# Presentation: 697228

## 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 University***
***Center for Ethics Education***
***Department of Psychology***
***Bronx, NY***

## Ethical Challenges

**Confidentiality & disclosure policies**
**Informed consent policies**
**Risk-benefit assessment**

## Confidentiality Myths

- <date/time>

**Confidentiality Myths**

**Teenagers prefer confidentiality**
**Disclosure policies reduce participation**
**Disclosure will jeopardize data analysis**
**There are few desirable reporting options**

## Steps for Determining Confidentiality & Disclosure Practices 

- Investigation
- Deliberation & Formulation
- Implementation & Communication
- Evaluation & Modification

## Investigation

**Know federal, state, & local reporting laws**
**Identify risks that might be revealed during the course of research**
**Evaluate the validity of risk assessments **
**Identify referral/reporting criterion levels **
**Investigate available services**

## DELIBERATION & FORMULATION

**Consult with community about potential harms of alternative policies**
**Speak with prospective participants about child and parent expectations**
**Consider threats to experimental validity & recruitment**
**Develop a confidentiality and disclosure policy**

## Implementation & Communication

**Establish appropriate relationships with referral sources**
**Train the research team to follow the policy**
**Explain the policy to prospective participants and guardians during informed consent**
**When ever feasible, inform a participant when a disclosure will be made**

## EVALUATION & MODIFICATION

**Monitor the impact of policy on**
***	******	******participant welfare***
***	******	******study integrity***
***	******	******recruitment***
***	******	******community attitudes***
**Based on the above, alter the policy when appropriate**

## 	Informed Consent

- <date/time>

- 	Informed Consent

- Informed
- Voluntary
- Rational

## Cash Incentives?

- <date/time>

**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?

- <date/time>

**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

- <date/time>

**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

- <date/time>

**Enhancing Consent Capacity**

**Simplified presentation **
**	****	*****Reading level (5******th****** 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

- <date/time>

**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

- <date/time>

**The Myth of Passive Consent**

**OPRR **
**Justice**
**Community perspectives**
***	******Deceptive ***
***	******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?

- <date/time>

**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

- <date/time>

**Community Perspectives:****Substance Abuse Research****Risks and Benefits**

**Community stigma**
**Increase risk behaviors**
**Personal distress**
**Control groups****	**

## Community Perspectives:Scientific Validity

- <date/time>

**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

- <date/time>

**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

- <date/time>

**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**