Advertising ||
Scripts ||
Follow-ups
The IRB considers recruitment of subjects to be all
procedures that take place from the first contact with a
potential subject to the point when they enroll in a study or
return a completed survey. This includes follow-up contacts, or
"nudges", used as reminders to complete mail, e-mail, or
telephone surveys.
Following are policies regarding advertising that may be
used, be it paper or oral, and the number of follow-up contacts
that will be allowed. Any deviations to these policies must be
submitted with justification for the need and are subject to
review by the full committee.
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, bulletin boards,
posters, and flyers that are intended for prospective subjects.
Also included are “dear doctor” letters when soliciting for
study subjects. Not included are: (1) news stories and (2)
publicity intended for other audiences, such as financial page
advertisements directed toward prospective investors.
The IRB 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. When the investigator
decides at a later date to advertise for subjects, the
advertising requires an amendment to the ongoing study. If such
advertisements are easily compared to the approved consent
document, the IRB chair, or other designated IRB member, may
review and approve the advertising document by expedited
procedures. If the IRB reviewer has doubts, or other
complicating issues are involved, the advertising will be
reviewed at a convened meeting of the IRB.
The IRB reviews 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 will 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 will 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
will review the final audio/video tape. The IRB may review and
approve the wording of the advertisement prior to taping. The
review of the final taped message prepared from IRB approved
text may be accomplished through expedited procedures. The IRB
cautions investigators to obtain IRB approval of message text
prior to taping, in order to avoid having to re-tape because of
a finding of inappropriate wording.
For clinical studies, 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
federal 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, 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 the IRB does not require
inclusion of all of the listed items.
- the name and address of the investigator and/or
research facility;
- the condition under study and/or the purpose of the
research;
- in summary form, the criteria that will be used to
determine eligibility for the study;
- a brief list of participation benefits, if any
(e.g., a no-cost health examination);
- the time or other commitment required of the
subjects; and
- the location of the research and the person or
office to contact for further information.
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B. Receptionist Scripts:
Often, the first contact a prospective study subject makes is
with a receptionist who follows a script to determine basic
eligibility for the specific study. The IRB will assure the
procedures followed adequately protect the rights and welfare of
prospective subjects. In some cases, personal and sensitive
information is gathered about the individual. The IRB should
have assurance that the information will be appropriately
handled. A simple statement such as "confidentiality will be
maintained" does not adequately inform the IRB of the procedures
that will be used.
Examples of issues that should be reviewed: What happens to
personal information if the caller ends the interview or simply
hangs up? Are the data gathered by a marketing company? If so,
are names, etc. sold to others? Are names of non-eligibles
maintained in case they would qualify for another study? Are
paper copies of records shredded or are readable copies put out
as trash? The acceptability of the procedures would depend on
the sensitivity of the data gathered, including personal,
medical and financial information.
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C. Follow-ups:
The IRB will generally allow 5 contacts with potential
subjects in mail, e-mail, or telephone surveys.
- Pre-contact postcard/letter
- Information sheet and survey
- Follow-up postcard/letter
- Second mailing of survey
- Telephone contact
After the telephone contact (actually speaking with a person,
as opposed to leaving a message), any further contact would be
with stipulations such as the caller verbally agrees to be
re-contacted in a couple of weeks by a postcard reminder if the
survey is not returned. The potential subject must explicitly
agree to any further follow-up. For example, in the telephone
contact, when the potential subject has agreed to have another
survey sent, the researcher could ask: "Could we call you again
in 2-3 weeks to remind you to return the survey?" or "Could we
send you a card in 2-3 weeks to remind you to return the
survey?" Anytime a referral to a more appropriate potential
subject is made, then the recruitment procedure can go back to
item one and start over.
All possible follow-up procedures must be approved by the IRB
first. Procedures requested outside of this policy will be
evaluated on a case by case basis. |
