
to, wherever possible, work in partnership with people with intel-
lectual disabilities, their families and advocates in the develop-
ment of research goals, questions, strategies, methodologies and
information dissemination (National Health and Medical
Research Council, 2002).
IASSID affirms the primacy of ethical decision making in
local communities, where research is to take place. However,
IASSID also acknowledges that the infrastructure and expertise
available to facilitate the ethical review and approval of proposed
research projects varies from country to country. Therefore,
IASSID asserts it is important to draw upon a number of inter-
nationally accepted principles to guide the development, ethical
review and implementation of research. Subsequently, this state-
ment has been developed with reference to a number of interna-
tionally accepted documents, including:
• Nuremberg Code, 1949
• the Universal Declaration of Human Rights, 1948
• the Declaration of Helsinki, 1964/2000
• International Ethical Guidelines for Biomedical Research
Involving Humans, 1993/2002
• the European Union Directive on the Conduct of Clinical
Trials, 2001
Other documents informing these guidelines are listed in the
bibliography.
IASSID acknowledges the diversity, internationally, of ethical
values and legal requirements. In publishing the current guide-
lines, IASSID intends to promote a wider debate among research-
ers, practitioners, people with intellectual disabilities and their
advocates from a variety of cultures, which will contribute to the
future revision of these guidelines.
Journal of Policy and Practice in Intellectual Disabilities Volume 1 Number 2 June 2004
A. J. Dalton and K. R. McVilly • Ethics Guidelines
59
INTRODUCTION
The International Association for the Scientific Study of Intel-
lectual Disabilities (IASSID) exists for “ . . . the worldwide promo-
tion of the scientific study of intellectual disabilities and related
developmental disabilities and of the conditions of persons with
such disabilities and their families” (IASSID By-laws, Article 1.1).
In this endeavour, IASSID encourages international cooperation
and multicenter research involving members of the scientific
community, people with intellectual disabilities and their
advocates.
IASSID is aware that developing countries in particular are
in urgent need of research to assist them devise and imple-
ment appropriate programs and strategies to support people
with intellectual disabilities and their advocates. For this rea-
son, consistent with the findings of the Nuffield Council on
Bioethics (2002), IASSID asserts that it is appropriate for those
in wealthier countries, both in the government and non-
government sectors, to assist and sponsor research in develop-
ing countries.
Also, IASSID wishes to ensure that the needs and priorities of
people with intellectual disabilities throughout the world are rep-
resented in all research activities designed to advance the health
and well-being of the general community. IASSID asserts that
people with intellectual disabilities should not be excluded (dis-
criminated against) as potential participants in generic research
and every effort should be made to include their perspectives,
priorities and needs in generic research activities.
However, IASSID is aware that people with intellectual dis-
abilities and their advocates can be vulnerable to exploitation and
even abuse when they participate in research. Consequently,
before research can proceed, rigorous ethical safeguards must be
in place to promote and protect the health, safety and human
rights of participants; and to prevent their exploitation.
IASSID is concerned that not all jurisdictions in which
research could be conducted have established infrastructure and
protocols to monitor and regulate ethical issues, and in turn
safeguard and protect the interests of people with intellectual
disabilities and their advocates involved in research activities.
Also, in the case of international multicenter research, different
ethical standards or principles could apply in different countries
and across different cultures. If not addressed, these differences
could pose a significant barrier to, or compromise international,
multicenter research activities.
IASSID endorses the principle that for research involving
human participants, “ . . . the well-being of the human subject
should take precedence over the interests of science and society”
(World Medical Association, 2000; Declaration of Helsinki,
Article 5). IASSID maintains that those persons proposing
research involving people with intellectual disabilities as partici-
pants need to justify to both their peers and their community
(including people with intellectual disabilities and their advo-
cates) that what they propose is in the interest of people with
intellectual disabilities, and the means by which they intend to
achieve it is acceptable in light of the highest international stan-
dards, both ethically and legally.
Importantly, in multicenter research, the onus is on those
initiating research to justify to those communities in which they
propose to conduct the research, both the ends and the means of
their research activities. This process will usually involve prepar-
ing an ethically based research protocol or a stand-alone docu-
ment that discusses the ethical considerations within the research
protocol (i.e., an ethics proposal), to be reviewed in both their
own country and other countries in which they propose to con-
duct the research. The ethics proposal process will ordinarily
involve the researchers explaining to an independent and compe-
tent authority what they intend to do; why such an investigation
is important; what potential benefits there are to society; what
dangers might be involved; how they intend to proceed; what
safeguards they will establish to protect the participants’ rights
and safety; and how they will make their findings available.
The independent and competent authority to which the ethics
application is to be made (i.e., the ethics committee/institutional
review board) will ordinarily consist of men and women, who
provide expertise in research processes from varied disciplines,
the law, religion and ethics, as well as lay persons from the general
community, and wherever possible, people with intellectual dis-
abilities. In the case of institutional-based ethics committees,
there will usually be at least one person who is independent of
the institution or the organization from which the ethics appli-
cation originates. Ideally, there should be at least one committee
member who can represent and advocate for the interests of those
persons identified as potential participants for the study. Such
representation or advocacy is particularly important where the
proposed research involves participants who could be considered
vulnerable or disadvantaged in some way or from a cultural back-
ground different from that of those proposing the research.
An ethics committee/institutional review board, or equivalent
local committee, will have the authority to approve, propose
modifications or reject an ethics application. Also, such commit-
tees will ordinarily have a right to request regular progress reports
concerning any research activities they have approved. They will
have the authority to withdraw approval for research that fails to
comply with an agreed protocol or local regulations.
If local ethics approval is withdrawn, then all local research
activities should cease immediately, or whatever local sanctions
in place against researchers would apply. In the case of multi-
center research, if the sponsor or originating authority is no
longer approved to continue, then all research should cease. In
any event, many funding bodies require current ethics approval
for projects they fund. Failure to obtain such approval or the
withdrawal of ethics approval will ordinarily result in the suspen-
sion or forfeiture of funding. In addition, research that has not
been approved by an ethics committee/institutional review board,
or for which approval has been withdrawn, will not ordinarily be
accepted for publication in peer-reviewed, scientific journals.
In making a determination, an ethics committee/institutional
review board will consider a number of issues:
Journal of Policy and Practice in Intellectual Disabilities Volume 1 Number 2 June 2004
A. J. Dalton and K. R. McVilly • Ethics Guidelines
60
a. how the research is to be explained to the participants;
b. how participant consent (and/or proxy consent) is to be
obtained;
c. how participants are to be treated during the research;
d. what safeguards are in place to minimize any potential
harm to participants;
e. what mechanisms are in place to respond to any adverse
events;
f. how participants’ personal information and research
results pertaining to them as an individual are to be kept
private and confidential;
g. what mechanisms are in place to report findings to the
participants and allow for peer review by the scientific
community; and
h. what mechanisms are in place to maximize any benefit to
participants (and their community) of research findings.
Where inter-jurisdictional or cross-cultural conflicts of pro-
cedural or ethical standards arise, the ethical standards or prin-
ciples maintained by the country or cultural group in which the
research is proposed to be conducted would ordinarily prevail. In
particular, local laws and regulations cannot be ignored. In the
case of international, multicenter research, researchers need to
consider if by incorporating different local standards into their
research protocol, they are not compromising the ethical frame-
work within which they ordinarily work; that they are not going
to act in a way they believe could compromise or harm their
participants; and/or act in a way that could undermine the scien-
tific credibility of their research activities. Where resolution of
such conflict is not possible, it could be that it is inappropriate
for the research to proceed.
There follows recommendations to assist with ethical review
processes for research involving participants with intellectual dis-
abilities, and in particular research involving international, mul-
ticenter trials investigating support needs and treatment options
for people with intellectual disabilities.
RECOMMENDATIONS
General
1. That international organizations, national and local gov-
ernments, together with the scientific community recognize peo-
ple with intellectual disabilities to be among the least privileged
and most vulnerable in the community and that if their circum-
stances are to improve, there is an urgent need to facilitate rigor-
ous and ethical research into issues of importance to people with
intellectual disabilities, their families and support systems.
2. That those involved in funding and conducting research
recognize the advantages of international, multicenter collabora-
tion; including broader funding bases, together with additional
infrastructure and expertise to progress and monitor research
activities.
3. That organizations involved in research and service provi-
sion for people with intellectual disabilities have established writ-
ten policies and procedures to promote ethical conduct in their
activities, including wherever possible, strategies for working in
partnership with people with intellectual disabilities, their fami-
lies and advocates.
Ethics Review Processes
4. That international, multicenter research involving people
with intellectual disabilities and/or their advocates be subject to
independent review by appropriately constituted ethics commit-
tees/institutional review boards or equivalent local committees
(i.e., independent committees consisting of men and women who
provide expertise in research processes from varied disciplines,
the law, religion and ethics, as well as lay persons from the general
community).
5. That where research involving people with intellectual dis-
abilities is proposed as an international, multicenter project, eth-
ics approval should ordinarily be obtained in both the country in
which the principal investigators work and those countries in
which the research is proposed to be conducted.
6. That where an international, multicenter research project
involving people with intellectual disabilities is proposed to be
conducted in a country where ethics committees or institutional
review boards are not yet established, the ethics committee or
institutional review board in the country of the principal inves-
tigator will take into account the local laws and customs of the
communities in which the research is proposed to be conducted.
However, to assist ethics committee/institutional review board
deliberations, it remains the responsibility of the principal inves-
tigator to provide the ethics committee or institutional review
board with relevant information concerning local laws and cus-
toms of the communities in which they propose to conduct
research (as they should have already familiarized themselves
with these information as part of preparing their research
proposal).
7. That local ethics committees/institutional review boards
be established in such a way that they have the authority to
approve or disapprove, recommend amendments to, and with-
draw approval for research projects within the area of their juris-
diction, and that local laws provide sanctions for noncompliance.
8. That ethics committees/institutional review boards be
established in such a way that they can act as independently as
possible of government and/or industry (especially where govern-
ment or industry are involved in the sponsorship and/or conduct
of research). These bodies should provide a forum for critical
reflection and a mechanism to address potential power imbal-
ances between researchers and those who are either direct partic-
ipants in research or who are members of communities whose
interests are the focus of research.
9. That ethics committees/institutional review boards include
men and women who provide expertise in research processes
Journal of Policy and Practice in Intellectual Disabilities Volume 1 Number 2 June 2004
A. J. Dalton and K. R. McVilly • Ethics Guidelines
61
from varied disciplines, the law, religion and ethics, as well as lay
persons from the general community and those in a position to
advocate the interests of people with intellectual disabilities.
10. That ethics committees/institutional review boards rec-
ognize the expertise of people with intellectual disabilities, their
families and advocates and, wherever possible, consult with and
involve people with intellectual disabilities, their families and
advocates in their deliberations. For this purpose, appropriate
mechanisms could include, but not be restricted to, the forging
of links between ethics committees/institutional review boards
and self-advocacy groups and/or family support organizations.
11. That in the course of their deliberations, ethics commit-
tees/institutional review boards acknowledge people with intel-
lectual disabilities can be vulnerable to coercion and exploitation.
Furthermore, they acknowledge that this vulnerability can be
exacerbated where people live independently of their family,
in institutional care and in countries where social and legal
infrastructure to protect individual human rights, and especially
the rights of people with intellectual disabilities, is not well
established.
12. That in their deliberations, ethics committees/institu-
tional review boards considering proposals to involve people with
intellectual disabilities as participants take into account the prin-
ciples and standards detailed in:
• the United Nations Universal Declaration of Human Rights,
1948
• the World Medical Association Declaration of Helsinki,
1964/2000
• the United Nations Declaration on the Rights of Disabled
Persons, 1975
• the United Nations Standard Rules on the Equalisation of
Opportunities for Persons with Disabilities, 1993
• the CIOMS and The World Health Organization Interna-
tional Ethical Guidelines for Biomedical Research Involving
Humans, 1993/2002
• the European Union Directive on the Conduct of Clinical
Trials, 2001
13. That approval for an international, multicenter trial
involving participants with intellectual disabilities should only be
given, where the ethics committee is satisfied that:
a. the proposed research is in the interests of people with
intellectual disabilities;
b. the methods proposed are scientifically sound and are both
culturally appropriate and legal in the communities in
which the research is proposed to be conducted; and
c. those who are to conduct the research are competent to do
so and/or will be supervised by appropriate specialists.
14. That the usual standard for measuring the merit of any
proposed research project be a comparison with either “the best
current intervention” or the “established effective intervention”
available internationally for people in a comparable circum-
stance. Alternatively, where the proposed protocol is not related
to an “intervention”, that wherever possible, it be assessed against
evidence-based best practice (e.g., Cochrane Collaboration,
2003) at an international level.
15. That ethics committees and institutional review boards
involved in the approval of international, multicenter research
projects concerning people with intellectual disabilities acknowl-
edge the complexity of coordinating such projects and work col-
laboratively, minimizing cost to researchers in terms of both time
and money.
Research Design Considerations
16. That in designing international, multicenter research pro-
posals, researchers take into account the diversity of cultural val-
ues and beliefs that could be encountered in the execution of their
project. Furthermore, that their protocols be designed in such a
way as to accommodate cultural variations, while at the same
time minimizing the need to adapt the protocol in a way that
could adversely affect the meaningful comparison of data
between research sites.
17. That as part of the process of designing an international,
multicenter research proposal, where interest groups are estab-
lished in local communities (e.g., self-advocacy organizations or
family support groups), researchers consult with these groups
and that this process of consultation be documented as part of
any subsequent ethics application.
18. That the option of collaboration with indigenous/
traditional practitioners in the participants’ communities of ori-
gin be considered in the development of any research protocol,
but that any such collaboration be ethical insofar as it reflects an
evidence-based approach or best practice in research.
19. That research proposed by external sponsors (i.e., govern-
ment or nongovernment sponsors from a country other than the
country in which it is proposed to conduct the research) be
informed by and in keeping with the national and/or local prior-
ities concerning the development and implementation of services
for people with intellectual disabilities, unless the reason for
doing so can be justified to the ethics committee in that country
or local community.
20. That sufficient resource for the proper execution of
research projects is provided by the sponsoring agencies/
investigators, to minimize any diversion of limited local resources
from the existing day-to-day support of people with intellectual
disabilities, especially where research is proposed to be conducted
in developing countries.
21. That international sponsors of research involving partic-
ipants with intellectual disabilities have an obligation to ensure
adequate training and on-going support for those who will con-
duct research on their behalf in a host country and that wherever
possible, the development of sustainable local research and clin-
ical expertise is to be considered integral to the establishment and
Journal of Policy and Practice in Intellectual Disabilities Volume 1 Number 2 June 2004
A. J. Dalton and K. R. McVilly • Ethics Guidelines
62
operation of any research project, …
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