1. Research, Program Evaluation, and Quality Improvement or Assurance: What’s in a Name? Ivor Pritchard, Ph.D. Senior Advisor to the Director of OHRP Ivor.Pritchard@hhs.gov April 1, 2011

2. Regulatory Jurisdiction HHS support, conduct, assurance declaration “Research” “Human Subject” Not Exempt

3. “Research” “Research means a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge” (.102(d))

4. “Program Evaluation”, “Quality Assurance”, and “Quality Improvement”. “Program Evaluation means...”(.102(k)) “Quality Assurance means..….”(.102(l)) “Quality Improvement means..”(.102(m))

5. The “Program Evaluation” Exemption “(5) Research and demonstration projects which are conducted by or subject to the approval of department or agency heads, and which are designed to study, evaluate, or otherwise examine: (i) Public benefit or service programs; (ii) procedures for obtaining benefits or services under those programs; (iii) possible changes in or alternatives to those programs or procedures; or (iv) possible changes in methods or levels of payment for benefits or services under those programs.” (.101(b)(5))

6. The Program Evaluation Exemption Condition “If, following review of proposed research activities that are exempt from these regulations under paragraph [], the Secretary determines that a research or demonstration project presents a danger to the physical, mental, or emotional well-being of a participant or subject of the research or demonstration project, then federal funds may not be expended for such a project without the written, informed consent of each participant or subject” (.101(i)).

7. HHS Preamble Examples of Potentially Exempt Program Evaluations Social Security benefits Co-sharing of medical costs under Medicaid Head Start program for low-income children Child Abuse Prevention and Treatment Developmental Disabilities Assistance The economic and social self-sufficiency of Native Americans The social service needs of older people

8. OHRP FAQ examples of QA/QI activities outside the regulations Delivering health care or implementing a practice known to improve care and collecting data for clinical, administrative, or reporting purposes Analyzing de-identified data Exempt research involving human subjects

9. OHRP FAQ example of QA/QI activity within the regulations Introducing an untested clinical intervention to both improve care and collect data to establish scientific evidence of effects. ??????????

10. Multiple Purposes, Multiple Activities One activity with more than one purpose Research and nonresearch activities

11. Insufficient Solutions Within a single institution Plans to publish Primary purpose Significant risks to subjects Random assignment Natural processes vs. social processes

13. The Dilemma: Making People Offers They Can’t Refuse Voluntary informed consent is an ineffective, burdensome mechanism for the minimization of research risks. Voluntary informed consent serves an ethical purpose independent of the minimization of research risks.

15. What, me worry? Psychological Factors Bias People’s Assessments Familiarity of Risk Affiliation Overconfidence Voluntariness The Asymmetry of Trust

16. Discussion?