5 th Annual Fetal Alcohol Canadian Expertise (FACE) Research Roundtable

1. 5th Annual Fetal Alcohol Canadian Expertise (FACE) Research Roundtable Keith Ogle, MD, CCFP Assoc. Prof. of Family Medicine and Health Care Ethics University of Saskatchewan September 9, 2004

2. A basic requirement of morals in medicine: • the science being used should be “good” science • “bad” science, whether in research or clinical medicine, is unethical • this is true whether individuals (patients, clients) will actually be affected or not • even when little is currently known about a specific issue, principles of “good” science need to be followed

3. … therefore, “good” science has minimal requirements for screening programs: • they should have clearly defined goals and purposes, and should: • screen for conditions of significant medical or social significance • be simple, accurate and relatively inexpensive tests • clearly define if they are testing for predisposed, pre-symptomatic, or affected individuals • be directed at a defined population • be clearly defined as “research” or “therapeutic” • if therapeutic, offer available interventions

4. Requirements for screening programs, cont: • should be adequately sensitive and specific: • this is especially relevant for clinical programs, where results will affect individuals • participants need to be aware of the implications of “less than 100% sensitivity and specificity”

5. Requirements for screening programs, cont: • should be subject to appropriate review before initiation: • to determine questions of consent • to consider impact on individuals, both competent and incompetent; immediately, and in the future • to consider the impact on self esteem, stigmatization, insurability, employability, altered family dynamics, social classification

6. Requirements for screening programs, cont: • should undergo periodic reevaluation to determine whether initial goals are being met: • in light of other competing needs, and finite resources, is the program sustainable? • is the science still “good” science? • have hidden risks been revealed? • have projected outcomes proved accurate? • are the benefits clearly demonstrable? • can you explain and justify it to your neighbor?

7. Ethical screening (i.e. “good” science) is not value-neutral: • If we accept the previous principles of good screening programs, we have implicitly accepted the moral principles on which they are founded: • respect for autonomy • right to choose, right to be treated with dignity and respect, right to safety, right to self-determination, etc. • beneficence • the need to strive for the “good”; the need to provide benefit • nonmaleficence • the need to avoid harm • justice • the need to be fair, to treat equals equally, to consider the broader needs of society, and distribute resources justly

8. The trouble is, with respect to FASD or any other disorder, conflicts amongst values and principles will arise: For example: • rights of the mother vs rights of the fetus or newborn – how do we avoid structuring the choice as favoring either the welfare of the mother or the welfare of the child? • a conflict between autonomies • a conflict between beneficence and nonmaleficence • rights of mothers to consent vs societal obligation to optimize fetal / postnatal outcomes • a conflict between autonomy and justice

9. … and our assumptions reflect similar conflicts between values: • do we personally favor a libertarian approach (freedom of choice, freedom of action, non-interference), a utilitarianapproach (reduction of costs to society, greatest good for the greatest number), or a communitarianapproach (shared responsibility for social outcomes, curtailment of individual rights)? • do we assume there is agreement upon selecting against specific anomalies, once discoverable? • do we assume the goals of biomedical science (normal outcomes) outweigh the needs of those seeking to normalize disability? • do we assume the disproportionately large caregiver burden experienced by women will be shouldered instead by society?

10. do we prematurely assume the science can be certain? (genetic variation in drug-metabolizing enzyme levels, multifactorial health outcomes, wide variation in outcomes with respect to prenatal alcohol exposure) • do we make assumptions about the “best interests of the child”, and if so, are they justified? (issues of adoption, treatment, family dynamics) • do we make assumptions about issues of personal responsibility? (e.g. maternal choice vs medical illness, addiction, absence of volition) • do we make assumptions based on the legality or illegality of the toxins discussed?

11. do we assume that a legalistic, coercive or punitive approach (nonconsensual testing, removal of child from home, forced treatment) is preferable to a public health approach (drug abuse is social problem requiring compassion and understanding), or vice versa? • do we make assumptions about the state’s primary interests? (e.g. obligation to provide for the welfare of infants vsobligation to reduce the financial implications of FASD) • do we make assumptions when we choose amongst: • target-based screening • universal screening • reliance on maternal report • screening based on specific scientific criteria

12. If we make any of these assumptions, we are faced with a conflict of values and principles . . . • cultural pluralism makes it enormously difficult to achieve democratically legitimate screening policies • there are obviously different ways to construe fairness • moral principles can conflict, and each be supported by substantive rational arguments • there are legitimate conflicts of interests: various groups will attach different values to various types of health programs, including screening programs • there are even deeper conflicts about the very meaning of health, disease, normality, and well-being

13. So a productive decision can be made to change the focus from matters of content to matters of process: • if the functional moral values and principles are too general, too controversial, or lack conciseness, we should, at the very least, aim to establish agreement about fair process • fair process* will be characterized by: • Publicity: the reasons or rationales for a screening program and its ongoing justification should be publicly available • Reasonableness / Relevance: the program will be reasonable if it appeals to reasons and principles that are accepted as relevant by both the deciders and those affected by the policy • Revisability / Appeals: there will be a mechanism for challenge and dispute resolution, and to revise decisions in light of new evidence or arguments • Enforcement: everyone agrees to “buy in” to the process * after N. Daniels and J. Sabin, ‘97 – ‘03

14. Implications of fair process on FASD screening: • reasons for the program will be publicly advertised • the program will be developed by representatives from all those groups either currently affected or likely to experience the impact, including FASD individuals • costs of the program will be publicly advertised • the decision-making process will be transparent and publicly accessible (public meetings, published proceedings) • a review process, including agreed-upon schedules, will be established before screening begins • effects of screening will be publicly available as they are determined