Participation
in Research
Background
Scientists
around the world are working to find the causes, better
treatments and, ultimately, a cure for Alzheimer's disease
and related dementias. Researchers are also trying to
better understand the psychological and social effects
of the disease on people with the disease and their families.
Many people with Alzheimer's disease are participating
in this research. They and their families take comfort
and find hope in being able to help increase our understanding
of the disease and its effects.
The
issues
For
people with Alzheimer's disease:
Ability
to make informed decisions: As cognitive abilities
such as memory, language, reasoning and judgment decline,
people with Alzheimer's disease become less able to understand
the consequences of their involvement in research.
This affects their ability to continue to make informed
decisions. There is concern that people with the disease
not be subjected to undue risk or exploitation.
For
family members and caregivers:
Conflicting
needs: The participation of people with Alzheimer's disease in research often places demands on families.
There is also a potential for conflict between the
wishes of the person with the disease and the wishes
of family members.
Substitute
decision-making: When a person is unable to understand
the consequences of participation in research, the
decision to participate in research, in some provinces,
rests with the person named as substitute decision-maker
(usually a family member). If the person with Alzheimer's disease does not have previously-stated wishes regarding
participation in research, it may be difficult for
the substitute decision-maker to weigh the risks and
benefits of research participation for that person.
For
researchers:
Ensuring
informed decision-making: Researchers should ensure
that research participants, including those with cognitive
problems, fully understand and appreciate the consequences
of their participation throughout the course of the
study. When a person is no longer able to make informed
decisions, the researcher should ensure that the substitute
decision-maker makes choices that respect that person's
wishes.
Keeping
care and research separate: The dividing line between
the provision of care for the person with Alzheimer's disease and the health-care professional's commitment
to research is sometimes unclear. There may also be
a potential for conflict of interest when researchers
in drug trials accept funding from the pharmaceutical
industry.
Using
placebos in drug trials: To determine if a new
drug is safe and effective for use, research studies
will compare a group of people taking the experimental
drug with a group taking a placebo (a pill that may
look like the new drug but has no medical effect).
This means a person participating in a drug study could
receive a placebo and not have access to existing medications.
The
availability of medications to treat Alzheimer's disease
symptoms has triggered a debate about the appropriateness
of continuing to use placebos in studies of new drugs
for Alzheimer's disease.
The
use of placebos in drug trials is the subject of a current
national initiative. The guidelines that emerge from
this initiative will likely influence future drug research
in Canada.
The
principles that guide research on Alzheimer's disease in
Canada
The Tri-Council
Policy Statement: Ethical Conduct for Research Involving
Humans governs research conducted by universities
and university-affiliated hospitals involving human
subjects in Canada. This policy statement was created
by the three federal government research organizations
that fund research involving human subjects in Canada.
It sets out standards and procedures for conducting
safe and ethical research and describes the consent
process. Each study must be reviewed and approved,
in advance, by an ethics review board or committee.
This body is also responsible for monitoring the research
process to ensure that it follows the Tri-Council
Policy Statement's requirements. These requirements
include obtaining and maintaining informed consent
for all research.
At
present, research involving human subjects in Canada
conducted outside a university or university-affiliated
hospital is not necessarily governed by the Tri-Council
Policy Statement and may be reviewed according
to different standards. An example of this would be research
on a new drug sponsored by a drug manufacturer and conducted
in the private offices of family doctors. Such studies
must meet certain ethical standards and undergo review.
However, they do not necessarily meet all of the standards
described in the Tri-Council Policy Statement.
When
considering participation in research, it is appropriate
to ask:
- Who
is the sponsor of the study?
- Who
conducted the ethical review of the study?
- Was
the ethical review conducted according to the Tri-Council
Policy Statement?
Preferred
choice
There
are certain principles that should be followed when people
with Alzheimer's disease participate in research:
Respect
for the person's wishes
The
wishes of the person with Alzheimer's disease should be
the guide when considering participation in research.
The assessment of the person's ability to provide informed
consent should focus on the individual's ability to understand
the nature of the research, appreciate the consequences
of participation in the study and understand alternative
choices. The person's ability to make an informed decision
will be affected by the progression of the disease. From
time to time, throughout the assessment, the person's
agreement to participate must be re-confirmed.
Some
factors to consider
- Role
of the substitute decision-maker
When
the person with Alzheimer's disease becomes unable
to provide informed consent, consent must be requested
or sought from a substitute decision-maker. The substitute
decision-maker may be appointed by the person or
by the courts. Laws about substitute decision-making
and participation in research vary from province
to province.
The
wishes of the person with Alzheimer's disease and those
of the substitute decision-maker may differ. The
research team has an obligation to determine, to
the best of its abilities, that the decision about
participation in research has been guided by the
wishes of the person with the disease. When that
cannot be determined, the decision should be made
with the person's best interests in mind.
- Balancing
the risks and benefits
Balancing
the risks and benefits of Alzheimer research is difficult
for all concerned. Levels of risk vary among studies.
Also, everyone has their own perception of risk.
Because of the frequent involvement of family caregivers
in Alzheimer research, analysis of the risks and
benefits should consider the effects of the research
on not only the participant but also the family members.
Local
ethics boards or committees have the task of evaluating
the risks and benefits of studies and take this into
account when deciding if a study can be approved.
Information about risks and benefits is then passed
on to the person and/or the substitute decision-maker
through the informed consent process.
Throughout
the course of the research, everyone involved should
continue to evaluate the balance between the risks
and benefits and re-confirm the commitment of individuals
and families to continue participation in the research.
- Separating
medical care from research
The
dividing line between the health-care professional's
management of a person's health care and the commitment
to research must be clearly understood by everyone.
Provision of the best medical care is the priority
and must not conflict with participation in research.
- Equitable
participation
All
people with Alzheimer's disease, no matter where they
may be in the disease process, should have the opportunity
to participate in research. However, for safety reasons
and for the scientific soundness of the study, each
study will have its own objectives and specific criteria
defining who can and cannot participate in the study.
People have the right to decide to participate or
not participate in a study. They also have the right
to withdraw from a study, at any time, without the
decision having a negative effect on their health
care.
- Ongoing
communication
It
is essential that the research team maintain an ongoing
dialogue with the person with Alzheimer's disease,
family members and health-care professionals throughout
the research process. The type and frequency of communication
will vary, depending on the research study. Everyone
involved should be given a summary of the outcome
of the study when it is completed.
In
closing...
Advancing
our knowledge of Alzheimer's disease and developing effective
treatments requires an open dialogue among everyone involved
in research to ensure that the interest of the person
with Alzheimer's disease remains a priority at all times.
Resources:
- Contact
your local Alzheimer
Society for province-specific information on:
Substitute decision-making for health care
- Tri-Council
Policy Statement: Ethical Conduct for Research Involving
Humans. Medical Research Council of Canada et
al., October, 1999.
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