Advertising Guidelines
(IRB Reference Book: Protecting the People Who Volunteer to Participate in Research, M.K. Russell-Einhorn and Thomas Puglisi, 2001)
The IRB reviews all advertising as well as the method and location of its communications to assure that procedure protections are in place when recruiting participants through various forms of advertising.
Direct advertising includes the following but is not limited to:
- Newspaper
- Flyers
- Bulletin Boards
- Radio Advertisements
- Post-cards
- Press Releases
- TV
- Posters
- Radio Advertisements
- Brochures
- Internet Postings
Not included are:
- Communication targeted to health professionals, (e.g., "dear doctor" letters and doctor to doctor letters even when soliciting for study subjects;
- News stories,
- Publicly intended for non-subject audiences (e.g., financial advertisements for prospective investors.
The information in advertisements should be limited to information that the prospective participant needs to determine their eligibility and interest. The following guidelines are encouraged for advertising:
- (a) Information should be comprehensible and should not be misleading to subjects, especially when vulnerable populations are involved.
- (b) The advertisement should state the condition under study and/or the purpose of the research; a summary of the eligibility criteria; and the required time commitments.
- (c) The advertisement should provide the name and address of the investigator or research facility, the location of the research, and appropriate contact information (e.g. phone numbers).
- (d) A statement may be included if subjects will be paid or otherwise compensated but the advertisement should not emphasize (e.g., by large or bold type) the payment or the amount to be paid.
- (e) There should be no claims of favorable outcome or other benefits beyond what is described in the consent process and the protocol. Claims of superiority, safety, or effectiveness should NOT be made.
- (f) The words ("treatment" and "cure") should not be permitted in advertisements.
Additional Items for consideration:
- The IRB must review and approve all final advertising materials before implementation.
- If a researcher decides at a later date to advertise, an Amendment/Revision Form must be completed to the ongoing study and reviewed/approved under the Expedite process.
- The IRB must review the final copy of the advertisement to evaluate the relative size of the font used and other visual effects.
- For video and audiotape broadcast advertisements, IRB review and approval of the wording of the advertisement prior to taping is required to avoid inappropriate wording. This may be reviewed through an Expedite procedure.