GUIDELINES
FOR ADVERTISEMENTS FOR RECRUITING SUBJECTS
Under Federal regulations, the Human Research Committee
must review and approve methods used to recruit subjects,
one of which is the use of advertisements in various media.
The Human Research Committee has prepared the following
guidelines to assist investigators in the preparation
of advertisements.
Recruitment
of Subjects through Advertising
Direct advertising for research subjects, i.e., advertising that is intended to be seen or heard by
prospective subjects, must be reviewed and approved by the PHRC prior to distribution, posting,
publication, or broadcasting. Direct advertising includes, but is not limited to, notices aimed at
recruiting research subjects that investigators intend to place in newspaper, radio, TV, bulletin boards
and the internet/world wide web. Advertisements developed by coordinating centers for multicenter
study recruitment also require PHRC approval if the MGH or BWH sites intend to enroll from among
the pool of prospective subjects responding to these ads. In addition, notices directed to clinical
colleagues seeking study referrals require PHRC approval. These include, but are not limited to,
letters, electronic and other postings, or notices in professional publications
Requests for approval of advertisements should specify the mode of advertisement and where the
advertisement is going to be placed/posted, e.g., newspapers, internet sites, T-stops, etc. The PHRC
must review and approve the final copy of text of print advertisements as the ad will appear in print in
the newspaper or other print media so the reviewer can assess the visual impact, emphasis and graphic
message. Similarly, the PHRC must review and approve the final copy of the script of the audio/video
tape that will be broadcast on radio or television. Note: Audio/video taped ads (for radio/television
broadcast) cannot be uploaded in Insight/eIRB. Contact your protocol administrator for
assistance.
Advertisements
should include:
- Name
of research facility;
- Purpose
of the research;
- Eligibility criteria (briefly stated);
- Duration of study and number of visits;
- Payment, if any, for participation;
- Contact
person for more information;
- The
word "research" somewhere prominent in the
advertisement.
Advertisements
should not include: (1) Claims, explicit or implicit,
that the drug, biologic or device is safe or effective
for the purposes under investigation or that the test
article (drug, biologic, device) is known to be equivalent
or superior to any other drug, biologic or device; and
(2) References to "new treatment", "new
medication" or "new drug" without explaining
that the drug, biologic or device is investigational.
All advertisements should be tastefully composed and not
inappropriately emphasize monetary remuneration. If you
wish to use BWH/MGH/Partners logos, contact Public Affairs
for relevant guidelines.
Do:
- USE
THE WORD "RESEARCH" in your advertisement,
the terms "Study" or "Treatment Study"
do not convey the same message
- Provide
information prospective subjects need to determine interest,
such as eligibility, significant study procedures, and
time commitment
- males,
females, adults, children, age range, taking no
medications, etc.
- x-rays,
MRIs, exercise testing, overnight stays, frequent
blood sampling, etc.
- duration
of study, number of visits and/or length of visits,
if only one or two visits
- Use
"healthy volunteers" instead of "normal
volunteers"
- Use
simple lay language without acronyms or abbreviations
unless these are well known to the public or to the
special patient group you are targeting, e.g., patients
with ALS or women with PMS will understand these abbreviations
- Provide
simple symptom complexes if you are looking for subjects
who do not already carry the diagnosis
- Provide
basic exclusion criteria whenever possible to reduce
unnecessary calls
- Use
the word "investigational " rather than "experimental"
- Name
drugs used if approved and/or known to the public, e.g.,
Aspirin, St. John's Wort
- Use
the words "at no cost" rather than "free"
where relevant
- Specify
amount of monetary compensation (if you wish)
- Use
the words "up to" if compensation
is pro-rated
- Specify
hospital affiliation (e.g. Cardiovascular Division,
BWH)
Don't:
- Feature
monetary compensation as a lead in before the description
of study purpose and procedures
- Bold,
italicize, underline or enlarge fonts on type describing
monetary compensation
- Imply
treatment benefit if the primary focus of the study
is safety and tolerability, drug kinetics, or basic
physiological processes rather than efficacy
- Imply
treatment benefit for chronic problems if the study
involves only short-term interventions
- Emphasize
no cost treatment if a placebo is involved (you don't
need to explicitly state that placebos are used in ads)
and/or the protocol involves drugs, biologics, or devices
not FDA approved for the condition under study
- Provide
detailed lists of risks and benefits (this should be
done in person)
- "Hype"
the study with overly optimistic or effusive language
implying benefit (commercially designed radio ads occasionally
do this)
- Use
words describing broader affiliations (e.g., "Harvard
researchers" or "Harvard Medical School Study")
which tend to mistakenly convey endorsement and/or direct
oversight of study treatments and procedures by the
university or medical school
Notices
or letters sent to other health care providers
When
seeking assistance of colleagues in referring patients
to you, include additional information about study design,
placebo, risks, and benefits. Provide enough information
for colleagues to reasonably present a study to their
patients.
Version Date: November 18, 2010
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