Ethical Issues in Clinical Research: An Overview

1. Ethical Issues in Clinical Research:An Overview H. Gerry Taylor, Ph.D., ABPP-CN Department of Pediatrics Case Western Reserve University Rainbow Babies and Children’s Hospital, University Hospitals Case Medical Center

2. Introduction Values and reasoning process rather than just rules: trust, integrity, commitment to rigor, cooperation, fairness, respect, service to society. Importance of being aware of issues and asking the right questions. Importance of case-based approach. Lessons to be learned: anticipate, review and rehearse procedures, provide oversight, discuss and consult with others, learn from critical incidents, listen and learn from colleagues, consider issues as pertain to your work.

3. Ethical Issues in Conducting Research Poor quality of research methods and procedures or lack of proper data monitoring/processing. Inappropriate procedures for informed consent/assent (Becky and Carolyn to discuss in greater detail in later seminar). Failure to consider risk-benefit ratio and special issues related to type of research design (e.g., intervention) or vulnerable populations. Failure to protect privacy and confidentiality. Carelessness or intentional misconduct.

4. Other Ethical Issues Conflict of interest Mentoring Publication/authorship practices Ethical issues related to clinical practice (not covered today)

5. Considerations in Assessing Risks Less significant: inconvenience, boredom, disruption of daily acts. More significant: anxiety, reaction to being asked for private information, adverse reactions in studies involving deception. Other potential risks: breach of confidentiality, potential to delay intervention, emotional upset. Vulnerable populations: already carry burden, possibility of greater discomfort and increased likelihood of adverse reaction.

6. Types of Risks No greater than minimal—types of risks encountered in daily life, allows research without prospect of direct benefit to child. Minor increase in minimal risk—likely to yield important information, risks consistent with those in view of child’s medical, psychological, social, or educational situation, allows research without prospect of direct benefit. Greater than minimal but with prospect of direct benefit. Research not otherwise approved—reasonable opportunity to understand or treat serious health condition.

7. Examples of Risks Sociometric ratings (revised class play). Observational studies. Studies of outcomes in children at high developmental risk such as low birth weight. Studies involving deception—explore alternative designs (e.g., prepare or warn), enlist parents, avoid when possible. Iatrogenic effects of treatment. Others examples?

8. Ways to Minimize Risks Consider developmental level (e.g., keep young children in proximity of parents, accompany to rest room, make socially comfortable) and special vulnerabilities. Rehearse to make sure you are anticipating potential problems or concerns. Use well-trained staff and learn from experience (your own and others’), monitor adverse events. Accommodate to family schedules. Build good rapport, solicit and answer questions, respond to signs of concern.

9. Special Issues in Clinical Interventions May need to stop study early if evidence that treatment is negative or clearly advantageous. Minimize risks related to development of possible dependencies. In prevention research, consider different perspectives on condition being “prevented,” avoid labeling, and consider risks of disclosure, especially for condition not yet present. has not yet emerged.

10. Privacy & Confidentiality De-identify data files and keep identifiable information in separate location with restricted access. Limit feedback to what is desired and interpretable. Use caution in responding to requests for information—get parent permission, share only what is interpretable, seek advise from legal dept for attorney requests. Issues regarding parent requests for information from third parties such as schools. Be circumspect in sharing information with parents from child/adolescent participants. Act responsibly on clinical concerns.

11. Additional Issues in Peds Research-Kodish 2005 Greater vulnerability of children--may not understand options, what participation means, possible discomforts, reasons for participation. As there may be little or not direct benefit, important to minimize risk, harm, and doing wrong. Parents are major decision-maker but child’s views also need to be respected by asking for assent and explanation of study. Stronger case for favorable risk-benefit ratio for pediatric research and need to chose suitable sample--use only more vulnerable children when necessary and limit sample size.

12. Scientific Misconduct Forging data Fudging or unjustified “trimming” of data Making careless errors Using biased methods Failing to acknowledge others’ work Plagiarism Dealing with misconduct

13. Conflicts of Interest Conflicts in conducting research: Duty to patients vs. research agenda Conflicting goals (knowledge vs. trainee goals vs. personal advancement) Financial or personal interests. Conflicts in peer review (papers, grants). Conflicts of commitment. Importance of disclosure.

14. Mentoring Definition: professional parent. Features: Commitment Responsiveness and give and take Scaffolding and security Opportunities for career development and establishing individual interests Encouragement to find additional mentors Modeling of ethical sensitivity.

15. Desirable Qualities of Mentoring Honesty. Ability to set realistic goals and provide constructive feedback. Help in arranging for breadth of training experiences. Balance of mentor and mentee interests Promotion of ethical behavior and decision-making.

16. Issues in Research Publication Acknowledge ideas from others and previous contributions to subject area through accurate citations of literature. Make sure data reported accurately and interpretations reasonable and take into account limitations. Do fair reviews and maintain confidentiality of pre-published papers and grants. Consider quality over “least-publishable unit.”

17. Authorship Requirements Participation in work on which paper is based. Contribution to design of paper, writing draft and revisions, getting final approval. At least one author/co-author must be able to defend all specific aspects of study (e.g., rationale, methods, statistics, interpretations). Acknowledgements only for data collection, advice, review, technical assistance. Order determined by extent of contribution. Best to discuss and work out ahead of time.

18. Assigning Authorship to Students Ethical issues at play: beneficence, justice, parentalism. Two types of concerns: faculty taking credit for students work, students receiving underserved credit. Resolution: discussion between parties regarding extent of contributions, consultation with others as needed. Considerations: contributions should be conceptual, integral to completion of paper, require overall perspective on work.