Review of "Generic" Materials
"Generic" materials include items that an investigator would like to use outside
of the context of a specific protocol, or materials that a sponsor/CRO/SMO would
like to use that don't identify any one specific investigator and/or protocol. Common
types of generic materials include:
- Generic Advertising, including Brochures, AV Media, Web Content
- Generic Pre-Study Screening Consent Forms
- Generic Telephone Screening Scripts
- Generic Consents for Photography
Generic Consent Forms
Generic consent forms should contain all the usual consent form elements defined
in federal regulations and guidance. As much detail as possible should be included.
Many times general research participation information will be included, with a listing
of types of research the investigator is conducting.
WIRB imposes the following limitations on pre-screening activities:
- Pre-study screening done outside of a specific research protocol should be limited
to minimal risk procedures.
- Current treatment or medications should not be adjusted in order to do the screening.
Accordingly, prospective subjects should not undergo a washout or biopsy as a generic
pre-screening activity; instead, the subject should be fully consented for the related
protocol before beginning that protocol's screening activities.
Generic Advertisements
WIRB reviews "generic" advertisements linked to a company or an investigator and
protocol-specific generics that do not contain any site-specific information. Approval
documents for generic advertisements are transmitted to the submitter; courtesy
copies of generic advertisements will not be distributed to multiple sites or investigators.
Unless subjects at all sites (and/or participating in all protocols) receive the
same payment for every study visit, it is wise to omit dollar amounts from generic
advertisements. A general statement such as "subjects will be paid for their participation"
is recommended instead.
Changes to approved generic materials must be reviewed and approved before use.
Expiration and Renewal of Generic Materials
Approved generic items are valid for one year. When the anniversary date approaches,
WIRB staff will contact the submitter and inquire if renewal is desired. WIRB will
conduct an annual review of the item if a response is not received by the date cited
in the correspondence to ensure continued use is valid and under IRB oversight.
Study Renewal Review fees apply. Expired generic items cannot be used. To prevent
unnecessary renewal reviews, notify WIRB when use of the generic material has ended.
Occasionally, the Board may modify an item during the renewal review, usually due
to changes in regulatory guidance or Board policy. Board-directed modifications
are indicated in the approval documentation provided to the submitter.
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