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Recruitment methods, including advertisements, and
participant payment arrangements affect the equitable
selection of participants and an appropriate consent
process, and therefore relate to two criteria for
IRB approval.
A
research study may have fair selection criteria, but
use recruitment methods or payment arrangements that
lead to inequitable selection. For example, recruitment
methods, advertisements, or payment arrangements that
target economically disadvantaged participants can
lead to unfair selection of participants despite reasonable
selection criteria. Therefore, the IRB should evaluate
whether recruitment processes, advertisements, and
payment arrangements affect the equitable selection
of participants.
Recruitment
methods, advertising materials and payment arrangements
also represent a part of the consent process. Recruitment
methods and advertisements are the beginning of the
consent negotiations; payments for participation are
provided to reimburse participants for their time,
effort, or other expenses. Recruitment methods, advertisements,
or payment arrangements that are misleading, inaccurate,
exculpatory, coercive, or unduly influential violate
the regulatory requirements for consent. Therefore,
the IRB should review proposed recruitment processes
and advertising materials to judge whether they fulfill
the regulatory requirements for consent.
FDA
considers direct advertising for study subjects to
be the start of the informed consent and subject selection
process. Generally, advertisements should be reviewed
and approved by the IRB as part of the package for
initial review. The FDA expects IRBs to review the
advertising to assure that it is not unduly coercive
and does not promise a certainty of cure beyond what
is outlined in the consent and the protocol. This
is especially critical when a study may involve subjects
who are likely to be vulnerable to undue influence.
When
direct advertising is to be used, the IRB should review
the information contained in the advertisement and
the mode of its communication, to determine that the
procedure for recruiting subjects is not coercive
and does not state or imply a certainty of favorable
outcome or other benefits beyond what is outlined
in the consent document and the protocol. In the recruitment
materials, no claims should be made, either explicitly
or implicitly, that the drug, biologic or device is
safe or effective for the purposes under investigation,
or that the test article is known to be equivalent
or superior to any other drug, biologic or device.
Such representation would not only be misleading to
subjects but would also be a violation of the Agency's
regulations concerning the promotion of investigational
drugs
Advertising
for recruitment into investigational drug, biologic
or device studies should not use terms such as "new
treatment," "new medication" or "new
drug" without explaining that the test article
is investigational. A phrase such as "receive
new treatments" leads study subjects to believe
they will be receiving newly improved products of
proven worth.
Advertisements
should not promise "free medical treatment,"
when the intent is only to say subjects will not be
charged for taking part in the investigation. Advertisements
may state that subjects will be paid, but should not
emphasize the payment or the amount to be paid, by
such means as larger or bold type.
Generally,
FDA believes that any advertisement to recruit subjects
should be limited to the information the prospective
subjects need to determine their eligibility and interest.
When appropriately worded, the following items may
be included in advertisements. It should be noted,
however, that FDA does not require inclusion of all
of the listed items:
1.
The name and address of the clinical investigator
and/or research facility;
2. The condition under study and/or the purpose of
the research;
3. In summary form, the criteria that will be used
to determine eligibility for the study;
4. A brief list of participation benefits, if any
(e.g., a no-cost health examination);
5. The time or other commitment required of the subjects;
and
6. The location of the research and the person or
office to contact for further information.
Please
see the PHRC advertisement guidelines for more information:
http://healthcare.partners.org/phsirb/advert.htm
References:
FDA’s Information Sheets for IRBs
AAHRPP’s Evaluation Tool
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