Methods of Research in Public Health MPH 606

1. Methods of Research in Public HealthMPH 606 Susan Bailey, PhD Fall 2010 Lecture 1

2. Introduction to MPH 606

3. Learning Objectives • Understand components of the syllabus • My Responsibilities • Course Objectives • Materials • Your Responsibilities • Assignments • Preparation and Participation • Academic Honesty • Special Needs • Grading • Course Outline

4. Research Ethics

5. Learning Objectives • Understand the need for human subjects protection • Realize the investigator’s and the IRB’s responsibilities • Learn the guidelines for protection • Develop an IRB application • Develop an informed consent form

6. The Need for Human Subjects Protection • Unethical research • Nazi Germany – criminal and unscientific behavior of physicians in concentration camps • Joseph Mengele (1911-1979) • Injected dye into children’s eyes to change color • Sterilizations, amputations, shock treatments • Murder to perform dissections • Sewed two children together to form conjoined twins • 1936 U.S. – Public Health Service began a study of the effects of untreated syphilis in Tuskeegee, AL long after effective treatment of disease was known

7. Human Subjects Protection • Unethical Research (cont.) • 1963 U.S. – Jewish Chronic Diseases Hospital – 22 elderly patients injected with cancer cells without their knowledge to test immunological response • Willowbrook State Hospital, NY – retarded children deliberately infected with viral hepatitis to study natural history • Response • 1947 – Nuremberg Code – research ethics for human research • 1974 – congress establishes the National Commission for the Protection of Biomedical and Behavioral Research – established Institutional Review Boards (IRB) • 1996 – Health Insurance Portability and Accountability Act (HIPPA) – protect individual’s health information

8. 10 Questionable Practices • Involving people without their knowledge or consent • Coercing people to participate • Withholding information about the true nature of the research • Otherwise deceiving the participant • Inducing participants to commit acts diminishing their self-esteem • Violating rights of self-determination • Exposing individuals to physical or emotional stress • Invading privacy • Withholding benefits • Not treating participants with respect (Kimmel, 1998)

9. Institutional Review Board (IRB) • Purpose – an IRB shall review and have authority to approve, require modification in, or disapprove all research activities covered by this policy • Membership – at least 5 members with expertise appropriate to safeguard the rights and welfare of human subjects • Mixed in terms of gender, race, and cultural background • One member not affiliated with the institution • One member with and one without scientific expertise • No member with a conflict of interest

10. Risk-Benefit Ratio • Minimal Risk - the probability and magnitude of harm or discomfort anticipated in the research are not greater in and of themselves than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests. • Benefits – may be for the subjects, their family, and/or the common good • Ratio – risks to subjects are reasonable relative to benefits, if any

11. Informed Consent • Requirements • Disclosure of relevant information to prospective subjects about the research • Subjects’ comprehension of the information • Subjects’ voluntary agreement, free of coercion and undue influence • OHSR information sheet

12. The Scientific Method

13. Learning Objectives • Understand the history of inquiry • Learn different approaches to inquiry • Define the modern scientific method

14. Traditional Scientific Method • Method of inquiry of phenomena, new knowledge, or evaluation of existing knowledge that is based on gathering observable, empirical, and measurable evidence subject to specific principles of reasoning • Collect data through observation or experimentation in order to formulate and test hypotheses • Hypotheses are building blocks for theories • Method must be value free

16. Hippocrates (B.C. 460-377) • First to base his conclusions on observation – rational approach • Rejected superstitions, legends and beliefs that credited supernatural or divine forces with causing illness • Four humours – fluids that are balanced in health • Blood • Black bile • Yellow bile • Phlegm

17. Positivism • Philosophy that postulates that the only authentic knowledge is that which is based on actual sense experience • Separate facts from values • Rely on strict rules and procedures, rejecting common sense • Purpose is to develop universal causal laws • Assumptions and methods of natural science can be applied to social science • Has been rejected in social science as being too strict • Not all phenomena can be physically observed • Reality can be defined subjectively

18. Relativism • Philosophy that maintains that there is no external reality independent of human consciousness • Reality is represented through the eyes of the observer • Research process generates “working” hypotheses rather than universal causal laws • All points of view are equally valid

19. Realism • Scientific approach which avoids both positivism and relativism • Knowledge is a social and historical product • Task of science is to invent theories to explain the real world, and to test these theories by rational criteria • Science should be understood as an ongoing process in which scientists improve the concepts they use to understand the mechanisms that they study

20. Realistic Explanation Gunpowder example mechanism outcome action context

21. Example in Epidemiology • Study by Bradbury (1933) of the incidence and causes of tuberculosis in north England • Three mechanisms • Poor housing conditions – overcrowding • Poor nutrition – compromising resistance • Being Irish – less generational exposure

22. Language of Research • Empirical – based on observations and measurements of reality • Operationalization – the act of translating the idea you want to measure into a real measurement • Methodology – specific ways or methods used to try to understand phenomena • Theory – analytic structure intended to explain a set of empirical observations • Hypothesis – proposed explanation for an observable phenomenon – it must be testable to be scientific

23. Our Research

24. Leading Causes of Death in the US (2006) • Heart disease • Cancer • Stroke (cerebrovascular diseases) • Chronic lower respiratory diseases • Accidents (unintentional injuries) • Diabetes • Alzheimer's disease • Influenza and Pneumonia • Nephritis, nephrotic syndrome, and nephrosis • Septicemia

25. Stages of a Study • Formulate the Research Question • May or may not test a hypothesis • Review the Literature • Choose/Design Measures and Instruments • Identify the Sampling Frame • Obtain IRB Approval • Conduct the Sampling • Collect Data • Process Data • Analyze Data • Report Results