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Subject Recruitment Materials (Ads, etc.)
General Information
Audio and Video Recruitment Materials
Ads for All Sites
Press Releases
Logos
Public service announcements and phone system "on hold" messages
Website Content
Recruitment materials that WIRB does not review
"Do's" and "Don'ts" for Recruitment Materials
The WIRB Change in Research/Subject
Recruitment Submission Form may be used to submit recruitment materials
for review after initial review of the research (use of the Change in Research/Subject
Recruitment Submission Form is optional, but is strongly recommended). As much as
possible, print ads should be submitted as they will appear in print, so that the
Board can assess the impact of design details such as photograpsh, other images,
and font sizes and styles.
WIRB does not allow physicians, study staff or subjects to offer or receive referral
fees for research under WIRB oversight. This is in accordance with the American
Medical Association Code of Medical Ethics (Policy
#E-6.03) which states, "Offering or accepting payment for referring patients
to research studies (finder's fees) is also unethical." Some states have laws that
ban such practices.
Most changes to approved advertisements must be reviewed by WIRB prior to their
use, particularly anything that could alter the impact of an advertisement previously
reviewed by the Board. Changes to approved advertisements that do not need to be
submitted for review include updates to phone numbers or contact names referenced
in an advertisement and corrections of spelling.
For best results, when submitting subject recruitment materials or other subject
materials (diaries, questionnaires, etc.) that have been previously reviewed by
WIRB, state in the cover letter that the items have been previously reviewed by
WIRB. WIRB support staff will provide the Board with information about the previous
Board review, so that the previous decision of the Board will be taken into account
when the materials are reviewed.
Information packets, patient brochures, sponsor brochures and informational videos
are all considered recruitment materials if they are intended to be seen by a potential
subject
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Audio and Video Recruitment Materials:
To avoid unnecessary additional productions costs due to re-work, it is strongly
recommended that WIRB approval of scripts for planned audio or visual recruitment
materials be obtained before producing the spots. Any Board-required modifications
to the material must be reflected in the final version of the recording.
When audio or video scripts are sent to WIRB for review, WIRB pre-reviews the script
and, if acceptable, finds the script "Approvable - As Modified" or "Approvable
- As Submitted." The submitter receives a letter documenting the Board's determination,
along with a copy of the script stamped with the WIRB "Approvable" stamp and displaying
the Board's modifications, if any. Recruitment materials found "approvable" will
not be considered "approved" until after the audio or video recording has been reviewed
by the Board. No additional fee is incurred for the review of recordings
if the script was previously found "approvable". The final recording MUST match
the WIRB approvable script. Submit a copy of the corresponding script bearing the
WIRB "approvable" stamp when you send the recording to WIRB for review.
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Ads for All Sites: Advertisements which will be used
by some or all participating investigators should be identified as such in the cover
letter or submission form. Identifying shared advertisements as such will help ensure
consistent review of materials for all participating sites.
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Press Releases: WIRB reviews submitted press releases as
advertising
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Logos: If the Board considers elements of a logo in an
advertisement to be coercive or overly reassuring, they will direct that the logo
be removed from the ad or be modified to eliminate the objectionable element(s).
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Public service announcements and phone system "on hold" messages:
Public service announcements and audio scripts of messages that will be broadcast
to callers who have been placed on hold are considered recruitment materials, and
will be reviewed by the Board and, if acceptable, approved either "as submitted"
or "as modified."
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Website Content: WIRB review requirements for web content
are dependent on the type of content in question:
- ClinicalTrials.gov-type sites which provide a limited set of pre-formatted fields
for inclusion of recruitment content do not need to be submitted for IRB review.
If requested, WIRB will review submissions of such content. FDA Guidance regarding
use of media advertising to recruit subjects can be found at http://www.fda.gov/oc/ohrt/irbs/toc4.html.
- Subject recruitment content on sponsor websites requires IRB review. Only the content
relevant to research should be submitted for review. It may be appropriate to request
WIRB review of these materials as generic
recruitment materials.
- Subject recruitment content on investigator or SMO websites requires IRB review.
Only content pertaining to research needs to be reviewed by the IRB. Submit to WIRB
only website content which provides information to potential subjects about research
participation, as well as information about specific studies that WIRB oversees.
General website information that does not relate to research participation, such
as disease information or driving directions to the research office, does not require
review.
WIRB does not review the content of the websites linked on submitted websites. The
website owner should ensure the links are appropriate.
The web site owner is responsible for making the Board-directed changes to reviewed
website content before using that content for recruitment.
Changes made to approved website content should be submitted for Board review before
the changes are posted to the web.
Website content can be reviewed either in relation to a specific protocol or as
generic recruitment material. If review is requested in the context of a specific
protocol, the material is re-reviewed at the time that the protocol is re-reviewed.
If the material is reviewed and approved as a generic, an expiration date is assigned
(usually a year from the approval), and the Board conducts re-review of the content
when the expiration date approaches, unless WIRB receives a request to close the
file.
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Recruitment materials that WIRB does not review
The FDA Information Sheets state:
- 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
Based on this guidance, WIRB does not require IRB review of doctor-to-doctor letters
or prior IRB review of interviews with the media (as noted previously, this does
not apply to "press releases").
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"Do's" and "Don'ts" for Recruitment Materials (Advertising)
Over time, WIRB has developed standards for ad review that are consistent with federal
guidance on recruitment materials, and which serve to maintain consistency in the
Board review of these materials. The following points summarize these standards
and serve as a guide to Board changes or disapprovals of recruitment materials.
Do:
- Comply with the guidance in the FDA Information Sheet, "Recruiting Study Subjects".
- Include a clear statement that the information concerns a research study.
- Include general information about who is eligible to participate.
- Provide information about how to find out more.
- Be conservative with the use of pictures, graphics, fonts and symbols
Don't:
- Do not state or imply that the FDA or IRB has approved the research.
- Do not refer to investigational drugs, devices, or procedures as "new,"
"safe," "effective," "a cure," "treatment" or "therapy."
- Do not call the investigational medication simply "medication" or
"drug"; qualify each use appropriately with "investigational" or "study"
as in "investigational medication" or "study medication."
- Do not emphasize payment to subjects or the word "free" (e.g., bold, large
font, dollar signs).
- Do not include payment amounts for studies involving underage subjects.
- Do not use the terms "confidential" or "completely private."
- Do not include exaggerated statements about the potential benefits of participating
in the research, receiving treatment from the investigator, or receiving treatment
from the organization
- Do not use the phrases "Enrollment Limited," "Study ends soon," or
"Call today!"
- Do not include the statements "You deserve to feel better," "Join this
study and take charge of your life," or similar phrases or logos.
- Do not include references to website recruitment content that has not been
reviewed and approved by an IRB.
- Do not include statements of implied safety and/or efficacy.
- Do not include inappropriate promises of benefit.
- Do not include misleading content.
- Do not use potentially coercive or reassuring graphics, pictures, fonts or
symbols.
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