Improving Minority Participation in Clinical Research: Designing a new role of “consent educators”

1. Improving Minority Participation in Clinical Research: Designing a new role of “consent educators” Elizabeth Cohn, RN, DNSc Elaine Larson, RN, PhD School of Nursing Columbia University Improving Minority Participation in Clinical Trials. Cohn, Columbia University 2010

2. Barriers to participation in clinical research • Women and minorities are been under-represented in clinical research (Hussain-Gambles, Atkin, and Leese, 2004). • The process of informed consent has left a legacy of mistrust in the medical community, especially among African Americans. (Corbie-Smith, Thomas, Williams & Moody-Ayers, 1999). • We examined the process of informed consent as a possible barrier to participation.

3. History of Informed Consent • Inadequate informed consent practices and historical incidents such as Nuremberg and Tuskegee have left religious and ethnic populations with feelings of exploitation (Corbie-Smith, Thomas, Williams & Moody-Ayers, 1999), distrust and stigma (Moutsiakis & Chin, 2007), and fear that the medical community is not being honest with them (Cao, Sullivan, Xu, & Wu, 2006).

4. This topic is highly relevant in the current press as well.

5. The process of consent continues to be flawed • Despite legal and ethical mandates such as the Declaration of Helsinki (1964), the Belmont Commission (1979), and increased scrutiny by institutional review boards -- most research participants still lack understanding of the research in which they have agreed to participate.

6. Flaws in communication during consent exacerbate mistrust

7. Significance of this study • This under-representation results in treatments and interventions that do not account of distinctive characteristics of women and minorities (Cohn, 2007). • We examined the informed consent process, considering issues of trust, communication, gender and race.

8. Study Aims • Aim 1: To develop and test an observational tool to assess the informed consent encounter in clinical research. • Aim 2: To develop a set of standardized vignettes (in the form of DVDs) to be used to establish the psychometrics of the tool.

9. We developed a model for the consent interaction. Information Informed Consent Communication A successful consent interaction (overlapping area) delivers information mandated by the Department of Health and Human Services, and fosters communication by following CLAS guidelines. Cohn and Larson, 2009

10. DVD scenarios We scripted and professionally filmed 8 DVD scenarios. Each scenario portrayed an encounter between a researcher and a patient being consented for a study. They varied in length from 2.5 minutes to 6 minutes.

11. The DVD’s differ in the quality of the encounter, and in the types people portrayed. • The quality of consent process • Skills of communication • Accuracy of information • Race • Ethnicity • Age

12. Items represented on the Process-Quality of Informed Consent (PQIC) • 20 items total • 11 items were derived from the legally required elements of informed consent for clinical research (DHHS) • 7 items were derived from the CLAS Guidelines. • 2 items represented factors identified in the literature: • the use of the 'playback technique’ and • the ability to read or have the consent form read to the participant. • Four-point Likert scale

13. PQIC Validated • We performed reliability and validity testing on the 20-item PQIC with 63 participants watching the DVDs and rating them. • After initial pilot work the PQIC was sent to Morehouse School of Medicine in Atlanta and the tool was further refined. • After the PQIC was validated we observed actual consents for research in New York Presbyterian Hospital across disciplines of medicine and surgery.

14. Workshop Development • Based on our findings we developed a 1.5 hour interactive workshop. • The workshop focused on minority patients’ issues of trust in researchers, and the clear communication of honest information.

15. Workshop: Becoming a Consent Educator • The workshop further re-defined the research coordinator as a ‘consent educator’. We advocate the use of a ‘playback’ where, at the end of the consent, the participant repeats back the study purpose and expectations in their own words. We offer this workshop monthly as part of the IRB training at Columbia University. • A complete description of the training can be found in: Larson, E.L., Cohn E. G., Meyer, D. and Boden-Albala, B. (2009). Consent Administrator Training to Reduce Disparities in Research Participation. Journal of Nursing Scholarship, 41, (1) 95-103

16. Results of validity testing of the PQIC

17. Conclusion continued The PQIC is a valid and reliable psychometrically tested tool for the observation of informed consent for clinical research.

18. Summary • An improved informed consent process will help build trust and increase the representation of participants. Improved representation would result in findings and policies that were more sensitive to the needs of those being served, and that could be implemented in ways that would reach the intended constituency. • Improved consent will provide researchers and clinicians with results and solutions that will take into account the political, social, and individual factors that influence the development and treatment of disease (Cohn, 2007).

19. Tools to improve informed consent • We developed: • a series of DVDs • a validated measurement tool • a 1.5 hours workshop offered to improve the informed consent process and increase recruitment and retention of minorities in clinical research • Contact email: ec2341@columbia.edu