Question of the week
QUESTION
I have several studies in my department for a particular group of people and:
- We would like to be able to present the studies during some community outreach events.
- In terms of study advertising, how would I be able to present the study information without requiring the IRB's approval?
ANSWER
Recruitment plans; advertisements or soliciting potential subjects for research must be reviewed and approved prior to implementing these recruitment practices. The investigator must obtain IRB approval for all television, radio, videotape or print advertisements, posters, flyers, handouts, e-mail solicitations, Internet websites, and other recruitment methods and materials intended for the recruitment of prospective subjects to a research protocol.
Under Federal regulations, an Institutional Review Board (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, MCW IRB must review and approve methods used to recruit subjects to ensure that the methods do not present an undue influence and that the confidentiality and privacy of potential subjects are maintained. Every protocol should include a recruitment section that clearly describes:
- How potential subjects are identified
- How and by whom subjects are approached about participation (if applicable)
- When consent is obtained in relation to the start of the study procedures (if applicable)
- Whether third parties (calling centers/centralized screening centers) will assist with recruitment of subjects for Partners' sites (if applicable)
It is important to be aware that the IRB considers recruitment methods are the first step in the informed consent process. FDA information sheets provide instruction to IRBs and Investigators indicating the following: the text of all 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 an IRB prior to distribution, posting, publication, or broadcasting. Direct advertising includes, but is not limited to newspaper, radio, TV, bulletin boards and the internet. IRB approval for recruitment materials is not required only in very specific circumstances. If the recruitment/advertisement will be posted on a website such as clinicaltrials.gov or the posting on a website only includes the following information:
- Study title.
- Purpose of the study.
- Protocol summary.
- Basic eligibility criteria.
- Study site location(s)
- How to contact the study site for further information
Other examples include the following which do not qualify as an advertisement and do not require IRB review:
- Communications intended only to be seen or heard by health professionals, such as letters to physicians.
- News stories where reporters or other non-study personnel are responsible for the final content, e.g. MCW Office of Public Affairs.
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