# Presentation: 002424

## Application of Ethical Principles During the Informed Consent Process for Clinical Trials

- Barbara E. Barnes, MD, MS
- Joanne Russell, MPPM
- Maurice Clifton, MD, MSEd
- David Barnard, PhD

- University of Pittsburgh School of Medicine

## Funded by

- Human Subject Research
- Enhancement Program
- S07 RR018239-02
- Department of Health and Human Services
- National Institutes of Health
- National Center for Research Resources

## Background

- Informed consent is the foundation for ethical research with human subjects
- Actual process presents many challenges
- Gulf between scientists and laypeople
- Required language in consent documents
- Psychological situation of patient-subjects

**Notes:**
Gulf includes literacy levels, 
Cultural differences

## Goals

- Develop communications skills curriculum for informed consent to research for clinical investigators and coordinators
- Demonstrate benchmark standards for ethical consent
- Interactive session to practice their skills
- Utilize their own protocols
- Focused feedback to the workshop participants on their communications skills
- Measure effect and satisfaction

## Tools

- Background reading
- Guidelines for ethical consent
- Behaviorally operationalize guidelines
- “Gold standard” video example
- Standardized Patient (SPs) cases

## Background Reading

- Pre-assigned reading material distributed three weeks prior to seminar
- Belmont Report
- Five articles on informed consent for research
- Course handouts

## Guidelines for Ethical Consent

- Content items and process items
- Formed basis for didactic curriculum
- Observer checklists (dichotomous)
- Content items
- Communication behaviors
- SP checklist (Likert)
- Communication behaviors

## Observer Content Checklist

- 27 items (Yes/No)
- Examples:
- Prognosis without treatment
- Review standard treatments,  including the no treatment option
- Advantages of standard treatment
- Disadvantages of standard treatment

## Observer communication checklist

- 14 items (Yes/No)
- Examples:
- Context:  Establishing a mutual understanding of the patient’s current situation
- Describe joint decision making
- Check preferred decision making style (involved or not)
- Check information preference of patient
- Assess medical knowledge

## SP communication checklist

- 14 items (Likert 1-5)
- Examples:
- The investigator provided opportunities for me to take an active role in the decision-making process.
- The investigator invited me to make comments about what I was told and invited me to ask him/her questions about things I did not completely understand.
-       Not at all               Some of the time           All of the time
**                   **1                2                3                4**                **5

## “Gold standard” Video Example

- Script written to include all positive behaviors
- 17 short clips integrated into didactic sessions
- 10 seconds – 2 minutes long

## Slide 12

## Standardized Patient (SPs) Cases

- Based on challenging but common subject types as perceived by the University’s Compliance Auditor
- Adapted to meet enrollment criteria of workshop participants’ studies

## Moderate Dementia

- Answers “yes” to all questions
- Doesn’t understand protocol

## Too Eager

- Already signed consent
- Medicine is hobby

## Adolescent

- Difficult to engage
- Sullen

## Distrustful

- African American
- Asks lots of questions

## Recruitment

- Email survey to faculty and staff on IRB email distribution list for faculty and staff involved in human subject research
- 200 responses
- 167 – yes   33 – no
- 90 registered
- 16 selected and submitted protocol
- (3 replaced)

## Participants

| Highest Level of Education | Registered | Invited | Participated |
| --- | --- | --- | --- |
|   PhD | 5 | 2 | 1 |
|   MD | 9 | 4 | 3 |
|   JD | 1 | 0 | 0 |
|   Masters | 33 | 6 | 4 |
|   Bachelors | 31 | 7 | 7 |
| Research Role |  |  |  |
|   Investigator | 15 | 6 | 4 |
|   Coordinator | 75 | 13 | 11 |

## Workshop Format

-   8:00 		Sign-In, breakfast
-   8:30 		Welcome
-   8:45		Video/pre-test
-   9:00		Lecture – Part I
- 10:00		Break
- 10:30		Lecture – Part II
- 11:30 		Instructions for SP Session and Lunch
- 12:45 		SP Session
-   2:45		Break
-   3:15		Feedback and Discussion
-   4:30		Video/post-test, Summary and Course Eval.

## Interactive Session with Standardized Patients

- 4 groups of participants
- Rotated through SPs so each participant:
- Presented their protocol to one SP of a given type
- Observed the other three present protocols to the other three SPs
- Gave feedback on the observed consents
- SPs gave feedback based on their subject type and communications checklist

## Results/Evaluation

## Pre-Post test

- Script written to include positive and negative behaviors
- 10 minute video consent developed using trained faculty member & SP
- Used same actors as “gold standard”
- Completed at beginning and end of workshop
- 1) Describe all the positive behaviors you observe
- 2) Describe all the behaviors which could be improved

## Slide 24

## Pre-Post Test

- Separated written comments into individual behaviors or ideas
- Qualitative methods to analyze comments
- 26 categories

## Participants recognized more behaviors in more categories

|  | Pre-test
mean (sd) | Post-test
mean (sd) |
| --- | --- | --- |
| Individual bits | 10.6 (4.2) | 13.0 (4.4)* |
| Individual concepts | 7.1(2.4)
 | 8.7 (2.7)** |

-  *p = 0.045
- **p = 0.029

- Mean number of new categories = 4.1

## Self-assessed Skills Increased

- %

- Rate your overall ability to use the communication skills required for obtaining a valid consent: (Likert 1- 5, 5 = excellent)

## Self-assessed Skills Stable at Three Months

|  | Day of training | 3 months later |
| --- | --- | --- |
| Before training | 3.6 | 3.7 |
| After training | 4.4* | 4.6** |

-  *p = 0.001
- **p = 0.000

- Rate your overall ability to use the communication skills
- required for obtaining a valid consent: (Likert 1- 5, 5 = excellent)

## Participants Liked the Course

- To what degree...

| (Likert 1-5, 5=high degree) | Mean |
| --- | --- |
| was the material new | 3.36 |
| was the information interesting   | 4.21 |
| did the course met expectations | 4.43 |
| will this course make positive difference in practice | 4.50 |

## Satisfaction Did Not Change at Three Months

| (Likert 1-5, 5=high degree) | Mean at course | Mean at 3 months |
| --- | --- | --- |
| met overall expectations | 4.43 | 4.50 |
| will make a positive difference in practice | 4.50 | 4.43 |

- To what degree do you think this course...

## Interactive Components Rated Higher

| (Likert 1-5, 5=high degree) | Mean at course | Mean at 3 months |
| --- | --- | --- |
|    Assigned Readings | 3.5 | 3.6 |
|    Audiovisuals | 4.2 | 3.4 |
|    Lecture | 4.2 | 4.1 |
|    Standardized Patients | 4.6 | 4.3 |
|    Feedback sessions | 4.1 | 4.1 |

- To what degree did the following contribute to your overall learning and understanding of the subject matter?

## Conclusions

- This innovative curriculum was well received
- and effective for teaching communication skills
- that facilitate the informed consent process.
- a highly interactive program can teach something new even to “experts”
- the effect didn't decrease after 3 months
- the more interactive parts of the program were evaluated highest