1. A Multi-Disciplinary Approach

2. Darran Boyer, Moderator Alicia (Ali) Craig-Rodriguez President, Comprehensive Neuroscience, Inc. Kim Lerner Chief Executive Officer, Independent Investigational Review Board, Inc.

3. Dual Enrollment: Video Overview "The Life of a Professional Guinea Pig" courtesy of TIME.

4. Dual Enrollment: Site Perspective Site Impact Traditional Detection Methods Available Courses of Action Business Risks Pre and Post Enrollment Customer Impact Others? Data Reliability, Negative Goodwill

5. Dual Enrollment: Human Research Participant Impact Participant Safety Belmont Report- Ethical Responsibility of Parties Subjects Sites Sponsors Ethical Guidance

6. The Problem of Dual Enrollment How do IRB’s become involved? ✔ When notified that an UAP problem has been identified based as an adverse event.... ✔ When a subject calls complaining that they were unfairly dropped from a study, and possibly not paid for their participation.

7. What are the issues presented to an IRB? Limited based on the requirements to protect privacy. Additional research procedures require consent. Is the clinic obliged to pay the subject that was dual enrolled for their participation?

8. Role of the Belmont Report Broad ethical principles provide a basis on which specific rules may be formulated, criticized and interpreted. The objective is to provide an analytical framework that will guide the resolution of ethical problems arising from research involving human subjects. This statement consists of a distinction between research and practice, a discussion of the three basic ethical principles, and remarks about the application of these principles. http://ohsr.od.nih.gov/guidelines/belmont.html

9. Role of the Belmont Report Justice * Benefit denied unduly * Burden placed unduly Beneficence * Do not harm * Maximize benefit while minimizing harm Autonomy * The individual has the right to consent to research vs. * Need to protect those with diminished capacity

10. Respect for Persons Individuals should be treated as “autonomous agents”. – capable of deliberation about personal goals and of acting under the direction of such deliberation. There situations where autonomy may be diminished. Persons with diminished autonomy are entitled to protection.

11. Beneficence Beneficence requires that persons are treated in an ethical manner not only by respecting their decisions and protecting them from harm, but also by making efforts to secure their well-being. Two general rules have been formulated as complementary expressions of beneficent actions in this sense: (1) do not harm and (2) maximize possible benefits and minimize possible harms.

12. Justice Who ought to receive the benefits of research and bear its burdens? This is a question of justice, in the sense of “fairness in distribution” or ”what is deserved.” An injustice occurs when some benefit to which a person is entitled is denied without good reason or when some burden is imposed unduly. Another way of conceiving the principle of justice is that equals ought to be treated equally. Too often dual enrollment is identified because of processes that are random and inconsistent.

13. Blind Cooperative Registry: One Research Community’s Response Subject Data Biometric Technology Controls for Privacy Sites Subjects Common Registry Participation Rules CFR 21 Part 11: Controls for Electronic Records

14. IRB (Human Participation Rights) Topics Subject Confidentiality Consent Form Subject Validation Mechanism Other Processes Blind Cooperative Registry: One Research Community’s Response

15. Blind Cooperative Framework A prospective consistent and accurate method for objectively documenting previous study participation is consistent with the intentions and principles outlined in the Belmont Report.

16. Through the Lens of the Belmont Report… A Blind Cooperative Registry Program is not “research”. The program must focus on “Authorization for Release of Health Information” HIPAA compliance… Accuracy Validation Mechanism- Subject’s right to validate the system in case of human error or incorrect reporting. What are IRB approval requirements?

17. Blind Cooperative Registry: One Research Community’s Response Registry Results: 76 studies at 5 Sites within 200 miles between 01/01/10 and 10/15/10 6634 Total Searches 254 Searches within 30 days of previous dose 444 Searches within 45 days of previous dose 747 Searches within 60 days of previous dose Site Perspective Subject Feedback Sponsor Relations Downsides?