Recruiting
Study Subjects
FDA requires
that an Institutional Review Board (IRB) review and have authority
to approve, require modifications in, or disapprove all research activities
covered by the IRB regulations [21 CFR 56.109(a)]. An IRB is required
to ensure that appropriate safeguards exist to protect the rights and
welfare of research subjects [21 CFR 56.107(a) and 56.111]. In fulfilling
these responsibilities, an IRB is expected to review all the research
documents and activities that bear directly on the rights and welfare
of the subjects of proposed research. The protocol, the consent document
and, for studies conducted under the Investigational New Drug (IND)
regulations, the investigator's brochure are examples of documents
that the IRB should review. The IRB should also review the methods
and material that investigators propose to use to recruit subjects.
A.
Media Advertising:
Direct
advertising for research subjects, i.e., advertising that is intended
to be seen or heard by prospective subjects to solicit their participation
in a study, is not in and of itself, an objectionable practice. Direct
advertising includes, but is not necessarily limited to: newspaper,
radio, TV, bulletin boards, posters, and flyers that are intended for
prospective subjects. Not included are: (1) communications
intended to be seen or heard by health professionals, such as "dear
doctor" letters and doctor-to-doctor letters (even when soliciting
for study subjects), (2) news stories and (3) publicity intended for
other audiences, such as financial page advertisements directed toward
prospective investors.
IRB review
and approval of listings of clinical trials on the internet would provide
no additional safeguard and is not required when the system format
limits the information provided to basic trial information, such as:
the title; purpose of the study; protocol summary; basic eligibility
criteria; study site location(s); and how to contact the site for further
information. Examples of clinical trial listing services that do not
require prospective IRB approval include the National Cancer Institute's
cancer clinical trial listing (PDQ) and the government-sponsored AIDS
Clinical Trials Information Service (ACTIS). However, when the opportunity
to add additional descriptive information is not precluded by the data
base system, IRB review and approval may assure that the additional
information does not promise or imply a certainty of cure or other
benefit beyond what is contained in the protocol and the informed consent
document.
FDA considers
direct advertising for study subjects to be the start of the informed
consent and subject selection process. Advertisements should be reviewed
and approved by the IRB as part of the package for initial review.
However, when the clinical investigator decides at a later date to
advertise for subjects, the advertising may be considered an amendment
to the ongoing study. When such advertisements are easily compared
to the approved consent document, the IRB chair, or other designated
IRB member, may review and approve by expedited means, as provided
by 21 CFR 56.110(b)(2). When the IRB reviewer has doubts or other complicating
issues are involved, the advertising should be reviewed at a convened
meeting of the IRB.
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.
[21 CFR 50.20, 50.25, 56.111(a)(3), 56.111(b) and 812.20(b)(11).]
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. The
IRB should review the final copy of printed advertisements to evaluate
the relative size of type used and other visual effects. When advertisements
are to be taped for broadcast, the IRB should review the final audio/video
tape. The IRB may review and approve the wording of the advertisement
prior to taping to preclude re-taping because of inappropriate wording.
The review of the final taped message prepared from IRB-approved text
may be accomplished through expedited procedures. The IRB may wish
to caution the clinical investigators to obtain IRB approval of message
text prior to taping, in order to avoid re-taping because of inappropriate
wording.
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 [21 CFR
312.7(a)] and of investigational devices [21 CFR 812.7(d)].
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.
