Remuneration
for Research Subjects
Research
subjects may be compensated for the time and effort they
devote to clinical studies. It is not necessary, required,
or desirable that all subjects involved in clinical research
receive monetary compensation for their participation.
Some subjects derive medical benefit as a result of their
participation; some subjects volunteer out of altruism,
a desire to further medical research into diseases that
affect them and their families, or for other personal
reasons. Even when subjects derive medical benefit from
participation, it is often the case that extra hospital
visits, meals at the hospital, parking fees or other inconveniences
will result in additional out-of-pocket expenses related
to study participation. Therefore many investigators reimburse
these and similar expenses for research subjects routinely,
when funding is available, either with or without a small
additional stipend as compensation for the individual's
time. Often it is not possible to compensate very ill
subjects, pediatric subjects, or those with rare diseases
for their unique and generous contributions to medical
research. Sometimes compensation may represent only a
small symbolic gesture in recognition of the major contributions
that these individuals make to research, and it is hoped,
to the health of future patients.
Most
often healthy volunteers who will derive no medical benefit
from their participation in the research study are compensated
reasonably for the time they devote to research projects.
Monetary compensation is not intended to be the only motivating
force to induce subjects to participate. The goal of IRB
oversight of research subject compensation is to ensure
that stipends paid to research subjects provide fair compensation
without undue pressure (coercion) to participate. Excessive
monetary compensation may cause subjects to undertake
risks or discomforts that they otherwise would not assume.
This unfairly targets subjects of lower socioeconomic
groups and places more of the "risk burden"
of medical research on these groups. In the case of healthy
volunteer studies, the IRB is often in the position of
suggesting decreased compensation over that suggested
by investigators, in an effort to decrease the element
of financial coercion.
Prorated
Compensation
It
is a general policy that compensation for participation
in research projects is pro-rated according to the amount
of time devoted to the project. Research subjects have
the right to withdraw from a study at any time, for any
reason. In many protocols where completion of all visits
or procedures is paramount, there is some element of "incentive"
provided by withholding some compensation until the end
of the study, or providing a "bonus" for completion
of all segments of the study. Such procedures should be
explained and rationalized in detail in the research protocol,
and clearly outlined in the informed consent documents.
Particularly where discomforts, stress or risks are involved,
it is not acceptable to withhold all compensation from
an individual who made a good faith effort to participate,
but withdrew prior to completion of all of the study procedures.
It may be appropriate to pay compensation to subjects
in "installments", provide parking or meal vouchers
with each visit, or in other ways compensate healthy volunteers
in a "rolling" fashion based upon ongoing participation
in the study.
Compensation
for Minors
Appropriate
compensation of minor subjects involves additional considerations
and may be viewed differently for children and adolescents.
While it may be acceptable to compensate some adolescents
monetarily, similar to adults, it may be more appropriate
to compensate younger children in another manner. Monetary
compensation for participation of younger children may
be provided to the parents for the time and inconvenience
to them associated with their child's participation. Although
parents will have expenses for travel, babysitting for
siblings, time off work to bring children in for appointments,
it should be recognized that the children are the research
subjects. They may undergo stress, discomfort or inconvenience
as a result of participation in research studies, and
there should be some effort made to compensate the children
directly and personally. Usually the committee recommends
that compensation for younger children can take the form
of a gift certificate to a toy store or children's bookstore
or other item of particular interest to the age group
being studied.
Parking
and Parking Vouchers
We
recommend you provide parking vouchers whenever possible
so subjects do not need to be reimbursed at a later time
or be concerned about having enough cash on hand to pay
hourly parking rates, which are high at Partners institutions.
If vouchers are given, note this on your forms or submission:
e.g. Parking: (voucher). If a single payment is given
to cover a stipend and transportation costs, as is the
case in some studies, this could be noted as: $75 to compensate
for time and parking expenses.
Suggested
Monetary Compensation for Certain Routine Research Procedures
In
an effort to guide investigators, a list of approximate
monetary compensations for a variety of frequently performed
clinical activities is listed below. This list is meant
to guide investigators, and is based upon active protocols
currently approved by the Human Research Committee. Although
not every procedure is listed, these amounts may guide
investigators by allowing comparison of new procedures
with these in terms of time and discomfort. There may
be some cases in which no compensation is warranted or
needed. There may be special instances where modifications
of these procedures might merit additional compensation.
Investigators are welcome to contact the Human Research
Committee offices and staff if additional guidance is
needed.
Suggested
Monetary Compensation |
Blood
draw for research purposes from healthy volunteer
subjects |
$5
- 25 |
Noninvasive
psychological testing or memory tasks, pencil paper
activities |
$5
– 30/hr |
Focus
groups (1-3 hrs) |
$20
– 75 |
Outpatient
visit: depending upon time, discomfort, inconvenience,
need to take medications, bringing in timed samples
(e.g. 24 h urine collections), diary completion
or other activities beyond simply appearing for
the visit |
$30
– 75 |
Laser/UV
treatments with no direct benefit to subjects
|
$30
– 75/visit |
Skin
biopsy |
$50
|
Muscle
biopsy, at the higher end of the range if special
preparation required |
$50
- 100 |
MRI
scan, depending upon duration of scan and use of
contrast agent |
$50
– 200 |
Oral
glucose tolerance test or other infusion tests,
more if special preparation or diet required
|
$50
– 150 |
Lumbar
Puncture |
$100
|
24
hour stay in sleep center or clinical research center,
for relatively non-invasive activities: blood draws,
IV lines, vital signs or other non-invasive clinical
monitoring |
$100
– 200/ 24 hour stay |
Bronchoscopy
with lavage in healthy volunteer subjects
|
$150
– 300 |
PET
scan with radiolabelled material, more if arterial
or IV line placed |
$200
– 300 |
Swan
Ganz catheter placement in healthy volunteer subjects
|
$200
– 400 |
|