Ethical and Legal Issues

Research Involving Drug Abuse and Mental Health Co-morbidities Among Youth

NIDA-NIMH Conference

May 23-24, 2000

Celia B. Fisher, Ph.D. Director, Fordham

UniversityCenter for Ethics EducationDepartment of Psychology

Bronx, NY

Ethical Challenges

• Confidentiality & disclosure policies

• Informed consent policies

• Risk-benefit assessment

Confidentiality Myths

o Teenagers prefer confidentiality

o Disclosure policies reduce participation

o Disclosure will jeopardize data analysis

o There are few desirable reporting options

Steps for Determining Confidentiality

& Disclosure Practices Investigation

Deliberation & Formulation

Implementation & Communication

Evaluation & Modification

Investigation

1. Know federal, state, & local reporting laws

2. Identify risks that might be revealed during the course of research

3. Evaluate the validity of risk assessments

4. Identify referral/reporting criterion levels

5. Investigate available services

DELIBERATION & FORMULATION

6. Consult with community about potential harms of alternative policies

7. Speak with prospective participants about child and parent expectations

8. Consider threats to experimental validity & recruitment

9. Develop a confidentiality and disclosure policy

Implementation & Communication

10. Establish appropriate relationships with referral sources

11. Train the research team to follow the policy

12. Explain the policy to prospective participants and guardians during informed consent

13. When ever feasible, inform a participant when a disclosure will be made

EVALUATION & MODIFICATION

14. Monitor the impact of policy on

participant welfare

study integrity

recruitment

community attitudes

15. Based on the above, alter the policy when appropriate

Informed Consent

Informed

Voluntary

Rational

Cash Incentives?

Can economically deprived youth Be coerced into participation?

Afford the time?

Afford to withdraw?

What is the message for socially disenfranchised youth?Is cash associated with “drug money?”

Will teens be encouraged lie?

Community perspectives

Fair market value

Alternative incentives

What Is Consent Capacity?

Psycho-Legal Standards of Consent

Communicate a choice

Understand relevant information

Appreciate the nature of the situation

& its consequences

Manipulate information rationally Appelbaum & Grisso, 1988

What is a fair standard?

Waiving Parental Consent

• Emancipated minor

• Mature minor

• Best interests of the child

• Research could not be practically carried out, and No more than minimal risk research Child’s rights & welfare protected Waiver does not conflict with law Participant advocate

Enhancing Consent Capacity

• Simplified presentation

Reading level (5th grade)

Video presentation

Sequential single-unit disclosure

Question-answer format

• Education

• Supported decision-making

• Surrogate consent and participant assent

Research Participant’s Bill of Rights

To be fully informed

To have all questions answered

To freely choose to participate or to refuse participation

To withdraw or not answer questions

To privacy and confidentiality

To be protected from harm

To know the results of the study

To understand these rights

Bruzzesse & Fisher, 1999

The Myth of Passive Consent

• OPRR

• Justice

• Community perspectivesDeceptive

Coercive & teaches children to deceive

Parents never receive the form

Parents are afraid to sign the form

Why do Parents Refuse to Sign Consent Forms?

Fear others will know child's problems

Desire for family privacy

Experimental procedures will harm child

Difficulty understanding the form

Disagree with study’s nature & purpose

Child should not be treated like "guinea pig"

Community Perspectives:Substance Abuse Research

Risks and Benefits

Community stigma

Increase risk behaviors

Personal distress

Control groups

Community Perspectives:Scientific Validity

• Accuracy of self and informant reports

• Sampling bias

• Laboratory error

• Trickle down interventions

• Access to drugs & government policies

• Investigator bias & misuse of data

Community Perspectives:Biological Basis for Adolescent

Risk Behaviors

Eugenics

Self-fulfilling prophecies

Risk of preventive treatments

Fallacy of genetic factors underlying racial disparities

The Challenge and Potential of Community Advisory Boards

Co-learning model

Opinions-in-progress analysis

Moral agency & the “is to ought” fallacy

Doing good well