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Preferred Consent Models for Secondary Uses of Biospecimens Among Diverse Women

2012-present

Background

The purpose of this study is to understand more about how women would like to be consented (asked) to allow their blood and tissue samples to be used in future research.

  • In 2011, the United States Department of Health and Human Services sought input on its decision to change the type of consent currently used to permit secondary use of biospecimens (blood, tissue, etc.).
  • There is a lack of data about public preferences for different models of informed consent, especially among minorities. Types of informed consent models currently include: notice; opt-out; broad consent; and study-specific consent.
  • Without information on how diverse populations want to be consented, research policies will only represent the wishes of a select few.
Overview

Our study has three aims, each designed to help us better understand what women are looking for in the informed consent process if their blood and tissue samples may be used for future research. These three aims will be completed one after the other over the next two and a half years.

  • Aim 1: We will interview women and ask them about their preferences for different models of informed consent. We will also ask them about factors that may affect their consent preferences. At completion, we will have interviewed 60 women. 
  • Aim 2: We will interview women and ask them about plain language consent forms that we will have developed using comments from women in Aim One interviews. At completion, we will have interviewed 36 women. 
  • Aim 3: We will test plain language informed consent documents for three consent models preferred by women and then look at how these consent models affect intentions to donate blood or tissue samples for future research. At completion, we will have surveyed 350 women for Aim Three.
Progress

Nearly all of the Aim 1 interviews have been completed. The project team is currently starting data analysis of this interview data, which will be used to construct the plain language consent documents for Aim 2.

Funding

National Cancer Institute at the National Institutes of Health (U54 CA153460-03S1)

Project Staff

Kimberly A. Kaphingst, ScD (Principal Investigator, Washington University)

Katherine Brown, MPH

Melissa Lovell, MPH

Ted Scheel, BA, Practicum student

Monami Majumder, BS, Practicum student

Contact Information

Katherine Brown, MPH
Phone: 314-747-3924
Email: brownk@wudosis.wustl.edu