Chapter 45

Review of “Generic” Materials

“Generic” materials include items that an investigator wishes to use outside of the context of a specific protocol, or materials that a sponsor/CRO/SMO would like to use that do not identify any one specific investigator and/or protocol, and do not include research procedures. Common types of generic materials include:

  • Generic Advertising, including Brochures, audio-visual materials, Web Content
  • Generic Telephone Screening Scripts
  • Generic Photography releases

Changes to approved generic materials must be reviewed and approved before use. Please note that generic document approvals are not linked to specific research protocols by the IRB, so board reviewers may have questions about documents referenced in submissions that were previously approved as generic documents. Please consider noting any previously approved generic documents related to new submissions in a cover letter.

As consent forms for IRB review are to obtain agreement for research procedures, they are only reviewable in the context of a description of those procedures. Therefore, pre-screening programs and similar kinds of activities should be submitted with a protocol that describes the activities to which participants are consenting through the new research submission process. 

Accordingly, prospective participants should not have current treatment or medications adjusted, undergo a washout, or have a biopsy as a pre-screening activity. In those cases, the participant should be fully consented for the related protocol before beginning that protocol’s screening activities.

Generic Advertisements

WCG IRB 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 participants 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 “participants will be paid for their participation” is recommended instead.