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The Clinical and Translational Science Awards (CTSA) is a registered trademark of DHHS. The Clinical and Translational Science Awards (CTSA) is a registered trademark of DHHS.

Influence of Financial Interests Disclosures in Informed Consent Documents on Decision Making

by Participants in Psychiatry Clinical Trials

Michael Linke Ph.D., C.I.P. Chair University of Cincinnati IRB

http://www.uchealth.com/


The Clinical and Translational Science Awards (CTSA) is a registered trademark of DHHS.

Purpose To examine how participants in actual

clinical trials perceive information on payments investigators might receive from companies that is contained in real consent forms.



Hypothesis Information on payments to investigators

has a greater influence on the participants’ decision to enroll in a study than other information provided in the consent form.



Experimental Design and Methods

The UC IRB and Cincinnati Department of Veterans Affairs Medical Center Research and Development Committee approved this study.




• focused on fees and honoraria – consulting – lecturing – service on an advisory board – any other purpose not directly related to the

reasonable costs of conducting the research




• most common types of financial relationships • difficult to manage. • disclosure most widely used management technique • unclear whether disclosure provides useful information



Experimental Design and Methods • Participants recruited from three clinical trials

• included financial disclosure information

• enrolled enough participants

• provided for recontact

• enrolled both adults and minors

• NIH funded all three clinical trials



Parent Studies Quetiapine Plus Topiramate for Bipolar Mania and

Alcohol /Cannabis Use in Adolescents • to study the effects of combining quetiapine and

topiramate for treating symptoms of bipolar mania and reducing use of alcohol/cannabis

• examine how bipolar disorder and alcohol/cannabis use effects brain chemicals and function



Parent Studies Quetiapine Plus Topiramate for Bipolar Mania and

Alcohol/Cannabis Use in Adolescents “The study doctors have received payments from Astra

Zeneca. They serve as speakers and consultants for the company. Astra Zeneca makes quetiapine but Astra Zeneca is not providing financial support for this study. This disclosure is made so that you can decide if these relationships will affect your willingness to participate in this study “



Parent Studies Functional and Neurochemical Brain Changes

Following Successful Treatment of Early Course Bipolar Depression.

• to study brain structure, function and chemistry of patients with bipolar disorder who are receiving quetiapine or lithium,

• in order to better understand who benefits from treatment and why they respond to medications.



Parent Studies Functional and Neurochemical Brain Changes

Following Successful Treatment of Early Course Bipolar Depression.

“Quetiapine is made by the drug company Astra Zeneca.

The study doctors have been paid by Astra Zeneca provide advice and to give lectures. Some of these payments may be perceived as significant. Astra Zeneca is not providing financial support for this study.”



Experimental Design and Methods Recruitment • contacted by mail

– basic study information – phone number for more information

• contacted by phone – explain study – obtain consent – collect demographic information – administer questionnaire – $25 compensation




• 96 potential participants identified • 34/96 (35%) were successfully contacted • 3/34 (9%) declined to participate • 31 participants completed the telephone interview

– 21 guardians – 10 adult participants



Demographics Median range

Age 44 18-66

Number Percentage Race White 24 77.4

Black 5 16.1 Other 2 6.5 Education level High school 15 48.4

Some college 8 25.8 College degree 6 19.4

Graduate degree 2 6.5 Household income <$15,000 6 19.4

$15 - $44,999 6 19.4 $45- $99,999 10 32.3 >$100, 000 4 12.9

No answer 5 16.1 Participant type Guardian 21 64.5 Participant 10 32.3




• How influential was the information • How well the participants recalled information • Five point Likert scale • Questionnaire validated and finalized • Data collected using Research Electronic Data Capture

(REDCap) software (Vanderbilt University, Nashville, TN)



How influential is information?

• that there might be risks related to their participation in the study?

• on rights as a participant? • about the reason why the study is being done? • that study doctors received payments from a drug

company? • on the benefits?



How influential is information?

1. Very Influential 2. Influential 3. Moderately Influential 4. Slightly Influential 5. Not at all Influential.



Influence of Information

0% 20% 40% 60% 80% 100%

Payments

Reason

Benefits

Health risks

Rights

Very Influential Influential Moderately InfluentialSlightly Influential Not at all Influential No response



Recall of Information

• reason why the research was being done? • about any risks to your health related to

participating in this study? • about any benefits that you would receive by

taking part in the study? • that some of the study doctors received payments

from a pharmaceutical company? • what your rights were as a participant in the study?



Recall of Information

20

20

32

68

84

92

92

72

64

36

20

12

8

8

8

16

32

12

4

0

0

0% 20% 40% 60% 80% 100%

No direct benefit

Payments

Unknown risks

Specific risks

Any Benefits

Future benefits

Leave the study

Yes No Do not remember



Conclusions • Information about risks and rights have the greatest

influence on a decision whether or not to participate in a study.

• Disclosure of payments does not substantially affect most participants’ decision to enroll in a clinical trial.

• Many participants may not comprehend or understand information presented in consent forms on payments to investigators.



Conclusions • Disclosure language is not the only piece of information

in the informed consent documents that participants have problems understanding

• What participants recall from the consent process does not always reflect the real content of the informed consent document itself.



Limitations • Parent protocols were sponsored by the NIH and not a

pharmaceutical company. • Parents/guardians and actual participants were surveyed • Participants that opted not to take part in this study might

have different perceptions



Future Directions • Conduct debriefing interviews to develop a better

understanding of the informed consent process and how it relates to information provide in the informed consent document.

• Considering implementation a mandatory post-consent process comprehension evaluation procedure for all studies



Support • NIH Institutional Clinical and Translational Science

Award (CTSA) through the Center for Clinical and Translational Science and Training (CCTST) at the University of Cincinnati Academic Health Center

• Grant Support for REDCap provided throughUL1-RR026314-01 NCRR/NIH



Collaborators • Danielle Poynter, BS, Graduate Student University of Missouri Department

of Communication • Caleb Adler, MD, Associate Professor of Clinical Psychiatry and

Neuroscience, University of Cincinnati College of Medicine, Department of Psychiatry

• Melissa DelBello, MD, MS, Associate Professor of Psychiatry, Pediatrics and Psychology, University of Cincinnati College of Medicine, Department of Psychiatry

• John Lynch, PhD, Assistant Professor, University of Cincinnati, Clinical & Translational Research Ethicist, Center for Clinical and Translational Science and Training

• Kimberly Hart, MA, Data Analyst/Data Manager, University of Cincinnati College of Medicine, Department of Emergency Medicine

• Christopher Lindsell, PhD, Professor, University of Cincinnati College of Medicine, Department of Emergency Medicine
