If a site uses a receptionist to screen subjects for studies, must the script he/she uses be reviewed by the IRB?

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The first contact prospective study subjects make is often with a receptionist who follows a script to determine basic eligibility for the specific study. The script should be reviewed by the IRB to assure the procedures followed adequately protect the rights and welfare of the prospective subjects. In some cases, personal and sensitive information is gathered about the individual. The IRB should have assurance that the information will be appropriately handled. A simple statement such as "confidentiality will be maintained" does not adequately inform the IRB of the procedures that will be used.

Examples of issues that are appropriate for IRB review:

  • What happens to personal information if the caller ends the interview or simply hangs up?
  • Are the data gathered by a marketing company? If so, are names, etc. sold to others?
  • Are names of non-eligibles maintained in case they would qualify for another study?
  • Are paper copies of records shredded or are readable copies put out as trash?

The acceptability of the procedures would depend on the sensitivity of the data gathered, including personal, medical and financial.

About the Author
Proxima CRO Team
Stephanie Mull
Director of Project Management

Stephanie has over 20 years of clinical research experience working from the site, CRO and sponsor perspectives. She graduated Summa Cum Laude from Concordia University in St. Paul, MN, with a degree in Natural Science - biology and math.

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