|
The regulations governing IRBs require the following
as one of the criterion for approval of research:
“Selection
of subjects is equitable. In making this assessment
the IRB should take into account the purposes of the
research and the setting in which the research will
be conducted and should be particularly cognizant
of the special problems of research involving vulnerable
populations, such as children, prisoners, pregnant
women, mentally disabled persons, or economically
or educationally disadvantaged persons.”
As
IRB members we must evaluate whether the selection
criteria and recruitment practices meet this criterion.
In their educational materials, OHRP reminds us “Defining
the appropriate group of subjects for a research project
involves a variety of factors - requirements of scientific
design, susceptibility to risk, likelihood of benefit,
practicability, and considerations of fairness. IRBs
are required to make a specific determination that
the selection of subjects is equitable”.
OHRP
provides the following example: “Patients may also
be susceptible to real or imaginary pressure to participate.
If an investigator also serves as a patient's primary
physician, he or she may feel obliged to participate
in the research out of a desire to please, gratitude,
or fear that failure to do so will result in hostility
or abandonment. Patients who are dependent upon a
particular facility for their care (e.g., Veterans
Hospitals, Indian Health Service Hospitals, or community
health clinics) may feel that they will be treated
less well or with less favor if they refuse to participate
in research”.
And
finally, OHRP suggests: “With these caveats in mind,
investigators and IRBs must be careful not to overprotect
vulnerable populations so that they are excluded from
participating in research in which they wish to participate,
particularly where the research involves therapies
for conditions with no available treatments (such
as HIV). So too, patients with serious or poorly understood
disorders may want to participate frequently in research
designed to provide a better understanding of their
condition. The fact that the subject may be either
a patient of the principal investigator or a patient
in the clinic or hospital where the investigator conducts
the research should not preclude them from the opportunity
to choose to participate as often as they wish”.
During
our review and assessment of subject selection, we
should consider the following issues:
• The purposes of the research.
• The setting in which the research would be conducted.
• Whether prospective participants would be vulnerable
to coercion or undue influence.
• The selection (inclusion/exclusion) criteria.
• Participant recruitment and enrollment procedures.
• The amount and timing of payments to participants.
References:
AHRPP Evaluation Tool
OHRP Guidebook
|
