# Presentation: 526078

## Informed Consent

- Jeremy Sugarman, MD, MPH, MA
- Phoebe R. Berman Bioethics Institute
- Johns Hopkins University

## Overview

- The evolution of informed consent
- The process of informed consent
- Obtaining evidence about informed consent

## The Evolution of Consent

- For Medical Treatment
- Patient litigation
- Laws and regulations
- For Research
- Early consent practices
- Infamous research

## Medical Treatment andThe Right to Liberty

-   “Every human being of adult years and sound mind has a right to determine what shall be done with his own body; and a surgeon who performs an operation without his patient’s consent commits an assault for which he is liable in damages.” *Schloendorff*

## Early Consent Practices for Research

- Sometimes recognized as important for research with volunteers
- Not necessarily free and voluntary
- Lack of consent central to the problems in a litany of infamous experiments
- Not typically recognized as relevant for patients enrolled in research

## Two Senses of Consent

- Autonomous authorization
- Social rules of consent

- Faden and Beauchamp

## Autonomous Authorization

- Arises from a littered history
- Respect for persons/autonomy
- Liberty interests

## Social Rules

- Consent of minors
- Special forms
- Witnesses

## The Process of Informed Consent

- Threshold
- Information
- Consent

## Threshold

- Decision making capacity
- Voluntariness

## Information

- Disclosure
- Understanding

## Content of Disclosure

- Nature of the proposed intervention
- Procedures and alternatives
- Potential risks and benefits
- Assurance that participation is voluntary
- Protection of confidentiality

## Information

- Disclosure
- Understanding

## Authorization

- An indication of agreement
- Consent forms
- Consistent with disclosure
- Readable

## An Empirical Imperative

- Clinical research is predicated on the notion that we need data to determine ‘truth’ and facilitate sound decision-making
- Ironically, methods of clinical research, including those designed to protect participants such as informed consent, are introduced without data regarding safety or efficacy
- Where relevant we need to evaluate these protections as we would any proposed clinical intervention

*Controlled Clinical Trials* 1999; 20:187-193

## Advisory Committee on Human Radiation Experiments

- Uncover the history of human radiation experiments between 1944 and 1974
- Examine cases of released radiation into the environment for research purposes
- Identify the ethical and scientific standards for evaluating these events
- Make recommendations to ensure that whatever wrongdoing may have occurred in the past cannot be repeated

## ACHRE’s Empirical Projects

- Review federal agency policies
- Examine contemporary research documents and consent forms
- Interview patients receiving out-patient medical care about their understanding of and attitudes towards medical research

## Methods

- Part 1: Brief Survey
- Interviewed 1,882 patients
- From medical oncology, cardiology, and radiation oncology waiting rooms
- Included 16 hospitals and 5 cities around the U.S.
- To determine beliefs and attitudes about medical research and to ask if they were, or ever had been, participants in medical research
- Paid $5.00

## Methods

- Part 2: In-Depth Interview
- Interviewed 103 patients
- All reported in Brief Survey that they were or had been in medical research
- To determine reasons for joining research and to describe their research experiences
- Paid $25.00

## DemographicsTotal Respondents = 1,882 (Response rate = 94.7%)

- Age > 59				53%
- White					80%
- African American			16%
- High School Graduates	54%
- College Graduates		25%

## IRB 1998;20:1-7. 

*IRB* 1998;20:1-7.

## EQUIC Study Chairs

- Phil Lavori, PhD
- Jeremy Sugarman, MD, MPH, MA

## Goals

- Create, field test, and validate an independent, real-time measure of the quality of informed consent encounters in actual clinical trials
- Develop specific interventions directed at improving the quality of informed consent
- Test interventions in CSP trials

## Expert Advisory Committee

- Membership
- Paul Appelbaum, MD
- Marguerite Hayes, MD
- Robert Pearlman, MD, MPH
- Findings
- Independent measurement
- Results confidential
- Evaluate IC process and not experience
- Not-interfere with research process
- Minimal burden
- Practical and simple

## EQUIC-Development Phase

- Telephone interview after “parent” study consent
- Brief Informed Consent Evaluation Protocol (BICEP)
- Substrate for all subsequent EQUIC studies

*Clinical Trials* 2005; 2:1-8

## EQUIC-DP Research Team

- Maryann Boeger, MBA - Program Manager
- Andres Busette - Research Health Scientist
- Carole Cain, PhD – Interviewer
- Eric Crawford - Interviewer
- Robert Edson, MS – Statistician
- Madhulika Gupta, MS – Interviewer
- Phil Lavori, PhD – Co-Principal Investigator
- Patrick Nisco, MA- Interviewer
- Lee Pickett, MS – Interviewer
- Jeremy Sugarman, MD – Co-Principal Investigator
- Carmen Tumialan-Lynas, MS - Interviewer

## EQUIC-DP Parent Studies

- 1. CSP 027 	FDG PET
- 2. CSP 403 	Shingles Vaccine
- 3. CSP 410 	FeAST
- 4. CSP 424 	COURAGE
- 5. CSP 453 	HOST
- 6. CSP 494 	PTSD and Women
- 7. CSP 499 	SELECT
- 8. CSP 719B 	Latent Prostate

## EQUIC-DP Participating Sites

_**Site**_**	****	****	**_**Study**_**         **_**Site**_**	****	****	**_**Study**_
- Ann Arbor, MI		CSP 424    Melbourne, FL	CSP 424
- Birmingham, AL		CSP 403    Minneapolis, MN  	CSP 403
- Buffalo, NY		CSP 027    Northport, NY     	CSP 403
- Durham, NC		CSP 424    Northport, NY     	CSP 499
- Houston, TX		CSP 410    Northport, NY     	CSP 719B
- Houston, TX		CSP 424    Reno, NV	      	CSP 410
- Indianapolis, IN		CSP 027    Seattle, WA        	CSP 424
- Lexington, KY		CSP 410    St. Louis, MO     	CSP 499
- Mayo Clinic		CSP 424    St. Louis, MO	CSP 719B
**13 VAMCs; 1 non-VAMC**

## EQUIC-DP Enrollment

- Total: 632 interviews completed
- BICEP-1
- 441 completed
- 8/21/00-7/31/01
- BICEP-2
- 191 completed
- 8/1/01-7/2/02

## EQUIC-DPSite Coordinators’ Reports

- 100% 	patient willingness to 					participate
- 98.9% 	“no difficulty with process”
- 99.5% 	“no difficulty with call”
- 95.4% 	“no difficulty reaching center”
- 98.4% 	“no interruption of clinic flow”
- 99.2% 	“no other difficulties”

## Degree of Disruption of Parent Study

- None		66.3%
- Mild		32.8
- Moderate 	 1
- Severe		 0

**Notes:**
Percentages don’t = 100

## Incremental Burden

- Site coordinators
- mean 14.2 min (std dev 9.6)
- Participants
- mean 10.9 min (std dev 7.8)

## Mean Timing of Interviews

- Completion of parent study IC and EQUIC IC: 19.8m (sd 28.0)
- EQUIC IC and initiation of call: 8.4m (sd 11.7)
- Duration of call: 8.8m (sd 3.6)
- Interview length: 7.7m (sd 2.9)

## Respondents’ Reports about Parent Study IC Process

- 95.1% received “just right” amount of information
- 99.3% remember signing consent form
- 99.8% “felt no pressure to consent”
- 98.4% “made a good decision to participate”
- 89.1% “completely satisfied with the IC process”

## Taking a Deeper Look

- Verbatim responses to selected items
- What is the primary purpose of the [parent study]?
- When can you stop participating in the [parent study]?
- Coding developed and refined during BICEP-1

## “What is the primary purpose of  [parent study]?” (n=191)

- _Code_
- Addresses a research question?
- Directed at an outcome to ultimately benefit others?
- Directed at an outcome to ultimately benefit self?
- Other?

- _Percent_
- 80
- 59
- 6
- 1

## “When can you stop participating in the [Parent Study]”

- _Code for clear appreciation of voluntariness_
- Yes
- No

- _Percent_
- 55
- 45

## Lessons

- BICEP is well-tolerated, by participants and staff
- BICEP imposes minimal burden
- Verbatim coding is reliable
- Patients who consent are uniformly satisfied with the process, but inspection of verbatims reveals considerable room for improvement, especially in the “therapeutic misconception”
- Innovations have scope to work

## Next Steps

- EQUIC-SM (Self-Monitoring)
- Consider other uses for BICEP and develop new interventions** **

## Concluding Comments

*Respect for persons* is manifest in the expectations of a meaningful informed consent process
- Meeting this obligation can be enhanced with the use of data about the consent process

## References

- Sugarman J, Kass NE, Goodman SN, Perentesis P, Fernandes P, Faden RR. What patients say about medical research. *IRB* 1998;20:1-7.
- Lavori PW, Sugarman J, Hays MT, Feussner JR. Improving informed consent in clinical trials: a duty to experiment. *Controlled Clinical Trials* 1999; 20:187-193.
- Sugarman J, Lavori PW, Boeger M, Cain C, Edson R, Morrison V, Yeh SS. Evaluating the quality of informed consent. *Clinical Trials* 2005; 2:1-8.